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:

Hair Growth and Loss Drug Products

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking11/7/198045FR73955
Proposed RuleDateFR Citation
Tentative Final Monograph1/15/198550FR2190
Final RuleDateFR Citation
Final Monograph7/7/198954FR28772
   Clarification: Effective date12/6/198954FR50364
Notice: Advisory Committee meeting on Rx-to-OTC switch of Rogaine6/24/199459FR32699


Page Last Updated: 12/02/2016
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