What happened
The FDA page compiles policy documents and related materials governing human drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Its latest listed item is final guidance dated September 4, 2026 on temporary policies for compounding certain starter parenteral nutrition drug products for neonates. It also lists an April 30, 2026 Federal Register notice on the section 503B clinical-need list for bulk drug substances, with an FDA statement proposing exclusion of semaglutide, tirzepatide, and liraglutide. Earlier entries cover bulk substances, temporary parenteral compounding policies, outsourcing facilities, insanitary conditions, current good manufacturing practice, reporting, distribution, and repackaging. The page identifies its content as current as of September 9, 2026.
Why it matters
From a GMP and pharmaceutical manufacturing perspective, this collection may matter because it centralizes FDA materials relevant to outsourcing-facility operations, use of bulk drug substances, and compounding of parenteral products. Entries addressing insanitary conditions, current good manufacturing practice, electronic product reporting, adverse-event reporting, and temporary shortage-related policies provide reference points for quality systems and production planning. Manufacturers and compounders may need to determine which listed documents apply to their activities.
Key topics: Temporary neonatal starter parenteral nutrition compounding, Section 503B bulk drug substance clinical-need list, FDA compounding policies for sections 503A and 503B