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Rulemaking History for OTC Hair Growth and Loss Drug Products
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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

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Hair Growth and Loss Drug Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 11/7/1980 45FR3955
    Correction 1/31/1981 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

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Date created: December 28, 2006; Last updated: May 4, 2007
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