HHS Draft Policy Lets 503A Pharmacies Compound BPC-157, TB-500 and 4 Other Peptides

The Department of Health and Human Services announced a draft, interim enforcement-discretion policy on October 28, 2026, covering six peptides that have been sold widely online but could not legally be compounded. Under it, HHS says it does not intend to take enforcement action against a State-licensed pharmacy, a Federal facility, or a licensed physician compounding one of those peptides, as long as every one of ten conditions is met.^[1] A notice announcing the policy, signed by HHS Secretary Robert F. Kennedy Jr., was published in the Federal Register on October 30. The notice calls the policy a draft, says it is not binding on HHS or the public, and accepts written comments for two weeks after publication, which runs to November 13.^[2]

The policy runs only until the FDA finishes the rulemaking that decides whether each peptide goes on the official list of bulk substances that 503A pharmacies may use. HHS also says it may revisit the policy, in whole or in part, if a safety signal or product-quality problem appears.^[1] For background on each compound, our peptide guide covers what is known and what is not, and our explainer on the HHS 503A peptide policy goes deeper into how it works.

The six peptides, and the route each is allowed in

Appendix A of the policy lists the six substances. Appendix B fixes the chemical identity of each one and limits how it may be given:^[1]

BPC-157 (acetate): subcutaneous or intramuscular injection, oral, or topical.
TB-500 (acetate): subcutaneous or intramuscular injection only.
MOTS-c (acetate): subcutaneous or intramuscular injection only.
Epitalon (acetate): subcutaneous or intramuscular injection, dispensed in intermittent courses.
KPV (acetate): topical or oral only. No injectable form is covered.
Semax (free base): intranasal only.

Those route limits matter more than they look. A KPV injection, a semax injection or a TB-500 capsule falls outside the policy even if every other condition is met.

The ten conditions, in plain English

HHS says it will hold off on enforcement only when all of these are true:^[1]

It is one of the six. The peptide must be on Appendix A.
It is the right molecule, given the right way. Identity (amino-acid sequence, structure, molecular weight and formula) and route must match Appendix B.
It has been tested. The raw ingredient comes from an FDA-registered facility with a valid certificate of analysis (COA) covering identity, purity, potency, and contaminants such as endotoxins, heavy metals, microbes and impurities.
The original maker is registered and follows good manufacturing practice. The factory’s physical location must be on the COA. If the ingredient passes through a repacker or reseller, that company must have checked the manufacturer and its COA itself.
Problems get reported. The compounder reports what it made, serious adverse events and quality problems to FDA’s MedWatch program and to the states involved, and the patient’s label explains how to report a problem.
A fixed label line. The product must carry the statement “This is a compounded drug product. Not for resale.”
One active ingredient per product. No blends. HHS says single-ingredient products make it easier to tie a side effect to a specific substance.
Oral forms need proof they are absorbed. Because peptides are hard to absorb by mouth, a pharmacy making an oral version must keep documentation that the specific formulation reaches adequate levels in humans.
Only a plain syringe. The only device that may be packaged with or contain the drug is an FDA 510(k)-cleared syringe. HHS says more complex delivery devices add risk.
Everything else in the law still applies, including sanitary conditions and a prescription written for a specific, named patient.

What this policy is not

It is not FDA approval. The policy itself says compounded drugs are not FDA-approved and that FDA does not review their safety, effectiveness or quality before they are sold.^[1]
It does not put any peptide on the 503A bulks list. That list is set by FDA rulemaking, which is still pending. The Federal Register notice says FDA’s future rulemakings may propose adding some or all of the six, and that the policy creates no rights and does not bind HHS.^[2]
It is a draft, it is interim, and it can be pulled back if a safety or quality problem shows up.^[1]
It covers 503A compounders only: State-licensed pharmacies, Federal facilities and licensed physicians. NPR reported that it does not extend to larger 503B outsourcing facilities.^[3]
It does not cover “research use only” vendors. HHS framed the policy as a way to discourage the widespread use of research-use-only peptides from foreign manufacturers, which it says pose a safety risk, by offering a more controlled alternative.^[1] A vial sold “not for human consumption” gains nothing from this policy. Our explainer on whether peptides are legal walks through those tiers.

