Regulatory Watch
Compounding eligibility in the US runs through FDA's evaluation of 'bulk drug substances' — the raw ingredients licensed pharmacies may use under sections 503A and 503B of the Food, Drug and Cosmetic Act. Nominated substances move through categories: under review, flagged for safety concerns, or insufficient data.
For peptides, those category moves are the whole ballgame: a compound's lawful availability can change with a single list update, in either direction, without anything about the molecule itself changing. This page logs the moves that matter, with dates.
Two honest cautions. First, this log tracks public regulatory actions — it is not legal advice, and it can lag; a licensed compounding pharmacy is the authority on today's status. Second, none of these moves make a compound 'proven' or 'safe' — eligibility for compounding and evidence of benefit are entirely separate questions.
The timeline
July 23, 2026
FDA advisory committee takes up popular compounding peptides
FDA's Pharmacy Compounding Advisory Committee scheduled formal review of several nominated peptides — including compounds popular in wellness programs — at its July 2026 meetings, part of the process that decides which substances licensed pharmacies may compound. Committee recommendations feed FDA decisions; they are a step in the process, not the final word. What a pharmacy may compound today remains a question for that pharmacy.
September 20, 2024
CJC-1295 and ipamorelin removed from Category 2
FDA removed CJC-1295 and ipamorelin acetate from Category 2 of its interim 503A bulk-substances list after their nominations were withdrawn — reversing part of the September 2023 action. Removal from Category 2 is not an approval and not a safety endorsement; it changes the compounding-eligibility posture while review processes continue.
September 29, 2023
FDA places BPC-157, CJC-1295, ipamorelin and others in Category 2
FDA added several nominated peptides — including BPC-157, CJC-1295 and ipamorelin acetate — to Category 2 of its interim 503A bulk-substances list, citing identified significant safety risks. Category 2 placement effectively directs licensed pharmacies not to compound a substance while so designated. This action is why 'can my clinic still offer it?' became the defining question of the 2023–2024 peptide market.