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U.S. Department of Health and Human Services


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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

Hair Growth and Loss Drug Products

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 11/7/1980 45FR73955
    Correction [PDF] 1/31/1981 46FR3030
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 1/15/1985 50FR2190
Final Rule Date FR Citation
Final Monograph [PDF] 7/7/1989 54FR28772
    Correction [PDF] 7/28/1989 54FR31405
    Clarification: Effective date [PDF] 12/6/1989 54FR50364
Notice: Advisory Committee meeting on Rx-to-OTC switch of Rogaine [PDF] 6/24/1994 59FR32699