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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE
 
PART 346ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
 

Subpart A - General Provisions
   § 346.1 - Scope.
   § 346.3 - Definitions.

Subpart B - Active Ingredients
   § 346.10 - Local anesthetic active ingredients.
   § 346.12 - Vasoconstrictor active ingredients.
   § 346.14 - Protectant active ingredients.
   § 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.
   § 346.18 - Astringent active ingredients.
   § 346.20 - Keratolytic active ingredients.
   § 346.22 - Permitted combinations of anorectal active ingredients.

Subpart C - Labeling
   § 346.50 - Labeling of anorectal drug products.
   § 346.52 - Labeling of permitted combinations of anorectal active ingredients.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.

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