Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
FDA's running list of bulk drug substances nominated for use in 503A pharmacy compounding, organized into Category 1 (under evaluation), Category 2 (significant safety risks), and Category 3 (nominated without adequate support).
Not legal or medical advice.
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U.S. Food and Drug AdministrationAgency listActive
- Docket / Citation
- FDA-2015-N-3534
- Published
- 2024-09-27
Provisions
- 503A bulk list categories
- Category 2 safety-risk substances