Policy

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.

15 October 2026 8 min read Editorial policy

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

Voting members and temporary voting members, FDA final roster
Name as listedRole or affiliation as listedTopics
Brian Serumaga, PhDActing chair; USP representativeAll
Gabriel Alizaidy, MD, MSScientific Director, Maximus HealthAll
Asare B. Christian, MD, MPHFounder, Aether MedicineAll
Timothy D. Fensky, RPhNational Association of Boards of Pharmacy representativeAll
Senator Bobby Harshbarger, PharmDTennessee State Senator; pharmacist, Premier Pharmacy IncAll
Melissa Loseke, DOChief Medical Officer, Re-new InstituteAll
Haleem Mohammed, MD, MBAGlobal Chief Medical Officer, Gameday HealthBPC-157, KPV, TB-500, MOTS-c, semax
David Pope, PharmDChief Pharmacy Officer, Xifin Pharmacy SolutionsAll
Elizabeth Rebello, MDProfessor, MD Anderson Cancer CenterBPC-157, KPV, TB-500, MOTS-c, emideltide
Joshua Starbuck, MDChief Medical Officer, Makena HealthAll
Kris H. Wusterhausen, DOFounder and Medical Director, The Resurge ClinicAll
Todd Durham, PhDTemporary member; consumer representativeAll
Josh Mailman, MBATemporary member; patient representativeAll
Brian P. Lee, MD, MASTemporary member; Keck School of Medicine of USCBPC-157 only
Maral Kibarian Skelsey, MDTemporary member; Georgetown dermatologyKPV, TB-500
William C. Zamboni, PharmD, PhDTemporary member; University of PittsburghAll except semax
Kevin L. Zacharoff, MDTemporary member; Stony BrookEmideltide only
Costantino Iadecola, MDTemporary member; Weill Cornell MedicineSemax only
Friedhelm Sandbrink, MDTemporary member; Veterans Health AdministrationSemax only
Donnette D. Staas, PhDIndustry 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

PCAC, 23 and 24 July 2026. Each vote covered the free base and the acetate
PeptideUse FDA reviewedFDA staffReported tallyOutcome
BPC-157Ulcerative colitisAgainst8 to 6, 1 abstentionRecommended
KPVWound healing, inflammatory conditionsAgainst8 to 6, 1 abstentionRecommended
TB-500Wound healingAgainst8 to 6, 1 abstentionRecommended
MOTS-cObesity, osteoporosisAgainst7 to 5, 2 abstentionsRecommended
Emideltide (DSIP)Opioid withdrawal, insomnia, narcolepsyAgainst6 for, 7 against, 1 abstentionNot recommended
EpitalonInsomniaAgainst7 to 5, 1 abstention (RAPS); 7 to 4, 1 abstention (McDermott)Recommended
SemaxCerebral ischaemia, migraine, trigeminal neuralgiaAgainst8 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

From FDA's approved minutes
MeetingSubstanceVote on placing it on the list
29 Oct 2024Ipamorelin (free base and acetate)0 for, 12 against, 1 abstention each
29 Oct 2024Kisspeptin-100 for, 11 against
29 Oct 2024Ibutamoren mesylate1 for, 13 against
4 Dec 2024CJC-1295, five forms0 for, 13 against (acetate 1 for, 12 against)
4 Dec 2024AOD-9604 (both forms, one vote)0 for, 12 against
4 Dec 2024Thymosin 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.

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