Bulk Drug Substances Nominated for Use in Compounding Under Section 503B
FDA's running list of bulk drug substances nominated for use by 503B outsourcing facilities. Category 1 substances are under evaluation; Category 2 substances raise significant safety risks; Category 3 substances were nominated without adequate support.
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U.S. Food and Drug AdministrationAgency listActive
- Docket / Citation
- FDA-2015-N-0030
- Published
- 2025-03-21
Provisions
- 503B bulk list categories
- Category 2 safety-risk substances