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Nine More FDA Bulk Compounding Denials Proposed Post-Vasopressin

Executive Summary

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

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US FDA 'Bulks Up' 503B Outsourcing Drug List By Proposing Four First-Time Additions

The US FDA has proposed allowing outsourcing facilities to compound from four drug substances, but not from 19 others that it says already are available in FDA-approved drug products. Compounding pharmacies also would be allowed to compound from two of the four drug substances.

The FDA Proposes Adding Five Of 31 Drug Substances To 503A Bulks List

FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.

Vasopressin Ruling May Greenlight More FDA Limits On Bulk Drug Compounding

By siding with the FDA against bulk compounding of vasopressin, is court encouraging more limits to Section 503B outsourcing facilities?

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