HHS Will Not Act Against 503A Pharmacies Compounding Six Peptides: What the Policy Requires

The Department of Health and Human Services has issued a draft, interim policy under which it “does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a bulk drug substance in Appendix A.” Appendix A lists six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. The policy applies only when ten conditions are met, and it lasts until each peptide “is addressed in a final rule as being included or not included on the 503A bulks list.” It is not FDA approval, and it does not place any of the six on that list.

What the policy says

Section 503A of the Federal Food, Drug, and Cosmetic Act exempts drugs compounded by a licensed pharmacist or physician from FDA approval, labeling and manufacturing-practice requirements when, among other things, the bulk ingredient has a USP or NF monograph, is a component of an FDA-approved drug, or appears on a list issued by regulation (the 503A bulks list). None of the six peptides meets those terms. The policy document says HHS believes, “based on the Pharmacy Compounding Advisory Committee (PCAC) meeting and data regarding utilization of peptides,” that there is significant interest in compounding them, and that the Secretary has determined the policy “will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients.”

HHS “may revisit application of this interim policy (in whole or in part) if, among other things, a safety signal or product quality issue arises with a compounded drug product within the scope of this policy,” and the Federal Register notice says the policy “does not establish any rights for any person and is not binding on HHS or the public.”

The six peptides and the forms covered

Appendix A names the six; Appendix B gives each one’s identity (amino-acid sequence, molecular formula and weight, salt form), HHS’s justification, and the dosage forms for which HHS says enforcement discretion is appropriate. Each is limited to the forms below, compounded from an ingredient whose certificate of analysis meets the policy’s conditions. The evidence level is Prof. Peptide’s own: the highest study design used in people, not whether results were good.

Appendix B also sets a testing standard for the ingredient: identity confirmed by two independent analytical methods, assay, peptide-related and nitrosamine impurities, residual solvents, elemental impurities, water content, bioburden and bacterial endotoxins, among others. A footnote says endotoxin and bioburden criteria are specific to injectable forms, “which should be the standard route of administration (ROA) for peptides due to their low oral bioavailability,” and that other dosage forms need the tests specific to them. The certificate must state the grade “Intended for human drug compounding.”

The ten conditions

All of the following must be present for HHS’s non-enforcement to apply, as the policy document lists them:

1. Interim access list. The peptide appears in Appendix A.
2. Identity. The peptide has the identity and the route limits described in Appendix B.
3. Characterization. The bulk ingredient comes from a facility registered with FDA under section 510 and has a valid certificate of analysis with test results meeting FDA’s guidance-based criteria in Appendix B.
4. Original manufacturer. The original manufacturer (not a later packer, repacker, labeler or distributor) is FDA-registered, complies with current good manufacturing practice, and is named with its physical location on the certificate; a registered repacker or reseller must itself have validated the manufacturer and its certificate.
5. Reporting. Compounders report the products compounded, serious adverse events (whether or not considered drug-related) and product quality issues to FDA’s MedWatch program and to the states where products are compounded and sent; product reports give the active ingredient and strength, the original manufacturer with its facility identifier, and the dosage form and route. The reporting procedure is to appear on the labeling given to the patient.
6. Labeling. The label reads “This is a compounded drug product. Not for resale.”
7. Single ingredient. The product contains only one active ingredient listed in Appendix A, so that adverse events can be attributed to a specific substance.
8. Oral forms. For an oral dosage form, the compounder keeps documentation confirming that the formulation “achieves an adequate level of oral bioavailability in humans.”
9. Device. The only drug delivery device co-packaged with or containing the product is an FDA 510(k)-cleared syringe.
10. Everything else in the Act. The product is compounded in compliance with all other applicable requirements, including the bar on insanitary conditions and section 503A’s patient-specific prescription requirement.

The document sets no quantity limit beyond these conditions.

What the policy does not do

• It does not approve anything. The document notes that “compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed.”
• It does not put the six peptides on the 503A bulks list. That still requires rulemaking; the notice says “FDA’s future rulemakings may propose adding some or all of these peptides.”
• It covers 503A compounding only: State-licensed pharmacies, Federal facilities and licensed physicians, against a patient-specific prescription. It does not extend to outsourcing facilities under section 503B.
• It does nothing for research-use-only sellers. Its stated aim is to discourage the use of research-use-only peptides from foreign manufacturers, and its conditions require an FDA-registered manufacturer, a certificate graded for human drug compounding and a prescription.
• It covers each peptide only in the forms Appendix B names: no oral or topical TB-500, Epitalon or MOTS-c, no injectable KPV, and Semax only for intranasal use.

Where BPC-157 stands now, question by question, is set out in Is BPC-157 legal?, and the legal position of research peptides in general in Are research peptides legal?

