Rulemaking History for OTC Food and Drink Overindulgence Drug Products
Pending Final Monograph (21 CFR part 357 subpart J):
Miscellaneous Internal Drug Products for Over-the-Counter Human Use: Orally Administered Drug Products for Relief of Symptoms Associated with Overindulgence in Food and Drink for Over-the-Counter Human Use
OTC Food and Drink overindulgence Drug Products found on this page:
Food and Drink Overindulgence Drug Products: Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking | 10/1/1982 | 47FR43540 |
| Correction | 12/10/1982 | 47FR55497 |
| Correction | 12/21/1982 | 47FR56871 |
| Extension of Comment Period | 1/4/1983 | 48FR270 |
| Notice: Classifies "prevention of inebriation" claim as nonmonograph | 7/19/1983 | 48FR32872 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph | 12/24/1991 | 56FR66742 |
| Correction | 3/4/1992 | 57FR7847 |
Food and Drink Overindulgence Drug Products: Internal Analgesics
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Amends 21 CFR part 343 to allow stimulant and internal analgesic combinations | 12/24/1991 | 56FR66762 |
Food and Drink Overindulgence Drug Products: Antacids
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Amends 21 CFR part 331 to allow overindulgence claims for antacids | 12/24/1991 | 56FR66754 |
Food and Drink Overindulgence Drug Products: Bismuth Subsalicylate
| Proposed Rule | Date | FR Citation |
|---|---|---|
| Proposed Rule: Requires Reye syndrome warning | 5/5/1993 | 58FR26886 |
| Proposed Rule: Adds "upset stomach" claim | 1/5/2005 | 70FR741 |