FDA Removes 12 Peptides from Category 2 List, Restoring a Path to Compounding Review
In April 2026, the FDA formally removed 12 peptides from its 503A Category 2 list - the tier reserved for bulk drug substances the agency believes may pose safety concerns. The move restored a regulatory path toward compounding eligibility for compounds including BPC-157.
The reclassification followed February 2026 statements from HHS Secretary Robert F. Kennedy Jr., who directed that roughly 14 of the 19 peptides restricted since September 2023 move toward Category 1 review.
Precision about what changed is essential: removal from Category 2 moved these peptides out of the banned tier without moving them into the permitted one. It was a procedural reopening, not an authorization - a distinction several commentators blurred in the weeks that followed.
The July 2026 PCAC meeting continued the process, with the advisory committee recommending six peptides for the 503A list. Final agency action remains pending as rulemaking proceeds.