The six peptides HHS opened for compounding, and what it takes to sell them

Which peptides, in which forms?

• BPC-157

  Subcutaneous, intramuscular, oral and topical. Sold for tissue and injury recovery, gut health. The most searched peptide on the list and the one most brands lead with.

  What your store needs to sell BPC-157

• TB-500

  Subcutaneous and intramuscular. Sold for injury recovery, often paired with BPC-157. The "BPC-157 and TB-500 blend" every price list carries is not covered.

  What your store needs to sell TB-500

• Epitalon

  Subcutaneous and intramuscular, in intermittent courses. Sold for longevity and sleep. The policy names intermittent courses rather than continuous use, which matters for how a subscription is structured.

  What your store needs to sell Epitalon

• KPV

  Topical and oral. Sold for inflammation, skin and gut. No injectable route.

  What your store needs to sell KPV

• MOTS-c

  Subcutaneous and intramuscular. Sold for metabolic health and exercise capacity. Usually sold next to weight-loss and metabolic programs.

  What your store needs to sell MOTS-c

• Semax

  Intranasal only. Sold for focus and cognitive support. The only one of the six limited to a nasal spray.

  What your store needs to sell Semax

How did we get here?

• 2023. FDA places BPC-157 and other peptides in Category 2 of the 503A interim bulks list, which means do not compound.
• April 15, 2026. FDA removes 12 peptides from Category 2, effective April 23. They are not moved to Category 1, so they are neither permitted nor prohibited.
• July 23 and 24, 2026. FDA's Pharmacy Compounding Advisory Committee recommends six of seven peptides for the 503A bulks list and rejects DSIP.
• October 28, 2026. HHS files an interim enforcement discretion policy covering the six. Published in the Federal Register on October 30.
• November 2026. Written comments due two weeks after publication, docket HHS-OASH-2026-0496.
• February 2027. Five more peptides scheduled for the advisory committee.
• Later. FDA rulemaking on the 503A bulks list. Industry counsel estimate 12 to 24 months. The interim policy stands until a final rule, unless HHS withdraws it on a safety signal.

What does the pharmacy have to meet?

• A patient-specific prescription. from a licensed prescriber, for a named patient. Nothing in the policy allows a pharmacy to make stock for resale.
• A 503A compounder. a state-licensed pharmacy, a federal facility or a licensed physician. 503B outsourcing facilities are not covered.
• Ingredient from an FDA-registered manufacturer. that follows current good manufacturing practice, with a certificate of analysis for identity, purity, potency and contaminants on every lot.
• One active ingredient per product. no blends, even of two peptides that are each on the list.
• The permitted form and route only. each peptide is cleared for named routes, and an oral form needs documented bioavailability.
• Labeling. every product states that it is a compounded drug product and not for resale, and any co-packaged syringe is FDA 510(k) cleared.
• Adverse event and quality reporting. serious adverse events and product quality problems go to FDA MedWatch and the relevant state board, whether or not the pharmacy thinks the product caused them.
• State law still applies. the policy is federal enforcement discretion. A state board of pharmacy or medical board can still say no.

These are the pharmacy's obligations, but they become yours the moment you sell. Ask for the supplier qualification record and the certificate of analysis before you list anything. A price list is not evidence of compliance.

What is still off limits?

Everything that is not one of the six, and every blend. On most price lists that means Selank, Ipamorelin, CJC-1295, AOD-9604, DSIP (emideltide), GHK-Cu as an injectable, Cathelicidin LL-37, Thymosin alpha-1, Melanotan II, PEG-MGF, Dihexa, Gonadorelin, and every combination vial, including BPC-157 with TB-500 and Semax with Selank. Five more peptides go to the advisory committee in February 2027. Until then, a store that lists them is outside the policy.

Separately from all of this, a few peptide drugs are FDA approved and sold as the approved product under their own rules: semaglutide, tirzepatide, tesamorelin and bremelanotide among them. Those are a different conversation and the platform already carries them.