FDA advisers narrowly back letting pharmacies make 6 unapproved peptides

Our last article in this thread covered a draft FDA policy, sent to the White House on October 14, on pharmacies making certain unapproved peptides. This article looks at a key step on the same road that took place earlier: a July meeting where the FDA’s outside advisers voted on which peptides pharmacies should be allowed to mix. Over two days, the agency’s Pharmacy Compounding Advisory Committee narrowly recommended adding six peptides to that list, against the advice of the FDA’s own scientists.¹

What the advisers decided

The committee met on July 23 and 24, 2026, at the FDA’s White Oak campus in Silver Spring, Maryland.² It voted to recommend that BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax be added to an approved list of ingredients that specialty pharmacies can use to make custom medicines.¹ The formal name is the “503A bulks list”, after the section of US drug law that covers this kind of pharmacy.²

Peptides are short chains of amino acids, smaller than a protein. Some, like insulin, are approved medicines that have been tested carefully. Others have become popular online without strong data, with influencers suggesting they help build muscle or improve metabolism.¹

The vote is not binding. The FDA still has to sign off.¹ The agency says its advisory committees give non-binding advice that it generally follows but does not have to.²

Which peptides, and how close it was

The first day covered four peptides. Advisers voted 8 to 6, with one person abstaining, in favor of BPC-157, KPV and TB-500. MOTS-c passed 7 to 5, with two abstentions.³ The second day covered emideltide, Semax and Epitalon.²

The FDA did not review these peptides for general wellness. It assessed each one for specific medical uses that people had nominated:²

• BPC-157: ulcerative colitis, a long-term inflammatory bowel disease.²
• KPV: wound healing and inflammatory conditions.²
• TB-500: wound healing.²
• MOTS-c: obesity and osteoporosis (thinning bones).²
• Semax: cerebral ischemia (reduced blood flow to the brain), migraine and trigeminal neuralgia, a type of facial nerve pain.²
• Epitalon: insomnia.²

The panel rejected a seventh peptide, emideltide, citing especially weak evidence. It was proposed as an injection under the skin for narcolepsy and opioid withdrawal, but the studies behind it gave it straight into a vein. Those studies were a single patient report for narcolepsy and two small studies without a comparison group for opioid withdrawal. The FDA also noted that approved treatments already exist for both conditions.¹

The sources do not give the exact vote counts for Semax and Epitalon.

Why the FDA’s own scientists objected

FDA staff scientists opposed adding every peptide on the agenda. They cited a lack of solid clinical trial data, recipes that vary from batch to batch, and the risk that the compounds could trigger harmful immune reactions.¹

Agency staff kept returning to a more basic problem: for these peptides there is no universally accepted chemical formula, so it is unclear what exactly is being evaluated.³ FDA official Russell Wesdyk told the panel:

“We’ve never faced a problem of, ‘What is it?’”³

BPC-157 has a longer regulatory history. The FDA placed it in “Category 2”, a group of substances the agency considered to raise significant safety risks, in September 2023, which in practice blocked these pharmacies from making it. On April 15, 2026, the FDA removed BPC-157 and eleven other peptides from that category.⁴ That account comes from a compounding pharmacy, a business with a stake in the outcome. It also notes that BPC-157’s reported effects come from animal studies and that it has never been approved for any human use.⁴

Who sat on the panel

Eight panel members were recently appointed under Health Secretary Robert F. Kennedy Jr., and the panel’s makeup drew criticism.³ Six of those eight run clinics that offer peptides, ABC News reported.¹ PharmExec, citing Reuters, reported that several could benefit directly if the compounds are cleared.³ Kennedy has publicly supported wider access to peptides.¹

One member, Tennessee state Sen. Bobby Harshbarger, is the son of Rep. Diana Harshbarger, who had written to Kennedy asking that compounders be allowed to make certain peptides, PharmExec reported.³ Paul Knoepfler, a cell biology professor at UC Davis, said: “Many members who voted in favor could stand to gain from allowing Bpc-157 for compounding. How is that acceptable?”³

The Department of Health and Human Services defended the process. A spokesperson, Emily Hilliard, said: “All committee members underwent the same ethics review and vetting process required of all FDA advisory committee members.” She added that candidates who could not meet ethics requirements were removed from consideration.³

The case for and against

Members who voted yes described it as harm reduction: a way to steer people away from an online black market, where many already buy these compounds from overseas sellers as “research chemicals”, with no doctor involved.¹ Dr. Haleem Mohammed, a panel member whose clinic offers peptides, said:³

“As a physician, I have to make sure that I’m keeping patients as safe as possible. So, when I look at something like saying no to this and pushing it to the gray market, am I doing greater harm? That’s what I lose sleep at night over.”¹

Another member, Dr. Gabriel Alizaidy, said he voted for BPC-157 despite being “frankly disappointed at how incomplete the data was.”³

Public health advocates and agency scientists pushed back.¹ Dr. Adriane Fugh-Berman, a pharmacology professor at Georgetown University, said in public testimony:

“Just because a market is large doesn’t mean that a product should be legalized. It means that a product should be studied.”¹

The money at stake runs in both directions. Telehealth, wellness and medical spa businesses stand to profit from offering more treatments. Drug manufacturers oppose the move, saying it creates a way around the years of trials normally needed to approve a medicine.¹

What a spot on the list would and would not mean

Being added to the list would not turn these peptides into supplements sold on store shelves, and it would not mean the FDA had found them safe or effective.¹ It would let licensed compounding pharmacies, which mix custom medicines for individual patients, buy the raw ingredients and prepare them for someone with a doctor’s prescription.¹

Listed ingredients come with some safeguards, such as checking where they come from and testing them for contamination. But custom-mixed products still skip protections that come with standard approved drugs, including ongoing tracking of side effects and clear safety labels.¹ Safety advocates worry that patients will read a spot on the list as an official stamp of approval.¹

What to watch next

Before anything becomes official, the FDA must review the meeting records, public comments and votes, then publish a proposed rule and take public feedback. ABC News reported that this can take up to a year, though top officials could speed it up.¹ A lawyer quoted by PharmExec estimated eight to twelve months before pharmacies have clear legal authority to make these peptides.³

Points to follow from here:

• Whether the FDA proposes a rule adding all six peptides, some of them, or none.¹
• The public comment period that opens once a rule is proposed.¹
• Whether officials move faster than the usual timeline, given Kennedy’s stated support for wider access.¹
• Whether the separate draft policy sent to the White House in October, covered in our earlier article, is published and how it relates to this list.