Title 21
PART 346
Part 346 - Anorectal Drug Products For Over-the-counter Human Use
- Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
- Source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.
| 21:5.0.1.1.22.1 | SUBPART A | Subpart A - General Provisions | |
| 21:5.0.1.1.22.1.1.1 | SECTION 346.1 | 346.1 Scope. | |
| 21:5.0.1.1.22.1.1.2 | SECTION 346.3 | 346.3 Definitions. | |
| 21:5.0.1.1.22.2 | SUBPART B | Subpart B - Active Ingredients | |
| 21:5.0.1.1.22.2.1.1 | SECTION 346.10 | 346.10 Local anesthetic active ingredients. | |
| 21:5.0.1.1.22.2.1.2 | SECTION 346.12 | 346.12 Vasoconstrictor active ingredients. | |
| 21:5.0.1.1.22.2.1.3 | SECTION 346.14 | 346.14 Protectant active ingredients. | |
| 21:5.0.1.1.22.2.1.4 | SECTION 346.16 | 346.16 Analgesic, anesthetic, and antipruritic active ingredients. | |
| 21:5.0.1.1.22.2.1.5 | SECTION 346.18 | 346.18 Astringent active ingredients. | |
| 21:5.0.1.1.22.2.1.6 | SECTION 346.20 | 346.20 Keratolytic active ingredients. | |
| 21:5.0.1.1.22.2.1.7 | SECTION 346.22 | 346.22 Permitted combinations of anorectal active ingredients. | |
| 21:5.0.1.1.22.3 | SUBPART C | Subpart C - Labeling | |
| 21:5.0.1.1.22.3.1.1 | SECTION 346.50 | 346.50 Labeling of anorectal drug products. | |
| 21:5.0.1.1.22.3.1.2 | SECTION 346.52 | 346.52 Labeling of permitted combinations of anorectal active ingredients. |