Rulemaking History for OTC Hair Growth and Loss Drug Products
Final Monograph (21 CFR 310.527):
Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention
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
Hair Growth and Loss Drug Products
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 11/7/1980 | 45FR73955 |
| Correction | 1/13/1981 | 46FR3030 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 1/15/1985 | 50FR2190 |
| Final Rule | Date | FR Citation |
| Final Monograph | 7/7/1989 | 54FR28772 |
| Correction | 7/28/1989 | 54FR31405 |
| Clarification: Effective date | 12/6/1989 | 54FR50364 |
| Notice: Advisory Committee meeting on Rx-to-OTC switch of Rogaine | 6/24/1994 | 59FR32699 |