WASHINGTON — Federal health officials have moved to allow specialty compounding pharmacies to produce six unapproved peptide treatments, implementing a regulatory shortcut that bypasses longstanding objections from government scientists.
Under a policy released Wednesday by the Department of Health and Human Services, the agency said it would exercise “enforcement discretion,” agreeing not to take punitive action against state-licensed compounding pharmacies, physicians or federal sites preparing the specific compounds while formal rulemaking proceeds.
The policy applies to six substances popular in the alternative health and fitness communities: BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. None of the six have received Food and Drug Administration approval, and FDA researchers have repeatedly warned that adequate data is lacking to establish their safety or clinical efficacy.
Scientific resistance within the FDA
The push to broaden access to the substances was championed by Health Secretary Robert F. Kennedy Jr., who has publicly called himself a “big fan” of peptides and cited personal use of BPC-157 for a muscle tear. However, the maneuver met broad internal resistance among FDA scientific staff, who cautioned that opening the market would erode the agency’s primary mission of safeguarding the public from unverified therapies, according to people familiar with internal deliberations reported by The Associated Press.
HHS initially sought to have the FDA issue an official regulation adding BPC-157 and related compounds to the federal bulk drug substances list, which formally sanctions ingredients for compounding pharmacies. FDA staff resisted that measure, citing significant hazards, including potential risks of organ damage, allergic episodes and tumor development. To circumvent the stalemate, HHS shifted to a non-enforcement approach.
In 2023, the FDA had placed several of the chemicals on a list of items prohibited from compounding because of safety risks. Both BPC-157 and TB-500 are also classified as banned doping agents by international sports bodies.
Tackling the gray market
Federal officials framed the shift as a necessary consumer protection response to a surging underground market. Many Americans currently buy imported injectable peptides on the internet from overseas suppliers, often sold under “for research use only” labels to evade regulatory oversight.
“Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care—and that includes confronting the risks of black-market peptides,” HHS spokesperson Emily Hilliard said in a statement reported by NBC News.
The temporary policy does require pharmacies to adopt specific safeguards negotiated with FDA technical staff. Pharmacies compounding the six peptides must verify compound identity and purity, report patient side effects to federal regulators, and obtain raw materials exclusively from FDA-registered manufacturing facilities.
Public health watchdogs raise alarms
Outside health specialists and regulatory watchdogs strongly condemned the administration’s compromise. Dr. Peter Lurie, a former FDA official who heads the Center for Science in the Public Interest, told NBC News that the regulatory body was “turning a blind eye” to accelerate distribution of unverified medications.
Shabbir Safdar, executive director of the Partnership for Safe Medicines, similarly criticized the enforcement retreat, telling NBC News that allowing untested products to reach consumers sets a troubling precedent for national drug standards.
The policy follows a narrow recommendation in July by an FDA advisory panel to permit the compounding of the six substances. That advisory panel included several newly appointed members connected to the commercial peptide industry. The administration continues to work on a permanent rule, though a final regulation typically requires months of formal review and public comment before taking full legal effect.
