21 CFR Part 335 — Antidiarrheal Drug Products for Over-the-Counter Human Use

PART 335—ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 68 FR 18881, April 17, 2003, unless otherwise noted. Subpart A—General Provisions § 335.1 Scope. (a) An over-the-counter antidiarrheal drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 335.3 Definitions. As used in this part: (a) Antidiarrheal. (b) Diarrhea. (c) Travelers' diarrhea. [68 FR 18881, Apr. 17, 2003, as amended at 69 FR 26302, May 12, 2004] Subpart B—Active Ingredients § 335.10 Antidiarrheal active ingredients. The active ingredient of the product consists of any one of the following when used within the dosage limits established for each ingredient in § 335.50(d): (a) Bismuth subsalicylate. (b) Kaolin. Subpart C—Labeling § 335.50 Labeling of antidiarrheal drug products. (a) Statement of identity. (b) Indications. (1) For products containing bismuth subsalicylate identified in § 335.10(a). (2) For products containing kaolin identified in § 335.10(b). (3) Additional indications (ii) In addition to the indication in paragraph (b)(1) of this section, one or both of the following may be used for products containing bismuth subsalicylate in § 335.10(a): “[bullet] reduces number of bowel movements” “[bullet] helps firm stool”. (c) Warnings. (1) For products containing any ingredient identified in § 335.10. (ii) “Ask a doctor before use if you have [bullet] fever [bullet] mucus in the stool”. (2) For products containing bismuth subsalicylate identified in § 335.10(a). (A) The Reye's syndrome warning in § 201.314(h) of this chapter. (B) “Allergy alert: Contains salicylate. Do not take if you are [bullet] allergic to salicylates (including aspirin), [bullet] taking other salicylate products”. (ii) “Do not use if you have [bullet] an ulcer [bullet] a bleeding problem”. (iii) “Ask a doctor or pharmacist before use if you are taking any drug for [bullet] anticoagulation (thinning the blood) [bullet] diabetes [bullet] gout [bullet] arthritis”. (iv) “When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur”. (v) “Stop use and ask a doctor if [bullet] symptoms get worse [bullet] ringing in the ears or loss of hearing occurs [bullet] diarrhea lasts more than 2 days”. (3) For products containing kaolin identified in § 335.10(b). (ii) “Stop use and ask a doctor if [bullet] symptoms get worse [bullet] diarrhea lasts more than 2 days”. (d) Directions. (1) For products containing any ingredient identified in § 335.10. (2) For products containing bismuth subsalicylate identified in § 335.10(a). 1/2 (3) For products containing kaolin identified in § 335.10(b). (e) Products that meet the criteria established in § 201.66(d)(10) of this chapter. (1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the information in § 201.66(c)(3) of this chapter may be omitted, and the information in § 201.66(c)(5) and (c)(6) of this chapter may be presented as follows: (i) The words “Contains salicylate.” may be omitted from the warning in § 335.50(c)(2)(i)(B). (ii) The subheading “When using this product” in § 335.50(c)(2)(iv) may be omitted. (iii) The words “continue to” may be omitted from the directions in § 335.50(d)(3). (2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(3) of this chapter and the bullet in the warning in § 335.50(c)(1)(i) may be omitted. [68 FR 18881, Apr. 17, 2003, as amended at 69 FR 26302, May 12, 2004]

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