21 CFR Part 526 — Intramammary Dosage Form New Animal Drugs

PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 360b. § 526.88 Amoxicillin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in lactating cows Amount. (2) Indications for use. Streptococcus agalactiae Straphylococcus aureus (3) Limitations. [57 FR 37334, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, 2003; 86 FR 13185, Mar. 8, 2021] § 526.313 Ceftiofur. (a) Specifications. (1) 125 milligrams (mg) ceftiofur equivalents as the hydrochloride salt; or (2) 500 mg ceftiofur equivalents as the hydrochloride salt. (b) Sponsor. (c) Related tolerances. (d) Conditions of use for syringe described in paragraph (a)(1) of this section in lactating cows Amount. (2) Indications for use. Streptococcus dysgalactiae, Escherichia coli; S. dysgalactiae (3) Limitations. (4) Special considerations. (e) Conditions of use for syringe described in paragraph (a)(2) of this section in dry cows Amount (2) Indications for use. Staphylococcus aureus, Streptococcus dysgalactiae, Streptococcus uberis (3) Limitations. (4) Special considerations. [70 FR 9516, Feb. 28, 2005, as amended at 70 FR 20048, Apr. 18, 2005. Redesignated and amended at 71 FR 39545, July 13, 2006; 79 FR 10973, Feb. 27, 2013; 79 FR 18159, Apr. 1, 2014; 80 FR 34279, June 16, 2015; 86 FR 13185, Mar. 8, 2021] § 526.363 Cephapirin benzathine. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in dry cows Amount (2) Indications for use. Streptococcus agalactiae Staphylococcus aureus, (3) Limitations. [43 FR 37174, Aug. 22, 1978, as amended at 53 FR 27851, July 25, 1988; 73 FR 12262, Mar. 7, 2008; 75 FR 10168, Mar. 5, 2010; 76 FR 17338, Mar. 29, 2011; 86 FR 13186, Mar. 8, 2021; 88 FR 16549, Mar. 20, 2023] § 526.365 Cephapirin sodium. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in lactating cows Amount. (2) Indications for use. Streptococcus agalactiae Staphylococcus aureus (3) Limitations. [40 FR 57455, Dec. 10, 1975, as amended at 53 FR 27852, July 25, 1988. Redesignated at 63 FR 8349, Feb. 19, 1998; 65 FR 20733, Apr. 18, 2000; 73 FR 3181, Jan. 17, 2008; 75 FR 10168, Mar. 5, 2010; 86 FR 13186, Mar. 8, 2021; 88 FR 16549, Mar. 20, 2023] § 526.464 Cloxacillin benzathine. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in dry cows Amount (2) Indications for use. Staphylococcus aureus Streptococcus agalactiae (3) Limitations. [86 FR 13186, Mar. 8, 2021] § 526.465 Cloxacillin sodium. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in lactating cows Amount. (2) Indications for use. Streptococcus agalactiae Staphylococcus aureus, (3) Limitations. [57 FR 37335, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, 2003. Redesignated at 85 FR 18120, Apr. 1, 2020. Redesignated and amended at 86 FR 13186, Mar. 8, 2021] § 526.820 Erythromycin. (a) Specifications. (2) Each single-dose, 12-mL syringe contains 600 mg erythromycin (as the base). (b) Sponsors. (c) Related tolerances. (d) Conditions of use for syringe described in paragraph (a)(1) of this section in lactating cows Amount. (2) Indications for use. Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis (3) Limitations. (e) Conditions of use for syringe described in paragraph (a)(2) of this section in dry cows Amount. (2) Indications for use. Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis (3) Limitations. [86 FR 13186, Mar. 8, 2021, as amended at 88 FR 14901, Mar. 10, 2023] § 526.1130 Hetacillin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in lactating cows Amount (2) Indications for use. Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus aureus, Escherichia coli (3) Limitations. [57 FR 37335, Aug. 18, 1992, as amended at 75 FR 10168, Mar. 5, 2010; 84 FR 53311, Oct. 7, 2019; 86 FR 13186, Mar. 8, 2021] § 526.1590 Novobiocin. (a) Specifications. (1) 150 milligrams (mg) of novobiocin equivalents as sodium novobiocin, or (2) 400 mg of novobiocin equivalents as sodium novobiocin. (b) Sponsor. (c) Related tolerances. (d) Conditions of use for syringe described in paragraph (a)(1) of this section in lactating cows Amount (2) Indications for use. Staphylococcus aureus (3) Limitations. (e) Conditions of use for syringe described in paragraph (a)(2) of this section in dry cows Amount (2) Indications for use. Staphylococcus aureus Streptococcus agalactiae (3) Limitations. [86 FR 13187, Mar. 8, 2021] § 526.1696 Penicillin G procaine. (a) Specifications. (b) See Nos. 042791 and 061133 in § 510.600(c) of this chapter. (c) Related tolerances. (d) Conditions of use in lactating cows Amount (2) Indications for use. Streptococcus agalactiae, S. dysgalactiae, S. uberus (3) Limitations. (e) Conditions of use in dry cows Amount (2) Indications for use. Streptococcus agalactiae (3) Limitations. [86 FR 13187, Mar. 8, 2021, as amended at 86 FR 57998, Oct. 20, 2021; 88 FR 27700, May 3, 2023; 88 FR 55567, Aug. 16, 2023] § 526.1697 Penicillin G procaine and dihydrostreptomycin. (a) Specifications. (1) Penicillin G procaine equivalent to 200,000 units penicillin G and dihydrostreptomycin sulfate equivalent to 300 milligrams dihydrostreptomycin; or (2) Penicillin G procaine equivalent to 1 million units penicillin G and dihydrostreptomycin sulfate equivalent to 1 gram dihydrostreptomycin. (b) Sponsor. (c) Related tolerances. (d) Conditions of use for syringe described in paragraph (a)(1) of this section in dry cows Amount (2) Indications for use. Staphylococcus aureus Streptococcus agalactiae (3) Limitations. (e) Conditions of use for syringe described in paragraph (a)(2) of this section in dry cows Amount (2) Indications for use. Staphylococcus aureus (3) Limitations. [57 FR 37336, Aug. 18, 1992, as amended at 78 FR 21060, Apr. 9, 2013; 83 FR 14587, Apr. 5, 2018. Redesignated and amended at 86 FR 13187, Mar. 8, 2021; 88 FR 55567, Aug. 16, 2023] § 526.1698 Penicillin G procaine and novobiocin. (a) Specifications. (1) Penicillin G procaine equivalent to 100,000 units penicillin G and 150 milligrams (mg) novobiocin as novobiocin sodium; or (2) Penicillin G procaine equivalent to 200,000 units penicillin G and 400 mg novobiocin as novobiocin sodium. (b) Sponsor. (c) Related tolerances. (d) Conditions of use for syringe described in paragraph (a)(1) of this section in lactating cows Amount. (2) Indications for use. Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis (3) Limitations. (e) Conditions of use for syringe described in paragraph (a)(2) of this section in lactating cows Amount. (2) Indications for use. Staphylococcus aureus Streptococcus agalactiae (3) Limitations. [57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 79 FR 10973, Feb. 27, 2014; 84 FR 32993, July 11, 2019. Redesignated and amended at 86 FR 13187, Mar. 8, 2021; 88 FR 14901, Mar. 10, 2023] § 526.1810 Pirlimycin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in lactating cows Amount. (2) Indications for use. Staphylococcus Staphylococcus aureus Streptococcus Streptococcus agalactiae Streptococcus dysgalactiae Streptococcus uberis. (3) Limitations. [58 FR 58486, Nov. 2, 1993, as amended at 65 FR 61091, Oct. 16, 2000; 73 FR 811, Jan. 4, 2008; 79 FR 10973, Feb. 27, 2014; 86 FR 13188, Mar. 8, 2021]

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