The Pharmacy Compounding Advisory Committee: members, votes and words
The same kind of committee looked at peptides in 2024 and in 2026 and reached opposite conclusions. The roster, the tallies and the members' own words show how.
The Pharmacy Compounding Advisory Committee advises FDA on which substances belong on the 503A list. Its charter was renewed on 30 April 2026 to April 2028. It votes; FDA decides. This page adds detail to our July 2026 vote explainer: the official roster, the topics each person was cleared to vote on, the tallies as reported, and what members and FDA staff said. Names below are as printed on FDA's final meeting roster. FDA had not posted minutes, a transcript or a roll call for July 2026 when this was written, so individual votes are given only where a named report states them.
The July 2026 roster
| Name as listed | Role or affiliation as listed | Topics |
|---|---|---|
| Brian Serumaga, PhD | Acting chair; USP representative | All |
| Gabriel Alizaidy, MD, MS | Scientific Director, Maximus Health | All |
| Asare B. Christian, MD, MPH | Founder, Aether Medicine | All |
| Timothy D. Fensky, RPh | National Association of Boards of Pharmacy representative | All |
| Senator Bobby Harshbarger, PharmD | Tennessee State Senator; pharmacist, Premier Pharmacy Inc | All |
| Melissa Loseke, DO | Chief Medical Officer, Re-new Institute | All |
| Haleem Mohammed, MD, MBA | Global Chief Medical Officer, Gameday Health | BPC-157, KPV, TB-500, MOTS-c, semax |
| David Pope, PharmD | Chief Pharmacy Officer, Xifin Pharmacy Solutions | All |
| Elizabeth Rebello, MD | Professor, MD Anderson Cancer Center | BPC-157, KPV, TB-500, MOTS-c, emideltide |
| Joshua Starbuck, MD | Chief Medical Officer, Makena Health | All |
| Kris H. Wusterhausen, DO | Founder and Medical Director, The Resurge Clinic | All |
| Todd Durham, PhD | Temporary member; consumer representative | All |
| Josh Mailman, MBA | Temporary member; patient representative | All |
| Brian P. Lee, MD, MAS | Temporary member; Keck School of Medicine of USC | BPC-157 only |
| Maral Kibarian Skelsey, MD | Temporary member; Georgetown dermatology | KPV, TB-500 |
| William C. Zamboni, PharmD, PhD | Temporary member; University of Pittsburgh | All except semax |
| Kevin L. Zacharoff, MD | Temporary member; Stony Brook | Emideltide only |
| Costantino Iadecola, MD | Temporary member; Weill Cornell Medicine | Semax only |
| Friedhelm Sandbrink, MD | Temporary member; Veterans Health Administration | Semax only |
| Donnette D. Staas, PhD | Industry representative, Jazz Pharmaceuticals (non-voting) | Non-voting |
On the roster's topic limits, 15 people were eligible to vote on BPC-157 and on KPV, which matches the 15 votes reported for each. FDA's non-voting participants included Matthew Lash (acting director, Office of Compounding Quality and Compliance), Mary Thanh Hai and Gautam Mehta of the Office of New Drugs, and Russell Wesdyk of the Office of Pharmaceutical Quality.
How the committee changed
When FDA announced the meeting in April 2026, Associated Press reported that the panel had vacancies, including the chair and the consumer representative. NBC News reported on 23 July that eight members had been "recently appointed under Health Secretary Robert F. Kennedy Jr." and that six of them run clinics offering peptides. AP had earlier named three new members and their businesses: Haleem Mohammed, Gabriel Alizaidy and Bobby Harshbarger, whose mother, Rep. Diana Harshbarger, had written to Kennedy in 2025 urging him to relax restrictions. An HHS spokesperson, Emily Hilliard, told reporters: "All committee members underwent the same ethics review and vetting process."
The votes
| Peptide | Use FDA reviewed | FDA staff | Reported tally | Outcome |
|---|---|---|---|---|
| BPC-157 | Ulcerative colitis | Against | 8 to 6, 1 abstention | Recommended |
| KPV | Wound healing, inflammatory conditions | Against | 8 to 6, 1 abstention | Recommended |
| TB-500 | Wound healing | Against | 8 to 6, 1 abstention | Recommended |
| MOTS-c | Obesity, osteoporosis | Against | 7 to 5, 2 abstentions | Recommended |
| Emideltide (DSIP) | Opioid withdrawal, insomnia, narcolepsy | Against | 6 for, 7 against, 1 abstention | Not recommended |
| Epitalon | Insomnia | Against | 7 to 5, 1 abstention (RAPS); 7 to 4, 1 abstention (McDermott) | Recommended |
| Semax | Cerebral ischaemia, migraine, trigeminal neuralgia | Against | 8 to 5 (RAPS); 8 to 5, 1 abstention (McDermott) | Recommended |
The two published tallies for epitalon and semax differ by one vote. The roster's topic limits allow 12 voters on epitalon and 14 on semax, which matches McDermott's figures if everyone eligible voted. The official minutes, once posted, will settle it.
What members said
In favour. Haleem Mohammed: "As a physician, I have to make sure that I'm keeping patients as safe as possible. That's my mandate, right? Do no harm." He added: "So when I look at something like saying no to this and pushing it to the gray market, am I doing greater harm?" (TIME). David Pope: "I voted yes because it's time to put this decision back in the hands of the physician and pharmacist" (RAPS). Gabriel Alizaidy voted for BPC-157 while saying he was "frankly disappointed at how incomplete the data was" (NBC News). On emideltide, Pope said "a physician and pharmacist are key to judging the risk" (RAPS).
