November 30, 2023

What does FD&C Act really say about USP compliance?

In response to inquiries from state boards of pharmacy regarding the enforceability of revised USP Chapters <795>, <797>, and <800>, a recent memo aims to clarify references in the Food, Drug & Cosmetic Act. APC issued the memo this week as a resource for state boards of pharmacy.

The focus is on Section 503A of the FD&C Act, which pertains to compounded drugs. Contrary to concerns, the memo emphasizes that the reference to USP standards in Section 503A applies specifically to bulk drug substances only — the API must be USP-compliant — and not to all compounding. It underscores that compliance with USP compounding chapters’ references to bulk drug substances is mandated, but it does not require states to adopt entire USP chapters for all compounding practices. 

APC’s clarifying memo aims to guide state boards in navigating the complex landscape of the new USP chapters.