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  7. Rulemaking History for OTC Vaginal Contraceptive Drug Products
  1. Status of OTC Rulemakings

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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking12/12/198045FR82014
    Correction2/6/198146FR11292
    Extension of Comment Period5/5/198146FR25107
Proposed RuleDateFR Citation
Proposed Rule: All products are nonmonograph because final formulation effectiveness test needed2/3/199560FR6892
Notice: Guidance for development of vaginal contraceptive drugs2/3/199560FR6713
Call for Data: Miscellaneous OTC drug products12/31/200368FR75585
Notice: Advisory Committee meeting on effectiveness10/30/199661FR55990
     Reopening of Administrative Record: Advisory Committee meeting12/19/199661FR66953
Proposed Rule: Requires warning that products do not protect against STDs1/16/200368FR2254
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph4/22/199863FR19799
Final Rule: Classifies octoxynol 9 as nonmonograph5/9/200267FR31123
Final Rule: Required labeling for products containing nonoxynol 912/19/200772FR71769

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