Can Clinics Prescribe Compounded BPC-157 and TB-500 Now? What the HHS 503A Peptide Policy Allows

What did the HHS peptide compounding policy change on October 28, 2026?

It created federal enforcement discretion for 503A compounding of six peptides. The notice says "HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician" compounding with a peptide on the policy's list, when every condition is met.

The law is the same. Under section 503A, a bulk substance needs a USP or NF monograph, a place in an FDA-approved drug, or a spot on FDA's list at 21 CFR 216.23. That list names six substances, none of them peptides. The policy covers peptides that fail all three routes.

HHS gives two reasons. The policy aims "to expand and improve patient access while FDA reviews these substances." It also aims to "discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients."

What is BPC-157's FDA compounding status now?

BPC-157 acetate may be compounded under 503A by subcutaneous, intramuscular, oral, or topical routes without federal enforcement, if every condition in the policy is met. It is still not on the 503A bulk list, and it has no monograph or approved drug.

The HHS document gives the history. FDA placed BPC-157 in Category 2 in September 2023 and removed it on April 22, 2026. HHS states that neither step changed the peptide's status under section 503A. FDA's safety risks page, current as of April 22, 2026, now lists BPC-157 under "bulk drug substances nominated but withdrawn."

Is compounded BPC-157 FDA approved now?

No. In a statement quoted by Medical Daily, HHS said the policy "does not grant FDA approval or establish clinical safety and effectiveness." The Federal Register notice states that "compounded drugs are not FDA-approved" and that the policy "is not binding on HHS or the public."

Even for listed substances, the bulk-list regulation says calling a compounded drug FDA approved "will cause the drug to be misbranded." A clinic page that says "FDA-approved BPC-157" is wrong.

Which peptides does the policy cover, and by which routes?

Six peptides, each in one salt form and limited to specific routes. The identities and routes are set in Appendix B of the HHS document, which also defines each peptide by amino acid sequence, structure, molecular weight, and formula. The "use FDA evaluated" column comes from FDA's July 2026 advisory committee meeting page. It is not an approved indication.

Three details catch people out:

• Injectable KPV and injectable Semax are not covered. No route in the policy is intravenous.
• HHS does not define how long an Epitalon "intermittent course" is. The document says only that the documented regimens are "intermittent," not continuous.
• Peptides not named are not covered, including emideltide, CJC-1295, ipamorelin, and AOD-9604, according to a Drug Topics analysis.

What must the pharmacy show before you prescribe?

A pharmacy only gets enforcement discretion if all ten conditions are present. The HHS document lists them:

• The peptide is on the policy's interim access list (Appendix A).
• It matches the identity and route limits in Appendix B.
• The bulk substance comes from an FDA-registered facility and has a valid certificate of analysis with results that meet FDA's described criteria.
• The original manufacturer, not a packer, repacker, labeler, or distributor, is registered under section 510 and follows CGMP, and its location appears on the certificate of analysis. Repackers and resellers must document that they validated the manufacturer and its certificate.
• The compounder reports products compounded, serious adverse events, and quality problems to FDA MedWatch and to the relevant states.
• The label reads "This is a compounded drug product. Not for resale." and explains how to report adverse events and quality problems.
• The product contains only one active ingredient from the list.
• For oral forms, the compounder keeps documentation that the specific formulation reaches adequate oral bioavailability in humans.
• The only device packaged with or containing the drug is an FDA 510(k)-cleared syringe.
• The product meets every other FD&C Act requirement, is not made under insanitary conditions, and is based on a valid patient-specific prescription.

The testing standard in the document covers identity, assay, impurities, residual solvents, elemental impurities, counter-ions, water, bioburden, and endotoxins. Frier Levitt's October 28 alert notes that a generic certificate of analysis will not meet that standard.

How can a clinic check that a 503A pharmacy meets the conditions?

Ask in writing, and keep the answers. Scriptura suggests these questions. They are not an FDA checklist:

• Which peptide, salt form, and route are you compounding, and does it match Appendix B?
• Who is the original API manufacturer, what is its FDA registration, and where is the facility?
• May we see the lot-specific certificate of analysis, and which tests does it include?
• For oral BPC-157 or KPV, what is your bioavailability documentation for this formulation?
• How do you report serious adverse events and quality problems, and how should our clinic send you reports?
• Is your pharmacy licensed in the patient's state, and does that state board allow this compounding?

Check the pharmacy's license with the patient's state board of pharmacy. A pharmacy that cannot name the original manufacturer does not meet the policy.

What must the prescriber do?

Write a valid prescription for an identified patient, for a covered peptide, form, and route. Section 503A applies to compounding "based on the receipt of a valid prescription order" for an individual patient, and the HHS policy repeats that requirement. Nothing in the policy creates a path for office stock.

The policy covers compounders. It does not change who may prescribe. NP and PA prescribing authority, collaboration rules, and any state board position on peptides still come from your state. Scriptura's state-by-state prescribing pages are a starting point.

Scriptura's suggestion for the chart: record the peptide, form, route, pharmacy, manufacturer, certificate lot, the patient's informed consent that the drug is compounded and not FDA-approved, and your reason for prescribing.

Do you have to report adverse events for compounded peptides?

The policy puts the reporting duty on the compounder. Serious adverse events must be reported "regardless of whether or not considered drug related," to MedWatch and to the states where the product was compounded and sent. Prescribers are not named, but anyone can file a MedWatch report. Scriptura suggests you report serious events yourself and also send them to the dispensing pharmacy, so it can meet its own condition.

