21 CFR Part 558 — New Animal Drugs for Use in Animal Feeds

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. Source: 40 FR 13959, Mar. 27, 1975, unless otherwise noted. Subpart A—General Provisions § 558.3 Definitions and general considerations applicable to this part. (a) Regulations in this part provide for approved uses of drugs and combinations of drugs in animal feeds. Approved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a combination of two or more drugs is not approved. (b) The following definitions apply to terms used in this part: (1) New animal drugs approved for use in animal feed are placed in two categories as follows: (i) Category I—These drugs require no withdrawal period at the lowest use level in each major species for which they are approved or are approved for use only in minor species. (ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one major species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of carcinogenic concern regardless of whether a withdrawal period is required in any species. (2) A “Type A medicated article” is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. It consists of a new animal drug(s), with or without carrier (e.g., calcium carbonate, rice hull, corn, gluten) with or without inactive ingredients. The manufacture of a Type A medicated article requires an application approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter. (3) A “Type B medicated feed” is intended solely for the manufacture of other medicated feeds (Type B or Type C). It contains a substantial quantity of nutrients including vitamins and/or minerals and/or other nutritional ingredients in an amount not less than 25 percent of the weight. It is manufactured by diluting a Type A medicated article or another Type B medicated feed. The maximum concentration of animal drug(s) in a Type B medicated feed is 200 times the highest continuous use level for Category I drugs and 100 times the highest continuous use level for Category II drugs. The term “highest continuous use level” means the highest dosage at which the drug is approved for continuous use (14 days or more), or, if the drug is not approved for continuous use, it means the highest level used for disease prevention or control. If the drug is approved for multiple species at different use levels, the highest approved level of use would govern under this definition. The manufacture of a Type B medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under § 515.20 of this chapter. (4) A “Type C medicated feed” is intended as the complete feed for the animal or may be fed “top dressed” (added on top of usual ration) on or offered “free-choice” (e.g., supplement) in conjunction with other animal feed. It contains a substantial quantity of nutrients including vitamins, minerals, and/or other nutritional ingredients. It is manufactured by diluting a Type A medicated article or a Type B medicated feed. A Type C medicated feed may be further diluted to produce another Type C medicated feed. The manufacture of a Type C medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under § 515.20 of this chapter. (5) A Type B or Type C medicated feed manufactured from a drug component (bulk or “drum-run” (dried crude fermentation product)) requires an application approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter. (6) A “veterinary feed directive (VFD) drug” is a drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 512(b) of the Federal Food, Drug, and Cosmetic Act, a conditionally approved application filed pursuant to section 571 of the Federal Food, Drug, and Cosmetic Act, or an index listing under section 572 of the Federal Food, Drug, and Cosmetic Act to use under the professional supervision of a licensed veterinarian. Use of animal feed bearing or containing a VFD drug must be authorized by a lawful veterinary feed directive. (7) A “veterinary feed directive” is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian's professional practice that orders the use of a VFD drug or combination VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combination VFD drug to treat the client's animals only in accordance with the conditions for use approved, conditionally approved, or indexed by the Food and Drug Administration. (8) A “medicated feed” means a Type B medicated feed as defined in paragraph (b)(3) of this section or a Type C medicated feed as defined in paragraph (b)(4) of this section. (9) For the purposes of this part, a “distributor” means any person who distributes a medicated feed containing a VFD drug to another person. Such other person may be another distributor or the client-recipient of a VFD. (10) An “animal production facility” is a location where animals are raised for any purpose, but does not include the specific location where medicated feed is made. (11) An “acknowledgment letter” is a written (nonverbal) communication provided to a distributor (consignor) from another distributor (consignee). An acknowledgment letter must be provided either in hardcopy or through electronic media and must affirm: (i) That the distributor will not ship such VFD feed to an animal production facility that does not have a VFD, (ii) That the distributor will not ship such VFD feed to another distributor without receiving a similar written acknowledgment letter, and (iii) That the distributor has complied with the distributor notification requirements of § 558.6(c)(5). (12) A “combination veterinary feed directive (VFD) drug” is a combination new animal drug (as defined in § 514.4(c)(1)(i) of this chapter) intended for use in or on animal feed which is limited by an approved application filed under section 512(b) of the Federal Food, Drug, and Cosmetic Act, a conditionally approved application filed under section 571 of the Federal Food, Drug, and Cosmetic Act, or an index listing under section 572 of the Federal Food, Drug, and Cosmetic Act to use under the professional supervision of a licensed veterinarian, and at least one of the new animal drugs in the combination is a VFD drug. Use of animal feed bearing or containing a combination VFD drug must be authorized by a lawful VFD. (13) “Major species” means cattle, horses, swine, chickens, turkeys, dogs, and cats. (14) “Minor species” means animals, other than humans, that are not major species. [51 FR 7392, Mar. 3, 1986, as amended at 52 FR 2682, Jan. 26, 1987; 54 FR 51386, Dec. 15, 1989; 56 FR 19268, Apr. 26, 1991; 64 FR 63206, Nov. 19, 1999; 65 FR 76929, Dec. 8, 2000; 72 FR 69130, Dec. 6, 2007; 80 FR 31733, June 3, 2015; 81 FR 57800, Aug. 24, 2016] § 558.4 Requirement of a medicated feed mill license. (a) A feed manufacturing facility must possess a medicated feed mill license in order to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article. (b) The manufacture of the following types of feed are exempt from the required license, unless otherwise specified: (1) Type B or Type C medicated feed using Category I, Type A medicated articles or Category I, Type B or Type C medicated feeds; and (2) Type B or Type C medicated feed using Category II, Type B or Type C medicated feeds. (c) The use of Type B and Type C medicated feeds shall also conform to the conditions of use provided for in subpart B of this part. (d) This paragraph identifies each drug by category, the maximum level of drug in Type B medicated feeds, and the assay limits for the drug in Type A medicated articles and Type B and Type C medicated feeds, as follows: Category I Drug Assay limits percent 1 Type B maximum (200x) Assay limits percent 1 2 Amprolium with Ethopabate 94-114 22.75 g/lb (5.0%) 80-120. Avilamycin 90-110 7.3 g/lb (1.6%) 80-110. Bacitracin methylenedisalicylate 85-115 25.0 g/lb (5.5%) 70-130. Bacitracin zinc 84-115 5.0 g/lb (1.1%) 70-130. Bambermycins 90-110 800 g/ton (0.09%) 80-120/70-130. Chlortetracycline 85-115 40.0 g/lb (8.8%) 80-115/70-130. Coumaphos 95-115 6.0 g/lb (1.3%) 80-120. Decoquinate 90-105 2.72 g/lb (0.6%) 80-120. Dichlorvos 100-115 33.0 g/lb (7.3%) 90-120/80-130. Diclazuril 90-110 182 g/t (0.02%) 85-115/70-120. Efrotomycin 94-113 1.45 g/lb (0.32%) 80-120. Iodinated casein 85-115 20.0 g/lb (4.4%) 75-125. Laidlomycin propionate potassium 90-110 1 g/lb (0.22%) 90-115/85-115. Lasalocid 95-115 40.0 g/lb (8.8%) Type B (cattle and sheep): 80-120; Type C (all): 75-125. Lincomycin 90-115 20.0 g/lb (4.4%) 80-130. Lubabegron 87-107 908 g/ton 85-115/80-120. Melengestrol acetate 90-110 10.0 g/ton (0.0011%) 70-120. Monensin 85-115 40.0 g/lb (8.8%) Chickens, turkeys, and quail: 75-125; Cattle: 5-10 g/ton 80-120; Cattle: 10-30 g/ton 85-115; Goats: 20 g/ton 85-115; Liq. feed: 80-120. Narasin 90-110 9.0 g/lb (1.98%) 85-115/75-125. Nicarbazin (granular) 90-110 9.0 g/lb (1.98%) 85-115/75-125. Narasin 90-110 9.0 g/lb (1.98%) 85-115/75-125. Nystatin 85-125 5.0 g/lb (1.1%) 75-125. Oxytetracycline 90-120 20.0 g/lb (4.4%) 75-125/65-135. Poloxalene 90-110 54.48 g/lb (12.0%) Liq. feed: 85-115. Ractopamine 85-105 2.46 g/lb (0.54%) 80-110/75-125. Salinomycin 90-110 6.0 g/lb (1.3%) 80-120. Semduramicin (as semduramicin sodium) 90-110 2.27 g/lb (0.50%) 80-110 Semduramicin (as semduramicin sodium biomass) 90-110 2.27 g/lb (0.50%) 80-120 Tylosin 80-120 10.0 g/lb (2.2%) 75-125. Tylvalosin 90-110 3.86 g/lb 85-115. Virginiamycin 85-115 10.0 g/lb (2.2%) 70-130. Zoalene 92-104 11.35 g/lb (2.5%) 85-115. 1 2 Category II Drug Assay limits percent 1 Type B maximum (100x) Assay limits percent 1 2 Amprolium 94-114 11.35 g/lb (2.5%) 80-120. Apramycin 88-112 7.5 g/lb (1.65%) 80-120. Carbadox 90-110 2.5 g/lb (0.55%) 75-125. Clopidol 94-106 11.4 g/lb (2.5%) 90-115/80-120. Erythromycin 85-115 4.625 g/lb (1.02%) 75-125. Famphur 100-110 5.5 g/lb (1.21%) 90-115/80-120. Fenbendazole 93-113 8.87 g/lb (1.96%) 75-125. Florfenicol 90-110 9.1 g/lb (2.0%) Swine feed: 85-115 Halofuginone hydrobromide 90-115 272.0 g/ton (.03%) 75-125. Hygromycin B 90-110 1,200 g/ton (0.13%) 75-125. Ivermectin 95-105 1,180 g/ton (0.13%) 80-110. Maduramicin ammonium 90-110 545 g/ton (.06%) 80-120. Morantel tartrate 90-110 66.0 g/lb (14.52%) 85-115. Neomycin 80-120 20 g/lb (4.4%) 70-125. Oxytetracycline 80-120 20 g/lb (4.4%) 65-135. Neomycin sulfate 80-120 100 g/lb (22.0%) 70-125. Nicarbazin (granular) 90-110 5.675 g/lb (1.25%) 85-115/75-125. Nicarbazin (powder) 96-104 9.08 g/lb (2.00%) 85-115/80-120. Novobiocin 85-115 17.5 g/lb (3.85%) 80-120. Pyrantel tartrate 90-110 36 g/lb (7.9%) 75-125. Robenidine 95-115 1.5 g/lb (0.33%) 80-120. Sulfadimethoxine 90-110 Poultry: 5.675 g/lb 80-115/75-125. Ormetoprim 90-110 Poultry: 3.405 g/lb 80-115. Sulfamerazine 85-115 18.6 g/lb (4.0%) 85-115. Sulfamethazine 85-115 10.0 g/lb (2.2%) 80-120. Chlortetracycline 85-115 10.0 g/lb (2.2%) 85-125/70-130. Sulfamethazine 85-115 10.0 g/lb (2.2%) 80-120. Tylosin 80-120 10.0 g/lb (2.2%) 75-125. Sulfaquinoxaline 98-106 11.2 g/lb (2.5%) 85-115. Tiamulin hydrogen fumarate 90-115 10 g/lb 90-115/70-130. Tilmicosin 90-110 37.9 g/lb (8.35%) Swine Type B/C feed: 85-115. Zilpaterol 90-110 680 g/t (0.075%) 80-110/75-115. 1 2 (e) When drugs from both categories are in combination, the Category II requirements will apply to the combination drug product. [51 FR 7392, Mar. 3, 1986] Editorial Note: For Federal Register www.govinfo.gov. § 558.5 Requirements for liquid medicated feed. (a) What types of liquid medicated feeds are covered by this section? (1) Type B feed that is intended for further manufacture of other medicated feeds (§ 558.3(b)(3)) or: (2) Type C feed that is intended for the following: (i) Further manufacture of another Type C feed, or (ii) Top-dressing (adding on top of the usual ration) (§ 558.3(b)(4)). (b) How is liquid free-choice medicated feed regulated? (c) What is required for new animal drugs intended for use in liquid feed? (1) An original NADA, (2) A supplemental NADA, or (3) An abbreviated NADA. (d) What are the approval requirements under section 512 of the act for new animal drugs intended for use in liquid feed? (1) Data, or a reference to data in a master file (MF), that shows the relevant ranges of conditions under which the drug will be chemically stable in liquid feed under field use conditions; and (2) Data, or a reference to data in an MF, that shows that the drug is physically stable in liquid feed under field conditions; or (3) Feed labeling with recirculation or agitation directions as follows: (i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. (e) How are chemical and physical stability data to be submitted? (1) Directly in the NADA, (2) By a sponsor, or (3) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder. (f) What will be stated in the published approval for a new animal drug intended for use in liquid feed? (1) The formula and/or specifications of the liquid medicated feed, where the owner of this information requests such publication; and/or (2) A statement that the approval has been granted for a proprietary formula and/or specifications. (g) When is a medicated feed mill license required for the manufacture of a liquid medicated feed? (1) All liquid medicated feeds that contain a Category II drug, and (2) Liquid medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications. (h) What measures are in place to prevent certain drugs, approved for use in animal feed or drinking water but not in liquid medicated feed, from being diverted to use in liquid feeds? (i) Can the labeling provisions of paragraph (h) of this section be waived, and how can I apply for a waiver? (2) To obtain a waiver, you must submit a letter requesting a waiver to the Office of New Animal Drug Evaluation (HFV-100), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. (3) The letter must include a copy of the product label; a description of the formulation; and information to establish that the physical, chemical, or other properties of the new animal drug are such that diversion to use in liquid medicated feed is unlikely. (j) What else do I need to know about the labeling provisions of paragraph (h) of this section? [69 FR 30197, May 27, 2004, as amended at 71 FR 74785, Dec. 13, 2006; 72 FR 69131, Dec. 6, 2007] § 558.6 Veterinary feed directive drugs. (a) General requirements related to veterinary feed directive (VFD) drugs. (2) A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD. (3) Use and labeling of a VFD drug or a combination VFD drug in feed is limited to the approved, conditionally approved, or indexed conditions of use. Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted. (4) All involved parties (the veterinarian, the distributor, and the client) must retain a copy of the VFD for 2 years. The veterinarian must retain the original VFD in its original form (electronic or hardcopy). The distributor and client copies may be kept as an electronic copy or hardcopy. (5) All involved parties must make the VFD and any other records specified in this section available for inspection and copying by FDA upon request. (6) All labeling and advertising for VFD drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs must prominently and conspicuously display the following cautionary statement: “Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.” (b) Responsibilities of the veterinarian issuing the VFD. (i) Be licensed to practice veterinary medicine; and (ii) Be operating in the course of the veterinarian's professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client-patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in § 530.3(i) of this chapter, the veterinarian must issue the VFD in the context of a valid VCPR as defined in § 530.3(i) of this chapter. (2) The veterinarian must only issue a VFD that is in compliance with the conditions for use approved, conditionally approved, or indexed for the VFD drug or combination VFD drug. (3) The veterinarian must ensure that the following information is fully and accurately included on the VFD: (i) The veterinarian's name, address, and telephone number; (ii) The client's name, business or home address, and telephone number; (iii) The premises at which the animals specified in the VFD are located; (iv) The date of VFD issuance; (v) The expiration date of the VFD. This date must not extend beyond the expiration date specified in the approval, conditional approval, or index listing, if such date is specified. In cases where the expiration date is not specified in the approval, conditional approval, or index listing, the expiration date of the VFD must not exceed 6 months after the date of issuance; (vi) The name of the VFD drug(s); (vii) The species and production class of animals to be fed the VFD feed; (viii) The approximate number of animals to be fed the VFD feed by the expiration date of the VFD. The approximate number of animals is the potential number of animals of the species and production class identified on the VFD that will be fed the VFD feed or combination VFD feed at the specified premises by the expiration date of the VFD; (ix) The indication for which the VFD is issued; (x) The level of VFD drug in the VFD feed and duration of use; (xi) The withdrawal time, special instructions, and cautionary statements necessary for use of the drug in conformance with the approval; (xii) The number of reorders (refills) authorized, if permitted by the drug approval, conditional approval, or index listing. In cases where reorders (refills) are not specified on the labeling for an approved, conditionally approved, or index listed VFD drug, reorders (refills) are not permitted; (xiii) The statement: “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted.”; (xiv) An affirmation of intent for combination VFD drugs as described in paragraph (6) of this section; and (xv) The veterinarian's electronic or written signature. (4) The veterinarian may, at his or her discretion, enter the following information on the VFD to more specifically identify the animals authorized to be treated/fed the VFD feed: (i) A more specific description of the location of animals ( e.g., (ii) The approximate age range of the animals; (iii) The approximate weight range of the animals; and (iv) Any other information the veterinarian deems appropriate to identify the animals specified in the VFD. (5) For VFDs intended to authorize the use of an approved, conditionally approved, or indexed combination VFD drug that includes more than one VFD drug, the veterinarian must include the drug-specific information required in paragraphs (b)(3)(vi), (ix), (x), and (xi) of this section for each VFD drug in the combination. (6) The veterinarian may restrict VFD authorization to only include the VFD drug(s) cited on the VFD or may expand such authorization to allow the use of the cited VFD drug(s) along with one or more over-the-counter (OTC) animal drugs in an approved, conditionally approved, or indexed combination VFD drug. The veterinarian must affirm his or her intent regarding combination VFD drugs by including one of the following statements on the VFD: (i) “This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drug(s) in combination with any other animal drugs.” (ii) “This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” [List specific approved, conditionally approved, or indexed combination medicated feeds following this statement.] (iii) “This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” (7) The veterinarian must issue a written (nonverbal) VFD. (8) The veterinarian must send a copy of the VFD to the distributor via hardcopy, facsimile (fax), or electronically. If in hardcopy, the veterinarian must send the copy of the VFD to the distributor either directly or through the client. (9) The veterinarian must provide a copy of the VFD to the client. (c) Responsibilities of any person who distributes an animal feed containing a VFD drug or a combination VFD drug. (2) The distributor is permitted to distribute an animal feed containing a VFD drug or combination VFD drug only if it complies with the terms of the VFD and is manufactured and labeled in conformity with the approved, conditionally approved, or indexed conditions of use for such drug. (3) The distributor must keep records of the receipt and distribution of all medicated animal feed containing a VFD drug for 2 years. (4) In addition to other applicable recordkeeping requirements found in this section, if the distributor manufactures the animal feed bearing or containing the VFD drug, the distributor must also keep VFD feed manufacturing records for 1 year in accordance with part 225 of this chapter. Such records must be made available for inspection and copying by FDA upon request. (5) A distributor of animal feed containing a VFD drug must notify FDA prior to the first time it distributes animal feed containing a VFD drug. The notification is required one time per distributor and must include the following information: (i) The distributor's complete name and business address; (ii) The distributor's signature or the signature of the distributor's authorized agent; and (iii) The date the notification was signed. (6) A distributor must also notify FDA within 30 days of any change in ownership, business name, or business address. (7) The notifications cited in paragraphs (c)(5) and (6) of this section must be submitted to the Food and Drug Administration, Center for Veterinary Medicine, Division of Food Compliance, 12225 Wilkins Ave., Rockville, MD 20852, or email (via attachment): [email protected]. (8) A distributor is permitted to distribute a VFD feed to another distributor only if the originating distributor (consignor) first obtains a written (nonverbal) acknowledgment letter, as defined in § 558.3(b)(11), from the receiving distributor (consignee) before the feed is shipped. Consignor distributors must retain a copy of each consignee distributor's acknowledgment letter for 2 years. [80 FR 31733, June 3, 2015; 80 FR 35841, June 23, 2015, as amended at 85 FR 50784, Aug. 18, 2020; 89 FR 51966, June 21, 2024] Subpart B—Specific New Animal Drugs for Use in Animal Feeds § 558.55 Amprolium. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Cattle. Amprolium in grams per ton Indications for use Limitations Sponsor (i) 113.5 to 11, 350; to provide 5 milligrams per kilogram of body weight per day Calves: As an aid in the prevention of coccidiosis caused by Eimeria bovis E. zuernii Top-dress on or mix in the daily ration. Feed for 21 days when experience indicates that coccidiosis is likely to be a hazard, as the sole source of amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal 016592 (ii) 113.5 to 11, 350; to provide 10 milligrams per kilogram of body weight per day Calves: As an aid in the treatment of coccidiosis caused by Eimeria bovis E. zuernii Top-dress on or mix in the daily ration. Feed for 5 days as the sole source of amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal 016592 (2) Chickens. Amprolium in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (i) 36.3 to 113.5 Replacement chickens: For development of active immunity to coccidiosis Feed continuously until onset of production as follows: 016592 Growing conditions Up to 5 weeks of age From 5 to 8 weeks of age Over 8 weeks of age Amprolium in grams per ton Amprolium in grams per ton Amprolium in grams per ton Severe exposure to coccidiosis 113.5 72.6-113.5 36.3-113.5 (0.0125%) (0.008%-0.0125%) (0.004%-0.0125%) Moderate exposure to coccidiosis 72.6-113.5 54.5-113.5 36.3-113.5 (0.008%-0.0125%) (0.006%-0.0125%) (0.004%-0.0125%) Slight exposure to coccidiosis 36.3-113.5 36.3-113.5 36.3-113.5 (0.004%-0.0125%) (0.004%-0.0125%) (0.004%-0.0125%) Amprolium in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (ii) 36.3 to 113.5 Bacitracin methylenedisalicylate 4 to 50 Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiency Feed according to subtable in item (i). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iii) 72.6 to 113.5 Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella Feed continuously as the sole ration; as sole source of amprolium 016592 (iv) 72.6 to 113.5 Bambermycins 1 to 2 Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella Feed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 016592 (v) 113.5 1. Laying chickens: For prevention of coccidiosis Feed continuously as the sole ration; as the sole source of amprolium 016592 2. Laying chickens: For treatment of coccidiosis in moderate outbreaks Feed for 2 weeks (vi) 113.5 to 227 1. Replacement chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired Feed continuously from day-old until onset of production; as the sole source of amprolium 016592 2. Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired Feed continuously as the sole ration; as sole source of amprolium (vii) 113.5 to 227 Bambermycins 1 to 2 Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired; and for increased rate of weight gain and improved feed efficiency Feed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 016592 (viii) 227 Laying chickens: For treatment of coccidiosis in severe outbreaks. Feed for 2 weeks 016592 (3) Turkeys. Amprolium in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (i) 113.5 Bambermycins 1 to 4 Growing turkeys: For prevention of coccidiosis; and for increased rate of weight gain and improved feed efficiency Feed continuously as the sole source of amprolium; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 016592 (ii) 113.5 to 227 Turkeys: For prevention of coccidiosis Feed continuously as the sole ration; as sole source of amprolium 016592 (4) Pheasants. Amprolium in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (i) 159 Growing pheasants: For the prevention of coccidiosis caused by Eimeria colchici, E. duodenalis, E. phasiani Feed continuously as sole ration. Use as sole source of amprolium 016592 (ii) [Reserved] (5) Permitted combinations. (i) Virginiamycin as in § 558.635. (ii) [Reserved] [41 FR 10985, Mar. 15, 1976] Editorial Note: For Federal Register www.govinfo.gov. § 558.58 Amprolium and ethopabate. (a) Specifications. (1) 25 percent amprolium and 8 percent ethopabate or 5 percent amprolium and 1.6 percent ethopabate; (2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent amprolium and 0.16 percent ethopabate. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use. Amprolium and ethopabate in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (1) Amprolium 113.5 and ethopabate 3.6 Broiler chickens: As an aid in the prevention of coccidiosis Feed continuously as sole ration; as sole source of amprolium. Not for laying chickens 016592 (2) Amprolium 113.5 and ethopabate 36.3 Broiler chickens and replacement chickens: where immunity to coccidiosis is not desired: As an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, E. brunetti Feed continuously as sole ration; as sole source of amprolium. Not for chickens over 16 weeks of age 016592 (3) Amprolium 113.5 and ethopabate 36.3 Bacitracin 4 to 50 1. Broiler chickens and replacement chickens: where immunity to coccidiosis is not desired; to aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, E. brunetti Feed as the sole ration from the time chickens are placed on litter until past the time when coccidiosis is ordinarily a hazard. Not for chickens over 16 weeks of age; do not feed to laying chickens; as sole source of amprolium; not for use as a treatment for outbreaks of coccidiosis. Bacitracin as bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 016592 (4) Amprolium 113.5 and ethopabate 36.3 Bacitracin (as feed grade bacitracin zinc) 4 to 50 2. Broiler chickens: As an aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, E. brunetti Feed as the sole ration from the time birds are placed on litter until past the time when coccidiosis is ordinarily a hazard, up to 16 weeks of age. If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist. Do not feed to chickens producing eggs for human consumption. Not for chickens over 16 weeks of age. Do not feed as a treatment for outbreaks of coccidiosis. Do not change the litter while giving this feed unless absolutely necessary. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. 066104 (5) Amprolium 113.5 and ethopabate 36.6 Bambermycins 1 to 3 Broiler chickens: As an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, E. brunetti Feed continuously as the sole ration; as sole source of amprolium 016592 (6) Amprolium 227 and ethopabate 3.6 For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis Not for laying chickens 016592 (f) Amprolium and ethopabate may also be used in combination with: (1)-(2) [Reserved] (3) Chlortetracycline as in § 558.128. [41 FR 10990, Mar. 15, 1976] Editorial Note: For Federal Register www.govinfo.gov. § 558.59 Apramycin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for apramycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for apramycin shall not be refilled. (e) Conditions of use in swine Apramycin Combination in Indications for use Limitations Sponsor (1) 150 For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli Feed as the sole ration for 14 consecutive days. Withdraw 28 days before slaughter 058198 (2) [Reserved] [81 FR 94995, Dec. 27, 2016, as amended at 87 FR 10970, Feb. 28, 2022] § 558.68 Avilamycin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for avilamycin medicated feeds must not exceed 90 days from the date of issuance. VFDs for avilamycin shall not be refilled. (e) Conditions of use. (1) Chickens Avilamycin in Combination in grams/ton Indications for use Limitations Sponsor (i) 13.6 to 40.9 Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age 058198 (ii) 13.6 to 40.9 Monensin, 90 to 110 Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, imeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. 