HHS has published its peptide compounding policy, and here's what it covers

What happened

The policy we've been waiting on is out, and it came from a slightly different place than expected. The Department of Health and Human Services (HHS), not the FDA, posted an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" on October 28, and the Federal Register published the notice on October 30. It's signed by Secretary Robert F. Kennedy, Jr. The notice carries the same tracking number (RIN 0910-ZD94) as the "Interim Access Policy" that went to the White House on October 14, so this appears to be that document under a new name.

The core sentence is short. "To expand and improve patient access," HHS says it "does not intend to take enforcement action" against a state-licensed pharmacy, federal facility or licensed physician compounding with the peptides listed in the policy's appendix. Those are the six the FDA's advisory committee backed in July: BPC-157, KPV, TB-500, MOTS-c, Epithalon and Semax. It lasts while the formal list of allowed compounding ingredients is built through rulemaking, and the notice calls it a draft, with public comments open for two weeks after publication through regulations.gov.

How it compares with what we expected

While the policy was still at the White House, we wrote that the likeliest design was enforcement discretion, that it wouldn't change the law, and that it could be withdrawn. All three held. What we didn't have is that it's an HHS policy rather than FDA guidance, and the FDA Law Blog notes it says nothing about the FDA's own position. The notice itself says the policy "does not establish any rights for any person and is not binding on HHS or the public."

The conditions, according to the lawyers who've read it

The Federal Register notice only summarizes the policy, and the full text sits in a separate HHS document, so for the details we're relying on two law-firm readings, Baker Hostetler's and the FDA Law Blog's, and we'll say so where it matters. Both describe the same structure. It's conditional, substance by substance and route by route, and not a blanket green light.

Per those summaries, the pharmacy or physician has to work from a valid prescription written for an individual patient, make a product with a single active ingredient, and buy the raw peptide from an establishment registered with the FDA. Serious adverse events and product quality problems have to be reported to the FDA's MedWatch program (its safety-reporting system), and the label has to say "This is a compounded drug product. Not for resale." The FDA Law Blog also lists the forms covered for each peptide. BPC-157 is covered as subcutaneous, intramuscular, oral and topical products, TB-500 and MOTS-c as subcutaneous or intramuscular, KPV as topical and oral, Epithalon as subcutaneous or intramuscular in intermittent courses, and Semax as intranasal.

AJMC, which counts ten conditions in all, adds that the raw peptide has to come from an FDA-registered manufacturer following current good manufacturing practice, with a certificate of analysis (the lab document showing a batch's identity, purity and strength) that also shows no endotoxins or heavy metals.

The same readings note what it leaves out. Baker Hostetler says it doesn't cover the large outsourcing facilities known as 503B, or products sold as research chemicals or dietary supplements. HHS also reserves the right to revisit the policy, in whole or in part, "if, among other things, a safety signal or product quality issue arises." The FDA Law Blog adds that it's unclear whether state boards will follow the federal lead.

Who said what

Reuters reported supporters and critics within hours. Lee Rosebush, chair of the American Academy of Peptide Medicine, called it a "landmark regulatory milestone." Robert Steinbrook of Public Citizen's Health Research Group said Kennedy acted "recklessly and unilaterally," and pointed to contamination and unknown side effects. The notice says the aim is to expand patient access, and the FDA Law Blog reports HHS expects the limited compounding it allows to discourage widespread use of research-use-only peptides from foreign manufacturers. Reuters also notes that FDA staff scientists had recommended against the peptides at the July meeting.

What the numbers behind it look like

AJMC's coverage, published October 29, adds some context. FDA briefing materials found the available studies, five of them on BPC-157, were short, small and not enough to establish safety or effectiveness. A preprint (a study not yet peer reviewed) that looked at clinical notes from one database found BPC-157 use climbing sharply since 2020, with about as many users getting it from compounding pharmacies as from gray-market vendors. Only about a third of the confirmed users had a documented response, and 79% of those reported improvement. Flynn McGuire, MD, of the University of Utah, who wasn't involved, noted there was no comparison group and that about half the users were also taking other drugs or trying other interventions. That makes it reported experience from one database, useful for seeing how people use BPC-157 and not a measure of what it does. AJMC also reports 10 serious BPC-157 reports in the FDA's adverse event system since 2021, 8 of them in 2026, which don't establish causation.

What this means for you right now

If you've been waiting on a pharmacy route, the federal door is now open a crack, with conditions, and it isn't the same as being able to get a vial this week. You'd need a prescriber willing to write for one of these peptides, a state-licensed pharmacy willing to compound it from a registered source, and a state pharmacy board that agrees. It's likely to vary by state and by pharmacy while that sorts itself out. Per Baker Hostetler's and the FDA Law Blog's readings, the policy covers prescribed, patient-specific products, so a pharmacy selling "no prescription needed" BPC-157 falls outside it. Shawn Hodges, PharmD, CEO of the compounding pharmacy network Revelation Pharma, told AJMC in August that prescribers should ask a pharmacy for its certificates of analysis and how it qualifies its suppliers, and that's a fair question to put to any source.

If you buy research-use, nothing in this policy covers those products, and Baker Hostetler notes it doesn't apply to products sold as research chemicals. The August warning letters still stand, as we reported. What you control is what it's always been, the vendor and the price, and our price comparison tool and vendor directory are where to check both.

What to watch next

The public comment window closes about two weeks after publication, in mid-November, and the notice says the HHS website will carry the current version, so the text may change. Watch for state pharmacy boards, for any pharmacy that publicly starts offering these, and for the FDA's second advisory meeting on five more peptides before the end of February 2027, which we previewed here. We'll update our pharmacy answer as that picture fills in.