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

 
• By Joanne S. Eglovitch

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.  

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US FDA Takes Action On 503B Bulks List • Source: Shutterstock

The US Food and Drug Administration has proposed allowing outsourcing facilities to compound drug products from four bulk drug substances in its first such decision permitting such compounding in the seven years since the Drug Quality and Security Act required the agency to establish the list.

The agency also proposed restricting 19 drug substances from compounding, saying they already exist in dosage forms that are available in FDA-approved drug products.

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