BSR Intelligence
Daily intelligence on the peptide research industry.
Independent briefings on regulatory moves, pharma deals, research pipeline shifts and the trust gaps that define this market. Updated daily, sourced inline.
Regulatory & Policy
FDA Proposes to Close Large-Scale GLP-1 Compounding for Good, Targeting the 503B Outsourcing Pathway
The FDA has proposed permanently excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, finding no clinical need for outsourcing facilities to compound these GLP-1 drugs from bulk substances. The move would close the last remaining large-scale compounding pathway, with implications for API supply, research procurement, and the broader peptide market.
09 May 2026
Regulatory & Policy
FDA Tightens GLP-1 Compounding Rules While Scheduling First Formal Review of BPC-157, TB-500 and Five Other Peptides
The FDA issued a proposal on 30 April 2026 to permanently exclude semaglutide, tirzepatide and liraglutide from the 503B bulk compounding list, citing no clinical need. Separately, the agency has confirmed a two-day Pharmacy Compounding Advisory Committee meeting on 23–24 July 2026 to evaluate seven peptides — including BPC-157, TB-500 and Semax — for potential inclusion on the 503A Bulks List, the first formal step toward regulated compounding access since twelve substances were removed from…
07 May 2026
Regulatory & Policy
FDA schedules July PCAC review for seven peptides as Category 2 compounding restrictions lapse
Twelve peptides — including BPC-157, TB-500, Semax and Epitalon — were removed from the FDA's Category 2 "unsafe to compound" list on 23 April 2026. Seven of them now go before the Pharmacy Compounding Advisory Committee on 23-24 July 2026 for potential addition to the 503A Bulks List. Removal from Category 2 is not the same as authorisation to compound.
05 May 2026
Regulatory & Policy
Peptide industry briefing — March to early May 2026
The single biggest story of 2026 is the RFK-led reclassification moving 14 peptides off the FDA's banned list. Compounded GLP-1s are dying. Mainstream attention is at an all-time high. Counterfeit product remains the trust gap that defines this market.
04 May 2026