Rulemaking History for OTC Vaginal Contraceptive Drug Products

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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

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

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