016592 (iii) 13.6 to 40.9 Narasin, 54 to 90 Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima Feed as the sole ration for 21 consecutive days to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens 058198 (iv) 13.6 to 40.9 Narasin, 27 to 45 plus nicarbazin, 27 to 45 Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima Feed as the sole ration for 21 consecutive days to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. 058198 (v) 13.6 to 40.9 Salinomycin sodium, 40 to 60 Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens 058198 (2) Swine Avilamycin in Combinationin grams/ton Indications for use Limitations Sponsor (i) 73 Weaned pigs less than 14 weeks of age: For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or older 058198 (ii) [Reserved] [80 FR 61297, Oct. 13, 2015, as amended at 80 FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 48703, July 26, 2016; 81 FR 59134, Aug. 29, 2016; 81 FR 67152, Sept. 30, 2016; 82 FR 11509, Feb. 24, 2017; 83 FR 14587, Apr. 5, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8974, Mar. 13, 2019; 84 FR 33001, July 11, 2019; 85 FR 4209, Jan. 24, 2020; 85 FR 45308, July 28, 2020; 86 FR 13188, Mar. 8, 2021; 86 FR 14821, Mar. 19, 2021; 88 FR 55567, Aug. 16, 2023; 90 FR 40971, Aug. 22, 2025] § 558.76 Bacitracin methylenedisalicylate. (a) Specifications. (2) Type A medicated article containing feed grade bacitracin methylenedisalicylate equivalent to 50 grams bacitracin per pound. (b) Sponsors. (1) No. 054771 for use of products in paragraph (a)(1) of this section as in paragraph (d) of this section. (2) No. 069254 for use of product in paragraph (a)(2) of this section as in paragraph (d) of this section. (c) Related tolerances. (d) Conditions of use Chickens Bacitracin in Indications for use Limitations Sponsor (i) 4 to 50 Broiler and replacement chickens: For increased rate of weight gain and improved feed efficiency Feed continuously as sole ration 054771 (ii) 10 to 25 Laying hens: For increased egg production and improved feed efficiency Feed continuously as sole ration for the first 7 months of egg production 054771 (iii) 50 Broiler and replacement chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium Feed continuously as sole ration 054771 (iv) 50 Broiler and replacement chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding 069254 (v) 100 to 200 Broiler and replacement chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium Feed continuously as sole ration. Start at first clinical signs of disease. Vary dosage based on severity of infection. Administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 grams/ton) 054771 (2) Turkeys Bacitracin in Indications for use Limitations Sponsor (i) 4 to 50 Growing turkeys: For increased rate of weight gain and improved feed efficiency Feed continuously as sole ration 054771 (ii) 200 Growing turkeys: As an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate Feed continuously as the sole ration 054771 (3) Swine Bacitracin in Indications for use Limitations Sponsor (i) 10 to 30 Growing and finishing swine: For increased rate of weight gain and improved feed efficiency 054771 (ii) 250 Growing and finishing swine: For control of swine dysentery (bloody scours) associated with Brachyspira hyodysenteriae Feed as the sole ration. Feed 250 grams per ton of complete feed on premises with a history of swine dysentery, but where signs of the disease have not yet occurred or following an approved treatment of the disease condition. Diagnosis should be confirmed by a veterinarian a when results are not satisfactory 054771 (iii) 250 Pregnant sows: For control of clostridial enteritis caused by Clostridium perfringens As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory 054771 (4) Cattle Bacitracin Indications for use Limitations Sponsor (i) 70 mg per head per day Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses Administer continuously throughout the feeding period 054771 (ii) 250 mg per head per day Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period 054771 (5) Game birds Bacitracin in Indications for use Limitations Sponsor (i) 4 to 50 Growing pheasants: For increased rate of weight gain and improved feed efficiency Feed continuously as sole ration 054771 (ii) 5 to 20 Growing quail: For increased rate of weight gain and improved feed efficiency in quail not over 5 weeks of age Feed continuously as sole ration to quail not over 5 weeks of age 054771 (iii) 200 Growing quail: For the prevention of ulcerative enteritis in growing quail due to Clostridium colinum Feed continuously as the sole ration 054771 (6) Bacitracin methylenedisalicylate may also be used in combination with: (i) Amprolium as in § 558.55. (ii) Amprolium and ethopabate as in § 558.58. (iii) Chlortetracycline as in § 558.128. (iv) Clopidol as in § 558.175. (v) Decoquinate as in § 558.195. (vi) Diclazuril as in § 558.198. (vii) Fenbendazole as in § 558.258. (viii) Halofuginone as in § 558.265. (ix) Ivermectin as in § 558.300. (x) Lasalocid as in § 558.311. (xi) Monensin as in § 558.355. (xii) Narasin as in § 558.363. (xiii) Narasin and nicarbazin as in § 558.364. (xiv) Nicarbazin as in § 558.366. (xv) Robenidine as in § 558.515. (xvi) Salinomycin as in § 558.550. (xvii) Semduramicin as in § 558.555. (xviii) Zoalene as in § 558.680. [41 FR 10993, Mar. 15, 1976] Editorial Note For Federal Register www.govinfo.gov. § 558.78 Bacitracin zinc. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. Bacitracin zinc in grams per ton Combinations in grams per ton Indications for use Limitations Sponsor (i) 4 to 50 Chickens: for increased rate of weight gain and improved feed efficiency Growing chickens 054771 (ii) 4 to 50 Turkeys and pheasants: for increased rate of weight gain and improved feed efficiency Growing turkeys and pheasants 054771 (iii) 5 to 20 Quail; for increased rate of weight gain and improved feed efficiency Growing quail; feed as the Type C feed to starting quail through 5 weeks of age 054771 (iv) 10 to 25 Laying chickens; improved feed efficiency and increased egg production 054771 (v) 10 to 50 Swine; increased rate of weight gain and improved feed efficiency Growing and finishing swine 054771 (vi) 20 Growing-finishing swine; increased rate of weight gain In Type C feed 054771 (vii) 20 to 40 Growing-finishing swine; improved feed efficiency 054771 (2) It is used in feed for growing cattle at 35 to 70 milligrams per head per day as follows: (i) To aid in stimulating growth and improving feed efficiency. (ii) For increased rate of weight gain and improved feed efficiency; see sponsor 054771. (3) Bacitracin zinc may also be used in combination with: (i) Amprolium and ethopabate as in § 558.58. (ii) Clopidol as in § 558.175. (iii) Decoquinate as in § 558.195. (iv) Lasalocid as in § 558.311. (v) Monensin as in § 558.355. (vi) Naracin as in § 558.363. (vii) Nicarbazin as in § 558.366. (viii) Robenidine as in § 558.515. (ix) Salinomycin as in § 558.550. [41 FR 10994, Mar. 15, 1976] Editorial Note: For Federal Register www.govinfo.gov. § 558.95 Bambermycins. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) The expiration date for the liquid Type B feed is 8 weeks after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 1 week after date of manufacture. (e) Conditions of use Chickens. Bambermycins in grams/ton Indications for use Limitations Sponsor (i) 1 to 2 Broiler chickens: For increased rate of weight gain and improved feed efficiency Feed continuously as the sole ration 016592. (ii) [Reserved] (2) Turkeys. Bambermycins in grams/ton Indications for use Limitations Sponsor (i) 1 to 2 Growing turkeys: For improved feed efficiency Feed continuously as the sole ration 016592 (ii) 2 Growing turkeys: For increased rate of weight gain and improved feed efficiency Feed continuously as the sole ration 016592 (3) Swine. Bambermycins in grams/ton Indications for use Limitations Sponsor (i) 2 Growing-finishing swine: For increased rate of weight gain and improved feed efficiency Feed continuously as the sole ration 016592 (ii) 2 to 4 Growing-finishing swine: For improved feed efficiency Feed continuously as the sole ration 016592 (4) Cattle. Bambermycins in grams/ton Indications for use Limitations Sponsor (i) 1 to 4 Growing beef steers and heifers fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency Feed continuously at a rate of 10 to 20 milligrams per head per day 016592. (ii) 2 to 80 Growing beef steers and heifers on pasture (stocker, feeder, and slaughter), and replacement beef and dairy heifers on pasture: For increased rate of weight gain Feed continuously on a hand-fed basis at a rate of 10 to 40 milligrams per head per day in 1 to 10 pounds of supplemental Type C medicated feed 016592. (iii) Used as a free-choice Type C medicated loose-mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows: ( a Specifications. Ingredient International Feed No. Percent Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) 6-01-080 42.50 Sodium chloride (salt) 6-04-152 20.10 Calcium carbonate (38% calcium) 6-01-069 15.24 Corn distillers dried grains w/solubles 5-28-236 9.57 Magnesium oxide 6-02-756 5.15 Vitamin and trace mineral premix * ......... 3.72 Mineral oil ......... 1.00 Yeast (primary dehydrated yeast) 7-05-533 0.75 Bambermycins Type A article (10 g/lb) ......... 0.60 Iron oxide 6-02-431 0.50 Magnesium sulfate (67%) 6-02-758 0.32 Selenium premix (270 mg/lb) * ......... 0.21 Copper sulfate 6-01-720 0.18 Potassium sulfate (0.33%) 6-06-098 0.16 *Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). ( b Amount per ton. ( c Indications for use. ( d Limitations. (iv) Use free-choice Type C medicated feeds for pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows: ( a Amount. ( b Indications for use. ( c Limitations. (v) Used as a free-choice Type C medicated loose mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers) as follows: (A) Specifications. Ingredient International Feed No. Percent Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) 6-01-080 42.50 Sodium chloride (salt) 6-04-152 20.10 Calcium carbonate (38% calcium) 6-01-069 15.45 Corn distillers dried grains w/solubles 5-28-236 9.57 Magnesium oxide 6-02-756 5.15 Vitamin and trace mineral premix * 3.72 Mineral oil 1.00 Yeast (primary dehydrated yeast) 7-05-533 0.75 Bambermycins Type A article (10 g/lb) 0.60 Iron oxide 6-02-431 0.50 Magnesium sulfate (67%) 6-02-758 0.32 Copper sulfate 6-01-720 0.18 Potassium sulfate (0.33%) 6-06-098 0.16 * Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). (B) Amount per ton. (C) Indications for use. (D) Limitations. (5) Combinations. (i) Amprolium as in § 558.55. (ii) Amprolium and ethopabate as in § 558.58. (iii) Clopidol as in § 558.175. (iv) Diclazuril as in § 558.198. (v) Halofuginone as in § 558.265. (vi) Lasalocid as in § 558.311. (vii) Monensin as in § 558.355. (viii) Narasin as in § 558.363. (ix) Narasin and nicarbazin as in § 558.364. (x) Nicarbazin as in § 558.366. (xi) Salinomycin as in § 558.550. (xii) Zoalene as in § 558.680. [40 FR 13959, Mar. 27, 1975] Editorial Note: For Federal Register www.govinfo.gov. § 558.115 Carbadox. (a) Approvals. (b) Related tolerances. (c) Special considerations. (d) Conditions of use. (1) Amount per ton. (i) Indications for use. (ii) Limitations. (2) Amount per ton. (i) Indications for use. Salmonella choleraesuis (ii) Limitations. (3) Amount per ton. (i) Indications for use. Salmonella choleraesuis Ascaris suum Oesophagostomum (ii) Limitations. (4) Carbadox may also be used in combination with oxytetracycline as in § 558.450. [40 FR 13959, Mar. 27, 1975, as amended at 40 FR 45164, Oct. 1, 1975; 40 FR 57798, Dec. 12, 1975; 42 FR 761, Jan. 4, 1977; 51 FR 7396, Mar. 3, 1986; 63 FR 59216, Nov. 3, 1998; 66 FR 47963, Sept. 17, 2001; 69 FR 51173, Aug. 18, 2004; 82 FR 21691, May 10, 2017] § 558.128 Chlortetracycline. (a) Specifications. (b) Sponsors. (1) No. 054771: (2) No. 066104: (3) No. 069254: (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for chlortetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline shall not be refilled. (3) In milk replacers or starter feed; include on labeling the warning: “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” (4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(vi) of this section must conform to § 510.455 of this chapter. (5) When manufactured for use as in paragraph (e)(5)(iii) of this section, include on labeling the warning: “Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.” (e) Conditions of use Chickens. Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 100 to 200 g/ton Chickens: For control of infectious synovitis caused by Mycoplasma synoviae Feed continuously for 7 to 14 days. For No. 066104: Do not feed to chickens producing eggs for human consumption 054771 066104 069254 (ii) 100 to 200 g/ton Clopidol, 113.5 Broiler and replacement chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, E. brunetti; M. synoviae Feed continuously as the sole ration from the time chicks are placed in floor pens for 7 to 14 days. Do not feed to chickens over 16 weeks of age. Do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; clopidol as provided by No. 016592 in § 510.600(c) of this chapter 016592 (iii) 100 to 200 g/ton Decoquinate, 27.2 Chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, E. brunetti; M, synoviae Feed continuously for 7 to 14 days. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption 054771 (iv) 100 g/ton Robenidine, 30 Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, E. necatrix; Mycoplasma gallisepticum M. synoviae Feed continuously as sole ration. Do not use this product in feeds conta 054771 (v) 200 to 400 g/ton Chickens: For the control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum Escherichia coli Feed continuously for 7 to 14 days. For No. 066104: Do not feed to chickens producing eggs for human consumption 054771 066104 069254 (vi) 200 g/ton Amprolium, 227 and ethopabate, 3.6 For chickens where immunity to coccidiosis is not desired: For prevention of coccidiosis; and for treatment of chronic respiratory disease (CRD) caused by M. gallisepticum Use in low calcium feed containing 0.8% dietary calcium and 1.5% sodium sulfate; feed continuously as sole ration for 7 to 14 days; do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter 054771 (vii) 200 g/ton Decoquinate, 27.2 Broilers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. mivati, E. maxima, E. brunetti; Feed continuously as the sole ration for no more than 8 weeks. Use in low calcium feed containing 0.8% dietary calcium. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption 054771 (viii) 200 g/ton Robenidine 30 Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, E. necatrix; M. gallisepticum M. synoviae Feed continuously as sole ration. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter 054771 (ix) 500 g/ton Chickens: For the reduction of mortality due to E. coli 1. Feed for 5 days. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: zero withdrawal time 054771 069254 2. Feed for 5 days; withdraw 24 hours prior to slaughter. Do not feed to chickens producing eggs for human consumption 054771 (x) 500 g/ton Monensin, 90 to 110 Chickens: As an aid in the reduction of mortality due to E. coli Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati Feed for 5 days as the sole ration. Do not feed to laying chickens. Not to be fed continuously for more than 5 days. Do not feed to chickens over 16 weeks of age. Withdraw 24 hours before slaughter. See § 558.355(d) of this chapter. Chlortetracycline as provided by No. 054771; monensin as provided by No. 058198 in § 510.600(c) of this chapter 054771 069254 (xi) 500 g/ton Robenidine, 30 Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, E. necatrix; E. coli Feed continuously as sole ration for up to 5 days. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter 054771 (xii) 500 g/ton Salinomycin, 40 to 60 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati; E. coli For use in low calcium feeds containing 0.8% calcium. Not approved for use with pellet binders. Not to be fed continuously for more than 5 days. Do not feed to laying chickens producing eggs for human consumption. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlortetracycline as provided by Nos. 054771 or 069254; salinomycin as provided by Nos. 054771 or 016592 in § 510.600(c) of this chapter 016592 054771 069254 (2) Turkeys. Chlortetracycline amount Combination in Indications for use Limitations Sponsor (i) 200 g/ton Turkeys: For control of infectious synovitis caused by M. synoviae Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption 054771 (ii) 400 g/ton 1. Turkeys: For control of hexamitiasis caused by Hexamita meleagridis Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption 054771 2. Turkey poults not over 4 weeks of age: For reduction of mortality due to paratyphoid caused by Salmonella typhimurium 054771 (iii) 25 mg/lb of body weight Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption 054771 (3) Swine. Chlortetracycline amount Combination in Indications for use Limitations Sponsor (i) 50 to 100 g/ton Swine: For reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci 054771 (ii) 400 g/ton Breeding swine: For the control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona Feed continuously for not more than 14 days 054771 (iii) 10 mg/lb of body weight Swine: For treatment of bacterial enteritis caused by Escherichia coli S. choleraesuis Pasteurella multocida Lawsonia intracellularis Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254 in § 510.600(c) of this chapter 054771 (iv) 10 mg/lb of body weight Bacitracin methylenedisalicylate, 10 to 30 Swine: For treatment of bacterial enteritis caused by E. coli S. choleraesuis P. multocida Lawsonia intracellularis Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Chlortetracycline and bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (v) 10 mg/lb of body weight Bacitracin methylenedisalicylate, 10 to 30 Swine: For treatment of bacterial enteritis caused by E. coli S. choleraesuis P. multocida Feed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254. Bacitracin methylenedisalicylate provided by No. 054771; chlortetracycline provided by Nos. 054771 and 069254 in § 510.600(c) of this chapter 054771 (vi) 10 mg/lb of body weight Tiamulin hydrogen fumarate, 35 For control of swine dysentery associated with Brachyspira Serpulina Treponema hyodysenteriae E. coli Salmonella choleraesuis P. multocida Feed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed continuously as the sole ration for 14 days. Withdraw medicated feed 2 days before slaughter. Tiamulin as provided by Nos. 058198 or 069254 in § 510.600(c) of this chapter 058198 (4) Cattle. Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) to provide 70 mg/head/day Growing cattle (over 400 lb): For reduction of liver condemnation due to liver abscesses Feed to provide chlortetracycline at the rate of 70 mg per animal daily. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal 054771 (ii) 5.83 to 14 g/ton to provide 70 mg/head/day Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day Growing beef heifers fed in confinement for slaughter (over 400 lb): For reduction of the incidence of liver abscesses, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 5.83 to 14 g/ton chlortetracycline. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iii) 7 to 17.5 g/ton Monensin, 5 to 40 Growing beef steers and heifers fed in confinement for slaughter over 400 lb: For reduction of the incidence of liver abscesses and for improved feed efficiency Feed as the sole ration to provide 70 mg chlortetracycline per head per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (iv) 7 to 17.5 g/ton Monensin, 10 to 40 Growing beef steers and heifers fed in confinement for slaughter over 400 lb: For reduction of the incidence of liver abscesses and for prevention and control of coccidiosis due to Eimeria bovis Eimeria zuernii Feed as the sole ration to provide 70 mg chlortetracycline per head per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (v) to provide 0.5 mg/lb of body weight daily Beef cattle (over 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale Feed to provide chlortetracycline at the rate of 0.5 mg per pound of body weight daily. Withdraw 48 hours prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time 054771 (vi) 33.33 to 50 g/ton to provide 0.5 mg/lb of body weight per day Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day Replacement beef heifers over 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 33.33 to 50 g/ton chlortetracycline. Feeding a Type C top-dress medicated feed containing melengestrol acetate shall not exceed 24 days. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (vii) 25 to 1,100 g/ton to provide 0.5 mg/lb of body weight daily Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) over 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale Feed continuously on a hand-fed basis 0.5 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (viii) 25 to 1,100 g/ton to provide 0.5 mg/lb of body weight daily Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement beef heifers on pasture over 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 1,100 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 0.5 mg chlortetracycline per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (ix) 33.33 to 66.67 g/ton Monensin, 5 to 40 Growing beef steers and heifers fed in confinement for slaughter over 700 lbs: For control of active infection of anaplasmosis caused by Anaplasma marginale Feed as the sole ration to provide 0.5 mg chlortetracycline per lb. body weight per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (x) 33.33 to 66.67 g/ton Monensin, 10 to 40 Growing beef steers and heifers fed in confinement for slaughter over 700 lbs: For control of active infection of anaplasmosis caused by Anaplasma marginale Eimeria bovis Eimeria zuernii Feed as the sole ration to provide 0.5 mg chlortetracycline per lb. body weight per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (xi) 50 to 117 g/ton Monensin, 7.14 to 40 Growing beef steers and heifers fed in confinement for slaughter under 700 lbs: For control of active infection of anaplasmosis caused by Anaplasma marginale Feed as the sole ration to provide 350 mg chlortetracycline per head per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (xii) 50 to 117 g/ton Monensin, 10 to 40 Growing beef steers and heifers fed in confinement for slaughter under 700 lbs: For control of active infection of anaplasmosis caused by Anaplasma marginale Eimeria bovis Eimeria zuernii Feed as the sole ration to provide 350 mg chlortetracycline per head per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (xiii) 50 to 117 g/ton Monensin, 7.14 to 40 Growing beef steers and heifers fed in confinement for slaughter: For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Feed as the sole ration to provide 350 mg chlortetracycline per head per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (xiv) 50 to 117 g/ton Monensin, >10 to 40 Growing beef steers and heifers fed in confinement for slaughter: For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Eimeria bovis Eimeria zuernii Feed as the sole ration to provide 350 mg chlortetracycline per head per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (xv) to provide 0.5 to 2.0 mg/lb of body weight daily Beef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale In Type C free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approved Type A articles. See paragraph (d)(4) of this section 054771 (xvi) to provide 10 mg/lb of body weight daily Calves, beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 days. To sponsor No. 054771 (NADAs 048-761 and 046-699) and to sponsor No. 069254 (ANADA 200-510): May be mixed in the cattle's daily ration or administered as a top-dress. In feed including milk replacers withdraw 10 days prior to slaughter. To sponsor No. 054771 under NADA 046-699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period. See paragraph (d)(3) of this section 054771 (xvii) to provide 10 mg/lb of body weight daily Calves (up to 250 lb): For the treatment of bacterial enteritis caused by Escherichia coli susceptible to chlortetracycline A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal 066104 (xviii) 400 to 2,000 g/ton Monensin, 5 to 40 Growing beef steers and heifers fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Feed as the sole ration to provide 10 mg chlortetracycline per lb. body weight per day and 50 to 480 mg monensin per head per day. Feed for not more than 5 days, then continue feeding monensin Type C medicated feed alone. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (xix) 400 to 2,000 g/ton Monensin, 10 to 40 Growing beef steers and heifers: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Eimeria bovis Eimeria zuernii Feed as the sole ration to provide 10 mg chlortetracycline per lb. body weight per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of the coccidiosis challenge, up to 480 mg monensin per head per day. Feed for not more than 5 days, then continue feeding monensin Type C medicated feed alone. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (xx) 400 to 2,000 g/ton Monensin, 10 to 200 Beef calves 2 months of age and older: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Eimeria bovis Eimeria zuernii Feed as the sole ration to provide 10 mg chlortetracycline per lb. body weight per day and 0.14 to 1.00 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 200 mg of monensin per head per day. Feed for not more than 5 days, then continue to feed monensin Type C medicated feed alone. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter 016592 (xxi) 400 to 2,000 g/ton Monensin, 15 to 84 Replacement beef and dairy heifers: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Eimeria bovis Eimeria zuernii For replacement beef and dairy heifers not currently being fed monensin: Feed as the sole ration for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day and 0.14 to 0.42 mg monensin per pound of body weight per day, depending upon severity of challenge, to provide 50 to 100 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone to provide 50 to 200 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. 069254, 016592 (xxii) 400 to 2,000 g/ton Monensin, 15 to 400 Replacement beef and dairy heifers: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida For replacement beef and dairy heifers not currently being fed monensin: Feed as the sole ration for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day and 50 to 100 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone to provide 50 to 200 mg monensin per head per day in a minimum of 1 pound of Type C medicated feed. 0692544, 0165924 (xxiii) 500 to 2,000 g/ton to provide 10 mg/lb of body weight daily Laidlomycin, 5 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxiv) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily Laidlomycin, 5 to 10 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxv) 500 to 2,000 to provide 10 mg/lb of body weight daily Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 100 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxvi) 500 to 1,200 g/ton to provide 10 mg/lb of body weight daily Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Feed continuously in complete feed to provide 10 mg chlortetracycline per lb body weight and not less than 250 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxvii) 500 to 4,000 to provide 10 mg/lb of body weight daily Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Feed continuously on a hand-fed basis for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxviii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily Lasalocid, 30 to 600: Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement dairy heifers on pasture less than 20 months of age and replacement beef heifers on pasture: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 10 mg chlortetracycline per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceeding 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254, lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xxix) 500 to 4,000 g/ton Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Hand feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 046-699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period 054771 (xxx) 500 to 4,000 g/ton Decoquinate, 12.9 to 90.8 Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Eimeria bovis E. zuernii Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxxi) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day Growing beef heifers fed in confinement for slaughter: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton chlortetracycline for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xxxii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day Replacement dairy heifers less than 20 months of age and replacement beef heifers: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton chlortetracycline for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceeding 24 days. