HHS Allows Pharmacies to Dispense Six Unapproved Peptides

A new federal policy is opening the door for greater access to experimental peptide treatments in the United States. The Department of Health and Human Services (HHS), led by Secretary Robert F. Kennedy Jr., announced on October 28 that it would not pursue enforcement action against licensed pharmacies and physicians dispensing six unapproved peptides through compounding, despite unresolved scientific and safety concerns.

The policy, published in the Federal Register, covers BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. These substances are short chains of amino acids that people inject into their bodies, although their claimed health benefits remain largely unsupported by established scientific evidence.

The decision follows a July meeting of an FDA committee that reviewed the substances and recommended allowing specialty pharmacies to dispense them. Several committee members had professional or business connections with companies interested in promoting or distributing peptides, while FDA staff had advised against the proposal.

HHS justified the change by pointing to growing consumer demand. The department's notice stated that there was "significant interest" in obtaining these substances through compounding pharmacies.

"Therefore, 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," the policy stated.

In a separate statement published on its website, HHS defended the decision as consistent with its approach to patient choice and safety.

"The Secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety," the department stated.

Kennedy has previously expressed support for these experimental substances, describing himself as a "big fan" of unapproved peptides.

The policy could also create new commercial opportunities in the healthcare sector. Hims & Hers had reportedly been preparing to introduce peptide products in 2026, while analysts estimated that the potential market could reach $3.3 billion.

Following the October 28 announcement, Hims stock increased 5%. Several telehealth websites also began advertising the six peptides shortly after the notice appeared, with monthly prices ranging from $199 to $249.

Lee Rosebush, chair of the American Academy of Peptide Medicine, a newly established advocacy organization, welcomed the change as an opportunity to expand access through regulated medical channels.

"This represents a vital step toward eliminating the unsafe gray and black markets, restoring safe patient access through legitimate, physician-supervised care," Rosebush said in a statement.

However, public-health advocates questioned whether the policy adequately protects consumers from treatments that have not undergone the FDA's standard scientific approval process.

"American consumers should not be treated like guinea pigs," said Fred Mills, chief policy officer for Americans for Safe and Effective Medicines.

He also argued that expanding access to legitimate medicines should not come at the expense of patient protection.

"It is possible to advance both patient safety and access to legitimate medicines, but this is not it," Mills said.

Opposition to the proposal had already emerged during the FDA committee's July hearings. Consumer advocacy organizations, including the Center for Science in the Public Interest, warned that allowing these substances to bypass the established FDA approval process would represent an unprecedented and potentially dangerous approach.

Dr. Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University Medical Center, also challenged the proposal during the public comment session.

"The peptides under consideration here are untested and poorly characterized experimental drugs that should not be allowed in compounded products," Fugh-Berman said.

She also cited an incident involving two women who required emergency medical treatment after receiving peptides at a festival in Las Vegas.

Pharmacists have raised additional concerns about the operational demands that could accompany growing consumer interest. Compounding pharmacies traditionally prepare customized medications for specific prescriptions, but some have expanded production to meet demand for drugs such as GLP-1 treatments.

Annie Lambert, a pharmacist and clinical program manager for compliance solutions at Wolters Kluwer Health, warned that the peptide market could increase pressure on pharmacies to expand production quickly.

"Compounding can and should play a legitimate clinical role, from hospitals to home infusion to filling gaps during drug shortages. But it is not a substitute for FDA-approved manufacturing, and that distinction is where a lot of today's risk sits," Lambert said in a statement.

She emphasized that pharmacies entering the market must maintain appropriate manufacturing and safety standards.

"My concern is that pharmacies rushing into this space will move to make a dollar faster rather than make sure they meet every requirement, from ingredient sourcing and facilities to staff training and sterility testing," Lambert said.