⚖️FDA's Final Guidance on Bulk Drug Substances Compounding Released
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A 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 503A of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used 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 This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.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 text outlines FDA's guidance on compounding using bulk drug substances, impacting regulatory compliance for pharmacies and physicians. It details the conditions under which drug compounding can occur, which is crucial for business owners in the pharmaceutical sector. Non-compliance may lead to significant legal and financial consequences.