What does the policy not cover?

Everything outside the six peptides, their listed forms and routes, and 503A compounding. Specifically:

• 503B outsourcing facilities. The policy names state-licensed pharmacies, federal facilities, and licensed physicians only, as NPR's report, syndicated by KPCW, and Drug Topics both note.
• Research-use-only vials. HHS describes these as the safety problem the policy is meant to discourage. LumaLex Law notes the policy does not change their legal status.
• Dietary supplements. The policy does not mention them.
• Combination vials and blends.
• Any route not in Appendix B.

What is the difference between 503A and 503B for compounded peptides?

503A pharmacies compound on patient-specific prescriptions under state board oversight. Under section 503B, outsourcing facilities register with the FDA, must follow CGMP, and may compound without a patient-specific prescription. The HHS policy covers 503A only, so a 503B facility offering these peptides is not protected by it. Frier Levitt notes that the policy does not extend enforcement discretion to 503B facilities on its own terms.

Can BPC-157 and TB-500 be combined in one compounded vial?

No. The policy requires a single active ingredient from the list. Frier Levitt uses this exact example: BPC-157 and TB-500 in one product is not covered. A pairing with any other ingredient is also outside the policy.

Why is this interim, and who disputes it?

The policy is a stopgap until FDA decides, by rulemaking, whether to add these peptides to the 503A bulks list. The HHS document says the policy applies until each peptide is addressed in a final rule, and that HHS "may revisit application of this interim policy (in whole or in part)" if a safety signal or quality problem appears.

The Federal Register notice calls it a draft. It says written comments can be submitted "until 2 weeks after date of publication." With publication set for October 30, that points to November 13, 2026. Confirm the date on the docket.

No one has set a rulemaking timeline. Frier Levitt estimates 12 to 24 months. Buchanan Ingersoll & Rooney points to an earlier bulk-list rule for ten substances: proposed in December 2016, final in February 2019.

What do supporters and critics say?

The record shows a split between FDA's advisory committee and FDA's own staff:

• In July, FDA reviewers recommended against listing all seven peptides they presented, AJMC reported. The committee voted 8 to 6, with one abstention, for BPC-157, KPV, and TB-500, and 7 to 5, with two abstentions, for MOTS-c.
• In an October 14 letter to FDA's acting commissioner, the Center for Science in the Public Interest said every vote in favor came from eight newly appointed permanent members, and that at least six of them have ties to peptide businesses or clinics.
• The Partnership for Safe Medicines filed a citizen petition asking FDA to set aside the July recommendation, NPR reported.
• Public Citizen's Dr. Robert Steinbrook told NPR that "Kennedy has undermined the FDA and threatened public health."
• Scott Brunner, CEO of the Alliance for Pharmacy Compounding, told NPR the policy offers a "more accountable alternative" for patients now buying gray-market peptides. He also said it may take time before pharmacies can dispense, because ingredients must first be verified.

Supply is another problem. Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals, told NPR, "We won't be able to meet demand."

What does the evidence on these peptides show?

It is thin, and the policy does not change it. FDA's safety risks page says it has identified no human exposure data on drug products containing KPV, MOTS-c, or TB-500. For BPC-157, FDA says it "lacks sufficient information to know whether the drug would cause harm when administered to humans."

FDA's BPC-157 briefing document found five clinical studies, all small and short, with human pharmacokinetic data only for rectal enemas. It concluded there is "insufficient clinical safety information to characterize the safety profile" and flagged a possible immunogenicity risk for injected or nasal use. Scriptura's BPC-157 clinician reference and TB-500 clinician reference summarize what has been studied.

What should your clinic do this week?

These are Scriptura's suggestions, not requirements from HHS, FDA, or a board:

1. Replace "not available" and "legal again" language with accurate wording. Say the peptide is compounded, not FDA-approved, and available only by the listed route.
2. Choose a pharmacy that can answer every question above in writing, and keep its answers on file.
3. Prescribe only the covered form and route, one peptide per prescription.
4. Stop sourcing, recommending, or tolerating research-use-only vials in your practice.
5. Update consent to say the drug is compounded, is not FDA-approved, has limited human safety data, and may become unavailable if HHS changes the policy.
6. Set up a path for adverse event reports to MedWatch and to the pharmacy.
7. Check your state boards of medicine, nursing, and pharmacy. A federal decision not to enforce does not override a stricter state position.
8. Plan for patients if the policy is withdrawn. LumaLex Law notes that FDA ended its GLP-1 shortage-era discretion with short wind-down windows.

What is already on record, and what should you watch?

On record as of October 29, 2026:

• HHS filed the notice on October 28. It publishes October 30, 2026, under Docket HHS-OASH-2026-0496.
• The policy covers six peptides, in set forms and routes, under ten conditions.
• The policy is a non-binding draft, open for two weeks of comment after publication.
• None of the six is on the 503A bulks list.

Watch:

• The Federal Register publication and the final comment date on the docket.
• Any revised version of the policy after comments close.
• An FDA proposed rule to add any of these peptides to the 503A bulks list.
• FDA's next advisory committee meeting, which its PCAC page says will be held before the end of February 2027 on LL-37, GHK-Cu, dihexa acetate, Melanotan II, and PEG-MGF.
• Responses to the Partnership for Safe Medicines petition.
• State board guidance on peptide compounding and prescribing.

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