Part 346 — Anorectal Drug Products for Over-the-Counter Human Use
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.
Sections
- § 346.1 Scope.
- § 346.3 Definitions.
- § 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.
- § 346.50 Labeling of anorectal drug products.
- § 346.52 Labeling of permitted combinations of anorectal active ingredients.