Can a Clinic Offer BPC-157, TB-500, Epitalon, Semax, KPV, MOTS-c?

Yes, with conditions. Under the HHS enforcement discretion policy announced October 30, 2026, a state-licensed 503A pharmacy or licensed physician may compound BPC-157, TB-500, Epitalon, Semax, KPV and MOTS-c for a telehealth clinic's patients on patient-specific prescriptions, as single-ingredient products in the routes HHS lists, from tested bulk substances. None is FDA-approved, and blends, injector pens and 503B facilities are outside the policy.

The six peptides at a glance

Every one of them was on FDA's Category 2 list of bulk substances that may present significant safety risks from September 2023 until April 22, 2026. FDA's drug center recommended against listing them for 503A compounding; the Pharmacy Compounding Advisory Committee voted in favor on July 23 and 24, 2026. HHS's policy sits between those two positions: limited compounding, under written safeguards, until rulemaking settles each one. What the HHS peptide policy says and does not say walks through the ten conditions in full.

What a clinic has to get right for each peptide

BPC-157

BPC-157 is the only one of the six with four named routes. The injectable and topical forms need nothing beyond the ten conditions. The oral form needs one thing more: HHS requires the compounder to hold documentation that the specific oral formulation given to the patient achieves adequate bioavailability in humans. A clinic offering oral BPC-157 should ask its pharmacy for that documentation before the first prescription, not after a question from a board or a certifier.

TB-500 and MOTS-c

Both are injectable only, subcutaneous or intramuscular, as acetate salts. Dispensing has to be in an FDA 510(k)-cleared syringe; a pen or any other device takes the product outside the policy. HHS notes for TB-500 that its drug center could not identify any pharmacy compounding it before the policy, so expect pharmacies to be building the sourcing and testing record for it now.

Epitalon

Injectable only, and HHS adds a qualifier the others do not carry: dispensed in intermittent courses. HHS's justification rests on documented regimens being intermittent rather than continuous, so a program design built on continuous daily use is not the one the policy describes.

Semax

Intranasal only, as the free base rather than an acetate. HHS points to an intranasal human record covering several hundred subjects with no reported adverse outcome. Any injectable or oral Semax product is outside the policy.

KPV

Topical and oral only; no injectable route is named. As with BPC-157, an oral KPV product requires the bioavailability documentation. HHS describes documented use as substantially single-ingredient, which is also what condition seven requires.

What is not allowed

• Any blend: a product must contain a single active ingredient from Appendix A, so BPC-157 with TB-500, or any covered peptide with another active, is out.
• Any route not named for that peptide: injectable Semax, injectable KPV, oral TB-500.
• Any delivery device other than an FDA 510(k)-cleared syringe, including injector pens.
• Compounding by a 503B outsourcing facility, office-use stock, or any product without a patient-specific prescription.
• Bulk substance without a valid certificate of analysis from an FDA-registered manufacturer, or research-use-only material, which the policy was written to displace.
• Marketing that describes the product as FDA-approved, or presents enforcement discretion as an endorsement.

How to add these peptides to a telehealth program

1. 1Decide which of the six fit the program and in which route, using the table above. Each addition is a separate formulary decision.
2. 2Confirm the pharmacy's sourcing for each one: certificate of analysis per lot, the original manufacturer's FDA registration and facility identifier, and the testing standard the policy's Appendix B sets out. How to choose and verify a compounding pharmacy lists the questions.
3. 3Write the clinical protocol as patient-specific prescribing by a clinician licensed in the patient's state, with the evaluation each state requires.
4. 4Set labeling and reporting with the pharmacy: the required "This is a compounded drug product. Not for resale." statement, reporting instructions for the patient, and the pharmacy's reporting of products compounded and serious adverse events to FDA and the states.
5. 5Review every patient-facing page and ad for approval claims and efficacy claims before launch. How to add peptide therapy to a medical practice covers advertising and consent.
6. 6Check state telehealth and pharmacy rules for each state the program opens in, and recheck FDA's lists whenever they change, since a final rule on any peptide ends the policy for it.

What changed recently

The policy was announced in the Federal Register on October 30, 2026, with comments accepted for two weeks on regulations.gov. LegitScript updated its certification review approach for the six peptides on November 2, 2026. FDA's rulemaking on the 503A bulks list, which the policy is meant to bridge, has no announced date.

How MDLaunchr fits

MDLaunchr is a white-label telehealth platform, not a pharmacy or a prescriber. Its provider and pharmacy network routes each prescription to a licensed pharmacy for the patient's state, a peptide program's formulary is checked against FDA's lists before launch and on every change, and every prescribing decision stays with the independently licensed clinician.

Disclaimer

This article summarizes a federal policy document for business planning and is not legal, medical or pharmacy advice. The policy is a draft that HHS may change, none of the products it covers is FDA-approved, and state rules apply on top of it. Confirm current requirements with a licensed attorney and the relevant boards before offering any compounded peptide.