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xxxiii) 4,000 to 20,000 g/ton Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Administer as a top dress, varying with body weight and feed consumption, to provide 10 mg/lb per day. Treat for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal 054771 (xxxiv) 4,000 to 20,000 g/ton Decoquinate, 90.8 to 535.7 Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Eimeria bovis E. zuernii Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxxv) 4,000 to 20,000 g/ton to provide 10 mg/lb of body weight per day Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day Growing beef heifers fed in confinement for slaughter: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Top dress 0.5 to 2 pounds of this medicated feed containing both drugs onto or mix at feeding with a non-medicated feed for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xxxvi) 4,000 to 20,000 g/ton to provide 10 mg/lb of body weight per day Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day Replacement dairy heifers less than 20 months of age and replacement beef heifers: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Top dress 0.5 to 2 pounds of this medicated feed containing both drugs onto or mix at feeding with a non-medicated feed for not more than 5 days to provide 10 mg chlortetracycline per pound of body weight per day. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceeding 24 days. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xxxvii) to provide 350 mg/head/day Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Feed to provide chlortetracycline at the rate of 350 mg per animal daily. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Withdrawal periods: To sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 048-480: Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADA 048-761 and No. 069254 under NADA 138-935 and ANADA 200-510: Zero withdrawal period 054771 (xxxviii) to provide 350 mg/head/day Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale Feed to provide chlortetracycline at the rate of 350 mg per animal daily. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Withdrawal periods: To sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 048-480: Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADA 048-761 and No. 069254 under NADA 138-935 and ANADA 200-510: Zero withdrawal period 054771 (xxxix) 50 to 350 g/ton to provide 350 mg/head/day Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day Replacement beef heifers under 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 50 to 350 g/ton chlortetracycline for up to 24 days of feeding. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xl) 20 to 350 g/ton Beef cattle and replacement dairy heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Feed to provide chlortetracycline at the rate of 350 mg per head per day. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period 054771 (xli) 20 to 350 g/ton to provide 350 mg/head/day Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day Growing beef heifers fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with the Type C medicated feed containing 20 to 350 g/ton chlortetracycline. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xlii) 20 to 350 g/ton to provide 350 mg/head/day Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day Replacement dairy heifers less than 20 months of age and replacement beef heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 20 to 350 g/ton chlortetracycline. Feeding a Type C top-dress medicated feed containing melengestrol acetate shall not exceed 24 days of feeding. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xliii) 23.3 to 58.3 g/ton to provide 350 mg/head/day Laidlomycin, 5 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xliv) 14.6 to 116.7 g/ton to provide 350 mg/head/day Laidlomycin, 5 to 10 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xlv) 25 to 42.2 g/ton to provide 350 mg/head/day Lasalocid, 25 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by Anaplasma marginale Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xlvi) 25 to 42.2 g/ton to provide 350 mg/head/day Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xlvii) 25 to 100 g/ton to provide 350 mg/head/day Lasalocid, 10 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by Anaplasma marginale Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xlviii) 25 to 100 g/ton to provide 350 mg/head/day Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xlix) 25 to 700 to provide 350 g/head/day Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (l) 25 to 700 g/ton to provide 350 mg/head/day Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement beef heifers on pasture: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 700 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (li) 25 to 700 to provide 350 mg/head/day Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (lii) 25 to 700 g/ton to provide 350 mg/head/day Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement beef heifers on pasture under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 700 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (liii) 25 to 2,800 to provide 350 mg/head/day Lasalocid, 30 to 181.8 Beef cattle weighing under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale Eimeria bovis E. zuernii Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Chlortetracycline and lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (liv) 25 to 2,800 g/ton to provide 350 mg/head/day Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/head/day melengestrol acetate Growing beef heifers fed in confinement for slaughter under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale Eimeria bovis E. zuernii, The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head per day and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (lv) 25 to 2,800 to provide 350 mg/head/day Lasalocid, 30 to 181.8 Beef cattle weighing up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Eimeria bovis E. zuernii Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (lvi) 25 to 2,800 g/ton to provide 350 mg/head/day Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/head/day melengestrol acetate Growing beef heifers fed in confinement for slaughter up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Eimeria bovis E. zuernii, The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See§ 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (lvii) 25 to 2,800 g/ton to provide 350 mg/head/day Lasalocid, 30 to 181.8; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement beef heifers up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella Eimeria bovis E. zuernii, The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (lviii) 500 to 4,000 to provide 10 mg/head/day Lasalocid, 30 to 181.8 Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Eimeria bovis E. zuernii Hand feed continuously for not more than 5 days at a rate of 10 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (lix) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/head/day melengestrol acetate Growing beef heifers fed in confinement for slaughter up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Eimeria bovis E. zuernii, The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 10 mg chlortetracycline per lb of body weight per day and 1 mg lasalocid per 2.2 lb of body weight per day with a maximum of 360 mg lasalocid per head per day for not more than 5 days of feeding. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (lx) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily Lasalocid, 30 to 181.8; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement dairy heifers up to 800 pounds and less than 20 months of age and replacement beef heifers up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Eimeria bovis E. zuernii, The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 10 mg chlortetracycline per lb of body weight per day and 1 mg lasalocid per 2.2 lb of body weight per day with a maximum of 360 mg lasalocid per head per day for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (5) Minor species. Chlortetracycline amount Indications for use Limitations Sponsor (i) 80 mg/head/day Breeding sheep; reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus 054771 (ii) 200 to 400 g/ton Ducks: For the control and treatment of fowl cholera caused by Pasteurella multocida Feed in complete ration to provide from 8 to 28 mg/lb of body weight per day, depending upon age and severity of disease, for not more than 21 days. Do not feed to ducks producing eggs for human consumption 054771 069254 (iii) 10 mg/g of finished feed daily Psittacine birds (cockatoos, macaws, and parrots) suspected or known to be infected with psittacosis caused by Chlamydia psittaci Feed continuously for 45 days. Each bird should consume daily an amount of medicated feed equal to one fifth of its body weight. See paragraph (d)(5) of this section 054771 069254 (6) It is used as a free-choice, loose mineral Type C feed as follows: (i) Specifications. Ingredient Percent International feed No. Dicalcium Phosphate 46.20 6-26-335 Sodium Chloride (Salt) 15.00 6-04-152 Magnesium Oxide 10.67 6-02-756 Cottonseed Meal 10.00 5-01-625 Trace Mineral/Vitamin Premix 1 3.80 Calcium Carbonate 3.50 6-01-069 Dried Cane Molasses 3.00 4-04-695 Potassium Chloride 2.00 6-03-755 Mineral Oil 2.00 8-03-123 Iron Oxide 0.50 6-02-431 Chlortetracycline Type A medicated article (90 gram/lb) 3.33 1 (ii) Amount. (iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale (iv) Limitations. (v) Sponsors. [81 FR 94995, Dec. 27, 2016, as amended at 82 FR 21691, May 10, 2017; 82 FR 43485, Sept. 18, 2017; 83 FR 13636, Mar. 30, 2018; 83 FR 14588, Apr. 5, 2018; 83 FR 48947, Sept. 28, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8975, Mar. 13, 2019; 84 FR 39185, Aug. 9, 2019; 86 FR 13189, Mar. 8, 2021; 86 FR 14822, Mar. 19, 2021; 86 FR 17064, Apr. 1, 2021; 86 FR 57999, Oct. 20, 2021; 86 FR 61686, Nov. 8, 2021; 87 FR 58963, Sept. 29, 2022; 87 FR 76422, Dec. 14, 2022; 88 FR 14901, Mar. 10, 2023; 88 FR 55567, Aug. 16, 2023; 89 FR 14411, Feb. 27, 2024; 89 FR 95103, Dec. 2, 2024; 90 FR 6801, Jan. 21, 2025] § 558.140 Chlortetracycline and sulfamethazine. (a) Specifications. (1) 35 grams (g) per pound (/lb) each, chlortetracycline and sulfamethazine. (2) 40 g/lb each, chlortetracycline and sulfamethazine. (b) Sponsors. (1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section. (2) No. 069254 for use of product described in paragraph (a)(1) as in paragraph (e)(1)(i) of this section. (3) Nos. 054771 and 069254 for use of product described in paragraph (a)(2) as in paragraph (e)(2) of this section. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled. (e) Conditions of use Cattle Chlortetracycline Combination in Indications for use Limitations Sponsors (i) To provide 350 milligrams per head per day Beef cattle: As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever. Feed for 28 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. 054771 (ii) 35 to 105 g/ton, each Lasalocid, 10 to 30 Beef steers and heifers fed in confinement for slaughter: As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever, and for improved feed efficiency. Feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg sulfamethazine, and 100 to 300 mg lasalocid per head per day. Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iii) 35 to 42.2 g/ton, each Lasalocid, 25 to 30 Beef steers and heifers fed in confinement for slaughter: As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever, and for improved feed efficiency and increased rate of weight gain. Feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg sulfamethazine, and 250 to 300 mg lasalocid per head per day. Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iv) 35 to 700 g/ton, each Lasalocid, 30 to 181.8 Beef cattle up to 800 lb: As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever, and for control of coccidiosis caused by Eimeria bovis E. zuernii Hand feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg sulfamethazine, and 1 mg lasalocid per 2.2 lb body weight per day up to a maximum of 360 mg lasalocid per head per day. Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (2) Swine Chlortetracycline and sulfamethazine amount Indications for use Limitations Sponsors (i) 100 g/ton of feed each, chlortetracycline and sulfamethazine Swine: For reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis Feed as the sole ration. Withdraw 15 days prior to slaughter 054771 (ii) [Reserved] [79 FR 37622, July 2, 2014, as amended at 80 FR 13231, Mar. 13, 2015; 81 FR 63054, Sept. 14, 2016; 81 FR 95004, Dec. 27, 2016; 82 FR 21691, May 10, 2017; 84 FR 12495, Apr. 2, 2019; 86 FR 13189, Mar. 8, 2021; 86 FR 14822, Mar. 19, 2021] § 558.175 Clopidol. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Chickens Clopidol in Combination in grams per ton Indications for use Limitations Sponsors (i) 113.5 Broiler chickens and re-placement chickens intended for use as caged layers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati. Do not feed to chickens over 16 weeks of age 016592 (ii) 113.5 Bacitracin methylenedisalicylate, 4 to 50 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati, Feed continuously as the sole ration from the time chicks are placed in floor pens until slaughter. Do not feed to chickens over 16 weeks of age; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 016592 (iii) 113.5 Bacitracin zinc, 5 to 25 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati, Feed continuously as sole ration; bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter 066104 016592 (iv) 113.5 Bambermycins, 1 to 2 Broiler chickens: As an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati; Feed continuously as the sole ration. Do not feed to chickens over 16 weeks of age 016592 (v) 227 Broiler and replacement chickens intended for use as caged layers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati. Feed continuously as the sole ration; feed up to 16 weeks of age if intended for use as caged layers; withdraw 5 days before slaughter if given at the level of 0.025 percent in feed or reduce level to 0.0125 percent 5 days before slaughter 016592 (vi) 227 Bambermycins, 1 to 2 Broiler chickens: As an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati; Feed continuously as sole ration until 5 days before slaughter. Withdraw 5 days before slaughter or feed 113.5 g/ton clopidol and 1 to 2 g/ton bambermycins during those 5 days before slaughter. Do not feed to chickens over 16 weeks of age 016592 (2) Turkeys Clopidol in Combination in grams per ton Indications for use Limitations Sponsors (i) 113.5 or 227 Turkeys: As an aid in the prevention of leucocytozoonosis caused by Leucocytozoon smithi. For turkeys grown for meat purposes only; feed continuously as the sole ration at 0.0125 or 0.025 percent clopidol depending on management practices, degree of exposure, and amount of feed eaten; withdraw 5 days before slaughter 016592 (ii) [Reserved] (3) Combinations. (i) Chlortetracycline as in § 558.128. (ii) Lincomycin as in § 558.325. [68 FR 17882, Apr. 14, 2003, as amended at 72 FR 60551, Oct. 25, 2007; 74 FR 61028, Nov. 23, 2009; 79 FR 10965, 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95004, Dec. 27, 2016; 84 FR 12495, Apr. 2, 2019; 86 FR 14822, Mar. 19, 2021; 91 FR 20343, Apr. 16, 2026] § 558.185 Coumaphos. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) See § 500.25 of this chapter. (e) Conditions of use in laying chickens. Coumaphos in Indications for use Limitations Sponsor (1) 27.2 (0.003 percent) Laying chickens: For control of capillary worm ( Capillaria obsignata Ascaridia galli Heterakis gallinae Feed continuously as the sole ration for 14 days. If reinfection occurs, treatment may be repeated, but not sooner than 3 weeks after the end of the previous treatment. Do not feed to chickens within 10 days of vaccination or other conditions of stress. 058198 (2) 36.3 (0.004 percent) Replacement pullets: For control of capillary worm ( Capillaria obsignata Ascaridia galli Heterakis gallinae Feed continuously as the sole ration for from 10 to 14 days. Do not feed to chickens under 8 weeks of age or within 10 days of vaccination or other conditions of stress. If birds are maintained on contaminated litter or exposed to infected birds, a second 10- to 14-day treatment is recommended, but not sooner than 3 weeks after the end of the previous treatment. If reinfection occurs after production begins, repeat treatment as recommended for laying flocks. 058198 [86 FR 14822, Mar. 19, 2021] § 558.195 Decoquinate. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) Type A medicated articles may be used to manufacture dry or liquid Type B cattle (including veal calf), sheep, and goat feeds as in paragraphs (e)(2) and (e)(3) of this section. (3) Type C cattle feeds may be manufactured from decoquinate liquid Type B feeds having a pH between 5.0 to 6.5 and containing a suspending agent to maintain a viscosity of not less than 500 centipoises. (e) Conditions of use. (1) Chickens Decoquinate in Combination in grams/ton Indications for use Limitations Sponsor (i) 27.2 Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, E. brunetti Do not feed to laying hens producing eggs for human consumption 066104 (ii) 27.2 Bacitracin (as bacitracin methylenedisalicylate), 4 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. mivati, E. maxima, E. brunetti, Feed as the sole ration. Do not feed to chickens producing eggs for human consumption. Do not use in feeds containing bentonite. Bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter 066104 (iii) 27.2 Bacitracin zinc, 10 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. mivati, E. maxima, E. brunetti; Feed as the sole ration. Do not feed to chickens producing eggs for human consumption. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter 066104 (2) Cattle Decoquinate in Combination in grams/ton Indications for use Limitations Sponsor (i) 12.9 to 90.8 Cattle (including ruminating and nonruminating calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis E. zuernii Feed Type C feed or milk replacer to provide 22.7 milligrams (mg) per 100 pounds (lb) of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for human consumption. See paragraph (d)(3) of this section 066104 (ii) 12.9 to 90.8 Monensin, 5 to 30 Growing beef steers and heifers fed in confinement for slaughter: For prevention of coccidiosis caused by Eimeria bovis E. zuernii; Feed as the sole ration to provide 22.7 mg of decoquinate per 100 lb of body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during periods of coccidiosis exposure or when experience indicates that coccidiosis is likely to be a hazard. Do not feed to cows producing milk for human consumption. A withdrawal period has not been established for this product in pre-ruminant calves. Do not use in calves to be processed for veal. Also see paragraph (d)(1) of this section and § 558.355(d)(9)(i). Monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter 066104 (iii) 90.9 to 535.7 Cattle (including ruminating and nonruminating calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis E. zuernii Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section 066104 (3) Minor species Decoquinate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 12.9 to 90.8 1. Young sheep: For the prevention of coccidiosis caused by Eimeria ovinoidalis, E. crandallis, E. parva, E. bakuensis Feed Type C feed or milk replacer at a rate to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for human consumption 054771 2. Young goats: For the prevention of coccidiosis caused by Eimeria christenseni E. ninakohlyakimovae Feed Type C feed or milk replacer at a rate to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for human consumption (ii) 90.9 to 535.7 1. Young sheep: For the prevention of coccidiosis caused by Eimeria ovinoidalis, E. crandallis, E. parva, E. bakuensis Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for human consumption 066104 2. Young goats: For the prevention of coccidiosis caused by Eimeria christenseni E. ninakohlyakimovae Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for human consumption (4) Decoquinate may also be used in combination with: (i)-(ii) [Reserved] (iii) Chlortetracycline as in § 558.128. (iv) Lincomycin as in § 558.325. [67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, 2003; 69 FR 26499, May 13, 2004; 69 FR 52816, Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR 67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005; 78 FR 25183, Apr. 30, 2013; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 79 FR 17860, Mar. 31, 2014; 80 FR 13231, Mar. 13, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 22525, Apr. 18, 2016; 81 FR 67152, Sept. 30, 2016; 81 FR 95004, Dec. 27, 2016; 83 FR 48947, Sept. 28, 2018; 84 FR 12496, Apr. 2, 2019; 85 FR 18121, Apr. 1, 2020; 86 FR 14822, Mar. 19, 2021; 91 FR 20343, Apr. 16, 2026] § 558.198 Dichlorvos. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) Dichlorvos is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. If human or animal poisoning should occur, immediately consult a physician or a veterinarian. Atropine is antidotal. (3) Labeling for Type A articles and Type B feeds must include a statement that containers or materials used in packaging such Type A articles and Type B feeds are not to be reused and all such packaging materials must be destroyed after the product has been used. (e) Conditions of use. Dichlorvos Combination in grams/ton Indications for use Limitations Sponsor (i) 348 Swine up to 70 pounds body weight: For the removal and control of mature, immature, and/or fourth-stage larvae of the whipworm ( Trichuris suis Oesophagostomum Ascaris suum Ascarops strongylina Feed as sole ration for 2 consecutive days. For swine from 70 pounds to market weight, feed as sole ration at the rate of 8.4 pounds of feed per head until the medicated feed has been consumed. For boars, open or bred gilts, and sows, feed as sole ration at the rate of 4.2 pounds per head per day for 2 consecutive days. 054628 (ii) 479 Boars, open or bred gilts, and sows: For the removal and control of mature, immature, and/or fourth-stage larvae of the whipworm ( Trichuris suis Oesophagostomum Ascaris suum Ascarops strongylina Feed as sole ration at the rate of 6 pounds per head for one feeding. 054628 (iii) 334 to 500 Pregnant swine: An aid in improving litter production efficiency by increasing pigs born alive, birth weights, survival to market, and rate of weight gain. Treatment also removes and controls mature, immature and/or fourth stage larvae of whipworm ( Trichuris suis Oesophagostomum spp. Ascaris suum Ascarops strongylina Mix into a gestation feed to provide 1,000 milligrams per head daily during last 30 days of gestation. 054628 [84 FR 12497, Apr. 2, 2019] § 558.205 Diclazuril. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Chickens. Diclazuril Combination Indications for use Limitations Sponsor (i) 0.91 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), E. maxima. E. maxima E. maxima Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption 058198 (ii) 0.91 Bacitracin methylenedisalicylate, 4 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), E. maxima, E. maxima E. maxima Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter 058198 (iii) 0.91 Bambermycins, 1 to 2 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), E. maxima, E. maxima E. maxima Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter 058198 (2) Turkeys. Diclazuril Combination Indications for use Limitations Sponsor (i) 0.91 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, E. meleagrimitis Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption 058198 (ii) 0.91 Bacitracin methylenedisalicylate, 4 to 50 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, E. meleagrimitis, Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 058198 (iii) 0.91 Bambermycins 1 to 2 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, E. meleagrimitis, Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 058198 (iv) 0.91 Bambermycins 2 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, E. meleagrimitis, Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 058198 (3) Diclazuril may also be used in combination with virginiamycin as in § 558.635. [64 FR 35923, July 2, 1999, as amended at 65 FR 50134, Aug. 17, 2000; 66 FR 47962, 47963, Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR 34830, May 16, 2002; 67 FR 47257, July 18, 2002; 67 FR 48549, July 25, 2002; 69 FR 9947, Mar. 3, 2004; 72 FR 60552, Oct. 25, 2007; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95004, Dec. 27, 2016. Redesignated and amended at 84 FR 12497, 12498, Apr. 2, 2019; 87 FR 10970, Feb. 28, 2022] § 558.235 Efrotomycin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in swine Efrotomycin Indications for use Limitations Sponsor (1) 3.6 Swine: For improved feed efficiency Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds 000010 (2) 3.6 to 14.5 Swine: For increased rate of weight gain Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds 000010 [57 FR 38442, Aug. 25, 1992, as amended at 62 FR 63271, Nov. 28, 1997; 84 FR 33001, July 11, 2019; 84 FR 39185, Aug. 9, 2019; 85 FR 45309, July 28, 2020] § 558.248 Erythromycin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for erythromycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for erythromycin shall not be refilled. (e) Conditions of use Chickens Erythromycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 92.5 Chickens: As an aid in the prevention of chronic respiratory disease during periods of stress Feed for 2 days before stress and 3 to 6 days after stress. Withdraw 24 hours before slaughter 061623 (ii) 92.5 Chickens: As an aid in the prevention of infectious coryza Feed for 7 to 14 days. Withdraw 24 hours before slaughter 061623 (iii) 185 Chickens: As an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease (CRD) Feed for 5 to 8 days. Withdraw 48 hours before slaughter. Do not use in birds producing eggs for food 061623 (2) Turkeys Erythromycin thiocyanate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 92.5 Turkeys: As an aid in the prevention of chronic respiratory disease during periods of stress Feed for 2 days before stress and 3 to 6 days after stress 061623 (ii) 185 Turkeys: As an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease (CRD) Feed for 5 to 8 days. Do not use in birds producing eggs for food 061623 [41 FR 10999, Mar. 15, 1976, as amended at 45 FR 56799, Aug. 26, 1980; 49 FR 31281, Aug. 6, 1984; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 54 FR 12189, Mar. 24, 1989; 66 FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 79 FR 10982, Feb. 27, 2014; 81 FR 36790, June 8, 2016; 81 FR 95004, Dec. 27, 2016; 84 FR 8975, Mar. 13, 2019] § 558.254 Famphur. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use. Famphur amount Indications for use Limitations Sponsor (1) To provide 1.1 milligrams per pound (mg/lb) body weight per day Beef cattle and nonlactating dairy cattle: For control of grubs and as an aid in control of sucking lice Feed for 30 days. Withdraw from dry dairy cows and heifers 21 days prior to freshening. Withdraw 4 days prior to slaughter 000061 (2) To provide 2.3 mg/lb body weight per day Beef cattle and nonlactating dairy cattle: For control of grubs Feed for 10 days. Withdraw from dry dairy cows and heifers 21 days prior to freshening. Withdraw 4 days prior to slaughter 000061 [84 FR 39185, Aug. 9, 2019, as amended at 87 FR 17947, Mar. 29, 2022] § 558.258 Fenbendazole. