Rulemaking History for OTC Menstrual Drug Products
Pending Final Monograph (21 CFR part 357 subpart K):
Miscellaneous Internal Drug Products for Over-the-Counter Human Use
FDA Archive-It webpage:
Search for Federal Register documents:
- GPO Federal Register Database (1994 to present)
- HeinOnline
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provides online access to Federal Registers from 1936-forward
OTC Menstrual Drug Products found on this page:
Menstrual Drug Products: Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice Of Proposed Rulemaking | 12/7/1982 | 47FR55076 |
| Correction | 1/14/1983 | 48FR1758 |
| Correction | 2/18/1983 | 48FR7202 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 11/16/1988 | 53FR46194 |
| Correction | 1/18/1989 | 54FR2039 |
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph | 8/25/1992 | 57FR38568 |
| Correction | 9/8/1992 | 57FR40944 |
| Technical Amendment: Correct an ingredient name | 10/1/1992 | 57FR45295--]){kind=small} |
| Correction | 11/9/1992 | 57FR53300 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph | 5/10/1993 | 58FR27636 |
Menstrual Drug Products: Nonmonograph Ingredients
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph | 8/25/1992 | 57FR38568 |
| Correction | 9/8/1992 | 57FR40944 |
| Technical Amendment: Correct an ingredient name | 10/1/1992 | 57FR45295 |
| Correction | 11/9/1992 | 57FR53300 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph | 5/10/1993 | 58FR27636 |