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FDA Outlines Expectations for Human Drug Compounders

Posted By Administration, Wednesday, July 16, 2014

On July 1, the US Food and Drug Administration released multiple policy documents concerning compounded drug products for human use.  These documents are part of the implementation of the November 2013 Drug Quality and Security Act (DQSA): a draft interim guidance, a proposed rule, a final guidance, and two Federal Register Notices that announce the reopening of the nomination process for bulk drug substances that may be used to compound drug products.  FDA invites public comment on the draft guidance and proposed rule for 60 days.  Public nomination of bulk drug substances for compounding is open for 90 days.

To access the announcement that includes links to these documents, click here.

Tags:  FDA  Patient Safety 

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