All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2024-P-4937
Requests that the FDA within 180 days of the date of this Citizen Petition, 1. Publish a notice in the Federal Register excluding semaglutide from the 503B Bulks List; 2. Rescind in its entirety the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (“503B Interim Policy”); 3. Exclude semaglutide from Category 1
Documents
4
Comments
5
Description
Open
Key Dates
Comment Period OpensOct 23, 2024
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
5
Keywords
CDER
Citizen Petition
Covington & Burling LLP
Novo Nordisk Inc.
Publish a notice in the Federal Register
excluding semaglutide from the 503B Bulks List
Rescind in its entirety the Interim Policy
Compounding Using Bulk Drug Substances
Data from Regulations.gov