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Turkeys. Amount fenbendazole in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (i) 14.5 Growing turkeys: For the treatment and control of gastrointestinal worms: roundworms, adults and larvae ( Ascaridia dissimilis Heterakis gallinarum Histomonas meleagridis Feed continuously as the sole ration for 6 days. For growing turkeys only 000061 (ii) [Reserved] (2) Swine. Fenbendazole Combination Indications for use Limitations Sponsor (i) 10 to 300 Swine: For the treatment and control of Lungworms: adult ( Metastrongylus apri M. pudendotectus Ascaris suum Oesophagostomum dentatum, O. quadrispinulatum Hyostrongylus rubidus Trichuris suis); Stephanurus dentatus Feed as the sole ration to provide 9 mg/kg of body weight (4.08 mg/lb) over a period of 3 to 12 consecutive days. Swine must not be slaughtered for human consumption within 4 days following last treatment with this drug product 000061 (ii) 10 to 300 (to provide 9 mg/kg of body weight) Bacitracin methylenedisalicylate, 10 to 30 Growing/finishing swine: For the removal and control of adult stage lungworms ( Metastrongylus apri M. pudendotectus Ascaris suum Oesophagostomum dentatum, O. quadrispinulatum Hyostrongylus rubidus Trichuris suis Stephanurus dentatus Feed as the sole ration. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iii) 10 to 300 (to provide 9 mg/kg of body weight) Bacitracin methylenedisalicylate, 250 1. Growing/finishing swine: For the removal and control of adult stage lungworms ( Metastrongylus apri M. pudendotectus Ascaris suum Oesophagostomum dentatum, O. quadrispinulatum Hyostrongylus rubidus Trichuris suis Stephanurus dentatus Treponema hyodysenteriae 1. Growing/finishing swine: Feed as sole ration. Not for use in growing and finishing swine that weigh more than 250 lbs. Diagnosis of swine dysentery should be confirmed by a veterinarian when results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 2. Pregnant sows: For the removal and control of adult stage lungworms ( Metastrongylus apri M. pudendotectus Ascaris suum Oesophagostomum dentatum, O. quadrispinulatum Hyostrongylus rubidus Trichuris suis Stephanurus dentatus Clostridium perfringens 2. Pregnant sows: Feed as sole ration. Diagnosis of clostridial enteritis should be confirmed by a veterinarian when results are not satisfactory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. (3) Cattle. Fenbendazole Indications for use Limitations Sponsor (i) 200 to 1,000 Dairy and beef cattle: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus Ostertagia ostertagi Haemonchus contortus H. placei Trichostrongylus axei Bunostomum phlebotomum Nematodirus helvetianus Cooperia punctata C. oncophora Trichostrongylus colubriformis Oesophagostomum radiatum Feed as the sole ration for 1 day to provide 5 mg/kg body weight (2.27 mg/lb). Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves 000061 (ii) [Reserved] (iii) Top dress medicated feed Proprietary formulas. Fenbendazole Indications for use Limitations Sponsor ( 1 Beef and dairy cattle: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus Ostertagia ostertagi Haemonchus contortus H. placei Trichostrongylus axei Bunostomum phlebotomum Nematodirus helvetianus Cooperia punctata and C. oncophora Trichostrongylus colubriformis Oesophagostomum radiatum Feed as a top dress for 1 day to provide 5 mg/kg body weight (2.27 mg/lb). Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves 000061 ( 2 (B) [Reserved] (iv) Free-choice medicated feeds Proprietary formulas (21 CFR 510.455(e)(2)). Fenbendazole Indications for use Limitations Sponsor ( 1 Beef cattle on pasture: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus Ostertagia ostertagi Haemonchus contortus H. placei Trichostrongylus axei Bunostomum phlebotomum Nematodirus helvetianus Cooperia punctata C. oncophora Trichostrongylus colubriformis Oesophagostomum radiatum Feed free-choice at the rate of 0.0375 lb per 100 pounds of body weight over a 3- to 6-day period to provide a total of 2.27 mg fenbendazole per pound of body weight. Not for use in dairy cattle. Beef cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves 000061 ( 2 Beef cattle on pasture: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus Ostertagia ostertagi Haemonchus contortus H. placei Trichostrongylus axei Bunostomum phlebotomum Nematodirus helvetianus Cooperia punctata C. oncophora Trichostrongylus colubriformis Oesophagostomum radiatum Feed free-choice at the rate of 0.10 lb (1.6 oz) per 100 pounds of body weight over a 3- to 6-day period, to deliver a total of 2.27 mg fenbendazole per pound of body weight. Not for use in dairy cattle. Beef cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves 000061 ( 3 Beef cattle: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus Ostertagia ostertagi Haemonchus contortus H. placei Trichostrongylus axei Bunostomum phlebotomum Nematodirus helvetianus Cooperia punctata C. oncophora Trichostrongylus colubriformis Oesophagostomum radiatum Feed free choice at a rate of 0.1 pound of block per 100 pounds of body weight per day for 3 days to deliver a total of 2.27 mg fenbendazole per pound of body weight. Cattle must not be slaughtered for human consumption within 16 days following last treatment with this drug product. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves 000061 ( 4 Beef cattle: For the treatment and control of: Lungworms: adult ( Dictyocaulus viviparus Ostertagia ostertagi Haemonchus contortus H. placei Trichostrongylus axei Bunostomum phlebotomum Nematodirus helvetianus Cooperia punctata C. oncophora Trichostrongylus colubriformis Oesophagostomum radiatum Feed free choice at a rate of 0.1 pound of block per 100 pounds of body weight per day for 3 days to deliver a total of 2.27 mg fenbendazole per pound of body weight. Cattle must not be slaughtered for human consumption within 11 days following last treatment with this drug product. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves 000061 (B) Published formulas (§ 510.455(e)(1) of this chapter). ( 1 Amount. Ingredient 1 Percent International Feed No. ( i Salt (sodium chloride) 59.00 6-04-152 Monosodium phosphate 31.16 6-04-288 Dried cane molasses 3.12 4-04-695 Zinc sulfate 0.76 6-05-556 Copper sulfate 0.45 6-01-720 Fenbendazole 20% Type A article 5.51 n/a ( ii Salt (sodium chloride) 35.93 6-04-152 Dicalcium phosphate (18.5% P) 32.44 6-00-080 Calcium carbonate (38% Ca) 15.93 6-01-069 Magnesium oxide (56% Mg) 10.14 6-02-756 Zinc sulfate 1.47 6-05-556 Mineral oil 1.00 8-03-123 Dried cane molasses (46% sugars) 0.98 4-04-695 Potassium iodide 0.01 6-03-759 Fenbendazole 20% Type A article 2.10 n/a ( iii 2 Cane molasses 3 80.902 4-13-251 Water 9.36 n/a Urea solution, 55% 7.05 5-05-707 Phosphoric acid 75% (feed grade) 2.00 6-03-707 Xantham gum 0.20 8-15-818 Trace minerals 4 0.20 n/a Vitamin premix 4 0.01 n/a Fenbendazole 20% Type A article 0.278 n/a 1 see 2 3 4 ( 2 Indications for use. ( 3 Limitations. (4) Horses. Fenbendazole Indications for use Limitations Sponsor (i) 4,540 5 mg/kg body weight (2.27 mg/lb) for the control of large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus Cyathostomum Cylicocyclus Cylicostephanus Oxyuris equi Parascaris equorum Feed at the rate of 0.1 lb of feed per 100 lb of body weight to provide 2.27 mg fenbendazole/lb of body weight in a 1-day treatment or 0.2 lb of feed per 100 lb of body weight to provide 4.54 mg fenbendazole/lb of body weight in a 1-day treatment. All horses must be eating normally to ensure that each animal consumes an adequate amount of the medicated feed. Do not use in horses intended for human consumption 000061 (ii) [Reserved] (5) Zoo and wildlife animals. Species/Class Fenbendazole Indications for use Limitations Sponsor (i) Feral swine ( Sus scrofa 90 to 325 For the treatment and control of kidney worm ( Stephanurus dentatus Ascaris suum Oesophagostomum dentatum Use as a complete feed at a rate to provide 3 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season 000061 (ii) Ruminants (subfamily Antilopinae, Hippotraginae, Caprinae) 50 to 300 For the treatment and control of small stomach worm ( Trichostrongylus Nematodirus Haemonchus Trichuris Use as a complete feed at a rate to provide 2.5 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season 000061 (iii) Rocky mountain bighorn sheep ( Ovis c. canadensis 375 to 1,000 For the treatment and control of Protostrongylus Use as a complete feed at a rate to provide 10 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season 000061 (iv) Wild quail 90.7 For the treatment and control of Gastrointestinal worms: cecal worms ( Aulonocephalus Feed for 21 consecutive days. Prior withdrawal of feed is not necessary 000061 (6) Fenbendazole may also be used in combination with: (i) [Reserved] (ii) Lincomycin as in § 558.325. [66 FR 58935, Nov. 26, 2001, as amended at 68 FR 34534, June 10, 2003; 72 FR 66046, Nov. 27, 2007; 73 FR 58873, Oct. 8, 2008; 74 FR 61517, Nov. 25, 2009; 79 FR 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, 2016; 84 FR 12499, Apr. 2, 2019; 86 FR 14822, Mar. 19, 2021; 87 FR 58964, Sept. 29, 2022; 88 FR 14904, Mar. 10, 2023; 89 FR 85428, Oct. 28, 2024] § 558.261 Florfenicol. (a) Specifications. (1) 40 grams per kilogram for use as in paragraph (e)(1) of this section. (2) 500 grams per kilogram for use as in paragraph (e)(2) of this section. (b) Sponsors. (1) No. 000061 for use of products described in paragraph (a) of this section as in paragraph (e) of this section. (2) No. 066104 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for florfenicol medicated feeds: (i) For swine must not exceed 90 days from the date of issuance. (ii) For fish must not exceed 6 months from the date of issuance. (3) VFDs for florfenicol shall not be refilled. (4) Type A medicated articles and medicated feeds intended for use in fish shall bear the following: “Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.” (e) Conditions of use Swine Florfenicol in grams/ton of feed Indications for use Limitations 182 For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae Pasteurella multocida Streptococcus suis Bordetella bronchiseptica Feed continuously as a sole ration for 5 consecutive days. The safety of florfenicol on swine reproductive performance, pregnancy, and lactation have not been determined. Feeds containing florfenicol must be withdrawn 13 days prior to slaughter. (2) Fish Florfenicol in grams/ton of feed Indications for use Limitations (i) 182 to 2,724 Catfish: For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri Feed as a sole ration for 10 consecutive days to deliver 10 to 15 milligrams (mg) florfenicol per kilogram (kg) of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. (ii) 182 to 2,724 Freshwater-reared salmonids: for the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum Aeromonas salmonicida Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. (iii) 182 to 2,724 Freshwater-reared finfish: For the control of mortality due to columnaris disease associated with Flavobacterium columnare Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish for freshwater-reared warmwater finfish and other freshwater-reared finfish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. (iv) 273 to 2,724 Freshwater-reared warmwater finfish: For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae Feed as a sole ration for 10 consecutive days to deliver 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. [70 FR 70047, Nov. 21, 2005, as amended at 71 FR 70304, Dec. 4, 2006; 72 FR 19798, Apr. 20, 2007; 72 FR 65885, Nov. 26, 2007; 77 FR 32012, May 31, 2012; 79 FR 18159, Apr. 1, 2014; 80 FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 67152, Sept. 30, 2016; 86 FR 14822, Mar. 19, 2021; 87 FR 10971, Feb. 28, 2022; 89 FR 85428, Oct. 28, 2024; 90 FR 6802, Jan. 21, 2025] § 558.265 Halofuginone. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (1) Chickens Halofuginone in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 2.72 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima Feed continuously as sole ration. Do not feed to layers. Withdraw 4 days before slaughter 016592 (ii) 2.72 Bacitracin methylenedisalicylate, 10 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima; Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter 016592 (iii) 2.72 Bambermycins, 1 to 2 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E, acervulina, E. brunetti, E. mivati, E. maxima; Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter 016592 (iv) 2.72 Replacement broiler breeder chickens and replacement cage laying chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati E. mitis, E. brunetti Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Do not feed to laying chickens or water fowl. Withdraw 4 days before slaughter 016592 (2) Turkeys Halofuginone in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 1.36 to 2.72 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, E. gallopavonis Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to layers or water fowl 016592 (ii) 1.36 to 2.72 Bacitracin methylenedisalicylate, 10 to 50 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, E. gallopavonis, Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl 016592 (iii) 1.36 to 2.72 Bambermycins, 2 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, E. gallopavonis, Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl 016592 (3) Halofuginone may also be used in combination with: (i) Lincomycin as in § 558.325. (ii) [Reserved] [50 FR 33719, Aug. 21, 1985, as amended at 50 FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR 1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54 FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, 1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; 66 FR 47962, Sept. 17, 2001; 71 FR 27956, May 15, 2006; 79 FR 10982, Feb. 27, 2014; 84 FR 8975, Mar. 13, 2019] § 558.274 Hygromycin B. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for hygromycin B medicated feeds must not exceed 6 months from the date of issuance. VFDs for hygromycin B shall not be refilled. (e) Conditions of use. (1) Chickens Hygromycin B grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 8 to 12 Chickens: For control of infections of large roundworms ( Ascaris galli Heterakis gallinae Capillaria obsignata Use in complete feed. Withdraw 3 days before slaughter 058198 (ii) [Reserved] (2) Swine Hygromycin B grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 12 Swine: For control of infections of large roundworms ( A. suis O. dentatum Trichuris suis In market hogs, use in complete feed for 8 weeks during the growing period. Withdraw 15 days before slaughter 058198 (ii) [Reserved] [81 FR 95005, Dec. 27, 2016] § 558.295 Iodinated casein. (a) Specifications. (b) Sponsor. See (c) Conditions of use Ducks Amount in grams/ton Indications for use Limitations Sponsor (i) 100 to 200 Growing ducks: For increased rate of weight gain 017762 (ii) [Reserved] (2) Dairy cows Amount in grams/pound Indications for use Limitations Sponsor (1) 0.5 to 1.5 per 100 lb of body weight Dairy cows: For increased milk production This drug is effective for limited periods of time, and the effectiveness is limited to the declining phase of lactation. Administration must be accompanied with increased feed intake. Administration may increase heat sensitivity of the animal 017762 (2) [Reserved] [85 FR 45309, July 28, 2020, as amended at 86 FR 14823, Mar. 19, 2021] § 558.300 Ivermectin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use in swine. Ivermectin in Combination in grams/ton Indications for use Limitations Sponsor (1) 1.8 Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms ( Ascaris suum, Ascarops strongylina, Hyostrongylus rubidus, Oesophagostomum Stephanurus dentatus, Metastrongylus Strongyloides ransomi, Haematopinus suis Sarcoptes scabiei suis Feed as the only feed for 7 consecutive days to provide 0.1 milligrams per kilograms (mg/kg) of body weight per day. Withdraw 5 days before slaughter 000010 (2) 1.8 Bacitracin methylenedisalicylate, 10 to 30 Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms ( Ascaris suum, Ascarops strongylina, Hyostrongylus rubidus, Oesophagostomum Stephanurus dentatus, Metastrongylus Strongyloides ransomi, Haematopinus suis Sarcoptes scabiei suis Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter 000010 (3) 1.8 Bacitracin methylenedisalicylate, 250 Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms ( Ascaris suum, Ascarops strongylina, Hyostrongylus rubidus, Oesophagostomum Stephanurus dentatus, Metastrongylus Strongyloides ransomi, Haematopinus suis Sarcoptes scabiei suis Treponema hyodysenteriae Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter 000010 (4) 1.8 to 11.8 Adult and breeding swine: For treatment and control of gastrointestinal roundworms ( Ascaris suum, Ascarops strongylina, Hyostrongylus rubidus, Oesophagostomum Stephanurus dentatus, Metastrongylus Strongyloides ransomi, Haematopinus suis Sarcoptes scabiei suis Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter 000010 (5) 1.8 to 11.8 Bacitracin methylenedisalicylate, 250 Pregnant sows: For treatment and control of gastrointestinal roundworms ( Ascaris suum, Ascarops strongylina, Hyostrongylus rubidus, Oesophagostomum Stephanurus dentatus, Metastrongylus Strongyloides ransomi, Haematopinus suis Sarcoptes scabiei suis Clostridium perfringens Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter. Feed bacitracin methylenedisalicylate Type C medicated feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours 000010 (6) 18.2 to 120 Adult and breeding swine: For treatment and control of gastrointestinal roundworms ( Ascaris suum, Ascarops strongylina, Hyostrongylus rubidus, Oesophagostomum Stephanurus dentatus, Metastrongylus Strongyloides ransomi, Haematopinus suis Sarcoptes scabiei suis Top dress on daily ration for individual treatment for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter 000010 [72 FR 37437, July 10, 2007, as amended at 81 FR 17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, 2016; 84 FR 12499, Apr. 2, 2019; 84 FR 39185, Aug. 9, 2019] § 558.305 Laidlomycin propionate potassium. (a) Specifications. (b) Sponsor. (c) Tolerances. (d) Special considerations. (i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. (2) The expiration date of the Type B liquid medicated feed is 21 days after date of manufacture. The expiration date for the dry Type C medicated feed made from the Type B liquid medicated feed is 7 days after date of manufacture. (3) Labeling for all Type B medicated feeds (liquid and dry) and Type C medicated feeds containing laidlomycin propionate potassium shall bear the following statements: (i) Do not allow horses or other equines access to feeds containing laidlomycin propionate potassium. (ii) The safety of laidlomycin propionate potassium in unapproved species has not been established. (iii) Not for use in animals intended for breeding. (e) Conditions of use. Laidlomycin propionate potassium in grams per ton Combination in grams/ton Indications for use Limitations Sponsor (1) 5 For increased rate of weight gain and improved feed efficiency Feed as the sole ration Type C medicated feeds to provide 30 to 75 mg laidlomycin propionate potassium per head per day 066104 (2) 5-10 For improved feed efficiency Feed as the sole ration Type C medicated feeds to provide 30 to 150 mg laidlomycin propionate potassium per head per day 066104 (f) Laidlomycin propionate potassium may also be used in combination with chlortetracycline as in § 558.128. [59 FR 18297, Apr. 18, 1994, as amended at 60 FR 53509, Oct. 16, 1995; 62 FR 9929, Mar. 5, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001; 68 FR 13839, Mar. 21, 2003; 68 FR 42590, July 18, 2003; 69 FR 30198, May 27, 2004; 79 FR 13545, Mar. 11, 2014; 81 FR 95005, Dec. 27, 2016; 86 FR 14823, Mar. 19, 2021; 91 FR 20343, Apr. 16, 2026; 91 FR 33072, June 3, 2026] § 558.311 Lasalocid. (a) Specifications. (b) Sponsor. (c) Related tolerance. (d) Special considerations. (i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. (2) A physically stable lasalocid liquid feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months. (3) If a manufacturer is unable to meet the requirements of paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure approval of a positionally stable liquid feed by: (i) Either filing a new animal drug application for the product or establishing a master file containing data to support the stability of its product; (ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental new animal drug application to establish physical stability; and (iii) Requesting the sponsor of an approved new animal drug application to file a supplement to provide for use of its lasalocid Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the supplemental new animal drug application will be approved. The approval will provide a basis for the individual liquid feed manufacturer to manufacture under a medicated feed license the liquid mediated feed described in the master file. A manufacturer who seeks to market a physically unstable lasalocid liquid feed with mixing directions different from the standard directions established in paragraph (d)(1) of this section may also follow this procedure. (4) If adequate information is submitted to show that a particular liquid feed containing lasalocid is stable outside the pH of 4.0 to 8.0, the pH restriction described in paragraphs (d)(1) and (d)(2) of this section may be waived. (5) Required label statements: (i) For liquid Type B feed (cattle and sheep): Mix thoroughly with grain and/or roughage prior to feeding. Feeding undiluted, mixing errors, or inadequate mixing (recirculation or agitation) may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. (ii) For Type A articles or Type B feeds (cattle and sheep): Feeding undiluted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. (iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (6) Lasalocid Type A medicated articles containing lasalocid dried fermentation residue are for use in cattle and sheep feed only. (7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(3)(vi) through (e)(3)(viii) of this section must be the subject of an approved NADA or supplemental NADA as provided in § 510.455 of this chapter. (e) Conditions of use. (1) The conditions of use for chickens are: Lasalocid in Combination in Indications for use Limitations Sponsor (i) 68 to 113 Broiler or fryer chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima. Feed continuously as the sole ration. 054771 (ii) 68 Bacitracin methylenedisalicylate, 10 to 50 Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima; Feed continuously as the sole ration. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iii) 68 to 113 Bacitracin methylenedisalicylate, 4 to 50 Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima; Feed continuously as the sole ration. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iv) 68 to 113 Bacitracin zinc, 4 to 50 Broiler chickens. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima; Feed continuously as the sole ration. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter. 054771 (v) 68 to 113 Bambermycins, 1 to 2 Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima; Feed continuously as sole ration. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter. 016592 (2) The conditions of use for turkeys are: Lasalocid in Combination in Indications for use Limitations Sponsor (i) 68 to 113 Growing turkeys; For prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, E. adenoeides. Feed continuously as sole ration. 054771 (ii) 68 to 113 Bacitracin methylenedisalicylate, 4 to 50 Growing turkeys: For prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, E. adenoeides; Feed continuously as the sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter. 054771 (iii) 68 to 113 Bacitracin zinc, 4 to 50 Growing turkeys: For prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, E. adenoeides; Feed continuously as the sole ration. Bacitracin zinc as provided by No. 054771 in § 510.600(c) in this chapter. 054771 (3) The conditions of use for cattle are— Lasalocid amount Indications for use Limitations Sponsor (i) 10 to 30 grams/ton of feed Cattle fed in confinement for slaughter: For improved feed efficiency. Feed continuously in complete feed to provide not less than 100 milligrams (mg) nor more than 360 mg of lasalocid sodium activity per head per day. 054771 (ii) 25 to 30 grams/ton of feed Cattle fed in confinement for slaughter: For improved feed efficiency and increased rate of weight gain. Feed continuously in complete feed to provide not less than 250 mg nor more than 360 mg of lasalocid sodium activity per head per day. 054771 (iii) Not less than 60 mg or more than 300 mg of lasalocid per head per day Pasture cattle (slaughter, stocker, feeder cattle, and beef replacement heifers): For increased rate of weight gain Feed continuously at a rate of not less than 60 mg or more than 300 mg of lasalocid per head per day when on pasture. The drug must be contained in at least 1 pound of feed. Daily intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day 054771 (iv) 1 mg lasalocid per 2.2 pounds (lb) body weight per day Cattle up to 800 lb: For control of coccidiosis caused by Eimeria bovis E. zuernii. Hand feed continuously at a rate of 1 mg of lasalocid per 2.2 lb body weight per day to provide not more than 360 mg of lasalocid per head per day. 054771 (v) 1 mg lasalocid per 2.2 lb body weight per day Replacement calves: For control of coccidiosis caused by E. bovis E. zuernii. In milk replacer powder, hand feed at a rate of 1 mg of lasalocid per 2.2 lb body weight per day. A withdrawal period has not been established for lasalocid in pre-ruminating calves. Do not use in calves to be processed for veal. 054771 (vi) 1,440 grams/ton Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. As a free-choice Type C medicated loose mineral, feed continuously at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day. 012286 (vii) 1,440 grams/ton Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. As a free-choice Type C medicated mineral block, feed continuously at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day. 017800 (viii) 300 grams/ton Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. As a free-choice Type C medicated protein block, feed continuously at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day. 067949 (ix) 60 to 300 mg of lasalocid per head per day Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and replacement beef and dairy heifers on pasture: For increased rate of weight gain Feed continuously as a Type C free-choice medicated feed at a rate of 60 to 300 mg of lasalocid per head per day. Daily intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day 054771 (4) The conditions of use for minor species are: Lasalocid in Indications for use Limitations Sponsor (i) 20 to 30 Sheep maintained in confinement: For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva, E. intricata. Feed continuously in complete feed to provide not less than 15 milligrams (mg) nor more than 70 mg of lasalocid sodium activity per head per day depending on body weight. 054771 (ii) 113 Chukar partridges: For prevention of coccidiosis caused by E. legionensis. Feed continuously as sole ration up to 8 weeks of age. 054771 (iii) 113 Rabbits: For prevention of coccidiosis caused by E. stiedae. Feed continuously as sole ration up to 6 1/2 weeks of age 054771 (5) It is used as a free-choice mineral Type C feed as follows: (i) Specifications. Ingredient Percent International feed No. Defluorinated phosphate (20.5% Ca, 18.5% P) 35.9 6-01-080 Sodium chloride (salt) 20.0 6-04-152 Calcium carbonate (38% Ca) 18.0 6-01-069 Cottonseed meal 10.0 5-01-621 Potassium chloride 3.0 6-03-755 Selenium premix (0.02 percent Se) 1 3.0 Dried cane molasses (46% sugars) 2.5 4-04-695 Magnesium sulfate 1.7 6-02-758 Vitamin premix 1 1.4 Magnesium oxide (58% Mg) 1.2 6-02-756 Potassium sulfate 1.2 6-06-098 Trace mineral premix 1 1.04 Lasalocid Type A medicated article (68 g/lb) 2 1.06 1 2 (ii) Amount. (iii) Indications for use. (iv) Limitations. (v) Sponsor. (6) It is used as a ruminant free-choice liquid Type C feed as follows: (i) Specifications. Ingredient Percent International feed No. Cane molasses 55.167 4-13-241 Condensed molasses fermentation solubles 24.0 50% Urea Solution (23% N) 12.0 Ammonium polyphosphate solution 1.0 6-08-42 Phosphoric acid (54%) 3.0 6-03-707 Xanthan gum 0.05 8-15-818 Water 4.0 Trace mineral premix 1 0.5 Vitamin premix 1 0.2 Lasalocid liquid Type A medicated article (90.7 g/lb) 2 0.083 1 2 (ii) Amount. (iii) Indications for use. (iv) Limitations. (v) Sponsor. (7) It is used as a free-choice, loose mineral Type C feed as follows: (i) Specifications. Ingredient Percent International feed No. Monocalcium phosphate (21% P) 57.70 6-01-082 Salt 17.55 6-04-152 Distillers dried grains w/ solubles 5.40 5-28-236 Dried cane molasses (46% Sugars) 5.20 4-04-695 Potassium chloride 4.90 6-03-755 Trace mineral/vitamin premix 1 3.35 Calcium carbonate (38% Ca) 2.95 6-01-069 Mineral oil 1.05 8-03-123 Magnesium oxide (58% Mg) 1.00 6-02-756 Iron oxide (52% Fe) 0.10 6-02-431 Lasalocid Type A medicated article (68 g/lb) 2 0.80 1 2 (ii) Amount. (iii) Indications for use. (iv) Limitations. (v) Sponsor. (8) Lasalocid may also be used in combination with: (i) Chlortetracycline as in § 558.128. (ii) Chlortetracycline and sulfamethazine as in § 558.140. (iii) Lincomycin as in § 558.325. (iv) Melengestrol as in § 558.342. (v) Oxytetracycline as in § 558.450. (vi) Tylosin alone or in combination with melengestrol acetate as in § 558.625. (vii) Virginiamycin as in § 558.635. [41 FR 44382, Oct. 8, 1976] Editorial Note: For Federal Register www.govinfo.gov. § 558.325 Lincomycin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for lincomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for lincomycin shall not be refilled. (3) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following: (i) “Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.” (ii) [Reserved] (4) Labeling of medicated feeds containing lincomycin intended for use in swine shall bear the following: (i) “Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.” (ii) “The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.” (e) Conditions of use Chickens Lincomycin Combination in grams/ton Indications for use Limitations Sponsors (i) 2 Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium Feed as the sole ration. Not for use in laying hens, breeder chickens, or turkeys 066104 (ii) [Reserved] (iii) 2 Clopidol, 113.5 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati, Clostridium Feed as the sole ration to broiler chickens. Do not feed to chickens over 16 weeks of age. Not for use in laying hens, breeder chickens, or turkeys. Consult a veterinarian or poultry pathologist if losses exceed 0.5% in a two-day period. