Rulemaking History for OTC Menstrual Drug Products

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Rulemaking History for OTC Menstrual Drug Products
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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:

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

Date created: December 28, 2006; Last updated: April 26, 2007