Six Peptides May Be Compounded, but Safety Evidence Remains Limited

Six peptides may become easier to obtain through compounding pharmacies under a temporary change in enforcement policy. That shift could offer an alternative to products sold through unlicensed suppliers, but it doesn't establish that the peptides are safe or effective. None has completed the testing needed for approval by the U.S. Food and Drug Administration (FDA) for human use.

The distinction matters: allowing pharmacies to compound a substance under enforcement discretion is not the same as approving it as a medicine. The policy does not report new research or clinical trial results. It describes circumstances in which authorities say they won't take action against compounding pharmacies that make and sell the listed products.

Which peptides are covered

The six substances named in the policy are BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Their suggested uses were discussed at an advisory committee meeting in July, but those uses have not been established by rigorous scientific evidence, according to the source article.

• BPC-157: proposed for ulcerative colitis.
• Epitalon: proposed for insomnia.
• KPV: proposed for wound healing and inflammatory conditions.
• MOTS-c: proposed for obesity and osteoporosis.
• Semax: proposed for migraine, cerebral ischemia and trigeminal neuralgia.
• TB-500: proposed for wound healing.

These proposed uses should not be read as proven benefits. A list of possible applications, even when discussed by experts, isn't a substitute for studies that show whether a treatment helps people and what harms it may cause.

“Peptide” covers a wide range of substances

Peptides are chains of amino acids, usually between two and 50 units long, according to Jamie Alan, PharmD, PhD, an associate professor of pharmacology and toxicology at Michigan State University. The category includes medicines with very different evidence and uses. Insulin and GLP-1 medicines such as Ozempic are peptides, but their existence doesn't establish the safety or effectiveness of the six substances in this policy.

For a new medicine, clinical trials assess its effects and risks in people. Arindam Bhattacharjee, PhD, a pharmacology and toxicology professor at the State University of New York at Buffalo, describes that process as extensive and costly, with evidence used to determine whether a drug should be approved. The six listed peptides haven't undergone the typical rigorous clinical testing, he says.

That leaves basic questions unresolved: whether a peptide improves the condition it is marketed for, which side effects it can cause, and how its effects might vary among people. The policy itself doesn't answer those questions. It also doesn't turn these products into approved medicines.

What the policy does and doesn't mean

The Alliance for Pharmacy Compounding has argued that the change could provide a more accountable option for people who already buy peptides from unlicensed “gray market” sellers. The group says such products may come with little assurance about what is in the vial. It presents pharmacy compounding as a way to address that existing demand.

There are also conditions described in the policy: ingredients must come from FDA-registered factories, and the finished product must undergo chemical identity and purity testing, Bhattacharjee says. Those safeguards address the source and composition of a product. They don't show that taking it is beneficial or safe. Identity and purity checks cannot replace clinical studies of outcomes and side effects.

Alan warns that the absence of adequate human safety and effectiveness data is a serious concern. Her assessment is that bypassing the usual testing leaves people exposed to unknown risks. The policy doesn't include new evidence that resolves those concerns, and its decision to use enforcement discretion should not be mistaken for an endorsement of the substances.

Access depends on how the product is supplied

The policy says compounding must be based on a valid prescription for an individual patient. Traditional compounding pharmacies generally need a prescription from a licensed health professional for that person, Alan says. She also notes that registered outsourcing facilities may compound certain products for clinic or hospital office stock without an individual prescription. As a result, a person could encounter a peptide in a provider's office or a medical spa under circumstances that differ from a direct pharmacy prescription.

Rules about a prescription don't settle whether a product is suitable for a particular person. Peptides may interact with other medicines, Bhattacharjee says, so a clinician needs an accurate account of what someone is using. That conversation can also help people discuss established treatment options for the health concern they hope to address.

Questions to raise with a clinician

For anyone considering one of these products, the practical takeaway is that easier access doesn't come with evidence of benefit. A doctor or pharmacist can discuss the lack of clinical data, possible interactions, and other treatments with stronger evidence. Alan recommends speaking candidly with a healthcare provider, including if someone is already using a peptide.

For now, the six compounds remain a case where the proposed uses are ahead of the evidence. What to watch is whether well-designed human studies clarify their benefits and risks; the current policy does not provide those answers.