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Clopidol as provided by No. 016592 in § 510.600 of this chapter 066104 (iv) 2 Decoquinate, 27.2 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. mivati, E. maxima, E. brunetti, Clostridium Feed as the sole ration. Do not feed to chickens producing eggs for human consumption. Do not use in feeds containing bentonite. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Decoquinate as provided by No. 066104 in § 510.600 of this chapter 066104 (v) 2 Halofuginone 2.72 Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima Feed continuously as sole ration. Withdraw 4 days before slaughter. Do not feed to laying chickens or waterfowl. Halofuginone hydrobromide as provided by No. 016592 in § 510.600 of this chapter 016592 (vi) 2 Lasalocid, 68 to 113 Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E maxima Feed as the sole ration. Type C feed must be used within 4 weeks of manufacture. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Lasalocid as provided by No. 054771 in § 510.600 of this chapter 054771 (vii) 2 Monensin, 90 to 110 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Clostridium Feed as the sole ration. Do not feed to chickens producing eggs for human consumption. Do not feed to chickens over 16 weeks of age. Not for use in laying hens, breeding chickens, or turkeys. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Not for broiler breeder replacement chickens. In the absence of coccidiosis in broiler chickens, the use of monensin with no withdrawal period may limit feed intake, resulting in reduced weight gain. Do not use this medicated feed after 90 days from the date of manufacture. Monensin as provided by No. 058198 in § 510.600 of this chapter 066104 (viii) 2 Robenidine hydrochloride, 30 Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, E. necatrix Feed as the sole ration. Do not use in feeds containing bentonite. Do not feed to laying hens producing eggs for human consumption. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Withdraw 5 days prior to slaughter. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Robenidine hydrochloride as provided by No. 054771 in § 510.600 of this chapter 054771 (ix) 2 Salinomycin sodium activity, 40 to 60 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E maxima, E. brunetti, E. mivati, Clostridium Feed as the sole ration to broiler chickens. Do not feed to chickens producing eggs for human consumption. Not for use in laying hens, breeding chickens, or turkeys. May be fatal if accidentally fed to adult turkeys or horses. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Do not use in Type C medicated feeds containing pellet binders. Salinomycin sodium activity as provided by No. 016592 in § 510.600 of this chapter 066104 (x) 2 Zoalene, 113.5 Broiler chickens: For prevention and control of coccidiosis and for the control of necrotic enteritis caused or complicated by Clostridium Feed as the sole ration from the time chicks are placed in floor pens until slaughtered for meat. Not for use in laying hens, breeding chickens, or turkeys. Consult a veterinarian or poultry pathologist if losses exceed 0.5% in a two-day period. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Zoalene as provided by No. 066104 in § 510.600 of this chapter 066104 (2) Swine Lincomycin Combination in grams/ton Indications for use Limitations Sponsors (i) 40 For the control of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis Feed as sole ration. For use in swine on premises with a history of swine dysentery but where symptoms have not yet occurred, or following use of lincomycin at 100 grams (g)/ton for the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) 066104 (ii) [Reserved] (iii) 40 Pyrantel, 96 For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; as an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum Oesophagostomum Feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (iv) 40 Pyrantel, 96 For the treatment and/or control of swine dysentery; for removal and control of large roundworm ( Ascaris suum Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (v) 40 or 100 Pyrantel, 96 For the treatment and/or control of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum Oesophagostomum For treatment of swine dysentery, feed 100 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed for 3 weeks or until clinical signs of the disease disappear, following with 40 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (vi) 40 Pyrantel, 800 For the treatment and/or control of swine dysentery; for removal and control of large roundworm ( Ascaris suum Oesophagostomum Feed as a single therapeutic treatment at a rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb and 5 lb of feed per head for animals over 200 lb. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. See paragraph (d) of this section. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (vii) 100 For the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis Feed as a sole ration for 3 weeks or until signs of disease (watery, mucoid, or bloody stools) disappear 066104 (viii) [Reserved] (ix) 100 Pyrantel, 96 For the treatment of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum Oesophagostomum Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (x) 100 Pyrantel, 96 For the treatment and/or control of swine dysentery; for removal and control of large roundworm ( Ascaris suum Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xi) 100 Pyrantel, 800 For the treatment and/or control of swine dysentery; for removal and control of large roundworm ( Ascaris suum Oesophagostomum Feed as a single therapeutic treatment. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xii) 100 to 200 For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae Feed as sole ration for 21 days 066104 (xiii) [Reserved] (xiv) 200 Pyrantel tartrate, 96 For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae; Ascaris suum Oesophagostomum Feed as the sole ration for 21 days. Not for use in swine that weigh more than 250 pounds. Withdraw 6 days before slaughter. Lincomycin as provided by No. 066104; pyrantel tartrate as provided by No. 066104 in § 510.600(c) of this chapter 066104 [81 FR 95005, Dec. 27, 2016, as amended at 82 FR 12170, Mar. 1, 2017; 82 FR 21691, May 10, 2017; 83 FR 13637, Mar. 30, 2018; 83 FR 14588, Apr. 5, 2018; 83 FR 48947, Sept. 28, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8976, Mar. 13, 2019; 84 FR 12501, Apr. 2, 2019; 84 FR 39185, Aug. 9, 2019; 86 FR 14824, Mar. 19, 2021; 88 FR 55570, Aug. 16, 2023; 91 FR 20344, Apr. 16, 2026] § 558.330 Lubabegron. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (1) Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. (2) Do not allow horses or other equines access to feed containing lubabegron. (3) A decrease in dry matter intake may be noticed in some animals receiving lubabegron. (e) Conditions of use. Lubabegron (as lubabegron fumarate) in grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 1.25 to 4.54 Beef steers and heifers fed in confinement for slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight during the last 14 to 91 days on feed Feed continuously as the sole ration to provide 13 to 90 mg lubabegron/head/day during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section. 058198 (ii) 1.25 to 4.54 Melengestrol acetate, 0.25 to 2 g/ton Growing beef heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and for reduction of ammonia gas emissions per pound of live weight and hot carcass weight during the last 14 to 91 days on feed Melengestrol acetate Type C top-dress medicated feed (0.5 to 2 lb(s) per head per day) must be top dressed onto or mixed at feeding with a Type C medicated feed containing 1.25 to 4.54 g/ton lubabegron to provide 0.25 to 0.5 mg melengestrol acetate and 13 to 90 mg lubabegron per head per day. Feed as the sole ration during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section and in § 558.342(d). Lubabegron fumarate as provided by No. 058198; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter. 058198 (iii) 1.25 to 4.54 Monensin, 5 to 40 Beef steers and heifers fed in confinement for slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight and for improved feed efficiency during the last 14 to 91 days on feed Feed continuously as sole ration to provide 13 to 90 mg lubabegron/head/day and 50 to 480 mg monensin/head/day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). See special labeling considerations in paragraph (d) of this section and in § 558.355(d). Lubabegron fumarate as provided by No. 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. 016592, 058198 (iv) 1.25 to 4.54 Monensin, 10 to 40 Beef steers and heifers fed in confinement for slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight; and for prevention and control of coccidiosis due to Eimeria bovis E. zuernii Feed continuously as the sole ration to provide 13 to 90 mg lubabegron/head/day and 0.14 to 0.42 mg monensin/lb body weight per day, depending upon severity of coccidiosis challenge, during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section and in § 558.355(d). Lubabegron fumarate as provided by No. 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. 016592, 058198 (v) 1.25 to 4.54 Monensin, 10 to 40 and melengestrol acetate, 0.25 to 2 Growing beef heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, and for the prevention and control of coccidiosis caused by Eimeria bovis Eimeria zuernii Melengestrol acetate Type C top-dress medicated feed (0.5 to 2 lb(s) per head per day) must be top dressed onto or mixed at feeding with a Type C medicated feed containing 1.25 to 4.54 g/ton lubabegron and 10 to 40 g/ton monensin, to provide 0.25 to 0.5 mg melengestrol acetate and 13 to 90 mg lubabegron per head per day, and 0.14 to 0.42 mg monensin per pound of body weight per day, depending upon severity of challenge, up to a maximum of 480 mg monensin per head per day. Feed as the sole ration during the last 14 to 91 days on feed. See special labeling considerations in paragraph (d) of this section, and in §§ 558.342(d) and 558.355(d). Lubabegron fumarate as provided by No. 058198; monensin as provided by No. 058198 or 016592; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter 058198, 016592 (2) Lubabegron may also be used in combination with: (i) [Reserved] (ii) Tylosin as in § 558.625. [84 FR 12501, Apr. 2, 2019, as amended at 84 FR 53311, Oct. 7, 2019; 88 FR 14905, Mar. 10, 2023; 88 FR 84701, Dec. 6, 2023; 90 FR 6802, Jan. 21, 2025; 91 FR 5301, Feb. 6, 2026] § 558.340 Maduramicin. (a) Specifications. (b) Sponsor. See (c) Tolerances. See (d) Conditions of use in chickens Amount in grams/ton Indications for use Limitations Sponsor (1) 4.54 to 5.45 Broiler chickens: For prevention of coccidiosis caused by Eimeria acervulina, E. tenella, E. brunetti, E. maxima, E. necatrix, E. mivati Feed continuously as sole ration. For broiler chickens only. Do not feed to laying hens. Withdraw 5 days before slaughter 054771 (2) [Reserved] [85 FR 45310, July 28, 2020] § 558.342 Melengestrol. (a) Specifications. (2) Liquid Type A medicated article containing 500 mg melengestrol acetate per pound. (b) Sponsor. (1) No. 054771 for use of products described in paragraph (a)(1) of this section: (2) Nos. 016592, 051311, 054771, and 058198 for use of product described in paragraph (a)(2) of this section. (c) Related tolerances. (d) Special considerations. (i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. (2) A physically stable melengestrol acetate liquid Type B or C feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months. (3) Liquid or dry combination Type B or C medicated feeds containing melengestrol acetate and lasalocid must be labeled in accordance with § 558.311(d). (4) Liquid or dry combination Type B or C medicated feeds containing melengestrol acetate and monensin must be labeled in accordance with § 558.355(d). (5) Liquid combination Type B or C medicated feeds containing melengestrol acetate and tylosin must be manufactured in accordance with § 558.625(d). (6) Liquid melengestrol acetate may not be mixed with oxytetracycline in a common liquid feed supplement. (e) Conditions of use Cattle. Melengestrol Combination Indications for use Limitations Sponsor (i) 0.25 to 0.5 Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). Administer 0.5 to 2.0 pounds (lb)/head/day of medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to provide 0.25 to 0.5 mg melengestrol acetate/head/day. 016592, 051311, 054771, 058198 (ii) 0.5 Heifers intended for breeding: For suppression of estrus (heat) Administer 0.5 to 2.0 lb/head/day of Type C feed containing 0.25 to 1.0 mg melengestrol acetate/lb to provide 0.5 mg melengestrol acetate/head/day. Do not exceed 24 days of feeding 016592, 051311, 054771, 058198 (iii) 0.25 to 0.5 Lasalocid, 10 to 30 Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for control of coccidiosis caused by Eimeria bovis Eimeria zuernii Add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 30 g of lasalocid per ton to provide 0.25 to 0.5 mg melengestrol acetate and 100 to 360 milligrams of lasalocid per head/day. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771, 058198 (iv) 0.25 to 0.5 Monensin, 10 to 40 Growing beef heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for the prevention and control of coccidiosis due to Eimeria bovis E. zuernii At the rate of 0.5 to 2.0 lb/head/day, a Type C top-dress medicated feed containing 0.25 to 2 g melengestrol acetate per ton must be top dressed onto or mixed at feeding with a Type C medicated feed containing 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg melengestrol acetate/head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/head/day. See § 558.355(d) of this chapter. Monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016952, 066104, or 058198 in § 510.600(c) of this chapter 016592 (2) Melengestrol may also be used in combination with: (i) Oxytetracycline as in § 558.450. (ii) Ractopamine as in § 558.500. (iii) Tylosin as in § 558.625. (iv) Zilpaterol as in § 558.665. [42 FR 28535, June 3, 1977] Editorial Note: For Federal Register www.govinfo.gov. § 558.348 Mibolerone. (a) Specifications. (b) Sponsor. See (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [85 FR 45310, July 28, 2020] § 558.355 Monensin. (a) Specifications. (b) Sponsors. (1) No. 058198 for use as in paragraph (e) of this section. (2) No. 016592 for use of a Type A medicated article containing 90.7 grams monensin, USP, per pound as in paragraphs (e)(1)(i), (e)(1)(ii), (e)(1)(vii), (e)(1)(xiv), (e)(2), (e)(3), (e)(4)(v), and (e)(5) of this section. (c) Related tolerances. (d) Special considerations. (2)-(3) [Reserved] (4) Liquid Type B feeds shall bear an expiration date of 8 weeks after its date of manufacture. (5) All Type A medicated articles containing monensin shall bear the following warning statement: When mixing and handling monensin Type A medicated articles, use protective clothing, impervious gloves, and a dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water. (6) All formulations containing monensin shall bear the following caution statement: Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. (7) Type A medicated articles containing monensin intended for use in cattle and goats shall bear, in addition to the caution statement in paragraph (d)(6) of this section, the following statements: (i) Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. (ii) Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. (iii) Must be thoroughly mixed in feeds before use. (iv) Do not feed undiluted. (v) Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. (vi) Do not feed to lactating goats. (vii) If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing (see paragraphs (d)(10)(i) and (d)(10)(ii) of this section). (viii) A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. (ix) You may notice the following: Reduced voluntary feed intake in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Rule out monensin as the cause of reduced feed intake before attributing to other causes such as illness, feed management, or the environment. Reduced milk fat percentage in dairy cows fed monensin. This reduction increases with higher doses of monensin fed. Increased incidence of cystic ovaries and metritis in dairy cows fed monensin. Reduced conception rates, increased services per animal, and extended days open and corresponding calving intervals in dairy cows fed monensin. Have a comprehensive and ongoing nutritional, reproductive, and herd health program in place when feeding monensin to dairy cows. (x) Inadequate mixing (recirculation or agitation) of monensin liquid Type B or Type C medicated feeds has resulted in increased monensin concentration which has been fatal to cattle and could be fatal to goats. (8) Type A medicated articles containing monensin intended for use in chickens, turkeys, and quail shall bear the following statements: (i) Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. (ii) Must be thoroughly mixed in feeds before use. (iii) Do not feed undiluted. (iv) Do not feed to laying chickens. (v) Do not feed to chickens over 16 weeks of age. (vi) Not for broiler breeder replacement chickens. (vii) Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. (viii) In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. (9) Type B feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in: (i) Cattle (as described in paragraphs (e)(3)(i) through (iii), (vi), and (vii); and (e)(4)(i) through (vi) of this section). (ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of this section). (iii) Goats (iv) Chickens (v) Turkeys: (vi) Quail (10) Type C feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in: (i) Cattle (as described in paragraphs (e)(3)(i) through (iii), (vi), and (vii); and (e)(4)(i) through (vi) of this section). (ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of this section). (iii) Goats (iv) Chickens (v) Turkeys (vi) Quail (11) Type B and Type C liquid feeds requiring recirculation or agitation that contain monensin and are intended for use in cattle (including dairy cows) and goats shall bear the caution statement specified in paragraph (d)(7)(x) of this section. (12) Mixing directions for liquid feeds requiring recirculation or agitation: (i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. (e) Conditions of use. (1) Chickens Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 90 to 110 Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima Feed continuously as the sole ration. Not for broiler breeder replacement chickens. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. 016592 (ii) 90 to 110 Laying hen replacement chickens and layer breeder replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima Feed continuously as the sole ration. Not for broiler breeder replacement chickens. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. 016592 (iii) 90 to 110 Bacitracin methylenedisalicylate, 4 to 50 Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter 054771 (iv) 90 to 110 Bacitracin methylenedisalicylate, 4 to 50 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed as the sole ration throughout the feeding period. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. In the absence of coccidiosis in broiler chickens, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Not for broiler breeder replacement chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter 069254 (v) 90 to 110 Bacitracin methylenedisalicylate, 4 to 50 Laying hen replacement chickens and layer breeder replacement chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed as the sole ration throughout the feeding period. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Not for broiler breeder replacement chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter 069254 (vi) 90 to 110 Bacitracin methylenedisalicylate, 4 to 50 Layer replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter 054771 (vii) 90 to 110 Bacitracin methylenedisalicylate, 5 to 25 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed as the sole ration. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section. 016592 (viii) 90 to 110 Bacitracin methylenedisalicylate, 50 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Clostridium perfringens Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. In the absence of coccidiosis in broiler chickens, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Not for broiler breeder replacement chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter 069254 (ix) 90 to 110 Bacitracin methylenedisalicylate, 50 Laying hen replacement chickens and layer breeder replacement chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Clostridium perfringens Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Not for broiler breeder replacement chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter 069254 (x) 90 to 110 Bacitracin methylenedisalicylate, 50 Broiler and layer replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Clostridium Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter 054771 (xi) 90 to 110 Bacitracin (as feed grade bacitracin zinc), 4 to 50 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed as the sole ration. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. In the absence of coccidiosis in broiler chickens, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Not for broiler breeder replacement chickens. Bacitracin zinc as provided by No. 054771 in 510.600(c) of this chapter 066104 (xii) 90 to 110 Bacitracin zinc, 10 Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter 058198 (xiii) 90 to 110 Bacitracin zinc, 10 to 30 Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter 058198 (xiv) 90 to 110 Bambermycins, 1 to 2 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed as the sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section. 016592 (2) Turkeys Monensin in Combination Indications for use Limitations Sponsor (i) 54 to 90 Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, E.gallopavonis For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Not for broiler breeder replacement chickens. Do not feed to laying hens. Do not feed to chickens over 16 weeks of age. Monensin may interfere with development of immunity to turkey coccidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. 016592 (ii) 54 to 90 Bacitracin methylenedisalicylate, 4 to 50 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, E. gallopavonis, Feed continuously as the sole ration. The optimum level depends upon the severity of coccidiosis exposure. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by Nos. 066104 or 069254 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section 016592 (iii) 54 to 90 Bacitracin methylenedisalicycate, 200 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, E. gallopavonis, Feed continuously as the sole ration. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter. 016592 (iv) 54 to 90 Bambermycins, 1 to 2 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, E. gallopavonis, Feed continuously as the sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section 016592 (v) 54 to 90 Bambermycins, 2 Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, E. gallopavonis, Feed continuously as sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section 016592 (3) Cattle Monensin in grams/ton Indications for use Limitations Sponsor (i) 5 to 40 Growing beef steers and heifers fed in confinement for slaughter: For improved feed efficiency Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). See special labeling considerations in paragraph (d) of this section 016592 (ii) 10 to 40 Growing beef steers and heifers fed in confinement for slaughter: For prevention and control of coccidiosis due to Eimeria bovis E. zuernii Feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day. See special labeling considerations in paragraph (d) of this section 016592 (iii) 10 to 200 Calves excluding veal calves: For prevention and control of coccidiosis due to Eimeria bovis E. zuernii Feed at a rate of 0.14 to 1.0 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 200 milligrams per head per day. See special labeling considerations in paragraph (d) of this section 016592 (iv) 11 to 22 Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) Feed continuously to dry and lactating dairy cows in a total mixed ration (“complete feed”). See special labeling considerations in paragraph (d) of this section 016592 (v) 11 to 400 Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake) Feed continuously to dry and lactating dairy cows in a component feeding system (including top dress). The Type C medicated feed must be fed in a minimum of 1 lb of feed to provide 185 to 660 mg/head/day monensin to lactating cows or 115 to 410 mg/head/day monensin to dry cows. See special labeling considerations in paragraph (d) of this section 016592 (vi) 15 to 400 Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria bovis E. zuernii For increased rate of weight gain, feed at a rate of 50 to 200 milligrams monensin per head per day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams per head per day every other day in not less than 2 pounds of feed. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending on severity of challenge, up to 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per day in not less than 1 pound of feed. See special labeling considerations in paragraph (d) of this section 016592 (vii) 25 to 400 Beef cows: For improved feed efficiency when receiving supplemental feed, and for the prevention and control of coccidiosis due to Eimeria bovis E. zuernii Feed as supplemental feed, either hand-fed in a minimum of 1 pound of feed or mixed in a total ration. For improved feed efficiency, feed continuously at a rate of 50 to 200 milligrams monensin per head per day. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milligrams per head per day in not less than 1 pound of feed. See special labeling considerations in paragraph (d) of this section 016592 (4) Free-choice cattle feeds Monensin Indications for use Limitations Sponsor (i) 150 milligrams per pound of protein-mineral block (0.033%) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and replacement beef heifers on pasture: For increased rate of weight gain, and for prevention and control of coccidiosis caused by Eimeria bovis E. zuernii Provide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds of block) per head per day, at least 1 block per 10 to 12 head of cattle. Roughage must be available at all times. Do not allow animals access to other protein blocks, salt or mineral, while being fed this product. See paragraph (d)(10)(i) of this section 012286 (ii) 175 milligrams per pound of protein-mineral block (0.038%) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter): For increased rate of weight gain Provide 40 to 200 milligrams of monensin (0.25 to 1.13 pounds or 4 to 18 ounces of block) per head per day, at least 1 block per 4 head of cattle. Do not allow cattle access to salt or mineral while being fed this product. Ingestion by cattle of monensin at levels of 600 milligrams per head per day and higher has been fatal. See paragraph (d)(10)(i) of this section 017800 (iii) 400 milligrams per pound of protein-mineral block (0.088%) Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain Provide 80 to 200 milligrams of monensin (0.2 to 0.5 pounds of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or minerals containing salt. