TIMELINE
- Sep 2023FDA places nineteen peptides, including BPC-157 and TB-500, in Category 2.
- Sep 2024Five substances (AOD-9604, CJC-1295, ipamorelin acetate, thymosin alpha-1, selank) leave 503A Category 2 after their nominations are withdrawn.
- 27 Feb 2026HHS Secretary says about fourteen will move toward compounding eligibility.
- 15 Apr 2026FDA removes twelve peptides from Category 2 after nominations are withdrawn; PCAC meetings scheduled.
- 30 Apr 2026FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list.
- 23–24 Jul 2026PCAC recommends six peptides for the 503A bulks list; emideltide not recommended.
- 27 Aug 2026Fifth Circuit upholds removal of semaglutide and tirzepatide from the shortage list (to verify against the opinion).
- by Feb 2027Second PCAC peptide meeting on five further substances.
ENTRIES ON THIS TOPIC · 5
PUBLIC
A 1 October 2026 Q&A from the Harvard T.H. Chan School of Public Health lists BPC-157, TB-500, MOTS-c, CJC-1295 and ipamorelin among synthetic peptides promoted online for recovery and performance.
POLICY
An AJMC feature describes the July advisory vote passing over the objection of FDA staff scientists, states diverging on peptide compounding, and more than forty state attorneys general writing to the agency.
REGULATION
On 23–24 July 2026 the FDA's Pharmacy Compounding Advisory Committee voted to recommend BPC-157, KPV, TB-500, MOTS-c, epitalon and Semax for the 503A bulks list. Emideltide was not recommended.
REGULATION
A 30 April 2026 proposal would exclude the three GLP-1 drugs from the 503B bulks list, closing the outsourcing-facility route that opened during the shortage years.
REGULATION
In September 2023 the FDA placed nineteen peptides in Category 2. In April 2026 it removed twelve of them after their nominations were withdrawn and scheduled advisory meetings to consider adding them to the 503A bulks list.