FDA finalizes interim policy on compounding using bulk drug substances- Drug Information Update

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

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Today the FDA issued two final guidances on compounding using bulk substances:

• Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 127KB)
• Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 106KB)

The agency also posted a statement and a webpage related to these two guidances: 

• FDA issues final guidances on interim policy for certain bulk drug substances used in compounding
• Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding; Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

For more information on pharmacy compounding, go to FDA’s Information on Compounding