Nine More FDA Bulk Compounding Denials Proposed Post-Vasopressin

Expected flurry of FDA proposals against 503B compounding from bulk drug substances follows vasopressin court ruling.

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The FDA Is Now Moving Quickly On Bulk Compounding • Source: Shutterstock

The US Food and Drug Administration proposed 3 September to restrict nine more active drug substances from being compounded in bulk by outsourcing facilities, saying these active substances already exist in dosage forms that are available in FDA-approved drug products.

This action may bolster predictions that the agency is accelerating its review and excluding more substances from compounding under Section...

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