Rulemaking History for OTC Digestive Aid Drug Product
Non-Monograph (21 CFR 310.545(a)(8)):
Drug Products Containing Certain Ingredients Offered Over-The-Counter (OTC) For Certain Uses
FDA Archive-It webpage:
Search for Federal Register documents:
- GPO Federal Register Database (1994 to present)
- Library of Congress (1936 - 1993)
OTC Digestive Aid Drug Products found on this page:
Digestive Aid Drug Products: Original Active Ingredients and Labeling:
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 1/5/1982 | 47FR454 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph: Classifies all active ingredients as nonmonograph | 1/29/1988 | 53FR2706 |
| Extension of Comment Period | 4/19/1988 | 53FR12779 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies all active ingredients as nonmonograph except defers lactase enzyme | 10/21/1993 | 58FR54450 |
Digestive Aid Drug Products: Nonmonograph Ingredients
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph | 5/16/1990 | 55FR20434 |
| Correction | 6/7/1990 | 55FR23235 |
| 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 | 11/7/1990 | 55FR46914 |
| Correction | 12/3/1990 | 55FR49973 |
| Technical Amendment: Corrects an ingredient name | 1/30/1992 | 57FR3526 |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph | 5/10/1993 | 58FR27636 |