Peptide News Digest

#Oral-Testimony

2 stories

Regulatory · View digest

PCAC Oral Testimony Registration Closes Tuesday June 30 at End-of-Day for July 23-24 Pharmacy Compounding Advisory Committee Hearing on BPC-157, KPV, TB-500, MOTS-c, Emideltide/DSIP, Semax, and Epitalon; Written Docket FDA-2025-N-6895 Remains Open Through July 9 for PCAC-Member Review, July 22 for Hard Comment Deadline

Registration for oral testimony at the FDA Pharmacy Compounding Advisory Committee meeting on July 23-24, 2026 closed at the end of business Tuesday June 30, 2026. Individuals or organizations who wanted to give a formal oral presentation at the public-comment portion of the meeting had to notify FDA by today with a brief description of the evidence or arguments to be presented, names and addresses of participants, in-person versus virtual preference, and a requested time allotment. Written comments to docket FDA-2025-N-6895 at regulations.gov remain open through July 9, 2026 for formal provision to PCAC members ahead of the meeting; the hard deadline for all written comments is July 22, 2026 at 11:59 PM ET. The two-day meeting at FDA's White Oak campus in Silver Spring, Maryland (with virtual attendance option) reviews seven peptides for 503A bulks list eligibility: BPC-157, KPV, TB-500, and MOTS-c on Day 1 (July 23); Emideltide (delta sleep-inducing peptide / DSIP), Semax, and Epitalon on Day 2 (July 24). Oral-testimony filers will face the FDA career-staff briefing documents released this week concluding the evidence is insufficient on all seven substances.

Regulatory · View digest

PCAC Oral Testimony Registration Window Closes Tuesday June 30 (1 Day Out) for July 23-24 Pharmacy Compounding Advisory Committee Meeting on 503A Bulks List Eligibility for BPC-157, KPV, TB-500, MOTS-c, Emideltide/DSIP, Semax, and Epitalon

Registration for oral testimony at the FDA Pharmacy Compounding Advisory Committee (PCAC) meeting on July 23-24, 2026 closes Tuesday June 30, 2026 — one day from this Monday digest. The two-day meeting at the FDA White Oak campus in Silver Spring, Maryland (with virtual attendance option) will vote on 503A bulks list eligibility for seven peptides: BPC-157, KPV, TB-500, and MOTS-c on Day 1 (July 23); Emideltide (delta sleep-inducing peptide / DSIP), Semax, and Epitalon on Day 2 (July 24). Pharmacist-facing guidance in Pharmacy Times (Annie Lambert, PharmD, BCSCP, Wolters Kluwer clinical program manager for compliance solutions, published two days ago) advised compounding pharmacies to prepare for the post-PCAC market regardless of which specific peptides receive affirmative votes. Written comments to docket FDA-2025-N-6895 remain open through July 22 at 11:59 PM ET. The seven peptides came off the FDA's Category 2 'do not compound' list effective April 23, 2026; PCAC affirmative votes plus FDA acceptance are needed for formal 503A bulks list addition. Hims & Hers (HIMS), LifeMD, Henry Meds, and the broader telehealth-peptide platform space have priced in some affirmative outcomes (Barclays $39 HIMS PT, June 17; Leerink Market Perform reiteration this past week).