HHS sends the White House a peptide access policy for specialty pharmacies

The peptide policy is now with the Office of Management and Budget, which reviews federal rules with the potential for significant economic impact ^[1][2]. The filing does not give specifics ^[15], so the description of its reach is secondhand ^[16]. HHS officials did not immediately respond to requests for comment on Thursday afternoon ^[14].

The policy follows a sequence Kennedy set in motion. Before joining the administration, he publicly declared that "FDA's war" on peptides and other wellness products would soon end ^[7]. Earlier this year he directed the agency to reconsider a short list of chemicals widely promoted by wellness influencers and fitness celebrities ^[5]. The panel of outside advisers that met in July was selected by his health department ^[12].

Kennedy's stated case is about the supply channel. As health secretary, he has argued that the country's compounding pharmacies must be permitted to sell peptides, because more and more Americans were buying "gray market" products made in China and other countries ^[6]. Those products remain widely available on platforms like TikTok ^[6]. FDA's staff scientists made a different point. They reiterated that none of the peptides had been studied enough to establish safety and effectiveness ^[10], and most of the existing data comes from animal studies ^[3]. In our view the two positions answer different questions: one is where people buy peptides, the other is whether the peptides are safe and effective. The sources do not include a comparison of pharmacy-made product with gray-market product.

The first public praise came from sellers. Brigham Buhler runs a wellness clinic and sells peptides through an online service. "This is huge," he wrote on X. "This isn't about whether you're for or against peptides. It's about whether you're for or against MEDICAL FREEDOM." ^[8] Some of the biggest MAHA figures sell peptide injections and supplements ^[9].

Sequencing is the open item. Enforcement discretion lets FDA selectively choose not to enforce some of its own regulations ^[17]. Formal listing would take rulemaking, and it was not immediately clear whether the administration still plans to pursue it ^[11][13]. A pharmacy that starts compounding BPC-157 this quarter on the interim assurance could still be relying on it next quarter, if no rulemaking follows. Its cover would be FDA's own decision not to enforce, and FDA is the agency whose staff scientists said in July that none of the peptides had been studied enough ^[17][10].