Peptide compounding in the United States has entered a new phase. The Department of Health and Human Services (HHS) will not act against compounders of six unapproved peptides, within strict conditions. The peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. The notice was filed for public inspection on 28 October 2026. It was published in the Federal Register on 30 October.
The move is not an approval. None of the six peptides has been reviewed by the Food and Drug Administration (FDA) for safety or effectiveness. Instead, HHS has set out an interim position. It applies while the FDA decides, through rulemaking, whether each substance belongs on its compounding list.
What Is the HHS Peptide Compounding Policy?
The document is titled “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances”. The accompanying Federal Register notice (docket HHS-OASH-2026-0496, RIN 0910-ZD94) was signed by HHS Secretary Robert F. Kennedy, Jr.
Section 503A of the Federal Food, Drug, and Cosmetic Act governs compounding by licensed pharmacists and physicians for individual patients. A compounded drug qualifies for 503A exemptions only if its bulk ingredients meet one of three tests. It needs a USP or NF monograph, a place in an FDA-approved drug, or a 503A bulks list entry. None of the six peptides meets any of those tests.
The enforcement discretion policy bridges that gap temporarily. HHS says it does not intend to act against compounders using a peptide listed in Appendix A. This covers state-licensed pharmacies, federal facilities and licensed physicians. That protection applies only when all ten of its conditions are met.
The Federal Register notice of availability describes the document as a draft. It states that the policy establishes no rights for any person and is not binding on HHS or the public.
Which Peptides Are Covered, and by Which Routes?
Appendix A lists six substances. Appendix B then fixes the chemical identity of each one, including its amino acid sequence, molecular formula and molecular weight. It also restricts the routes of administration that fall within the policy.
The six peptides and their permitted routes
BPC-157 acetate is covered for subcutaneous, intramuscular, oral and topical dosage forms. TB-500 acetate and MOTS-c acetate are covered for subcutaneous or intramuscular injection only. Epitalon acetate is limited to subcutaneous or intramuscular injection, dispensed in intermittent courses. Semax free base is covered for intranasal use only. KPV acetate is limited to topical and oral forms.
A product outside these parameters falls outside the policy. Semax prepared as an injection, for example, would not qualify. Nor would KPV given by injection.
The Ten Conditions for Peptide Compounding
The conditions focus heavily on the quality and traceability of the active ingredient. In summary, compounders must meet the following requirements.
The peptide must appear in Appendix A and match the identity and route limits in Appendix B. The bulk substance must come from a facility registered with the FDA under section 510. It must carry a valid certificate of analysis showing identity, purity and potency. The certificate must also confirm the absence of contaminants such as endotoxins and heavy metals.
The original manufacturer must itself be FDA-registered and compliant with current good manufacturing practice (CGMP). Its physical address must appear on the certificate. If a repacker or reseller supplies the peptide, that entity must have validated the manufacturer and its certificate.
Compounders must report serious adverse events and product quality issues to FDA MedWatch and to the relevant states. Each product label must state: “This is a compounded drug product. Not for resale.”
Each product may contain only one active ingredient from Appendix A. HHS says single-ingredient products make it easier to attribute adverse events to a specific substance. In practice, that rules out combinations such as BPC-157 with TB-500.
Oral products carry an extra burden. The compounder must keep documentation showing that the specific formulation achieves adequate oral bioavailability in humans. The only drug delivery device that may be co-packaged is an FDA 510(k)-cleared syringe.
Finally, every other requirement of the Act still applies. That includes the ban on insanitary conditions and the 503A requirement for a valid patient-specific prescription.
What Peptide Compounding Under the Policy Does Not Allow
The policy does not add any peptide to the 503A bulks list. It does not make any of the six an FDA-approved drug. It also does not authorise the use of research-grade ingredients.
The arrangement is time-limited. It lasts until a final rule addresses each peptide, either including it on the 503A bulks list or excluding it. HHS may also revisit the policy, in whole or in part, if a safety signal or product quality issue emerges.
Why HHS Departed From FDA Staff Advice
HHS frames the policy as a public safety measure. It says the policy will discourage widespread use of research-use-only peptides from foreign manufacturers. HHS describes those products as a safety risk to US patients. According to HHS, limited compounding under safeguards gives patients “a more controlled alternative”.
The history is contested. All six peptides were placed in Category 2 of the FDA’s interim compounding policy in September 2023. They remained there until 22 April 2026. The FDA’s safety risk assessments flagged immunogenicity concerns and gaps in human safety data. The agency now lists all six as nominated but withdrawn.
In July 2026, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted in favour of the six peptides. It voted against a seventh, emideltide. Appendix B nonetheless acknowledges a dissenting view. The FDA’s Center for Drug Evaluation and Research (CDER) recommended against listing each of the six.
HHS justifies its departure from CDER on three broad grounds. It cites new lot-specific certificates of analysis from FDA-registered facilities and newly documented historical use. For several peptides, it also describes CDER’s safety concerns as mechanistic or inferential rather than observed.
Industry Reaction Splits Sharply
Compounding pharmacies welcomed the decision. Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, called it “an important step for patients”. He argued that patients already obtain peptides from illicit suppliers with little assurance of content.
Brunner also cautioned that dispensing may not start immediately. Suppliers must first show that their ingredients meet the policy’s testing requirements. “That may take time, and patients and prescribers should understand that,” he said.
Branded drugmakers took the opposite view. Jim Stansel, executive vice president, general counsel and corporate secretary at PhRMA, said the policy “jeopardizes patient safety”. He argued that it contradicts the statutory requirement for notice-and-comment rulemaking. He also noted that FDA career staff had recommended against permitting compounding of these peptides.
The Partnership for Safe Medicines has also petitioned the FDA to disregard the committee vote, AJMC reported. The petition argues that the evidence for the peptides’ safety is insufficient.
Pharmacy practice voices raised operational concerns. Annie Lambert, a pharmacist at Wolters Kluwer Health, commented in a statement reported by TIME. Compounding “is not a substitute for FDA-approved manufacturing,” she said. She warned that some pharmacies may put speed ahead of meeting every requirement. TIME also reported that telehealth websites soon began marketing the six peptides. Prices ranged from $199 to $249 a month.
What the US Policy Means for UK Readers
The HHS peptide compounding policy has no legal effect in the United Kingdom. A search of the electronic medicines compendium on 30 October 2026 returned no authorised product for BPC-157.
The Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into UK peptide clinics in April 2026. That followed reporting in The Guardian on clinics promoting experimental peptides with medicinal claims. An MHRA spokesperson was quoted by Aesthetics Journal at the time. “The MHRA will take action against clinics which are identified as breaching the legal requirements,” the spokesperson said.
The US decision does not change that position. Earlier contributor commentary on the US ‘Wild West’ of peptide medicine set out the gap between authorised and qualified prescribers.
What Happens Next for Peptide Compounding
Written comments can be submitted for two weeks after Federal Register publication via regulations.gov. The notice was published on 30 October, so the window closes on 13 November 2026.
Several practical questions remain open. The Alliance for Pharmacy Compounding says it will seek clarity on when the policy takes effect. It also wants guidance on how certificates of analysis will be validated and how utilisation reporting will work. Coordination with state boards of pharmacy is a further unknown.
The longer-term test is FDA rulemaking. HHS says public comments may inform future FDA rulemaking addressing some or all of the six substances. That process will determine whether today’s discretion becomes permanent access. The background to the July vote is covered in an earlier contributor preview of the committee meeting.
For now, peptide compounding of these six substances is tolerated only within narrow limits. Pharmacists, clinics and prescribers will need to check every condition before treating the policy as permission.
