US lets pharmacies compound six unapproved peptides

HHS says it will not act against licensed pharmacies and physicians that compound six unapproved peptides, including BPC-157, under an interim policy.

The US Department of Health and Human Services (HHS) has announced an interim policy under which it does not intend to take enforcement action against licensed pharmacies, federal facilities and physicians that compound six peptides the FDA has not approved, BioSpace reported on 29 October and BakerHostetler's law-firm briefing confirms. The policy was announced on 28 October. It is not an approval, and the drugs remain unapproved. For Indian readers, the interest is regulatory: it shows how a major regulator can allow access to a product class before the evidence is settled.

What the policy covers

Peptides are short chains of amino acids, the building blocks of proteins. The six named in the law-firm briefing are BPC-157, TB-500, Epitalon, Semax (free base), KPV and MOTS-c, each limited to listed routes such as injection, oral, topical or nasal. BioSpace says BPC-157 and TB-500 are promoted online together as the "Wolverine stack" for muscle building and soft-tissue repair. A seventh peptide, emideltide (also called DSIP), was excluded.

"Compounding" means a pharmacist or physician prepares a medicine for an individual patient rather than a manufacturer making it in bulk. The policy rests on Section 503A of the US food and drug law, which governs this individual-patient compounding. It does not apply to larger 503B outsourcing facilities, nor to products sold as research chemicals or dietary supplements, BakerHostetler says.

The conditions attached

According to the law-firm briefing, enforcement discretion applies only if several conditions are met. The bulk ingredient must come from an FDA-registered establishment and carry a valid certificate of analysis, and the original manufacturer must follow current good manufacturing practice. Each product needs a patient-specific prescription and one listed active ingredient. Serious adverse events and quality issues must be reported to FDA's MedWatch and to state authorities. Labels must say "This is a compounded drug product. Not for resale." The policy is interim and lasts while FDA continues its rulemaking on the 503A bulks list; no end date is given. HHS may revise or withdraw it if safety or quality concerns arise. The briefing says the notice was scheduled for the Federal Register on 30 October, with comments due two weeks after, but could not confirm the actual publication date.

Why HHS says it did this

BioSpace reports HHS argues the policy discourages use of "research-use-only" peptides from foreign manufacturers, which it describes as a safety risk, and offers a more controlled route. HHS says the aim is to "advance patient choice and freedom while appropriately protecting patient safety". In July, FDA's Pharmacy Compounding Advisory Committee voted to support compounding of the six peptides and against emideltide. The FDA raised immunogenicity concerns about these peptides in 2023, per BioSpace. Immunogenicity means the body might react to the peptide as a foreign threat.

Who supports and who objects

Supporters include the Alliance for Pharmacy Compounding, which called it "an important step for patients", and the American Academy of Peptide Medicine, which said it helps end unsafe black markets. Critics include the Partnership for Safe Medicines, which said it "leaves Americans in a gray area", and PhRMA's Jim Stansel, who called it "deeply concerning" that HHS is telling the FDA to ignore the law.

What it means for readers

For US patients, access to these products through compounding pharmacies may widen, but the policy gives no proof that they work or are safe. People already buying research-labelled peptides online face the same uncertainty, since no approved dosing or outcome data underpins them. Nothing here is medical advice, and a doctor should be asked about any such product.

For regulators elsewhere, the case shows the pressure between consumer demand and the evidence needed for approval. The policy applies only to US pharmacies and does not change Indian law.

What to watch next

- Federal Register publication and the two-week comment period. - Whether states follow HHS or set their own rules. - FDA's rulemaking on the 503A bulks list, which could take years. - Any safety reports sent to MedWatch.

Key takeaways

- HHS announced on 28 October that it will use enforcement discretion for six unapproved peptides compounded by licensed pharmacists and physicians. - This is not an FDA approval, and the drugs stay unapproved. - Conditions include prescriptions, certified ingredients, adverse-event reporting and specific labels. - Backers see safer access, while critics say it sidesteps the evidence standard. - The policy is temporary, with no end date, and it may change if safety signals appear.

Sources

- [BioSpace: HHS clears compounding pharmacies to manufacture 6 unapproved peptides](https://www.biospace.com/drug-delivery/hhs-clears-compounding-pharmacies-to-manufacture-6-unapproved-peptides) - [BakerHostetler: HHS issues enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances](https://www.bakerlaw.com/insights/hhs-issues-enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances/)

Tags: Peptides HHS FDA Drug compounding US health policy