FDA Publishes Compounding Guidance on the Evaluation of Bulk Drug Substances

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The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.

On March 23, 2018, FDA released draft guidance on drug compounding as part of its implementation of the Drug Quality and Security Act and section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act. The new draft guidance details the agency’s policy for evaluating bulk drug substances in compounding by outsourcing facilities registered under section 503B of the FD&C Act.

The guidance addresses the agency’s policies for developing bulk lists, including the definition of “bulk drug substances for which there is a clinical need.” Factors and processes used by the agency to evaluate bulk drug substances are also discussed.

“Today’s draft guidance is a significant milestone in our work to implement that compounding priorities plan … As the agency further refines what we intend our policies to be on this important topic, we know that stakeholders will, through the public comment process, bring competing concerns to our attention,” FDA Commissioner Scott Gottlieb, MD, stated in a press release


Source: FDA