U.S. Health Department proposes interim policy to permit compounding of select peptide drugs
The Health and Human Services department has submitted an interim access policy to the White House that would allow specialty pharmacies to compound certain peptide injections, a move praised by some industry participants.
The U.S. Department of Health and Human Services (HHS) has forwarded a draft "interim access policy" on peptide compounds to the White House for review, according to a posting on a government website on Thursday. The proposal, which is now with the Office of Management and Budget, would permit specialty compounding pharmacies to prepare a limited set of peptide injections that are currently unregulated and not approved by the Food and Drug Administration (FDA).
Peptides, the building blocks of proteins, are used in several FDA-approved medications for conditions such as diabetes and obesity. The peptides targeted by the plan, including BPC-157, have not undergone the standard clinical testing required for drug approval and are marketed primarily for muscle growth, anti-aging and energy-boosting purposes. The FDA has previously listed BPC-157 and other injectable peptides as too risky for compounding because of concerns about contamination, allergic reactions and potential tumor growth.
HHS officials did not respond to requests for comment. The filing does not detail the specific regulatory changes, but two sources familiar with the draft said it would grant compounding pharmacies enforcement discretion, meaning the FDA would not pursue action against pharmacies that produce the specified peptides. Formal rulemaking to add the peptides to the FDA’s list of drugs eligible for compounding could take years and would involve public comment.
The policy follows a July advisory panel, selected by HHS, that recommended dropping restrictions on six of seven peptides under review, despite FDA staff scientists concluding that safety and efficacy data were insufficient. Earlier this year, Health Secretary Robert F. Kennedy Jr. directed the agency to reconsider the list of restricted chemicals.
"This is huge," Brigham Buhler, who operates a wellness clinic that sells peptides online, 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."
The proposal has drawn attention from individuals and businesses that market peptide products, reflecting ongoing debate over the balance between regulatory oversight and access to emerging wellness compounds.