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 for Over-the-Counter Human Use
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 | 68FR75585 |
| 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 |