HHS Lets Pharmacies Compound BPC-157 and Five Other Peptides. None Is FDA-Approved.
An HHS policy filed Oct. 28 shields 503A compounding of six unapproved peptides if sourcing, labeling and reporting rules are met. Comments close Nov. 13.
Idea in Brief
The News
HHS says it will not act against state-licensed pharmacies, federal facilities or licensed physicians that compound BPC-157, TB-500, MOTS-c, Epitalon, Semax or KPV under section 503A, if every condition is met.
What Changes
Six peptides that had no lawful 503A route now have an interim one, limited by peptide and route, with FDA-registered sourcing, a certificate of analysis, set label text and adverse event reporting.
Why It Matters
Nothing has been approved. The policy is nonbinding, can be withdrawn if a safety signal appears, and patients will be asking about these products now.
The Department of Health and Human Services (HHS) says it will not take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound six unapproved peptides, including BPC-157 and TB-500, under a policy filed Oct. 28. None of the six is in an approved drug.
The notice, signed by Health and Human Services Secretary Robert F. Kennedy Jr., was filed for public inspection at the Federal Register on Oct. 28 and is scheduled for publication Oct. 30. It announces an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," which applies while the Food and Drug Administration (FDA) builds the list of bulk substances allowed in 503A compounding through rulemaking. Comments are open for two weeks after publication, through Nov. 13, on docket HHS-OASH-2026-0496.
It is the policy The Script Pad reported in draft form when HHS sent it to the White House for review on Oct. 14. The notice is explicit that compounded drugs "are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed."
Which peptides does the policy cover?
It covers six, each limited to particular routes. According to the policy's appendices, as summarized by attorneys Karla Palmer and Charles Snow of Hyman, Phelps & McNamara on the FDA Law Blog, BPC-157 acetate may be compounded in subcutaneous, intramuscular, oral and topical forms. TB-500 acetate and MOTS-c acetate are limited to subcutaneous or intramuscular injection, and Epitalon acetate to the same routes dispensed in intermittent courses. Semax free base is limited to intranasal use, and KPV acetate to topical and oral forms.
They are the same six peptides the FDA's Pharmacy Compounding Advisory Committee recommended in July, TIME reported. HHS gives its reason in the notice: based on the committee meetings and utilization data, it "believes that there is significant interest in the use of these peptides in compounding given the lack of availability of approved products."
What conditions do compounders have to meet?
Enforcement discretion applies only when all of the policy's requirements are met. The bulk peptide must come from a manufacturer registered with FDA as a drug establishment and compliant with current good manufacturing practice, and the certificate of analysis must name the manufacturer's physical location and include the testing the policy specifies. A repacker or reseller in the chain must have documented validation of the manufacturer and its certificate.
Each product may contain only one of the six peptides, which excludes blends. Only an FDA-cleared syringe may be packaged with the drug. Compounders must report serious adverse events and product quality problems to FDA's MedWatch and to the states where products are made and sent, and labels must carry the line "This is a compounded drug product. Not for resale." The policy runs for each peptide until a final rule decides whether it goes on the 503A bulks list.
Enforcement discretion is a decision not to act. It is not a finding that these peptides are safe or that they work.
Clinical Pearls
- The six peptides are BPC-157, TB-500, MOTS-c, Epitalon, Semax and KPV, the same six the FDA's Pharmacy Compounding Advisory Committee recommended in July.
- Each is limited to listed routes: BPC-157 subcutaneous, intramuscular, oral or topical; TB-500, MOTS-c and Epitalon by injection; Semax intranasal; KPV topical or oral.
- A product may contain only one of the six peptides, so multi-peptide blends fall outside the policy.
- The bulk peptide must come from an FDA-registered manufacturer that follows current good manufacturing practice, with a certificate of analysis that names the manufacturing site.
- Serious adverse events and product quality problems must be reported to FDA's MedWatch and to the states involved.
- HHS says it may revisit the policy, in whole or in part, if a safety signal or product quality issue arises.
What does the evidence look like?
Thin, by the FDA's own staff account. FDA staff advised against the advisory committee's recommendation, TIME reported, and the committee voted for the six anyway. As The Script Pad reported on Oct. 18, BPC-157, KPV and TB-500 each passed 8 to 6 with one abstention. At the July meeting Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University Medical Center, said, "The peptides under consideration here are untested and poorly characterized experimental drugs," as quoted by TIME.
Supporters see the policy as harm reduction. Lee Rosebush, chair of the American Academy of Peptide Medicine, said the move "represents a vital step toward eliminating the unsafe gray and black markets," TIME reported. The FDA Law Blog authors note that HHS expects limited compounding to discourage use of research-use-only peptides from foreign manufacturers, which the policy does not cover.
What the notice says versus how it is being sold
TIME reported that telehealth sites were marketing the six peptides at $199 to $249 a month shortly after the notice appeared. By The Script Pad's reading of the notice and the route list, the permission is narrower than that marketing suggests. It is limited to 13 specific peptide and route pairings rather than to the peptides in general, so injectable KPV or oral TB-500, for example, falls outside it. The notice states that it "does not establish any rights for any person and is not binding on HHS or the public," and that HHS may revisit it if "a safety signal or product quality issue arises."
"Interim" may also last a long time. The FDA Law Blog authors count only six bulk substances moved off FDA's interim list through notice-and-comment rulemaking in about 15 years. Until the FDA finishes rulemaking on each peptide, this policy, not an approval, is what stands behind any prescription for one.
What it means in clinic
Expect questions, especially from patients who already buy research-use-only vials online. A prescription for a compounded peptide is a prescription for an unapproved drug with limited human data, and the informed-consent conversation should say so. If you prescribe one, ask the pharmacy for the certificate of analysis and the name of the bulk manufacturer, confirm that the route matches the policy, and report any serious adverse event to MedWatch. Physicians who compound in their own offices fall under the same conditions as pharmacies. The same department is taking the opposite approach with kratom-derived 7-OH, so consumer-market substances are getting very different treatment. Clinicians who want to weigh in have until Nov. 13.
Reported, fact-checked and edited by The Script Pad's editorial staff. See How we use AI.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
