Peptide News Digest

#Semax

3 stories

Regulatory · View digest

FDA Pharmacy Compounding Advisory Committee (PCAC) Oral-Testimony Registration Deadline June 30, 2026: Written Docket FDA-2025-N-6895 Closes July 22 Ahead of July 23-24 503A Bulks List Vote on BPC-157, KPV, TB-500, MOTS-C, Emideltide/DSIP, Semax, Epitalon

The FDA's Pharmacy Compounding Advisory Committee meeting on July 23-24, 2026 at the agency's White Oak campus (Silver Spring, Maryland) reaches its first procedural cutoff next Tuesday: June 30, 2026 is the deadline to register for oral testimony in the public-comment portion of the meeting. Written comments to docket FDA-2025-N-6895 at regulations.gov must arrive by 11:59 PM ET July 22, 2026 (one day before the meeting opens). The Committee will discuss BPC-157, KPV, TB-500, and MOTS-C on Day 1 (July 23) and Emideltide/DSIP, Semax, and Epitalon on Day 2 (July 24). All seven peptides came off FDA Category 2 effective April 23, 2026. PCAC recommendations are advisory: the agency makes the final 503A bulks list decision, and the Hims & Hers (HIMS) stock breakout above $30 reflected market consensus that the July vote will tilt toward eligibility. Lengea Law and PeptideClarity have both published prescriber-facing trackers ahead of the meeting.

Regulatory · View digest

FDA Pharmacy Compounding Advisory Committee Public Docket FDA-2025-N-6895 Open for Comments Ahead of July 23–24 Peptide Review

The FDA's PCAC public docket FDA-2025-N-6895 is now accepting written comments on the proposed addition of seven peptides to the Section 503A bulk drug substances list ahead of the July 23–24 advisory committee meeting at White Oak. Day 1 will cover BPC-157, KPV, TB-500, and MOTs-C; Day 2 will cover Emideltide (DSIP), Semax, and Epitalon. Comments received by July 9 are guaranteed to be presented to the committee, and the docket closes July 22. The window gives compounders, prescribers, and patient advocates roughly twelve weeks to formally submit clinical evidence, pharmacovigilance data, and access arguments.

Regulatory · View digest

BPC-157, TB-500, and 10 Other Peptides Formally Exit FDA Category 2 Restricted List

Effective April 22, BPC-157, TB-500, Semax, Epitalon, MOTS-c and seven other peptides were formally removed from the FDA's 503A Category 2 significant-safety-concerns list after original nominators withdrew submissions. The FDA Pharmacy Compounding Advisory Committee will meet July 23-24 to decide whether to add these peptides to the 503A bulks list, which would restore legal compounding under prescription.