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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Menstrual Drug Products

Pending Final Monograph (21 CFR part 357 subpart K):  
Miscellaneous Internal Drug Products for Over-the-Counter Human Use

OTC Menstrual Drug Products found on this page:


Menstrual Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice Of Proposed Rulemaking [PDF] 12/7/1982 47FR55076
    Correction [PDF] 1/14/1983 48FR1758
    Correction [PDF] 2/18/1983 48FR7202
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 11/16/1988 53FR46194
    Correction [PDF] 1/18/1989 54FR2039
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 8/25/1992 57FR38568
    Correction [PDF] 9/8/1992 57FR40944
    Technical Amendment: Correct an ingredient name [PDF] 10/1/1992 57FR45295
    Correction [PDF] 11/9/1992 57FR53300
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/10/1993 58FR27636

Menstrual Drug Products: Nonmonograph Ingredients
Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 8/25/1992 57FR38568
    Correction [PDF] 9/8/1992 57FR40944
    Technical Amendment: Correct an ingredient name [PDF] 10/1/1992 57FR45295
    Correction [PDF] 11/9/1992 57FR53300
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/10/1993 58FR27636
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