🏥FDA Issues Interim Guidance on Compounding Bulk Drug Substances
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's interim policy provides guidance on the compounding of bulk drug substances, directly impacting compliance and regulatory requirements for outsourcing facilities. Business owners must adapt to these guidelines to avoid penalties and ensure product safety.