How the six got here

According to Appendix B, each of the six sat in FDA’s Category 2 from September 2023 until April 22, 2026. HHS notes that neither the listing nor the removal changed their legal status under section 503A: removal from Category 2 did not by itself let pharmacies compound them, because they were still not on the bulks list.^[1]

For every one of the six, FDA’s drug center (CDER) recommended against listing it, and the Pharmacy Compounding Advisory Committee voted in favor.^[1] NPR reported that the advisory vote came at a July meeting where FDA’s own scientists argued against loosening the restrictions.^[3] HHS’s stated reasons for siding with the committee are similar across the six: newer certificates of analysis that supply test results CDER said were missing, better documentation of how widely each peptide is already used, and a view that CDER’s safety concerns rested on mechanism or missing data rather than observed harm.^[1] That is HHS’s characterization. The human evidence for most of these compounds is still thin: see our reviews of BPC-157 safety, BPC-157 versus TB-500, MOTS-c, KPV, epitalon and semax.

Reaction

NPR reported a split response.^[3] The Alliance for Pharmacy Compounding welcomed the decision as a more accountable alternative to gray-market products, while warning that it may take time before pharmacies dispense anything, because ingredient suppliers have to meet the new requirements and pharmacies have to verify that they do. Public Citizen said Kennedy had undermined the FDA and that all peptides should go through the standard approval process. The Partnership for Safe Medicines, which NPR said had filed a citizen petition the week before urging FDA not to follow its advisers, said the decision leaves Americans in a gray area on safety. The president of a Florida compounding company told NPR he doubted 503A pharmacies nationwide could meet demand.^[3]

What it means if you buy peptides through a telehealth clinic

Many telehealth clinics sell peptides alongside GLP-1s. Under this policy, a compliant product should look like this:

A prescription for you, after a clinician reviews your history. A checkout page with no medical intake is not a patient-specific prescription.
A named 503A pharmacy that you can look up. Our pharmacy directory and guide to compounding-pharmacy accreditation help with that, and FDA warning letters show which compounders have had problems.
One peptide per vial. A BPC-157 and TB-500 “recovery blend” does not meet the single-ingredient condition. Our review of peptide stacking explains why combinations are harder to judge.
The right route. Injectable KPV, injectable semax or oral TB-500 are outside the policy. Oral BPC-157 and oral KPV are allowed only if the pharmacy has documented absorption; see our look at oral peptides.
The label line “This is a compounded drug product. Not for resale.”
A plain syringe, not a prefilled pen or other device.
A clinic willing to show the COA or name the ingredient manufacturer if you ask. The policy requires the pharmacy to hold it; it does not require the pharmacy to give it to you, so a refusal is a signal rather than proof of a problem.

Open questions

Supply. Pharmacies need ingredient lots with COAs that meet the policy’s testing table, and the compounding trade group told NPR that will take time.^[3]
Comments and changes. The Federal Register notice opens docket HHS-OASH-2026-0496 for written comments for two weeks after its October 30 publication, and calls the policy a draft. Whether the text changes after that is not yet known.^[2]
The final rule. Each peptide’s status will eventually be settled by FDA rulemaking on the 503A bulks list, which could include or exclude any of the six.^[1]
State rules. The policy is federal. State pharmacy boards set their own requirements, and nothing in the policy overrides them.

What we will track

Our provider pages for BPC-157, TB-500, MOTS-c, KPV, epitalon and semax list every seller we confirmed sells the peptide as a single-ingredient product and show the form each one sells. A form outside the Appendix B routes is labeled as not covered, and blends are left off. A listing does not confirm that the pharmacy meets the policy’s other conditions, so use the checklist above to check them yourself. We will update this article and those pages as more clinics offer these peptides, when the policy is finalized, and if HHS revises or withdraws it.