Rulemaking History for OTC Hormone Drug Products
Final Monograph (21 CFR 310.530):
Topically applied hormone-containing drug products for over-the-counter (OTC) human use
FDA Archive-It webpage:
Search for Federal Register documents:
- GPO Federal Register Database (1994 to present)
- HeinOnline provides online access to Federal Registers from 1936-forward
OTC Hormone Drug Products found on this page:
Hormone Drug Products: Drug Rulemakings
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 1/5/1982 | 47FR430 |
| Correction | 5/18/1982 | 47FR21274 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule | 10/2/1989 | 54FR40618 |
| Final Rule | Date | FR Citation |
| Final Rule | 9/9/1993 | 58FR47608 |
Hormone Drug Products: Related Cosmetic Rulemakings
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Cosmetic product concentration limits | 9/9/1993 | 58FR47611 |
| Notice: Intent to withdraw 9/9/1993 proposed rule | 4/22/2003 | 68FR19766 |
| Final Rule | Date | FR Citation |
| Notice: Withdraws 9/9/1993 proposed rule | 11/26/2004 | 69FR68831 |