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section 067949 (iv) 400 mg per pound of block Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and beef replacement heifers): for increased rate of weight gain Provide 50 to 200 mg of monensin (2 to 8 ounces of block) per head per day, in at least one block per five head of cattle. Feed blocks continuously. Do not feed salt of mineral supplements in addition to this block. Discontinue feeding if block consumption falls below 2 ounces or rises above 8 ounces daily. See paragraph (d)(10)(i) of this section. 086113 (v) 1,620 grams per ton of mineral granules as specified in paragraph (e)(4)(v)(A) of this section Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria bovis E. zuernii Feed at a rate of 50 to 200 milligrams per head per day. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with grain or other feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or water-deprived cattle should be adapted to the pasture and to unmedicated mineral supplement before using the monensin mineral supplement 016592 (A) Specifications. Ingredient Percent International feed No. Monocalcium phosphate (21% phosphorus, 15% calcium) 29.49 6-01-082 Sodium chloride (salt) 24.37 6-04-152 Dried cane molasses 20.0 4-04-695 Ground limestone (33% calcium) or calcium carbonate (38% calcium) 13.75 6-02-632 Cane molasses 3.0 4-04-696 Processed grain by-products (as approved by AAFCO) 5.0 Vitamin/trace mineral premix 1 2.5 Monensin Type A article, 90.7 grams per pound 2 0.89 Antidusting oil 1.0 1 2 (B) [Reserved] (5) Minor species Monensin in Indications for use Limitations Sponsor (i) 73 Growing bobwhite quail: For the prevention of coccidiosis caused by Eimeria dispersa E. lettyae Feed continuously as sole ration. Not for broiler breeder replacement chickens. Do not feed to laying hens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. 016592 (ii) 20 Goats maintained in confinement: For the prevention of coccidiosis caused by Eimeria crandallis, E. christenseni, E. ninakohlyakimovae Feed continuously. Do not feed to lactating goats. See paragraph (d)(11) of this section for provisions for monensin liquid Type C goat feeds. 016592 (6) Monensin may also be used in combination with: (i) Avilamycin as in § 558.68. (ii) Chlortetracycline as in § 558.128. (iii) Decoquinate as in § 558.195. (iv) Lubabegron as in § 558.330. (v) Lincomycin as in § 558.325. (vi) Melengestrol acetate as in § 558.342. (vii) Oxytetracycline as in § 558.450. (viii) Ractopamine as in § 558.500. (ix) Tilmicosin as in § 558.618. (x) Tylosin as in § 558.625. (xi) Virginiamycin as in § 558.635. (xii) Zilpaterol alone or in combination as in § 558.665. [40 FR 13959, Mar. 27, 1975] Editorial Note: For Federal Register www.govinfo.gov. § 558.360 Morantel. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. (e) Conditions of use. Morantel tartrate in grams/ton Indications for use Limitations Sponsor (1) 0.44 to 4.4 grams of morantel tartrate per pound of feed Cattle: For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms ( Haemonchus Ostertagia Trichostrongylus Cooperia Trichostrongylus Nematodirus Oesophagostomum radiatum Feed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat cattle within 14 days of slaughter 066104 (2) 0.44 to 4.4 grams of morantel tartrate per pound of feed Goats: For removal and control of mature gastrointestinal nematode infections of goats including Haemonchus contortus, Ostertagia (Teladorsagia) circumcincta, Trichostrongylus axei Feed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat goats within 30 days of slaughter 066104 [84 FR 39185, Aug. 9, 2019] § 558.363 Narasin. (a) Specifications. (b) Sponsor. (c) Tolerances. (d) Special considerations. (e) Conditions of use. (1) Chickens Narasin Combination in grams/ton Indications for use Limitations Sponsor (i) 54 to 90 Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal 058198 (ii) 54 to 72 Bacitracin (as feed grade bacitracin methylenedisalicylate), 10 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed as the sole ration. The narasin concentration should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter 066104 (iii) 54 to 90 Bacitracin (as feed grade bacitracin methylenedisalicylate), 4 to 50 Broiler chickens: For increased rate of weight gain and improved feed efficiency, and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima Feed as the sole ration throughout the feeding period. The narasin concentration should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 069254 in § 510.600(c) of this chapter 069254 (iv) 54 to 90 Bacitracin (as feed grade bacitracin methylenedisalicylate), 50 Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. The narasin concentration should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 069254 in § 510.600(c) of this chapter 069254 (v) 54 to 72 Bacitracin (as feed grade bacitracin zinc), 4 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed as the sole ration. The narasin concentration should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter 066104 (vi) 54 to 72 Bambermycins, 1 to 2 Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 016592 (2) Swine Narasin Combination in grams/ton Indications for use Limitations Sponsor (i) 13.6 to 27.2 Growing-finishing swine: For increased rate of weight gain when fed for at least 4 weeks Feed continuously for at least 4 weeks to swine during the growing-finishing period as the sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins ( e.g. 058198 (ii) 18.1 to 27.2 Growing-finishing swine: For increased rate of weight gain and improved feed efficiency when fed for at least 4 weeks Feed continuously for at least 4 weeks to swine during the growing-finishing period as the sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins ( e.g. 058198 (3) Narasin single-ingredient Type A medicated articles may also be used in combination with: (i) Avilamycin as in § 558.68. (ii) [Reserved] [83 FR 64741, Dec. 18, 2018, as amended at 86 FR 14825, Mar. 19, 2021; 91 FR 20345, Apr. 16, 2026] § 558.364 Narasin and nicarbazin. (a) Specifications. (b) Sponsor. (c) Tolerances. (d) Conditions of use. (1) Chickens Narasin and Combination in grams/ton Indications for use Limitations Sponsor (i) 27 to 45 of each drug Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. The two drugs can be combined only at a 1:1 ratio for the 27 to 45 grams per ton range. Only granular nicarbazin as provided by No. 058198 in § 510.600(c) of this chapter may be used in the combination 058198 (ii) 27 to 45 of each drug Bacitracin methylenedisalicylate, 4 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Withdraw 5 days before slaughter. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 058198 (iii) 27 to 45 of each drug Bacitracin methylenedisalicylate, 4 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Feed as the sole ration throughout the feeding period. For broiler chickens only. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 069254 in § 510.600(c) of this chapter 069254 (iv) 27 to 45 of each drug Bacitracin methylenedisalicylate, 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati, Clostridium Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Withdraw 5 days before slaughter. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (v) 27 to 45 of each drug Bacitracin methylenedisalicylate, 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima, Clostridium perfringens Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. For broiler chickens only. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 069254 in § 510.600(c) of this chapter 069254 (vi) 27 to 45 of each drug Bacitracin methylenedisalicylate, 100 to 200 Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati, Clostridium To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (vii) 27 to 45 of each drug Bambermycins, 1 to 2 Broiler chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella E. acervulina, E. maxima, E. necatrix, E. brunetti Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 058198 (2) Narasin and nicarbazin fixed-ratio, combination drug Type A medicated articles may also be used in combination with: (i) Avilamycin as in § 558.68. (ii) Virginiamycin as in § 558.635. [83 FR 64742, Dec. 18, 2018, as amended at 84 FR 8981, Mar. 13, 2019; 88 FR 14907, Mar. 10, 2023; 88 FR 16550, Mar. 20, 2023] § 558.365 Neomycin sulfate. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for neomycin shall not be refilled. (e) Conditions of use. Neomycin Sulfate Combination Indications for Use Limitations Sponsor (1) 250 to 2,250 grams per ton (g/t) of dry type C feed. Cattle, swine, sheep, and goats. For treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli To provide 10 milligrams (mg) of neomycin sulfate per pound of body weight per day for a maximum of 14 days. The concentration of neomycin sulfate required in medicated feed must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects feed consumption. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in dry feeds only. Not for use in liquid feed supplements. 054771 (2) 400 to 2,000 g/t of type C milk replacer. Do. To provide 10 mg of neomycin sulfate per pound of body weight per day for a maximum of 14 days. Amount consumed will vary depending on animal's consumption and weight. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in milk replacers only. 054771 [64 FR 70576, Dec. 17, 1999, as amended at 65 FR 45881, July 26, 2000; 79 FR 13545, Mar. 11, 2014; 81 FR 95009, Dec. 27, 2016. Redesignated at 83 FR 64742, Dec. 18, 2018] § 558.366 Nicarbazin. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use. (1) Chickens Nicarbazin in Combination Indications for use Limitations Sponsor (i) 90.8 to 181.6 Chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella E. acervulina, E. maxima, E. necatrix, E. brunetti Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton 066104 (ii) 90.8 to 181.6 Bacitracin methylenedisalicylate, 4 to 50 Broiler chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella E. acervulina, E. maxima, E. necatrix, E. brunetti Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iii) 90.8 to 181.6 Bacitracin methylenedisalicylate, 30 Broiler chickens; As an aid in preventing outbreaks of cecal ( Eimeria tenella E. acervulina, E. maxima, E. necatrix, E. brunetti Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 066104 (iv) 90.8 to 181.6 Bacitracin methylenedisalicylate 50 Broiler chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella E. acervulina, E. maxima, E. necatrix, E. brunetti Clostridium Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (v) 113.5 Chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella E. acervulina, E. maxima, E. necatrix, E. brunetti Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter 060728 (vi) 113.5 Bacitracin methylenedisalicylate, 30 Broiler chickens; aid in preventing outbreaks of cecal ( Eimeria tenella E. acervulina, E. maxima, E. necatrix, E. brunetti Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 060728 (vii) 113.5 Bacitracin zinc, 4 to 50 Broiler chickens; aid in preventing outbreaks of cecal ( Eimeria tenella E. acervulina, E. maxima, E. necatrix, E. brunetti For broiler chickens only. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. Nicarbazin as provided by No. 066104, bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter 054771 (viii) 113.5 Bambermycins, 1 to 2 Broiler chickens: As an aid in preventing outbreaks of cecal ( Eimeria tenella E. acervulina, E. maxima, E. necatrix, E. brunetti Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. Nicarbazin as provided by No. 066104; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 016592 (2) Nicarbazin single-ingredient Type A medicated articles may also be used in combination with: (i) [Reserved] (ii) Virginiamycin as in § 558.635. [83 FR 64743, Dec. 18, 2018, as amended at 86 FR 14825, Mar. 19, 2021; 88 FR 14907, Mar. 10, 2023; 88 FR 55570, Aug. 16, 2023] § 558.415 Novobiocin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (1) Chickens Novobiocin amount Indications for use Limitations Sponsor (i) To provide 6 to 7 milligrams per pound (mg/lb) of body weight per day. Chickens: As an aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin. Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying chickens. Withdraw 4 days before slaughter. 054771 (ii) To provide 10 to 14 mg/lb of body weight per day. Chickens: For the treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin. Administer feed which contains not less than 350 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying chickens. Withdraw 4 days before slaughter. 054771 (2) Turkeys Novobiocin amount Indications for use Limitations Sponsor (i) To provide 4 to 5 mg/lb of body weight per day. Turkeys: As an aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin. Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw 4 days before slaughter. 054771 (ii) To provide 5 to 8 mg/lb of body weight per day. Turkeys: As an aid in the control of recurring outbreaks of fowl cholera caused by strains of Pasteurella multocida Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw 4 days before slaughter. 054771 (iii) To provide 7 to 8 mg/lb of body weight per day. Turkeys: For the treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin; and treatment of acute outbreaks of fowl cholera caused by strains of Pasteurella multocida Administer feed which contains not less than 350 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw 4 days before slaughter. 054771 (3) Minor species Novobiocin amount Indications for use Limitations Sponsor (i) 350 grams per ton. Ducks: For the control of infectious serositis and fowl cholera in ducks caused by Pasteurella anatipestifer P. multocida, Administer as the sole ration for 5 to 7 days. Continue medication for 14 days if necessary. Repeat if reinfection occurs. Discontinue use at least 3 days before slaughter. Not for use in laying ducks. 054771 (ii) To provide 20 mg/lb of body weight per day. Mink: For the treatment of generalized infections, abscesses, or urinary infections caused by staphylococcal or other novobiocin sensitive organisms. Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 7 days. 054771 [40 FR 13959, Mar. 27, 1975, as amended at 45 FR 42263, June 24, 1980; 51 FR 7399, Mar. 3, 1986; 52 FR 36402, Sept. 29, 1987; 79 FR 13545, Mar. 11, 2014; 84 FR 12501, Apr. 2, 2019] § 558.430 Nystatin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount in grams/ton Indications for use Limitations Sponsor (1) 50 Growing and laying chickens and growing turkeys: As an aid in the control of crop mycosis and mycotic diarrhea ( Candida albicans 054771 (2) 100 Growing and laying chickens and growing turkeys: For the treatment of crop mycosis and mycotic diarrhea ( Candida albicans To be fed for 7 to 10 days 054771 [41 FR 11002, Mar. 15, 1976, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 53 FR 40729, Oct. 18, 1988; 55 FR 8461, Mar. 8, 1990; 57 FR 8578, Mar. 11, 1992; 79 FR 13545, Mar. 11, 2014; 85 FR 45310, July 28, 2020] § 558.450 Oxytetracycline. (a) Specifications. (1) Oxytetracycline (from oxytetracycline quaternary salt) equivalent to 50 or 100 grams oxytetracycline hydrochloride; or oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 30, 50, 100, or 200 grams oxytetracycline hydrochloride. (2) Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams oxytetracycline hydrochloride. (b) Sponsors. (1) No. 066104: Type A medicated articles as in paragraph (a)(1) of this section. (2) No. 069254: Type A medicated articles as in paragraph (a)(2) of this section. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled. (3) In accordance with § 558.5, labeling shall bear the statement: “For use in dry animal feed only. Not for use in liquid feed supplements.” (e) Conditions of use Chickens Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 100 to 200 g/ton Chickens: For control of infectious synovitis caused by Mycoplasma synoviae Pasteurella multocida Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period 066104 (ii) 200 g/ton Monensin, 90 to 110 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima; Mycoplasma gallisepticum Escherichia coli Feed continuously as the sole ration. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (iii) 400 g/ton Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum Escherichia coli Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period 066104 (iv) 400 g/ton Robenidine, 30 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima; Mycoplasma gallisepticum Escherichia coli Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 5 days before slaughter. Oxytetracycline as provided by No. 066104; robenidine as provided by No. 054771 in § 510.600(c) of this chapter 066104 (v) 500 g/ton Chickens: For reduction of mortality due to air sacculitis (air sac infection) caused by E. coli Feed continuously for 5 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter 066104 (vi) 500 g/ton Monensin, 90 to 100 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima; Escherichia coli Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter. Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (vii) 500 g/ton Salinomycin, 40 to 60 Chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima; E. coli Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter. Oxytetracycline as provided by No. 066104; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter 066104 (2) Turkeys Oxytetracycline amount Indications for use Limitations Sponsor (i) 100 g/ton Turkeys: For control of hexamitiasis caused by Hexamita meleagridis Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. Zero-day withdrawal period 066104 (ii) 200 g/ton Turkeys: For control of infectious synovitis caused by M. synoviae Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period 066104 (iii) 25 mg/lb of body weight daily Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period 066104 (3) Swine Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily Swine: For treatment of bacterial enteritis caused by E. coli Salmonella choleraesuis Pasteurella multocida Feed continuously for 7 to 14 days 066104 (ii) 10 mg/lb of body weight daily Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona Feed continuously for not more than 14 days 066104 (iii) 10 mg/lb of body weight daily Carbadox, 10 to 25 Swine: For treatment of bacterial enteritis caused by E. coli Salmonella choleraesuis Pasteurella multocida Feed continuously as the sole ration for 7 to 14 days. Not for use in pregnant swine or swine intended for breeding purposes. Do not mix in feeds containing bentonite. Do not feed to swine within 42 days of slaughter. Oxytetracycline and carbadox as provided by No. 066104 in § 510.600(c) of this chapter 066104 (4) Cattle Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida Feed continuously for 7 to 14 days. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period 066104 (ii) 10 mg/lb of body weight daily Calves: For treatment of bacterial enteritis caused by E. coli Feed continuously for 7 to 14 days in milk replacer or starter feed. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period 066104 (iii) 75 mg/head/day Growing cattle (over 400 lb): For reduction of incidence of liver abscesses Feed continuously. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows 066104 (iv) 75 mg/head/day Lasalocid 25 to 30 Heifers fed in confinement for slaughter (over 400 lb): For reduction of incidence of liver abscesses; and for increased rate of weight gain and improved feed efficiency Feed continuously to provide 250 to 360 mg lasalocid and 75 mg of oxytetracycline per head per day. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (v) 75 mg/head/day Melengestrol acetate, 0.25 to 2.0 Heifers fed in confinement for slaughter (over 400 lb): For reduction of incidence of liver abscesses; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Feed continuously to provide 0.25 to 0.5 mg of melengestrol acetate and 75 mg of oxytetracycline per head per day. Melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771 (vi) 0.5 to 2.0 g/head/day Cattle: For prevention and treatment of the early stages of shipping fever complex Feed 3 to 5 days before and after arrival in feedlots. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows 066104 (5) Minor species Oxytetracycline amount Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily Sheep: For treatment of bacterial enteritis caused by E. coli P. multocida Feed continuously for 7 to 14 days; withdraw 5 days before slaughter 066104 (ii) 200 mg/colony as a dust (200 mg/oz) or syrup (200 mg/5 lb) Honey bees: For control of American foulbrood caused by Paenibacillus larvae Melissococcus plutonius Apply every 4 to 5 days for a total of three applications. Remove at least 6 weeks prior to main honey flow 066104 (iii) 800 mg/colony as an extender patty (800 mg/patty) Honey bees: For control of American foulbrood caused by Paenibacillus larvae Melissococcus plutonius Use as a single application. Remove at least 6 weeks prior to main honey flow 066104 (iv) 333 to 7,500 g/ton to provide 2.5 to 3.75 g/100 lb of fish/day 1. Freshwater-reared salmonids: for control of ulcer disease caused by Haemophilus piscium, Aeromonas salmonicida, A. hydrophila, Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed 066104 2. Catfish: for control of bacterial hemorrhagic septicemia caused by A. hydrophila Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water temperature is below 16.7 °C (62 °F) 066104 (v) 500 to 7,500 g/ton to provide 3.75 g/100 lb of fish/day 1. Freshwater-reared salmonids: for control of mortality due to coldwater disease associated with Flavobacterium psychrophilum Flavobacterium columnare Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed 066104 2. Freshwater-reared salmonids weighing up to 55 grams: for marking of the skeletal tissue Feed for 10 days. Immediate release is permitted following last feeding of medicated feed 066104 3. Catfish: for control of mortality due to columnaris disease associated with Flavobacterium columnare Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water temperature is below 16.7 °C (62 °F) 066104 (vi) 1.25 to 25 g/kg to provide 11.35 g/100 lb of fish/day Pacific salmon not over 30 grams body weight: for marking of the skeletal tissue Administer medicated feed as the sole ration for 4 consecutive days. Do not liberate for at least 7 days following last feeding of medicated feed 066104 (vii) 1 g/lb of medicated feed Lobsters: For control of gaffkemia caused by Aerococcus viridans Administer as sole ration for 5 consecutive days; withdraw medicated feed 30 days before harvesting lobsters 066104 [81 FR 95009, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 83 FR 48948, Sept. 28, 2018; 84 FR 12502, Apr. 2, 2019; 86 FR 14825, Mar. 19, 2021; 87 FR 10972, Feb. 28, 2022; 87 FR 76423, Dec. 14, 2022; 88 FR 14907, Mar. 10, 2023; 88 FR 55571, Aug. 16, 2023; 89 FR 85429, Oct. 28, 2024] § 558.455 Oxytetracycline and neomycin. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for oxytetracycline and neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline and neomycin shall not be refilled. (3) Cattle feeds shall bear the following warning statement: “Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.” (e) Indications for use Chickens. Oxytetracycline and neomycin sulfate amount in grams per ton of feed Indications for use Limitations Sponsors (i) 100 to 200 Chickens: For control of infectious synovitis caused by Mycoplasma synoviae Pasteurella multocida Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feed, withdraw 3 d before slaughter. 066104 (ii) 400 Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum Escherichia coli Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feeds, withdraw 3 d before slaughter. 066104 (iii) 500 Chickens: For reduction of mortality due to air sacculitis (air-sac- infection) caused by E. coli Feed continuously for 5 d; do not feed to chickens producing eggs for human consumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter. 066104 (2) Turkeys. Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors (i) 100 g/ton of feed Turkeys: For control of hexamitiasis caused by Hexamita meleagridis Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption. 066104 (ii) 200 g/ton of feed Turkeys: For control of infectious synovitis caused by M. synoviae Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not feed to turkeys producing eggs for human consumption. 066104 (iii) To provide 25 milligrams per pound (mg/lb) of body weight daily. Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline. Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not feed to turkeys producing eggs for human consumption. 066104 (3) Swine. Oxytetracycline and neomycin sulfate amount Limitations Sponsors (i) To provide 10 mg/lb of body weight daily Swine: For treatment of bacterial enteritis caused by E. coli Salmonella choleraesuis P. multocida E. coli Feed continuously for 7 to 14 d; withdraw 5 d before slaughter 066104 (ii) To provide 10 mg/lb of body weight daily Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona Feed continuously for not more than 14 d; withdraw 5 d before slaughter 066104 (4) Cattle. Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors (i) To provide 10 mg/lb of body weight daily Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by E. coli P. multocida E. coli Feed continuously for 7 to 14 d; in feed or milk replacers. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter 066104 (ii) To provide 10 mg/lb of body weight daily Calves (up to 250 lb): For treatment of bacterial enteritis caused by E. coli E. coli Feed continuously for 7 to 14 d; in milk replacers or starter feed. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter 066104 (iii) To provide 75 mg/head/day Growing cattle (over 400 lb): For the reduction of the incidence of liver abscesses Feed continuously 066104 (iv) To provide 0.5 to 2.0 g/head/ day Cattle: For prevention and treatment of the early stages of shipping fever complex Feed 3 to 5 d before and after arrival in feedlots. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older 066104 (5) Sheep. Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors (i) To provide 10 mg/lb of body weight daily Sheep: For treatment of bacterial enteritis caused by Escherichia coli Pasteurella multocida E. coli Feed continuously for 7 to 14 days. Treatment should continue 24 to 48 hours beyond remission of clinical signs of disease. Withdraw 5 days before slaughter 066104 (ii) [Reserved] [71 FR 16225, Mar. 31, 2006, as amended at 74 FR 40724, Aug. 13, 2009; 80 FR 13232, Mar. 13, 2015; 81 FR 95012, Dec. 27, 2016; 87 FR 76423, Dec. 14, 2022; 88 FR 27701, May 3, 2023] § 558.464 Poloxalene. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (2) Poloxalene dry Type A article and liquid Type A article must be thoroughly blended and evenly distributed in feed prior to use. This may be accomplished by adding the Type A article to a small quantity of feed, mixing thoroughly, then adding this mixture to the remaining feed and again mixing thoroughly. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily and continued during exposure to bloat producing conditions. If bloating conditions are severe, the dose is doubled. Treatment should be started 2 to 3 days before exposure to bloat-producing conditions. Repeat dosage if animals are exposed to bloat-producing conditions more than 12 hours after the last treatment. Do not exceed the higher dosage levels in any 24-hour period. [40 FR 39857, Aug. 29, 1975, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 56 FR 50654, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 79 FR 13545, Mar. 11, 2014; 84 FR 33001, July 11, 2019] § 558.470 Polyoxyethylene. (a) Specifications. (b) Sponsor. (c) [Reserved] (d) Conditions of use Amount. (2) Indications for use. (3) Limitations. [86 FR 14826, Mar. 19, 2021] § 558.485 Pyrantel. (a) Specifications. (b) Sponsors. (1) No. 066104: 48 and 80 grams per pound for use as in paragraph (e)(1) of this section. (2) Nos. 017135 and 054771: 48 grams per pound for use as in paragraph (e)(2) of this section. (c) Related tolerances. (d) Special considerations. (2) Do not mix in Type B or Type C medicated feeds containing bentonite. (e) Conditions of use Swine Pyrantel Indications for use Limitations Sponsor (i) 96 Swine: As an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum Oesophagostomum Feed continuously as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter 066104 (ii) 96 Swine: For the removal and control of large roundworm ( Ascaris suum Feed for 3 days as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter 066104 (iii) 800 Swine: For the removal and control of large roundworm ( Ascaris suum Oesophagostomum Feed as the sole ration for a single therapeutic treatment in Type C feed at a rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb, and 5 lb of feed per head for animals 200 lb or over. Withdraw 24 hours prior to slaughter 066104 (2) Horses Pyrantel tartrate Indications for use Limitation Sponsor (i) 120 to 1,200 to provide 1.2 mg/lb body weight For prevention of Strongylus vulgaris S. vulgaris, S. edentatus Cyathostomum Cylicocyclus Cylicostephanus Cylicodontophorus Poteriostomum Triodontophorus Oxyuris equi Parascaris equorum Feed continuously as the horse's daily grain ration during the time that the animal is at risk of exposure to internal parasites. Do not use in horses intended for human consumption. