Glossary
Category 2 of the interim 503A bulks list holds nominated substances for which the FDA has identified significant safety concerns. Placement in Category 2 bars a licensed pharmacy from compounding the substance.
The category matters most for what leaving it does not do. In April 2026 the FDA removed twelve peptides from Category 2 without adding them to Category 1; the removal ended an explicit prohibition and conferred no authorization, and the substances sit on no list. Removal from a list named after safety concerns reads like clearance and is not one.