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Rulemaking History for OTC Vaginal Contraceptive Drug Products
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Pending Final Monograph (21 CFR part 351):  
Vaginal Contraceptive Drug Products for Over-the-Counter Human Use


Date Federal Register Citation Description
12/12/1980 45FR82014 PDF document Advance Notice of Proposed Rulemaking
2/6/1981 46FR11292 PDF document Correction: Advance Notice of Proposed Rulemaking
5/5/1981 46FR25107 PDF document Extension of Comment Period: Advance Notice of Proposed Rulemaking
2/3/1995 60FR6713 PDF document
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Availability: Guidance for development of vaginal contraceptive drugs
2/3/1995 60FR6892 PDF document
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Proposed Rule: All products are nonmonograph because final formulation effectiveness test needed
10/30/1996 61FR55990 PDF document Notice: Advisory Committee meeting on effectiveness
12/19/1996 61FR66953 PDF document
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Reopening of Administative Record: 10/30/1996 notice
4/22/1998 63FR19799 PDF document Final Rule: Classifies category II and III ingredients without data as nonmonograph
5/9/2002 67FR31123 PDF document Final Rule: Classifies octoxynol 9 as nonmonograph
1/16/2003 68FR2254 PDF document
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Proposed Rule: Requires warning that products do not protect against STDs
12/31/2003 68FR75585 PDF document
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Call for Data: Miscellaneous OTC drug products
12/19/2007 72FR71769 PDF document
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Final Rule: Required labeling for products containing nonoxynol 9

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Date updated: December 28, 2006; Last updated: January 15, 2008

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