FDA's Drug Reviewers Recommended Against All Six Peptides HHS Is Now Letting Pharmacies Compound, Policy Document Shows

The Department of Health and Human Services' new policy allowing small compounding pharmacies to make six popular peptides overrides a recommendation from the Food and Drug Administration's own drug-review center on every one of the six substances, according to the policy document HHS posted this week.

The six peptides, listed in Appendix A of the policy, are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. For each one, Appendix B states that the FDA's Center for Drug Evaluation and Research, known as CDER, "recommended against listing" the substance, and that the agency's Pharmacy Compounding Advisory Committee voted in favor. HHS then gives a three-part justification for each peptide, generally citing new documentation of historical use, new manufacturer test certificates and the safeguards built into the policy.

NPR reported Wednesday that the advisory panel's vote came at a July meeting, at which FDA scientists recommended against loosening the restrictions.

Under the policy, HHS "does not intend to take enforcement action" against a state-licensed pharmacy, a federal facility or a licensed physician that compounds a drug using one of the six peptides, as long as a list of conditions is met. The policy applies to compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act, the provision that covers drugs made for individual patients. It does not name 503B outsourcing facilities, which produce larger volumes; NPR reported that the larger facilities are not covered.

The policy says it is meant to steer patients away from what it calls "research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients," and that the HHS secretary has determined it "advances patient choice and freedom while appropriately protecting patient safety." It will apply until FDA addresses each peptide in a final rule on the list of bulk substances allowed in 503A compounding.

The conditions are specific. The bulk ingredient must come from a facility registered with the FDA and carry a certificate of analysis showing tests for identity, purity, potency and contaminants such as endotoxins and heavy metals. The original manufacturer must be FDA-registered and compliant with current good manufacturing practice. Each compounded product may contain only one of the six peptides as its active ingredient. Compounders must report the products they make, along with serious adverse events and quality problems, to the FDA's MedWatch program and to the states involved. Labels must read: "This is a compounded drug product. Not for resale." The only delivery device allowed is an FDA-cleared syringe, and any oral version requires documentation that the formulation is adequately absorbed in humans. A valid patient-specific prescription is still required.

The appendix also limits how each peptide may be given. BPC-157 may be compounded for injection under the skin or into muscle, or in oral or topical forms. TB-500 and MOTS-c are limited to injection under the skin or into muscle. Epitalon is limited to injection and to "intermittent courses." Semax is limited to intranasal use, and KPV to topical and oral forms.

The appendix states that each of the six was in FDA's "Category 2" from September 2023 until April 22, 2026, and that neither the placement nor the removal changed its status under Section 503A.

In several entries, HHS characterizes CDER's safety concerns as theoretical. For TB-500, it says the concerns "are inferential rather than observed." For epitalon and semax, it calls them "mechanistic rather than based on observed harm" or "mechanistic rather than observed." For KPV, it says CDER's conclusion "reflects an absence of information rather than an observed signal." For MOTS-c, it cites a randomized, placebo-controlled trial of a related compound that reported no serious adverse events.

HHS also reserves the right to change course. The policy says the department "may revisit application of this interim policy (in whole or in part) if, among other things, a safety signal or product quality issue arises."

The formal notice, filed for public inspection at the Federal Register at 11:15 a.m. Wednesday and scheduled for publication Friday, Oct. 30, describes the document in its background section as a "draft" policy and states that it "does not establish any rights for any person and is not binding on HHS or the public." It sets a comment period of two weeks after publication, through regulations.gov under Docket No. HHS-OASH-2026-0496. Counting from the scheduled Oct. 30 publication date, that window would close in mid-November. The notice is signed by Health and Human Services Secretary Robert F. Kennedy Jr.

The notice says the bulk-substance list for 503A compounding is still being developed through rulemaking and that "FDA's future rulemakings may propose adding some or all of these peptides" to that list "based on the available evidence."

Industry and consumer groups split along predictable lines, NPR reported. Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, called the policy a "more accountable alternative" to the gray market but warned that suppliers and pharmacies will need time to verify ingredients. Dr. Robert Steinbrook of Public Citizen said Kennedy "has undermined the FDA and threatened public health" and that all peptides "should go through the standard FDA approval process for new drugs." The Partnership for Safe Medicines, which NPR said filed a citizen petition last week urging the FDA to reject its advisers' recommendation, said the decision leaves Americans "in a grey area." Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in Florida, told NPR that only his company's smaller facility will qualify and that it will likely compound just one of the six at first.

The policy does not make any of the six peptides an FDA-approved drug. In the policy's own words, compounded drugs "are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed."

Still unknown: how many pharmacies can meet the sourcing and testing conditions, how quickly compliant ingredients will reach them, and whether comments filed in the two-week window lead HHS to change the draft.