Against or cautious. Elizabeth Rebello: "I'm concerned that we're responding to a market-induced demand rather than a decision based on solid science" (NBC News, TIME). Josh Mailman, on KPV: "I'm voting on something here, but I don't know what that something is" (Pharmaceutical Executive). Brian Lee, on BPC-157: "we know that 30% of patients on placebo will have a self-reported response" (Pharmaceutical Executive). William Zamboni: "There are too many unknowns about this product" (RAPS). Todd Durham, the consumer representative: "As a consumer representative, I worry what placing a bulk substance on the list conveys in terms of FDA approval" (TIME), and on emideltide, "I voted 'no' primarily for low-quality evidence around efficacy" (RAPS). Kevin Zacharoff: "As a clinician, it's impossible for me not to take FDA's recommendations to heart" (RAPS).
What FDA staff said
Each briefing document ended with a balancing conclusion. For BPC-157: "a balancing of the criteria weighs against BPC-157 (free base) and BPC-157 acetate being placed on that list", citing poor characterization, missing safety and immunogenicity data, "insufficient evidence" for ulcerative colitis, and existing approved treatments. For KPV and TB-500, FDA described "non-existing information" on use in humans. At the meeting, Russell Wesdyk asked: "If you don't know what it is and I don't know what it is, how do I put it on the list?" (ABC News).
Public speakers
Dr. Anant Vinjamoori of Hims and Hers argued for "legitimate pharmacies to compound peptides in controlled conditions" (TIME). Dr. Peter Lurie of the Center for Science in the Public Interest said allowing compounding "removes incentives to go through FDA's rigorous drug approval process" (TIME). Dr. Adriane Fugh-Berman of Georgetown asked: "Would the government endorse manufacturing heroin because it's cleaner than what is sold on the street?" (ABC News). Ricardo Rossello, a former governor of Puerto Rico, said "there is a cost of doing nothing" (RAPS).
The 2024 meetings for comparison
| Meeting | Substance | Vote on placing it on the list |
|---|---|---|
| 29 Oct 2024 | Ipamorelin (free base and acetate) | 0 for, 12 against, 1 abstention each |
| 29 Oct 2024 | Kisspeptin-10 | 0 for, 11 against |
| 29 Oct 2024 | Ibutamoren mesylate | 1 for, 13 against |
| 4 Dec 2024 | CJC-1295, five forms | 0 for, 13 against (acetate 1 for, 12 against) |
| 4 Dec 2024 | AOD-9604 (both forms, one vote) | 0 for, 12 against |
| 4 Dec 2024 | Thymosin alpha-1 (each form) | 4 for, 17 against |
In 2024, the minutes record that members voting no on thymosin alpha-1 found "no compelling evidence demonstrating clinical effectiveness and safety", while those voting yes said it "should be accessible to patients as an option". The arguments were the same two years later. The balance of the room was not. The policy timeline places both meetings in sequence.
Rules change faster than most people's records. If you are on a prescribed peptide, the dose log keeps each dose with the product, the pharmacy and the concentration, and bloodwork sits on the same timeline, so a change of product or source is easier to plan with your prescriber. The peptide library grades how much research exists behind each compound, and that grading does not move when a committee votes. The app is on iOS and Android.
Questions people ask
Who chaired the July 2026 PCAC meeting?
Brian Serumaga, PhD, of the United States Pharmacopeia, listed on FDA's roster as acting chairperson.
How close were the July 2026 votes?
BPC-157, KPV and TB-500 passed 8 to 6 with one abstention. MOTS-c passed 7 to 5 with two abstentions. Emideltide failed with 6 for and 7 against. Reported tallies for epitalon and semax differ slightly between sources.
Did FDA staff support any of the seven peptides?
No. FDA's briefing documents recommended against placing each of the seven on the 503A list.
How did the 2024 committee vote on peptides?
Against every peptide put to it. Thymosin alpha-1 drew the most support, at 4 for and 17 against. CJC-1295, AOD-9604, ipamorelin and kisspeptin-10 received no more than one vote in favour.
Are the committee's votes binding?
No. FDA must still publish a proposed rule, take comments and issue a final rule before any substance is added to the 503A list.
Sources
- Final Meeting Roster, Pharmacy Compounding Advisory Committee, July 23-24, 2026, U.S. Food and Drug Administration
- July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee, U.S. Food and Drug Administration
- FDA Briefing Document: BPC-157-related bulk drug substances, U.S. Food and Drug Administration, evaluation dated 11 May 2026
- FDA panel, with ties to the peptide industry, recommends easing restrictions on four of the compounds, NBC News, 23 July 2026
- An FDA committee just voted in favor of peptides, despite the agency's opposition, TIME, 23 July 2026, updated 24 July
- FDA advisory committee backs two controversial peptides, Regulatory Affairs Professionals Society, 23 July 2026
- FDA advisory committee backs two more peptides, rejects one for compounding list, Regulatory Affairs Professionals Society, 24 July 2026
- FDA panel votes to loosen restrictions for four peptides, Pharmaceutical Executive, 24 July 2026
- FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What's next?, ABC News, 24 July 2026
- Bulk-list bound? PCAC backs majority of peptides in two-day public meeting, McDermott Will and Schulte, 27 July 2026
- Final summary minutes, Pharmacy Compounding Advisory Committee, October 29, 2024, U.S. Food and Drug Administration, approved 15 January 2025
- Final summary minutes, Pharmacy Compounding Advisory Committee, December 4, 2024, U.S. Food and Drug Administration, approved 21 February 2025
