Drugs

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

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OTC Menstrual Drug Products found on this page:

Menstrual Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice Of Proposed Rulemaking12/7/198247FR55076
   Correction1/14/198348FR1758
    Correction2/18/198348FR7202
Proposed RuleDateFR Citation
Tentative Final Monograph11/16/198853FR46194
   Correction1/18/198954FR2039
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph8/25/199257FR38568
    Correction9/8/199257FR40944
    Technical Amendment: Correct an ingredient name10/1/199257FR45295
    Correction11/9/199257FR53300
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph5/10/199358FR27636

Menstrual Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph8/25/199257FR38568
    Correction9/8/199257FR40944
    Technical Amendment: Correct an ingredient name10/1/199257FR45295
    Correction11/9/199257FR53300
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph5/10/199358FR27636

 

Page Last Updated: 12/08/2016
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