U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has authorized pharmacies to compound six Peptides that remain unapproved by the Food and Drug Administration for human use. The policy uses “enforcement discretion,” meaning the FDA will not enforce its prohibition on compounding these substances until further notice.
The peptides covered by the decision are BPC-157, TB-500, MOTS-c, Semax, KPV and Epitalon. BPC-157 and TB-500 are particularly popular among influencers and are often marketed together as the “Wolverine stack” because of claims about their regenerative properties.
The substances had previously been placed on the FDA’s “do not compound” list under the Biden administration. The restrictions reflected serious safety concerns and the lack of comprehensive human trials. The report says no new research prompted Kennedy’s decision; rather, he has argued that the peptides should not have been banned and that restrictions helped fuel an online black market.
Edgar J. Asebey, a life sciences regulatory attorney and partner at Frier Levitt, explained that enforcement discretion does not approve the drugs. Instead, it means the agency will decline to enforce a specific rule—in this case, the prohibition against compounding the six peptides. Pharmacies will therefore be allowed to dispense them with a prescription, despite their unapproved status.
Supporters of the change say regulated access could reduce the risks associated with buying peptides from online sellers and med spas. Meena Verma, an internist and nephrologist who runs a longevity clinic, said licensed pharmacies and physician oversight could provide patients with a more accountable source and greater assurance of product safety.
The online market is already substantial. The Alliance for Safe Online Pharmacies said it had tracked nearly 21,000 peptide listings across more than 300 websites since July, including more than 8,800 listings for BPC-157. The organization warned that allowing legitimate pharmacies to compound the substances could make it more difficult for consumers to distinguish compliant providers from illegal sellers.
Kennedy’s policy includes criteria such as requiring the peptides to be manufactured in an FDA-registered facility. Critics argue that this safeguard may be limited because registration primarily requires a manufacturer to notify the agency of its address. They also question whether the FDA has enough resources to enforce the rules across the large number of compounding pharmacies and online providers.
Leigh Verbois, a former FDA official and current chair of ASOP Global’s board, said safeguards would have little value without the resources needed to enforce them. The report also notes that the FDA has laid off 3,500 workers, raising further concerns about its ability to police the expanding market.
Medical specialists remain concerned about the lack of human evidence. Motisola Lewis, an internal medicine physician, pointed to BPC-157’s reported effects on tissue growth and vascularization. She said it is unknown whether those properties could affect cancer growth, raising particular concerns for patients with a history of cancer.
Although some doctors view controlled access as a harm-reduction measure, other experts advise patients to avoid the peptides altogether until their safety and effectiveness have been established. The policy brings substances with limited research into mainstream medical settings, where patients may encounter physicians and telehealth providers with differing levels of familiarity with their risks.
Sources: GQ.