HHS just opened six peptides for compounding. What it means for a telehealth brand
The short answer
Six peptides can now be compounded for named patients without federal enforcement, as of the HHS policy published October 30, 2026: BPC-157, TB-500, Epitalon, KPV, MOTS-c and Semax. Each must be a single-ingredient product in a named form, made by a state-licensed pharmacy or licensed physician from an FDA-registered manufacturer's ingredient, with testing, labeling and adverse event reporting. Nothing is FDA approved, blends are not covered, and the policy can be withdrawn. For a telehealth brand the work is a prescriber, a pharmacy that meets every condition, state rules, and a store that makes no claims.
What exactly did HHS do?
The HHS Secretary issued an enforcement discretion policy, filed October 28, 2026 and published in the Federal Register on October 30, docket HHS-OASH-2026-0496. It says HHS does not intend to take enforcement action against a state-licensed pharmacy, a federal facility or a licensed physician that compounds a drug using one of six peptide bulk substances, provided a list of conditions is met.
It came from the Secretary's office, not from FDA. FDA's career scientists had said there was not enough evidence to evaluate safety or effectiveness, and the policy was issued over that objection. That is worth knowing because it is the reason the policy is interim and the reason critics are already petitioning against the advisory vote behind it.
The policy is not approval. HHS wrote that it "does not grant FDA approval or establish clinical safety and effectiveness," and that it is not binding on HHS or the public. It stands until FDA finishes a rule on the 503A bulks list, which counsel estimate at 12 to 24 months, or until HHS pulls it on a safety signal.
Which peptides, and in which forms?
BPC-157 acetate for subcutaneous, intramuscular, oral and topical use. TB-500 acetate for subcutaneous and intramuscular. Epitalon acetate for subcutaneous and intramuscular, in intermittent courses. KPV acetate for topical and oral. MOTS-c acetate for subcutaneous and intramuscular. Semax free base as a nasal spray only.
Each of the six has its own page with the status, the routes and what a store needs: the peptides hub.
A product may contain one of them. Not two. The BPC-157 and TB-500 blend on every price list is a combination and is not covered, even though each ingredient is. The same goes for Semax with Selank, and Selank itself is not on the list at all.
What has to be true of the pharmacy?
A patient-specific prescription for every product, from a licensed prescriber. The ingredient from an original manufacturer registered with FDA and following current good manufacturing practice, with a certificate of analysis on every lot covering identity, purity, potency and contaminants, verified by two independent methods. An oral form needs documented bioavailability. A label that says it is a compounded drug product and not for resale. Any co-packaged syringe cleared by FDA. Serious adverse events and quality problems reported to FDA MedWatch and the state board, whether or not the pharmacy thinks the product caused them.
503B outsourcing facilities are not covered. The policy is for 503A compounding, which is one prescription for one patient. That is a feature for a telehealth brand, because it is exactly how a prescription store already works, and a limit, because nobody can make stock in advance.
State law is untouched. A state board of pharmacy or medical board can still restrict a peptide the federal policy permits, and a few have said so. Your prescriber has to be licensed where the patient is and your pharmacy has to be allowed to ship there.
What does a brand need to sell one?
A clinician for every order. The prescription is patient-specific, so each order starts with an intake a licensed provider reviews. A provider network covering 50 states does this without you employing doctors. The provider can decline.
A pharmacy that can show its paperwork. Supplier qualification record, certificate of analysis for the current lot, adverse event procedure, labeling. If you already have a pharmacy, it can be routed to through Surescripts. If not, the platform's partners are the starting point.
Single-ingredient products in permitted forms. One vial, one peptide. The store's catalogue has to be built that way from the start.
State logic before payment. The visit is refused for a state the product cannot be sold into before the patient pays, not after.
A storefront that makes no claims. There is no approved labeling to quote and no trial to cite. The page says what the product is, that it is compounded and not FDA approved, and shows safety information. What it is prescribed for is the clinician's call. See what your store can and cannot say.
An off switch. The policy is interim. If it changes, every affected product comes off the shelf the same day and subscribers are told.
Why move now rather than wait for the rule?
Because the rule is the slow part and the store is the fast part. The entity, the licensing questions, the pharmacy's documentation and the provider relationship take weeks. The storefront, the intake, the state logic and the subscription take a day on a platform built for prescriptions. A brand that does the slow part now is live the day its pharmacy is ready, and a brand that waits for a final rule starts the slow part then.
The honest risk is withdrawal. Build so that it costs you a product, not the business: a peptide line next to products that are already on firm ground, never a store that is only peptides.
Questions
Is BPC-157 legal now?
For a licensed prescriber to prescribe and a 503A pharmacy to compound for a named patient, under the conditions in the HHS policy of October 30, 2026, yes as a matter of federal enforcement. It is not FDA approved, state law still applies, and the policy is interim.
Can I sell a BPC-157 and TB-500 blend?
No. The policy covers products with one active ingredient. You can sell each as its own product with its own prescription.
Does this cover 503B outsourcing facilities?
No. Only state-licensed pharmacies, federal facilities and licensed physicians compounding under section 503A.
How long does the policy last?
Until FDA issues a final rule on the 503A bulks list, estimated by industry counsel at 12 to 24 months, unless HHS withdraws it earlier on a safety signal. Written comments were due two weeks after the October 30 publication.
What about the other peptides on price lists?
Selank, ipamorelin, CJC-1295, AOD-9604, DSIP, injectable GHK-Cu, LL-37, thymosin alpha-1, melanotan II and the rest are outside the policy. Five more peptides go to the advisory committee in February 2027.