The Department of Health and Human Services (HHS) announced it will allow compounding pharmacies to manufacture and sell six peptides that have not received federal approval, a move that aligns with the Make America Healthy Again (MAHA) agenda championed by Health Secretary Robert F. Kennedy Jr.
In a formal notice, HHS said it will exercise enforcement discretion — refraining from taking regulatory or disciplinary action — regarding the production and distribution of BPC-157, TB-500, Epitalon, KPV, MOTS-c, and Semax. This effectively grants compounding pharmacies a green light to market these substances without fear of federal crackdowns.
The decision comes despite evaluations by Food and Drug Administration (FDA) scientists who found insufficient evidence to support the peptides' purported benefits for various conditions. However, the FDA's Pharmacy Compounding Advisory Committee (PCAC) voted in favor of allowing compounding pharmacies to make and sell them, a factor HHS cited in its decision.
“The Trump administration is committed to expanding and improving patient access while FDA reviews these substances,” the notice stated. “In the circumstances below, HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using” the listed peptides.
HHS acknowledged that these peptides are not FDA-approved, have not been evaluated for safety, and may “pose risks to patients,” but pointed to the PCAC vote as evidence of “significant interest” in their use. The agency's notice also noted that state-level regulations on compounding vary and may conflict with federal rules, potentially creating a patchwork of legal standards.
Earlier this month, the FDA submitted an “interim access policy” to the White House for review, though its details were not publicly released at that time. The new HHS guidance appears to be a precursor to that broader policy.
Kennedy, who has been a vocal advocate for peptide therapies, reshaped the PCAC last year by appointing several new members, including owners of wellness clinics and pharmacies who share his favorable views on these compounds. That move drew criticism from public health experts who question the evidence base for such treatments.
The decision is likely to intensify the ongoing debate over how health policies are framed and who gets to shape them. Critics argue that allowing unapproved substances undermines the FDA's regulatory authority, while supporters see it as a victory for patient choice and innovation.
For now, compounding pharmacies in states with permissive rules may begin offering these peptides, but those in stricter jurisdictions could face legal challenges. The HHS notice does not resolve those conflicts, leaving the ultimate implementation to state regulators and the courts.