Dates and comments

HHS filed the notice of availability on October 28, 2026, and the Federal Register published it on October 30, 2026 (91 FR 68526, FR Doc. 2026-22192). The notice says “This announcement is published in the Federal Register as of October 30, 2026”; neither it nor the policy document states a separate effective date. Written comments can be submitted “until 2 weeks after date of publication in the Federal Register” on regulations.gov, Docket No. HHS-OASH-2026-0496. The Alliance for Pharmacy Compounding said it wants clarity on details including when the policy takes effect, the Associated Press reported.

The July vote and FDA staff

Appendix B records the same history for each peptide: it was in FDA’s Category 2 from September 2023 until April 22, 2026, and “neither the placement nor the removal changed” its status under section 503A; FDA’s Center for Drug Evaluation and Research (CDER) “recommended against listing” it; and the Pharmacy Compounding Advisory Committee voted in favor. Each entry then gives a three-part justification. For BPC-157 it is that historical use “is now documented and quantified,” that the characterization record now includes “a lot-specific certificate from an FDA-registered facility” reporting the results CDER found lacking, and that the policy’s conditions address the risks through lot-level testing, single-ingredient products and MedWatch reporting. The committee met on July 23–24, 2026; its votes peptide by peptide are in the July 2026 vote report.

The Associated Press reported that most FDA scientific staff opposed the plan and had limited input; that HHS first wanted FDA to write a regulation adding BPC-157 and other peptides to the 503A bulks list, and moved to non-enforcement after FDA officials said staff would not support one; and that FDA staff then supplied technical assistance, including the requirement to use ingredients from FDA-registered facilities.

Evidence and safety

The policy changes how the six may be supplied, not what is known about them. By Prof. Peptide’s evidence levels, BPC-157, Epitalon and Semax have small human studies, and KPV, MOTS-c and TB-500 have no human study. For BPC-157, the human record is three small uncontrolled studies, 30 people in all, with no randomized trial reporting results, and a 2026 systematic review rated the certainty of the evidence very low (the October 2026 reviews). CDER’s recommendation against listing each of the six still stands in the record; the policy answers it with conditions, not new trials. Each profile sets out its own human evidence and the side effects reported: BPC-157, TB-500, Epitalon, Semax, KPV and MOTS-c.

The policy’s own safety measures are reporting and testing: serious adverse events and product quality problems go to MedWatch, each product holds a single active ingredient so events can be attributed, and every lot is tested against Appendix B’s standard. HHS says it may revisit the policy if a safety signal or quality issue arises.

Reaction

• HHS. Spokesperson Emily Hilliard told CNN the policy “does not grant FDA approval or establish clinical safety and effectiveness” and “requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting.”
• Public Citizen. Dr. Robert Steinbrook, director of its Health Research Group, said in a statement quoted by NPR that Kennedy “has undermined the FDA and threatened public health” and that “all peptide substances should go through the standard FDA approval process for new drugs.”
• Center for Science in the Public Interest. Dr. Peter Lurie, a former FDA official, told the Associated Press that FDA has approved rigorously tested drugs for the uses these peptides are promoted for, and that federal law does not give FDA authority to enforce the policy’s pharmacy requirements.
• Partnership for Safe Medicines. Executive director Shabbir Imber Safdar said the policy leaves it unclear whether peptides are safe, “even though the FDA’s own scientists recommended against voting in favor of these substances due to concerns with evidence” (CNN, NPR). The coalition filed a citizen petition asking FDA to block the compounding.
• Alliance for Pharmacy Compounding. Chief executive Scott Brunner called it a “more accountable alternative” to gray-market peptides and said it may take time before pharmacies dispense them, because ingredient suppliers and pharmacies must first meet and verify the new requirements (NPR).
• A 503A pharmacy. Joshua Fritzler of Olympia and Wesley Pharmaceuticals in Florida told NPR his company would likely compound only one of the six, in small quantities: “We won’t be able to meet demand.”
• American Peptide Association. Co-founder Jeff Cohen called it “much needed clarity” and said the path for people who do not want a clinician involved “remains obscure” (CNN).

Sources

• U.S. Department of Health and Human Services. HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendix A (list) and Appendix B (identities, justifications and testing standard). 16 pages; PDF dated October 28, 2026; read in full October 31, 2026. hhs.gov
• U.S. Department of Health and Human Services. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, notice of availability. 91 FR 68526, FR Doc. 2026-22192, Docket No. HHS-OASH-2026-0496; published October 30, 2026. federalregister.gov
• Sydney Lupkin, NPR. Small compounding pharmacies won’t be penalized for making peptides. October 28, 2026. npr.org
• Jacqueline Howard, CNN. Peptides could soon be easier to get in the United States. Here’s what to know. October 29, 2026. cnn.com
• Associated Press, via CNN. RFK Jr. acts to ease access to unproven peptides despite opposition from FDA scientists. October 28, 2026. cnn.com
• Matthew Perrone, Associated Press, via ABC News. FDA scientists opposed the Trump administration’s effort to ease peptides access. October 28, 2026. abcnews.com