RFK Jr. clears 6 unapproved peptides for compounding as FDA scientists warn on safety

The Department of Health and Human Services said on Wednesday, October 28, 2026, that it will not take enforcement action against pharmacies, federal facilities or licensed physicians that compound six peptides the Food and Drug Administration has never approved as safe and effective. The move, signed under Secretary Robert F. Kennedy Jr., uses a tool called enforcement discretion to open access now while a formal FDA rule is still years away. Shares of companies tied to compounding and telehealth moved on the news.

What the notice actually does

The six substances named are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500, a group of research peptides marketed in wellness circles for recovery, longevity and weight goals. In the notice, HHS wrote that "to expand and improve patient access, HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A." It is not an approval. It is a promise not to prosecute, conditioned on the compounder meeting requirements on ingredient identity and purity, manufacturing standards, labeling, patient-specific prescriptions and, newly, reporting of adverse events.

That distinction matters. Under section 503A of the federal drug law, a bulk substance a pharmacy wants to compound normally has to clear the FDA's own process. The agency sorts nominated substances into three buckets: Category 1, under evaluation and tolerated for now; Category 2, raising significant safety concerns and barred from compounding unless the FDA issues a final rule; and Category 3, nominated without adequate support. Adding an ingredient to the permitted list requires a proposed rule, public comment and a final rule, a process the FDA itself describes as multi-year. HHS says that formal rulemaking is still underway and that the Wednesday notice is the stopgap.

Timeline

• Earlier in 2026: An FDA advisory committee reviewed the wellness peptides as part of the compounding nomination process, a step HHS has cited in support of the change.
• October 28, 2026: HHS publishes the enforcement-discretion notice listing the six peptides in its Appendix A.
• Still pending: A formal FDA rule that would actually add any of these substances to the compounding list, with the usual comment periods.

Who is involved, and who it hits

Kennedy has framed the decision as a safety-and-freedom measure, arguing that Americans are already buying these peptides from an unregulated "gray market," often imported from China, and that supervised compounding is safer than that. The people most directly affected are the state-licensed compounding pharmacies that can now make these products, the telehealth platforms that prescribe and distribute compounded drugs, and the patients who buy them.

For investors, the clearest read-through was to compounding-linked names. Hims & Hers Health closed at $29.35 on Wednesday, up about 5.1% on the day, according to Nasdaq quote data; the stock has traded between $13.74 and $49.17 over the past year and reports earnings on November 9. The company has built a large compounding business, so a federal signal that widens what pharmacies may compound is a direct revenue question for it and its peers.

Confirmed, claimed and unknown

Confirmed: HHS issued the notice; the six peptides are named; the policy is enforcement discretion, not approval; the substances are not FDA-approved; conditions including adverse-event reporting apply. Claimed and not independently verified by The Chronicle: reporting that most FDA scientific staff opposed the policy and had limited input in drafting it, attributed to anonymous people familiar with the process. Treat that as an unconfirmed claim. Unknown: the exact date the measure publishes in the Federal Register, and when or whether a formal rule will follow.

Reactions from both sides

Supporters, including Kennedy, say the change pulls a fast-growing and already-popular category out of the shadows and puts it under licensed pharmacists with purity and reporting rules attached. Public-health critics counter that the government is letting pharmacies dispense drugs that have not been shown safe and effective, and that decisions on compounding peptides have almost always been the FDA's to make, not the HHS secretary's. The FDA's own framework is built around proving safety before access, which is the tension at the center of this notice.

What it means and what to watch

For business readers, the signal is that a federal door has opened for compounded peptides, and companies positioned in telehealth and compounding are the obvious beneficiaries, with the obvious caveat that enforcement discretion can be narrowed or reversed by a future notice. For patients and prescribers, "not prosecuted" is not the same as "proven safe," and the adverse-event reporting requirement is new.

• Whether and when the notice appears in the Federal Register, and the exact conditions in the final text.
• Any FDA statement, since the agency, not HHS, normally runs this process.
• Hims & Hers earnings on November 9 and any guidance on its compounding mix.
• Legal challenges, which have followed past compounding fights.

Sources: HHS enforcement-discretion notice dated October 28, 2026 (Appendix A peptide list); U.S. Food and Drug Administration, "Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act" (fda.gov); Hims & Hers (HIMS) price and range via Nasdaq. Some figures are as of the October 28, 2026 close. This is market information, not investment advice.