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism 017135 (ii) Top dress medicated feed Proprietary Formulas. Pyrantel tartrate amount Indications for use Limitations Sponsor ( 1 Prevention of Strongylus vulgaris S. vulgaris, S. edentatus Cyathostomum Cylicocyclus Cylicostephanus Cylicodontophorus Poteriostomum Triodontophorus Oxyuris equi Parascaris equorum Feed continuously as a top dress during the time that the animal is at risk of exposure to internal parasites. Do not use in horses intended for human consumption. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism 017135 ( 2 (B) [Reserved] (3) Pyrantel may also be used in combination with: (i) Carbadox as in § 558.115. (ii) Lincomycin as in § 558.325. (iii) Tylosin as in § 558.625. [83 FR 48948, Sept. 28, 2018, as amended at 83 FR 64744, Dec. 18, 2018; 86 FR 14826, Mar. 19, 2021; 89 FR 42360, May 15, 2024] § 558.500 Ractopamine. (a) Specifications. (b) Sponsors. (1) Nos. 016592 and 058198: Type A medicated articles containing 9 or 45.4 grams per pound (g/lb) ractopamine hydrochloride. (2) Nos. 051311 and 066104: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride. (c) Related tolerances. (d) Special considerations. (2) Labeling of Type A medicated articles and Type B and Type C medicated feeds intended for swine shall bear the following: (i) “No increased benefit has been shown when ractopamine hydrochloride concentrations in the diet are greater than 4.5 g/ton (5 ppm).” (ii) “Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride.” (iii) “Additional Recommendations: To help mitigate the signs identified in the Animal Safety Warnings section, see the Pork Quality Assurance (PQA Plus) and Transport Quality Assurance (TQA) recommendations for best practices in swine care during handling, transport, and marketing.” (3) Labeling of Type B and Type C tom turkey feeds shall bear the following: “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.6 g/ton.” (4) Tylosin in combinations as tylosin phosphate. (5) Ractopamine liquid Type B cattle feeds may be manufactured from dry ractopamine Type A articles. The liquid Type B feeds must be maintained at a pH of 4.5 to 7.5 or, if in combination with monensin and/or tylosin, at a pH of 4.5 to 6.0. Mixing directions for liquid Type B feeds requiring recirculation or agitation: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (6) Labeling of Type A medicated articles and Type B and Type C medicated feeds intended for cattle feeds shall bear the following: (i) “Behavioral signs such as agitation and decreased feed consumption have been reported in cattle fed ractopamine hydrochloride.” (ii) “Additional Recommendations: See the Beef Quality Assurance (BQA) recommendations for best practices in cattle care and handling during ractopamine hydrochloride feeding, transport, and marketing to help mitigate the behavioral signs stated in the Animal Safety Warnings section above.” (e) Conditions of use Swine Ractopamine hydrochloride in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 4.5 to 9.0 For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine, weighing at least 150 lb, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lb of gain prior to slaughter Not for use in swine intended for breeding. Feed as sole ration 016592 (ii) [Reserved] (2) Cattle. Ractopamine hydrochloride in grams/ton Combination in Indications for use Limitations Sponsor (i) 8.2 to 24.6 For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed Feed as the sole ration to provide 70 to 430 mg of ractopamine hydrochloride per head per day during the last 28 to 42 days on feed. Not for use in cattle intended for breeding 016592 (ii) 8.2 to 24.6 to provide 70 to 430 mg/head/day Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and prevention and control of coccidiosis due to Eimeria bovis E. zuernii Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 066104, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter 016592 (iii) 9.8 to 24.6 For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed Feed as the sole ration to provide 90 to 430 mg ractopamine hydrochloride per head per day during the last 28 to 42 days on feed. Not for use in cattle intended for breeding 016592 (iv) 9.8 to 24.6 to provide 90 to 430 mg/head/day Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, and prevention and control of coccidiosis due to Eimeria bovis E. zuernii Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter 016592 (v) 9.8 to 24.6 to provide 90 to 430 mg/head/day Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis E. zuernii, Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in §§ 558.342(d) and 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016592, 054771 or 058198 in § 510.600(c) of this chapter 016592 (vi) 100 to 800 For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed Feed a minimum of 1 lb per head per day of Type C top-dress medicated feed to provide 70 to 400 mg ractopamine hydrochloride per head per day during the last 28 to 42 days on feed. Not for use in cattle intended for breeding 016592 (vii) Not to exceed 800; to provide 70 to 400 mg/head/day Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and prevention and control of coccidiosis due to Eimeria bovis E. zuernii Top dress ractopamine at a minimum of 1.0 lb/head/day of medicated feed continuously during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter 016592 (3) Turkeys Ractopamine hydrochloride in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 4.6 to 11.8 (5 to 13 ppm) Finishing hen turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 7 to 14 days prior to slaughter. Feed continuously as sole ration during the last 7 to 14 days prior to slaughter. 058198 (ii) 4.6 to 11.8 (5 to 13 ppm) Finishing tom turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 14 days prior to slaughter. Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality. 058198 (iii) 4.6 to 11.8 (5 to 13 ppm) Monensin 54 to 90 Finishing hen turkeys: As in paragraph (e)(3)(i) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides E. meleagrimitis E. gallopavonis. Feed continuously as sole ration during the last 7 to 14 days prior to slaughter. See § 558.355(d). 058198 (iv) 4.6 to 11.8 (5 to 13 ppm) Monensin 54 to 90 Finishing tom turkeys: As in paragraph (e)(3)(ii) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides E. meleagrimitis E. gallopavonis. Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality. See § 558.355(d). 058198 (4) Ractopamine may also be used in combination with tylosin in as in § 558.625. [67 FR 71820, Dec. 3, 2002, as amended at 68 FR 54659, Sept. 18, 2003; 69 FR 12068, Mar. 15, 2004; 69 FR 51174, Aug. 18, 2004; 71 FR 31074, June 1, 2006; 71 FR 67301, Nov. 21, 2006; 72 FR 10358, Mar. 8, 2007; 72 FR 41619, July 31, 2007; 72 FR 56897, Oct. 5, 2007; 72 FR 62571, Nov. 6, 2007; 72 FR 65667, Nov. 23, 2007; 72 FR 70777, Dec. 13, 2007; 73 FR 72715, Dec. 1, 2008; 73 FR 75323, Dec. 11, 2008; 74 FR 66914, Dec. 17, 2009; 75 FR 1276, Jan. 11, 2010; 75 FR 5888, Feb. 5, 2010; 75 FR 20917, Apr. 22, 2010; 75 FR 54018, Sept. 3, 2010; 77 FR 31724, May 30, 2012; 78 FR 63872, Oct. 25, 2013; 79 FR 13546, Mar. 11, 2014; 79 FR 37621, July 2, 2014; 79 FR 44278, July 31, 2014; 79 FR 53136, Sept. 8, 2014; 80 FR 61298, Oct. 13, 2015; 81 FR 48703, July 26, 2016; 81 FR 95013, Dec. 27, 2016; 85 FR 18122, Apr. 1, 2020; 85 FR 45311, July 28, 2020; 86 FR 58013, Oct. 20, 2021; 87 FR 17947, Mar. 29, 2022; 89 FR 42361, May 15, 2024; 91 FR 20346, Apr. 16, 2026; 91 FR 33072, June 3, 2026] § 558.515 Robenidine. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use. Robenidine hydrochloride in grams/ton Combination in Indications for use Limitations Sponsor 30 (0.0033 pct) Broiler chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, E. necatrix. Feed continuously as sole ration. Do not feed to chickens producing eggs for food. Withdraw 5 days prior to slaughter. 054771 Bacitracin (as bacitracin methylenedisalicylate) 4 to 30 For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, E. necatrix. Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter. 054771 Bacitracin (as bacitracin methylenedisalicylate) 27 to 50 For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, E. necatrix. Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter. 054771 Bacitracin (as bacitracin methylenedisalicylate) 50 For broiler and fryer chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium Feed continuously as sole ration. Do not feed to laying hens. Withdraw 5 days before slaughter. 054771 Bacitracin (as bacitracin methylenedisalicylate) 100 to 200 For broiler and fryer chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. To control a necrotic enteritis outbreak, start medication at first clinical signs of disease; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin methylenedisalicylate to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter. 054771 Bacitracin (as bacitracin zinc) 4 to 30 For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, E. necatrix. Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter. 054771 Bacitracin (as bacitracin zinc) 27 to 50 For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, E. necatrix. Feed continuously as sole ration. Do not feed to laying chickens. Withdraw 5 days prior to slaughter. 054771 (f) Robenidine may also be used in combination with: (1) Chlortetracycline as in § 558.128. (2) Lincomycin as in § 558.325. (3) Oxytetracycline as in § 558.450. [40 FR 13959, Mar. 27, 1975] Editorial Note: For Federal Register www.govinfo.gov. § 558.550 Salinomycin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use. (1) Chickens Salinomycin in grams/ton Combination in Indications for use Limitations Sponsor (i) 40 to 60 Broiler, roaster, and replacement (breeder and layer) chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati Feed continuously as sole ration. Do not feed to birds producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses 016592 (ii) 40 to 60 Bacitracin (as feed grade bacitracin methylenedisalicylate) 4 to 50 Broiler chickens and replacement chickens. Not for use in laying hens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati, Feed continuously as sole ration. Discontinue use prior to sexual maturity. The dosage of salinomycin sodium should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter 016592 (iii) 40 to 60 Bacitracin (as feed grade bacitracin methylenedisalicylate) 50 Broiler chickens and replacement chickens. Not for use in laying hens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati, Clostridium Feed continuously as sole ration. Discontinue use prior to sexual maturity. The dosage of salinomycin sodium should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter 066104 (iv) 40 to 60 Bacitracin (as feed grade bacitracin methylenedisalicylate) 100 to 200 Broiler chickens and replacement chickens. Not for use in laying hens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati, Clostridium Feed continuously as the sole ration. Discontinue use prior to sexual maturity. The dosage of salinomycin sodium should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. To control a necrotic enteritis outbreak, start medication at the first clinical signs of disease. The bacitracin methylenedisalicylate dosage range permitted provides for different levels based on severity of the infection. Consult a poultry diagnostic laboratory or pathologist to determine the diagnosis and advice regarding the optimal level of bacitracin methylenedisalicylate. Administer continuously for 5-7 days or as long as clinical signs persist, and then reduce bacitracin methylenedisalicylate dosage to prevention level (50 g/ton). May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) in this chapter 066104 (v) 40 to 60 Bacitracin (as feed grade bacitracin zinc), 10 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati, Feed as the sole ration. The dosage of salinomycin sodium should be adjusted to meet the severity of coccidial challenge, which varies with environmental and management conditions. Do not feed to chickens producing eggs for human consumption. May be fatal if accidently fed to adult turkeys or horses. Do not use in Type C medicated feeds containing pellet binders. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter 016592 (vi) 40 to 60 Bambermycins, 1 to 3 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati, Feed continuously as sole ration. Do not feed to laying chickens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) in this chapter 016592 (2) Game birds Salinomycin in grams/ton Combination in Indications for use Limitations Sponsor (i) 50 Quail: For the prevention of coccidiosis caused by Eimeria dispersa E. lettyae Feed continuously as sole ration. Do not feed to birds producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses 016592 (ii) [Reserved] (3) Combinations. (i) Avilamycin as in § 558.68. (ii) Chlortetracycline as in § 558.128. (iii) Lincomycin as in § 558.325. (iv) Oxytetracycline as in § 558.450. (v) Virginiamycin as in § 558.635. [48 FR 30616, July 5, 1983] Editorial Note: For Federal Register www.govinfo.gov. § 558.555 Semduramicin. (a) Specifications. (1) 22.7 grams (g) per pound (lb) (50 g/kilogram (kg)) semduramicin (as semduramicin sodium). (2) 22.7 g/lb (50 g/kg) semduramicin (as semduramicin sodium biomass). (b) Sponsor. (c) Related tolerances. (d) Conditions of use in chickens. Semduramicin in grams per ton Combinations in grams per ton Indications for use Limitations Sponsor (1) 22.7 (25 ppm) Broiler chickens: For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati E. mitis, E. necatrix E. tenella. Do not feed to laying hens. 066104 (2) 22.7 Bacitracin methylenedisalicylate 10 to 50 Broiler chickens: As in paragraph (d)(1) of this section; for improved feed efficiency. Feed continuously as sole ration. Do not feed to laying hens. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. 066104 (e) Conditions of use in chickens. Semduramicin in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (1) 22.7 (25 ppm) Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis. Do not feed to laying hens. 066104 (2) [Reserved] (f) Semduramicin may also be used in combination with virginiamycin as in § 558.635. [59 FR 17477, Apr. 13, 1994, as amended at 60 FR 57928, Nov. 24, 1995; 61 FR 29481, June 11, 1996; 61 FR 43451, Aug. 23, 1996; 61 FR 66584, Dec. 18, 1996; 62 FR 66985, Dec. 23, 1997; 64 FR 48296, Sept. 3, 1999; 66 FR 47964, Sept. 17, 2001; 69 FR 13221, Mar. 22, 2004; 70 FR 41961, July 21, 2005; 73 FR 812, Jan. 4, 2008; 74 FR 41631, Aug. 18, 2009; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95013, Dec. 27, 2016; 86 FR 14826, Mar. 19, 2021; 87 FR 17948, Mar. 29, 2022] § 558.575 Sulfadimethoxine and ormetoprim. (a) Specifications. (1) 25 percent sulfadimethoxine and 15 percent ormetoprim; or (2) 25 percent sulfadimethoxine and 5 percent ormetoprim. (b) Sponsors. (1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraphs (e)(1), (e)(2)(i), and (e)(3)(i) through (iii) of this section. (2) No. 015331 for use of the product described in paragraph (a)(2) as in paragraphs (e)(3)(iv) and (v) of this section. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for sulfadimethoxine and ormetoprim medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfadimethoxine and ormetoprim shall not be refilled. (e) Conditions of use. (1) Chickens Sulfadimethoxine Indications for use Limitations Sponsors (i) Sulfadimethoxine, 113.5; ormetoprim, 68.1. Broiler chickens: As an aid in the prevention of coccidiosis caused by all Eimeria E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima, Haemophilus gallinarum Escherichia coli Pasteurella multocida Feed as sole ration. Withdraw 5 days before slaughter. 066104 (ii) Sulfadimethoxine, 113.5; ormetoprim, 68.1. Replacement chickens: As an aid in the prevention of coccidiosis caused by all Eimeria E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima, Haemophilus gallinarum Escherichia coli Pasteurella multocida Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter. 066104 (2) Turkeys Sulfadimethoxine Indications for use Limitations Sponsors (i) Sulfadimethoxine, 56.75; ormetoprim, 34.05. Turkeys: As an aid in the prevention of coccidiosis caused by all Eimeria E. adenoeides, E. gallopavonis, E. meleagrimitis Pasteurella multocida Do not feed to turkeys producing eggs for food. Withdraw 5 days before slaughter. 054771 (ii) [Reserved] (3) Minor species Sulfadimethoxine Indications for use Limitations Sponsors (i) Sulfadimethoxine, 227; ormetoprim, 136.2 grams/ton of feed. Ducks, including breeding ducks: As an aid in the control of bacterial infections due to Pasteurella multocida Feed as sole ration for 7 days. Medication should be started at the first signs of infection. Do not feed to ducks producing eggs for food. Withdraw 5 days before slaughter. 054771 (ii) Sulfadimethoxine, 454; ormetoprim, 272.4 grams/ton of feed. Ducks: As an aid in the control of bacterial infections due to Escherichia coli, Riemerella anatipestifer, Pasteurella multocida Feed as a sole ration for 7 days. Medication should be started at the first signs of infection. Not for breeding ducks. Do not feed to ducks producing eggs for food. Withdraw 5 days before slaughter. (iii) Sulfadimethoxine, 113.5; ormetoprim, 68.1 grams/ton of feed. Chukar partridges: For prevention of coccidiosis caused by Eimeria kofoidi E. legionensis. Feed continuously to young birds up to 8 weeks of age as sole ration. 054771 (iv) 630 to 3780 g/ton sulfadimethoxine and 126 to 756 g/ton ormetoprim to provide 50 milligrams (mg) of active ingredients per kilogram of body per day Salmonids: For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter 015331 (v) 630 to 3780 g/ton sulfadimethoxine and 126 to 756 g/ton ormetoprim to provide 50 mg of active ingredients per kilogram of body per day Catfish: For control of enteric septicemia of catfish caused by Edwardsiella ictaluri Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish 015331 [40 FR 13959, Mar. 27, 1975, as amended at 42 FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23, 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR 2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63 FR 27846, May 21, 1998; 64 FR 26672, May 17, 1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, Sept. 7, 2001; 70 FR 52292, Sept. 2, 2005; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 95013, Dec. 27, 2016; 83 FR 13637, Mar. 30, 2018; 84 FR 12502, Apr. 2, 2019; 86 FR 14827, Mar. 19, 2021; 87 FR 76424, Dec. 14, 2022; 91 FR 20347, Apr. 16, 2026] § 558.582 Sulfamerazine. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for sulfamerazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfamerazine shall not be refilled. (e) Conditions of use. Sulfamerazine Combination in Indications for use Limitations Sponsor (1) To deliver 10 grams of sulfamerazine per 100 pounds of fish per day Rainbow trout, brook trout, and brown trout: For control of furunculosis Formulate to deliver 10 grams of sulfamerazine per 100 pounds of fish per day. Treat for not more than 14 days. Do not treat within 3 weeks of marketing or stocking in stream open to fishing 054771 (2) [Reserved] [81 FR 95013, Dec. 27, 2016] § 558.586 Sulfaquinoxaline. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for sulfaquinoxaline medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfaquinoxaline shall not be refilled. (e) Conditions of use Chickens Sulfaquinoxaline Combination in grams/ton Indications for use Limitations Sponsor (i) 0.015 percent As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption 016592 (ii) 0.0175 percent As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption 016592 (iii) 0.1 to 0.05 percent As an aid in controlling outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti Feed at 0.1 percent level for first 48 to 72 hours. Skip 3 days; 0.05 percent for 2 days, skip 3 days; 0.05 percent for 2 days. If bloody droppings recur, give 0.05 percent for another 2 days. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption 016592 (iv) 0.05 or 0.1 percent As an aid in the control of acute fowl cholera caused by Pasteurella multocida Salmonella gallinarum Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption 016592 (2) Turkeys Sulfaquinoxaline Combination in grams/ton Indications for use Limitations Sponsor (i) 0.0175 percent As an aid in preventing outbreaks of coccidiosis caused by Eimeria meleagrimitis E. adenoeides Feed continuously during time birds are closely confined. May be continued for a week to 10 days after flock is transferred to range to reduce danger of an outbreak following moving of the flock. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption 016592 (ii) 0.05 percent As an aid in controlling outbreaks of coccidiosis caused by Eimeria meleagrimitis E. adenoeides Feed for 2 days. Follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Again follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Continue this schedule if necessary until all signs of the outbreaks have subsided. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption 016592 (iii) 0.05 or 0.1 percent As an aid in the control of acute fowl cholera caused by Pasteurella multocida Salmonella gallinarum Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption 016592 (3) Rabbits Sulfaquinoxaline Combination in grams/ton Indications for use Limitations Sponsor (i) 0.025 percent As an aid in preventing coccidiosis caused by Eimeria stiedae Treatment to be started after weaning. Feed continuously for 30 days or feed medicated feed for 2 days out of every week until marketing. Do not treat within 10 days of slaughter 016592 (ii) 0.1 percent As an aid in controlling outbreaks of coccidiosis caused by Eimeria stiedae Feed for 2 weeks. Do not treat within 10 days of slaughter 016592 [81 FR 95013, Dec. 27, 2016] § 558.612 Tiamulin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been determined. (3) Use as sole source of tiamulin. (e) Conditions of use Swine. Tiamulin hydrogen fumarate in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (i) 35 1. For control of swine dysentery associated with Brachyspira Serpulina Treponema hyodysenteriae Feed continuously as sole ration on premises with a history of swine dysentery but where signs of disease have not yet occurred or following approved treatment of disease. Withdraw 2 days before slaughter 058198 2. For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis Feed continuously as the sole ration for not less than 10 days. Withdraw 2 days before slaughter 058198 (ii) 200 For treatment of swine dysentery associated with Brachyspira Serpulina Treponema hyodysenteriae Feed continuously as the sole feed for 14 consecutive days. Withdraw feed 7 days before slaughter 058198 (2) Tiamulin may also be used in combination with chlortetracycline as in § 558.128. [67 FR 7268, Feb. 19, 2002, as amended at 69 FR 62407, Oct. 26, 2004; 70 FR 75018, Dec. 19, 2005; 74 FR 6, Jan. 2, 2009; 77 FR 24139, Apr. 23, 2012; 79 FR 13546, Mar. 11, 2014. Redesignated and amended at 80 FR 13232, Mar. 13, 2015; 81 FR 95015, Dec. 27, 2016; 86 FR 14827, Mar. 19, 2021] § 558.618 Tilmicosin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) VFDs for tilmicosin phosphate shall not be refilled. (3) Labeling of tilmicosin Type B or Type C medicated feeds must bear the following warnings: (i) Do not allow horses or other equines access to feeds containing tilmicosin. (ii) [Reserved] (4) Special considerations for use of tilmicosin medicated swine feeds include the following: (i) The expiration date of VFDs for tilmicosin must not exceed 90 days from the time of issuance. (ii) Labeling of tilmicosin Type B or Type C medicated feeds for swine must bear the following warning: “Do not use in any feeds containing bentonite. Bentonite in feeds may affect the efficacy of tilmicosin.” (iii) Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production without ceasing administration for reevaluation of antimicrobial use by a licensed veterinarian before reinitiating a further course of therapy with an appropriate antimicrobial. (5) Special consideration for use of tilmicosin medicated cattle feeds include the following: (i) The expiration date of VFDs for cattle must not exceed 45 days from the time of issuance. (ii) Labeling of tilmicosin Type B or Type C medicated feeds for cattle must bear the following warning: “Do not use in any feeds containing bentonite, cottonseed meal, or cottonseed hulls. Bentonite, cottonseed meal, or cottonseed hulls in feeds may affect the efficacy of tilmicosin.” (iii) To assure both food safety and responsible use in cattle, administration of feed containing tilmicosin to cattle experiencing an outbreak of BRD must be initiated during the first 45 days of the production period, shall not exceed a single 14-consecutive-day treatment, should not occur concurrent with or following administration of an injectable macrolide, and should not occur within 3 days following administration of a nonmacrolide injectable BRD therapy. Tilmicosin medicated feed treatment has not been evaluated in cattle with severe clinical disease. Cattle with severe clinical illness should be evaluated for individual treatment with an alternative non-macrolide therapy. (e) Conditions of use. (1) Swine Tilmicosin Combination in grams/ton Indications for use Limitations Sponsor (i) 181 to 363 Swine: For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae Pasteurella multocida Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product 058198, 016592 (ii) [Reserved] (2) Cattle Tilmicosin Combination in grams/ton Indications for use Limitations Sponsor (i) 568 to 757 Beef and nonlactating dairy cattle: For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg of bodyweight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in preruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product 058198, 016592 (ii) 568 to 757 Monensin, 5 to 40 Cattle fed in confinement for slaughter: For improved feed efficiency; and for the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg of bodyweight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See § 558.355(d). Tilmicosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter 016592 (iii) 568 to 757 Monensin, 10 to 40 Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to Eimeria bovis E. zuernii Mannheimia haemolytica, Pasteurella multocida, Histophilus somni Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg of bodyweight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See § 558.355(d). Tilmicosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter 016592 [61 FR 68148, Dec. 27, 1996; 62 FR 15391, Apr. 1, 1997, as amended at 64 FR 13679, Mar. 22, 1999; 65 FR 76930, Dec. 8, 2000; 67 FR 21997, May 2, 2002; 69 FR 78306, Dec. 30, 2004; 76 FR 76894, Dec. 9, 2011; 77 FR 60623, Oct. 4, 2012; 78 FR 19987, Apr. 3, 2013; 80 FR 61298, Oct. 13, 2015; 80 FR 76387, Dec. 9, 2015; 81 FR 48703, July 26, 2016; 81 FR 59135, Aug. 29, 2016; 81 FR 67153, Sept. 30, 2016; 85 FR 18123, Apr. 1, 2020; 86 FR 14827, Mar. 19, 2021] § 558.625 Tylosin. (a) Specifications. (b) Sponsors. (1) No. 016592: Type A medicated articles containing 40 or 100 grams per pound (g/lb). (2) No. 054771: Type A medicated article containing 40 g/lb. (3) No. 058198: Type A medicated articles containing 10, 40, or 100 g/lb. (4) No. 066104: Type A medicated articles containing 20 or 40 g/lb. