FDA Releases Compounding Guidance

In December 2023, FDA released two guidance documents on drug compounding using bulk drug substances. FDA provides a list of bulk drug substances that can be used in compounding, and the documents provide the agency’s interim policy for use of bulk drug substances in compounding by facilities that are considered outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and those facilities that are not considered outsourcing facilities (under Section 503A of the FD&C Act).

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act describes a background on compounding from bulk drug substances that includes efforts the agency made to develop the list of bulk drug substance that may be used for compounding. The document covers current nominations for the 503A bulk substance list and process for developing the list. Also included are the agencies policies on compounding from bulk drug substances on the 503A list, substances that are not nominated for the list as of the publication of the guidance, and comments about nominated bulk drug substances.

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Revision 2 features similar information but in regards to 503B facilities. According to the guidance document, “Section 503B of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by an outsourcing facility to be exempt from the following three sections of the FD&C Act: section 505 (concerning the approval of drugs under new drug applications or abbreviated new drug applications); section 502(f)(1) (concerning the labeling of drugs with adequate directions for use); and section 582 (concerning drug supply chain security requirements).”

The new draft guidance documents replace guidance from January 2017.

Source: FDA