Peptide News Digest

#Apha

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Regulatory · View digest

FDA Pharmacy Compounding Advisory Committee Peptide Meeting Two Days Out — Written-Comment Docket FDA-2025-N-6895 Closes at 11:59 PM ET Wednesday July 22, With the Thursday-Friday July 23-24 Vote Opening at 8:00 AM ET Thursday and Closing at 3:50 PM ET Friday at FDA White Oak Campus in Silver Spring, Maryland: Day 1 (Thursday) Reviews BPC-157, KPV, TB-500, and MOTS-c; Day 2 (Friday) Reviews Emideltide (DSIP), Semax, and Epitalon; The Washington Post Reports on July 17 That FDA Career Staff Raised Conflict-of-Interest Concerns Ahead of the New Peptide Panel

The FDA Pharmacy Compounding Advisory Committee (PCAC) peptide meeting is two days out. Written-comment docket FDA-2025-N-6895 closes at 11:59 PM ET on Wednesday July 22, 2026 (comments received via the Regulations.gov electronic filing system after that time will not be considered). The two-day meeting opens Thursday July 23 at 8:00 AM ET and closes Friday July 24 at 3:50 PM ET at FDA's White Oak Campus in Silver Spring, Maryland. Day 1 (Thursday) reviews BPC-157, KPV, TB-500, and MOTS-c for 503A bulks-list eligibility. Day 2 (Friday) reviews DSIP (Emideltide), Semax, and Epitalon. The Washington Post reported on July 17 that FDA career staff had raised conflict-of-interest concerns ahead of the new panel composition, adding to the June 29 STAT News reporting that seven of eight new PCAC members named have documented ties to peptide-related businesses. FDA career-staff briefing documents released June 29-30 recommended against adding any of the seven peptides to the 503A Bulks List. The American Pharmacists Association (APhA) filed docket comments this month urging the FDA to put patient safety first in the review.

Regulatory · View digest

American Pharmacists Association (APhA) Formally Submits Docket Comments to FDA-2025-N-6895 Urging the Pharmacy Compounding Advisory Committee to Prioritize Patient Safety, Scientific Evidence, and Regulatory Oversight in the July 23-24 Review of Seven Peptide Substances; Statement From APhA Vice President of Professional Affairs Brigid Groves, PharmD, MS: 'Pharmacists Believe in Innovation, But Innovation Must Be Grounded in Science and Patient Safety' — The Filing Joins Partnership for Safe Medicines, Public Citizen, and Institute for Safe Medication Practices in the Formal Public-Comment Record

The American Pharmacists Association (APhA) submitted comments to FDA docket FDA-2025-N-6895 on Thursday July 17, 2026 urging the Pharmacy Compounding Advisory Committee to prioritize patient safety, scientific evidence, and regulatory oversight when evaluating the seven peptide substances up for review July 23-24. APhA warned that current black and gray markets for peptides expose patients to significant risks including contamination, inaccurate dosing, counterfeit ingredients, and serious adverse health consequences. Brigid Groves, PharmD, MS, APhA Vice President of Professional Affairs, said in the associated statement: 'Pharmacists believe in innovation, but innovation must be grounded in science and patient safety.' APhA emphasized that compounding pharmacists have a long history of helping patients access customized and safely prepared therapies when there is a legitimate clinical need, and that if rigorous peer-reviewed research demonstrates safety and efficacy for the seven peptides under review, pharmacists will play an essential role in preparing high-quality compounded formulations. The APhA filing joins docket comments from the Partnership for Safe Medicines (opposing addition), Public Citizen (opposing addition), Institute for Safe Medication Practices (raising safety concerns), the Alliance for Pharmacy Compounding (supporting bulks-list inclusion with quality safeguards), and individual academic scientists including UC Davis's Paul Knoepfler.