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for tylosin medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin shall not be refilled. (3) Type C medicated feeds for cattle may be manufactured from tylosin liquid Type B medicated feeds which have a pH between 4.5 and 6.0 and which bear appropriate mixing directions as follows: (i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. (4) Tylosin liquid Type B medicated feeds must bear an expiration date of 31 days after the date of manufacture. (5) Do not use tylosin liquid Type B medicated feeds in any liquid feed containing sodium metabisulfite or in any finished feed (supplement, concentrate, or complete feed) containing in excess of 2 percent bentonite. (e) Conditions of use Swine Tylosin Combination in Indications for use Limitations Sponsors (i) 40 or 100 For control of swine dysentery associated with Brachyspira hyodysenteriae Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight 016592 (ii) 40 or 100 Pyrantel, 96 For control of swine dysentery associated with Brachyspira hyodysenteriae; Ascaris suum Oesophagostomum Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (iii) 40 or 100 For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight 016592 (iv) 40 or 100 Pyrantel, 96 For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; Ascaris suum Oesophagostomum Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (v) 40 or 100 Ractopamine hydrochloride, For increased rate of weight gain, improved feed efficiency, increased carcass leanness, control of swine dysentery associated with Brachyspira hyodysenteriae, Lawsonia intracellularis Feed as the sole ration to finishing swine weighing at least 150 lb for the last 45 to 90 lb (group average) of weight gain prior to slaughter. Feed 100 g of tylosin per ton of complete feed for at least three weeks, followed by 40 g tylosin per ton of complete feed until pigs reach market weight. Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine hydrochloride as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter 016592 (vi) 40 to 100 For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter 016592 (vii) 40 or 100 Pyrantel, 96 For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae Ascaris suum Oesophagostomum Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (viii) 40 to 100 For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter 016592 (ix) 40 or 100 Pyrantel, 96 For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis Ascaris suum Oesophagostomum Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (x) 40 to 100 Ractopamine hydrochloride, For increased rate of weight gain, improved feed efficiency, increased carcass leanness, the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae, Lawsonia intracellularis Feed as the sole ration to finishing swine weighing at least 150 lb for the last 45 to 90 lb (group average) of weight gain prior to slaughter. Feed 40 to 100 grams of tylosin per ton of complete feed for 2 to 6 weeks immediately after medicating with tylosin in drinking water (250 mg tylosin per gallon) for 3 to 10 days as in § 520.2640(e)(3) of this chapter. Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine hydrochloride as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter (xi) 100 For reduction in severity of effects of atrophic rhinitis Feed continuously as the sole ration 016592 (xii) 100 Pyrantel, 96 For reduction in severity of effects of atrophic rhinitis; aid as an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum Oesophagostomum Feed continuously as the sole ration. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xiii) 100 Ractopamine hydrochloride, For increased rate of weight gain, improved feed efficiency, increased carcass leanness, and control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis Feed as the sole ration to finishing swine weighing at least 150 lb for the last 45 to 90 lb (group average) of weight gain prior to slaughter. Feed 100 g of tylosin per ton of complete feed for 21 days. Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine hydrochloride as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter 016592 (2) Cattle Tylosin Combination in grams/ton Indications for use Limitations Sponsors (i) 8 to 10 Beef cattle: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium pyogenes Feed continuously as the sole ration to provide 60 to 90 mg/head/day tylosin 016592 (ii) 8 to 10 Lasalocid, 100 to 1440; plus melengestrol, 0.25 to 2.0 Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium pyogenes; Feed continuously as sole ration. Feed to heifers at the rate of 0.5 to 2.0 pound(s) per head per day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate per head per day (specify one level), 100 to 360 mg lasalocid per head per day (specify one level), and 90 mg tylosin per head per day. This Type C product may be top dressed onto or mixed into a complete feed prior to feeding. Tylosin as provided by Nos. 016592 and 058198; lasalocid as provided by No. 054771; melengestrol as provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.342(d) in this chapter 016592 (iii) 8 to 10 Melengestrol, 0.25 to 2.0 Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium pyogenes; Feed continuously as sole ration. Each pound contains 0.125 to 1.0 mg melengestrol acetate and 45 to 180 mg of tylosin. Feed to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg melengestrol acetate and 60 to 90 mg tylosin per head per day. Prior to feeding, this Type C product must be top-dressed onto a complete feed or mixed into the amount of complete feed consumed by an animal per day. Tylosin provided by Nos. 016592 and 058198; melengestrol provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter. See § 558.342(d) in this chapter 016592 (iv) 8 to 10 Monensin, 5 to 40 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium Actinomyces pyogenes Feed continuously as sole ration to provide 50 to 480 monensin mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by Nos. 016592 or 058198 in § 510.600(c) of this chapter. See § 558.355(d) in this chapter 016592 (v) 8 to 10 Monensin, 10 to 40 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium Actinomyces pyogenes Eimeria bovis E zuernii Feed continuously as sole ration to provide 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by Nos. 016592 or 058198 in § 510.600(c) of this chapter. See § 558.355(d) in this chapter 016592 (vi) 8 to 10 Monensin, 5 to 30 plus decoquinate, 13.6 to 27.2 Growing beef steers and heifers fed in confinement for slaughter: For the prevention of coccidiosis caused by Eimeria bovis E. zuernii, Fusobacterium necrophorum Arcanobacterium pyogenes Feed as the sole ration to provide 22.7 mg of decoquinate per 100 lb. of body weight per day, 50 to 360 mg of monensin per head per day, and 60 to 90 mg tylosin (as tylosin phosphate). Feed for at least 28 days during periods of coccidiosis exposure or when experience indicates that coccidiosis is likely to be a hazard. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle feed is safe only for use in cattle. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. Do not use in feeds containing bentonite. Do not feed to cows producing milk for food. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; decoquinate as provided by No. 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.355(d) 016592 (vii) 8 to 10 Monensin, 5 to 40 plus lubabegron fumarate, 1.25 to 4.54 Beef steers and heifers fed in confinement for slaughter: for reduction of ammonia gas emissions per pound of live weight and hot carcass weight; for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum Arcanobacterium pyogenes Feed continuously as sole ration to provide 13 to 90 mg lubabegron/head/day, 50 to 480 mg monensin/head/day, and 60 to 90 mg tylosin/head/day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). A decrease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in § 558.355(d) of this chapter. Tylosin as provided by No. 016592 or 058198, monensin as provided by No. 016592 or 058198, lubabegron fumarate as provided by No. 058198 in § 510.600(c) of this chapter 016592, 058198 (viii) 8 to 10 Monensin, 10 to 40 plus lubabegron fumarate, 1.25 to 4.54 Beef steers and heifers fed in confinement for slaughter: for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum Arcanobacterium pyogenes Eimeria bovis E. zuernii Feed continuously as sole ration to provide 13 to 90 mg lubabegron/head/day, 0.14 to 0.42 mg monensin/lb body weight per day, depending upon severity of coccidiosis challenge, up to 480 mg/head/day, and 60 to 90 mg tylosin/head/day during the last 14 to 91 days on feed. A decrease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in § 558.355(d) of this chapter. Tylosin as provided by No. 016592 or 058198, monensin as provided by No. 016592 or 058198, lubabegron fumarate as provided by No. 058198 in § 510.600(c) of this chapter 016592, 058198 (ix) 8 to 10 Monensin, 10 to 40 plus lubabegron (as lubabegron fumarate), 1.25 to 4.54, plus melengestrol acetate, 0.25 to 2.0 Growing beef heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, for the prevention and control of coccidiosis caused by Eimeria bovis Eimeria zuernii, Fusobacterium necrophorum Arcanobacterium pyogenes Feed as the sole ration during the last 14 to 91 days on feed. Melengestrol acetate Type C top-dress medicated feed (0.5 to 2.0 lb per head per day) must be top dressed onto or mixed at feeding with a Type C medicated feed containing 8 to 10 g/ton tylosin, 1.25 to 4.54 g/ton lubabegron, and 10 to 40 g/ton monensin, to provide 0.25 to 0.5 mg melengestrol acetate, 60 to 90 mg tylosin per head per day, 13 to 90 mg lubabegron per head per day, and 0.14 to 0.42 mg monensin per pound of body weight per day, depending on severity of challenge, up to 480 mg monensin per head per day. See special labeling considerations in §§ 558.330(d), 558.342(d), and 558.355(d). Tylosin and monensin as provided by No. 058198 or 016592; lubabegron fumarate as provided by No. 058198; melengestrol acetate as provided in No. 054771 in § 510.600(c) of this chapter 058198 (x) 8 to 10 Monensin 10 to 40 plus melengestrol 0.25 to 2.0 Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium pyogenes; Eimeria bovis E. zuernii; Feed continuously as sole ration to heifers at a rate of 0.5 to 2 pounds per head per day to provide 0.25 to 0.5 mg/head/day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See §§ 558.342(d) and 558.355(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; melengestrol provided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter 016592 (xi) 8 to 10 Monensin 10 to 40 plus ractopamine 8.2 to 24.6 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium pyogenes; Eimeria bovis E. zuernii; Feed continuously as sole ration to provide 70 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §§ 558.355(d) and 558.500(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine provided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter 016592 (xii) 8 to 10 Monensin 10 to 40 plus ractopamine, not to exceed 800 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium pyogenes; Eimeria bovis E. zuernii; Feed a minimum of 1.0 lb/head/day ractopamine Type C top dress feed continuously to cattle fed in confinement for slaughter, to provide 70 to 400 mg/head/day ractopamine for the last 28 to 42 days on feed. Feed on top of a ration containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin phosphate, to provide 0.14 to 0.42 mg monensin/lb body weight/day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §§ 558.355(d) and 558.500(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine provided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter 016592 (xiii) 8 to 10 Monensin 10 to 40 plus ractopamine 9.8 to 24.6 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium pyogenes; Eimeria bovis E. zuernii; Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §§ 558.355(d) and 558.500(d) of this chapter. Tylosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine as provided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter 016592 (xiv) 8 to 10 Monensin, 10 to 40 plus ractopamine, 9.8 to 24.6, plus melengestrol, 0.125 to 1 mg/lb Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium pyogenes; Eimeria bovis E. zuernii; Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §§ 558.342(d), 558.355(d), and 558.500(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine as provided by No. 016592, 054771, or 058198; melengestrol acetate as provided by No. 016592 or 054771 in § 510.600(c) of this chapter 016592 (xv) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium pyogenes Eimeria bovis E zuernii Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to provide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Do not use in veal calves. Withdrawal period 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.665(d) in this chapter 000061 (xvi) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 to 24 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium pyogenes Eimeria bovis E zuernii Feed this component feed continuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Do not use in veal calves. Withdrawal period 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.665(d) in this chapter 000061 (xvii) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 plus melengestrol, 0.125 to 1 mg/lb Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium Actinomyces pyogenes Eimeria bovis E zuernii Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to provide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter 000061 (xviii) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 to 24 plus melengestrol, 0.125 to 1 mg/lb Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum Arcanobacterium Actinomyces pyogenes Eimeria bovis E zuernii Feed this component feed continuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter 000061 [40 FR 13959, Mar. 27, 1975] Editorial Note: For Federal Register www.govinfo.gov. § 558.630 Tylosin and sulfamethazine. (a) Specifications. (b) Sponsors. (1) No. 058198 for use as in paragraph (e)(1) of this section. (2) No. 066104: 10 or 40 grams per pound each for use as in paragraph (e)(2) of this section. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for tylosin and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin and sulfamethazine shall not be refilled. (3) Labeling shall bear the statement: “Do not use in medicated feeds containing in excess of 2% bentonite.” (e) Conditions of use. Tylosin phosphate and sulfamethazine Combination in grams/ton Indications for use Limitations Sponsors (1) 100 each For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica Brachyspira hyodysenteriae; Pasteurella multocida Arcanobacterium pyogenes Streptococci. Withdraw 15 days before swine are slaughtered 058198 (2) 100 each For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica Brachyspira hyodysenteriae; Pasteurella multocida Arcanobacterium pyogenes Withdraw 15 days before swine are slaughtered 066104 [81 FR 95021, Dec. 27, 2016, as amended at 84 FR 33002, July 11, 2019; 91 FR 5303, Feb. 6, 2026] § 558.633 Tylvalosin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (2) VFDs for tylvalosin shall not be refilled. (3) Crumbled Type C medicated feeds must bear an expiration date of 7 days after the date of manufacture. (e) Conditions of use. Tylvalosin in Indications for use Limitations Sponsor (i) 38.6 Swine: For the control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis Feed continuously as the sole ration for 14 consecutive days. 066916 (ii) [Reserved] [81 FR 36790, June 8, 2016, as amended at 81 FR 67153, Sept. 30, 2016; 84 FR 12504, Apr. 2, 2019; 87 FR 17948, Mar. 29, 2022; 87 FR 58968, Sept. 29, 2022] § 558.635 Virginiamycin. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Special considerations. (2) The expiration date of VFDs for virginiamycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for virginiamycin shall not be refilled. (3) Not for use in breeding swine over 120 pounds. (4) Dilute Type A article with at least 10 pounds of a feed ingredient prior to final mixing in 1 ton of Type C feed. (e) Conditions of use Chickens Virginiamycin Combination in grams/ton Indications for use Limitations Sponsors (i) 20 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens Not for use in layers 066104 (ii) 20 Amprolium 72.6 to 113.5 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens Eimeria tenella For field conditions where only E. tenella 066104 (iii) 20 Amprolium 113.5 to 227 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens For most field conditions as they exist under modern management practices, feed 113.5 g/ton amprolium continuously. Where severe coccidiosis conditions exist, feed 227 g/ton. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Not for use in laying chickens. Amprolium as provided by No. 016592 in § 510.600(c) of this chapter 066104 (iv) 20 Diclazuril, 0.91 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis mivati), E. maxima. E. maxima E. maxima Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Diclazuril as provided by No. 058198 in § 510.600(c) of this chapter 058198 (v) 20 Lasalocid 68 to 113 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, E. maxima Feed continuously as the sole ration. Do not feed to laying chickens. For broiler or fryer chickens only. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 066104 (vi) 20 Monensin 90 to 110 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, E. mivati Feed continuously as the sole ration. Do not feed to laying chickens. See § 558.355(d) in this chapter. Monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (vii) 20 Narasin, 54 to 90 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima Feed as the sole ration for broiler chickens. Do not feed to chickens producing eggs for human consumption. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Naracin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (viii) 20 Narasin, 27 to 54 plus nicarbazin, 27 to 54 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, E. maxima Feed as the sole ration for broiler chickens. Do not feed to chickens producing eggs for human consumption. Nicarbazin medicated broilers may show reduced heat tolerance if exposed to high temperature and high humidity. Provide adequate drinking water and ventilation during these periods. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Naracin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (ix) 20 Salinomycin 40 to 60 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati Feed continuously as the sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided by No. 016592 in § 510.600(c) of this chapter (x) 20 Semduramicin 22.7 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, E. tenella Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xi) 20 Semduramicin (biomass) 22.7 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, E. tenella Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (2) Swine Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 25 Growing-finishing swine: As an aid in control of dysentery in swine up to 120 pounds in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred 066104 (ii) 50 or 100 Growing-finishing swine: For treatment and control of swine dysentery in swine up to 120 pounds Feed 100 grams per ton for 2 weeks, 50 grams per ton thereafter 066104 (iii) 100 Growing-finishing swine: For treatment of swine dysentery in nonbreeding swine over 120 pounds Feed for 2 weeks 066104 (3) Cattle Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 13.5 to 16.0 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses Feed continuously as the sole ration to provide 85 to 240 milligrams per head per day. Not for use in animals intended for breeding 066104 (ii) 13.5 to 16.0 Monensin, 5 to 40 Growing beef steers and heifers fed in confinement for slaughter: For improved feed efficiency and reduction of incidence of liver abscesses Feed at every feeding to provide 50 to 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104 (iii) 13.5 to 16.0 Monensin, 10 to 40 Growing beef steers and heifers fed in confinement for slaughter: For the prevention and control of coccidiosis caused by Eimeria bovis Eimeria zuernii, Feed at every feeding to provide 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104 (iv) 13.5 to 16.0 Monensin, 5 to 40; and lubabegron, 1.25 to 4.54 Growing beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, improved feed efficiency, and reduction of incidence of liver abscesses Feed at every feeding as sole ration to provide 13 to 90 mg lubabegron/head/day, 50 to 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104 (v) 13.5 to 16.0 Monensin, 10 to 40; and lubabegron, 1.25 to 4.54 Growing beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, the prevention and control of coccidiosis caused by Eimeria bovis Eimeria zuernii, Feed at every feeding as sole ration to provide 13 to 90 mg lubabegron/head/day, 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 14 to 91 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104 (vi) 13.5 to 16.0 Monensin, 10 to 40; and ractopamine hydrochloride, 8.2 to 24.6 Growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed: For increased rate of weight gain, improved feed efficiency, the prevention and control of coccidiosis caused by Eimeria bovis Eimeria zuernii, Feed at every feeding as a sole ration to provide 70 to 430 mg ractopamine hydrochloride/head/day, 0.14 to 0.42 mg monensin/lb of body weight per day, depending upon severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 28 to 42 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104 (vii) 13.5 to 6.0 Monensin, 10 to 40; and ractopamine hydrochloride, 9.8 to 24.6 Growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, the prevention and control of coccidiosis caused by Eimeria bovis Eimeria zuernii, Feed at every feeding as a sole ration to provide 90 to 430 mg ractopamine hydrochloride/head/day, 0.14 to 0.42 mg monensin/lb of body weight per day, depending upon severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 28 to 42 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d) 066104 (viii) 13.5 to 16.0 Monensin, 10 to 40; and ractopamine hydrochloride, not to exceed 800 Growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed: For increased rate of weight gain and improved feed efficiency, the prevention and control of coccidiosis caused by Eimeria bovis Eimeria zuernii, Feed a minimum of 1.0 lb per head per day of this Type C top-dress medicated feed to provide 70 to 400 mg/head/day ractopamine hydrochloride during the last 28 to 42 days on feed. Must be top dressed onto or mixed at feeding with a Type C medicated feed containing 10 to 40 g/ton monensin and 13.5 to 16 g/ton virginiamycin (90% dry matter basis), to provide 0.14 to 0.42 mg monensin/lb of body weight per day, depending upon severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day. See § 558.355(d) 066104 [81 FR 95022, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 82 FR 21692, May 10, 2017; 85 FR 18125, Apr. 1, 2020; 87 FR 10972, Feb. 28, 2022; 88 FR 14908, Mar. 10, 2023; 90 FR 40972, Aug. 22, 2025] § 558.665 Zilpaterol. (a) Specifications. (b) Approvals. (c) Tolerances. (d) Special considerations. (2) Labeling of Type A medicated articles and Type B medicated feeds used to manufacture complete Type C medicated feeds shall bear the caution statement in paragraph (d)(3) of this section. (3) Labeling of complete Type C medicated feeds shall bear the following caution statements: “Not to be fed to cattle in excess of 90 mg zilpaterol/head/day in complete feed. If pen consumption of complete feed exceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol should not be fed in complete feed.” (4) Type B Liquid Feeds can be manufactured containing 68 to 680 g zilpaterol hydrochloride/ton. The liquid Type B feeds must be maintained at a pH of 3.8 to 7.5. For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. (e) Conditions of use in cattle. Zilpaterol Combination in grams/ton Indications for use Limitations Sponsor (1) 6.8 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section 000061 (2) 6.8 Monensin 10 to 40 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis E. zuernii Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter Monensin as provided by No. 058198 in § 510.600(c) of this chapter 000061 (3) 6.8 Melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; and for suppression of estrus (heat) Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section 000061 (4) 6.8 Monensin 10 to 40 plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis E. zuernii; Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter 000061 (5)-(6) [Reserved] (7) 6.8 to 24 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section 000061 (8) 6.8 to 24 Monensin 10 to 40 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; and for prevention and control of coccidiosis due to Eimeria bovis E. zuernii Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter 000061 (9) 6.8 to 24 Melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; and for suppression of estrus (heat) Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.342(d) of this part 000061 (10) 6.8 to 24 Monensin 10 to 40, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis E. zuernii; Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter 000061 (f) Zilpaterol may also be used in combination with tylosin as in § 558.625. [71 FR 53006, Sept. 8, 2006, as amended at 72 FR 9245, Mar. 1, 2007; 72 FR 6019, Feb. 1, 2008; 73 FR 14385, Mar. 18, 2008; 73 FR 16755, Mar. 31, 2008; 73 FR 18959, Apr. 8, 2008; 73 FR 19432, Apr. 10, 2008; 74 FR 61517, Nov. 25, 2009; 75 FR 11451, Mar. 11, 2010; 77 FR 31724, May 30, 2012; 78 FR 42008, July 15, 2013; 78 FR 52852, Aug. 27, 2013; 80 FR 13232, Mar. 13, 2015; 80 FR 53460, Sept. 4, 2015; 81 FR 48703, July 26, 2016; 81 FR 95025, Dec. 27, 2016] § 558.680 Zoalene. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use Chickens Zoalene in grams/ton Combination in grams per ton Indications for use Limitations Sponsor (i) 36.3 to 113.5 Replacement chickens: For development of active immunity to coccidiosis Feed continuously as sole ration. Grower ration not to be fed to birds over 14 weeks of age. Starter ration not to be fed to laying birds 054771 Growing conditions Starter ration Grower ration Severe exposure 113.5 (0.0125%) 75.4-113.5 Light to moderate exposure 75.4-113.5 36.3-75.4 Zoalene in grams/ton Combination in grams per ton Indications for use Limitations Sponsor (ii) 36.3-113.5 Bacitracin methylenedisalicylate 4 to 50 Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiency Feed continuously as sole ration as in subtable in item (i). Grower ration not to be fed to birds over 14 weeks of age. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iii) 36.3 to 113.5 Bacitracin methylenedisalicylate, 50 Replacement chickens: For development of active immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium Feed continuously as the sole ration as in the subtable in item (i). Grower ration not to be fed to birds over 14 weeks of age. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iv) 36.3 to 113.5 Bacitracin methylenedisalicylate, 100 to 200 Replacement chickens: For development of active immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium Feed continuously as sole ration as in the subtable in item (i). To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (v) 113.5 Broiler chickens: For prevention and control of coccidiosis Feed continuously as sole ration. Not to be fed to laying birds 054771 (vi) 113.5 Bacitracin methylenedisalicylate 4 to 50 Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency Feed continuously as sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (vii) 113.5 Bacitracin methylenedisalicylate, 50 Broiler chickens: For prevention and control of coccidiosis; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium Feed continuously as the sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (viii) 113.5 Bacitracin methylenedisalicylate, Broiler chickens: For prevention and control of coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (ix) 113.5 Bambermycins 1 Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency Feed continuously as sole ration. Do not feed to chickens over 14 weeks of age. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 016592 (2) Turkeys Zoalene in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 113.5 to 170.3 Growing turkeys: For prevention and control of coccidiosis Feed continuously as sole ration. For turkeys grown for meat purposes only. Not to be fed to laying birds 054771 (ii) 113.5 to 170.3 Bacitracin methylenedisalicylate, 4 to 50 Growing turkeys: For prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency Feed continuously as sole ration until 14 to 16 weeks of age. For turkeys grown for meat purposes only. Not to be fed to laying birds 054771 (3) Zoalene may also be used in combination with: (i)-(ii) [Reserved] (iii) Lincomycin as in § 558.325. [41 FR 11005, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 FR 20817, Apr. 22, 1977; 42 FR 36995, July 19, 1977; 51 FR 7401, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8461, Mar. 8, 1990; 57 FR 8403, Mar. 10, 1992; 57 FR 8578, Mar. 11, 1992; 61 FR 35957, July 9, 1996; 63 FR 38750, July 20, 1998; 67 FR 6868, Feb. 14, 2002; 71 FR 16223, Mar. 31, 2006; 71 FR 27958, May 15, 2006; 76 FR 17027, Mar. 28, 2011; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 17610, Mar. 30, 2016; 81 FR 95025, Dec. 27, 2016; 82 FR 21693, May 10, 2017; 86 FR 14827, Mar. 19, 2021; 87 FR 17948, Mar. 29, 2022]

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