HHS will not act against pharmacies compounding BPC-157 and five other peptides

Section 503A of the Food, Drug, and Cosmetic Act lets a pharmacy compound from a bulk substance only if the substance has a USP or NF monograph, is a component of an FDA-approved drug, or is on the 503A bulks list. None of the six meets any of the three. Until April 2026 all six were also in FDA's Category 2, the bin for substances the agency says may pose significant safety risks.

The policy is signed by HHS Secretary Robert F. Kennedy Jr. and issued by the Office of the Secretary, not by FDA. Its stated reason is to "discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers," by giving patients "a more controlled alternative." It covers 503A compounding for a named patient. It says nothing about 503B outsourcing facilities.

The Federal Register notice calls the document a draft, says it is not binding on HHS or the public, and takes comments for two weeks after publication, to November 13, on docket HHS-OASH-2026-0496. HHS also says it may revisit the policy, in whole or in part, if a safety signal or a product-quality problem appears.

The policy ties each peptide to a salt form and to the routes HHS considers appropriate. A product outside these routes is outside the policy.

Two things follow. An injectable KPV, an oral TB-500 or an injectable Semax is not covered. And for any oral form, the compounder is expected to keep documentation that the specific formulation "achieves an adequate level of oral bioavailability in humans." For BPC-157 and KPV capsules, no such human data has been published that we know of; our KPV page notes there is no pharmacokinetic study of KPV in any species.

All ten must hold for HHS's non-enforcement to apply:

• The peptide is on the policy's Appendix A list of six.
• It has the identity and route limits in Appendix B: amino-acid sequence, structure, molecular weight and formula.
• The bulk substance comes from an FDA-registered facility with a certificate of analysis that meets FDA's guidance-based tests for identity, purity, potency, endotoxins, heavy metals, microbes and impurities.
• The original manufacturer, not a repacker or distributor, is FDA-registered and CGMP-compliant, and its physical address is on the certificate. A registered repacker must have validated the manufacturer and its certificate.
• The compounder reports serious adverse events, whether or not they look drug-related, and quality problems to FDA's MedWatch and to the states involved, along with the product's strength, manufacturer and route. The reporting procedure goes on the patient's labeling.
• The label says: "This is a compounded drug product. Not for resale."
• The product contains only one active ingredient from the list.
• Oral forms carry documented human bioavailability.
• The only device packaged with it is an FDA 510(k)-cleared syringe.
• Everything else in the law still applies, including the ban on insanitary conditions and the patient-specific prescription requirement.

The single-ingredient condition rules out blends. Many peptide products sold today are blends. We read the public menus of two sellers we review that list these peptides with prices, on October 28.

RxPepsDirect lists 16 products containing at least one of the six peptides. Seven of them combine two or more active ingredients in one vial, capsule or spray: the "Wolverine Stack" (BPC-157 and TB-500), BPC-157/TB-500/KPV, "KLOW" (BPC-157, TB-500, GHK-Cu and KPV), BPC-157/KPV capsules, GHK-Cu with Epithalon, a Semax/Selank nasal spray, and a "Lean Stack" of SS-31, MOTS-C and tesamorelin. Its nine single-peptide products use routes the policy names: injectable BPC-157, TB-500, Epithalon and MOTS-C, oral BPC-157 and KPV capsules, and a Semax nasal spray.

Live Vital lists six treatments with these peptides. Three are single peptides: MOTS-c, BPC-157 and TB-500. Three are blends: "Wolverine" (BPC-157 and TB-500, $175 a month), "Glow" (GHK-Cu, BPC-157 and TB-500, $200) and "Klow" (GHK-Cu, KPV, BPC-157 and TB-500, $200).

A blend on a menu does not tell us what a pharmacy dispenses, and neither seller's page shows a certificate of analysis or names the bulk manufacturer. The certificate, manufacturer and reporting conditions cannot be checked from outside. What a menu can show is whether a product could fit the policy at all, and ten of the 22 listings could not.

For a patient, the change is that a pharmacy can now compound these six peptides, singly and by the named routes, without expecting FDA action, if it follows the conditions. That was not true last week. Nothing about the evidence has changed: none of the six is approved for any use, FDA's reviewers proposed against listing all of them, and the human data behind most of the uses sold is thin or absent. Our peptide pages set out what is known for each.

"Research use only" products are untouched. The policy covers licensed pharmacies and physicians compounding for a named patient. A website selling vials labelled not for human use is not compounding, and FDA has kept sending those sellers warning letters.

If you are prescribed one of these peptides, four questions follow from the conditions. Is it a single peptide? Is the route the one the policy names? Does the label carry the "compounded drug product" statement and tell you how to report a side effect? Which manufacturer made the bulk substance, and will the pharmacy show the certificate? A provider who cannot answer the last one is the same signal it was before this policy.

We have updated our regulatory tracker and the six peptide pages to reflect the policy.

On November 2, LegitScript said it would no longer refuse certification to sellers of the six whose products meet the policy's conditions; our report covers what its seal now means. The comment window closes November 13. HHS can change or withdraw the policy at any time, and says a safety signal could do it. FDA's own decision on the six, by proposed and then final rule on the 503A bulks list, has no published date. The adverse-event reports the policy requires go to MedWatch, so FDA's adverse-event data is where any signal would first show.