Nonrulemaking

Requests that, within 180 days of the date of this Citizen Petition, the U.S. Food and Drug Administration (FDA or Agency): 1. Publish a notice in the Federal Register excluding liraglutide 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);

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1
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Comment status
Open
Last activity
Mar 17, 2025
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Rules, notices, and supporting material — the primary rule pinned first.

📄 Primary document
OtherJan 2, 2025
Citizen Petition from Covington & Burling LLP on behalf of Novo Nordisk Inc.
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