Rulemaking History for OTC Vaginal Contraceptive Drug Products

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


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


Page Last Updated: 04/06/2016
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