U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Vaginal Contraceptive Drug Products
  1. Historical 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
    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

Back to Top

Back to Top