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The Department of Health and Human Services submitted an interim peptide access policy to the White House Office of Management and Budget on October 15, 2026. People familiar with the plan say it would temporarily let specialty pharmacies compound certain popular peptides, but the filing does not spell out which products or the policy’s terms.
The Department of Health and Human Services has sent a proposed interim policy on peptides to the White House for review, a step toward potentially allowing specialty pharmacies to compound some of the injections. The government filing does not describe the policy’s terms; two people familiar with the plan said it would temporarily permit compounding of certain popular peptides, including BPC-157.
The policy was submitted to the Office of Management and Budget, which reviews federal rules and regulations that may have significant economic effects, according to a posting on a government website on Thursday, October 15. HHS did not immediately respond to a request for comment, MedPage Today reported. The filing itself offers no details about which peptides would be covered or how long any temporary arrangement would last.
The two people familiar with the plan described it as a form of enforcement discretion: the Food and Drug Administration could choose not to enforce certain restrictions against pharmacies compounding specified peptides. They spoke anonymously because the deliberations are confidential. The approach would not be the same as formally adding peptides to the FDA’s list of substances considered suitable for compounding, which would require a rulemaking process and public comments.
The FDA has previously listed BPC-157 and more than a dozen other injectable peptides as substances that pose safety concerns when compounded. The agency has cited possible contamination, allergic reactions and tumor growth. People who use peptides for muscle building, injury recovery, appearance or energy are using them for purposes that are not FDA-approved, and much of the available research cited in the report comes from animal studies rather than rigorous human testing.
A Potential Shift in Pharmacy Access
If adopted, the policy could change how consumers obtain some peptides in the United States, shifting part of the market toward specialty compounding pharmacies rather than online sellers of products from abroad. The people familiar with the proposal said its temporary approach would give pharmacies assurance that they would not be targeted for making covered peptides, although the precise protections and products remain unknown.
The development also carries commercial implications. Telehealth companies Hims & Hers and Noom have announced plans to offer peptides if federal access rules ease. Wall Street analysts estimate the potential market at $2 billion to $3 billion, according to the source report. That estimate is a market projection, not evidence that the policy has been approved or that products have established safety or effectiveness.
For patients and consumers, the central issue is the gap between wider access and established medical evidence. Compounding can provide customized medications, but it does not by itself establish that a peptide is safe, effective or approved for a particular use. The FDA’s stated concerns and the limited research described in the report remain relevant even if enforcement policy changes.
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Kennedy’s Peptide Review Effort
Robert F. Kennedy Jr. had criticized FDA restrictions on peptides before joining the administration. As health secretary, he said U.S. compounding pharmacies should be allowed to sell them, arguing that consumers were turning to “gray market” products made in China and elsewhere. Such products remain available through online platforms, including TikTok, according to the report.
Earlier this year, Kennedy directed the FDA to reconsider a shortlist of peptides promoted by wellness and fitness figures. In July, an external advisory panel recommended lifting restrictions on six of seven peptides it reviewed. The panel was selected by Kennedy’s department and included doctors, pharmacists and consultants who work in the peptide field. FDA staff scientists, by contrast, said the substances had not been studied sufficiently to establish safety and effectiveness.
Advisory panel recommendations do not themselves change FDA policy. Formally changing the agency’s compounding list would require federal rulemaking, a process that can take years and includes public comment. The plan now at OMB appears to take a different, potentially temporary route, according to people familiar with it.
““FDA’s war” on peptides and other wellness products would soon end.”
— Robert F. Kennedy Jr., before joining the administration
compounded peptides for injury recovery
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Policy Scope Still Undisclosed
The government filing does not identify the peptides that would qualify, specify when a policy might take effect, or explain how long any temporary enforcement approach would last. The report’s account that BPC-157 may be included comes from two people familiar with the plan, not from published policy text.
It is also unclear whether the administration intends to pursue formal rulemaking alongside the interim approach. OMB review is a step in the process, not confirmation that the policy has been approved. The FDA has not publicly changed its safety position in the information reported, and no new evidence establishing the safety and effectiveness of the peptides was described.
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OMB Review and FDA Decisions
The immediate next step is review by the Office of Management and Budget. The administration has not announced a decision date or released the policy text. HHS and the FDA may clarify the covered products, timing and legal mechanism if the proposal advances.
Readers should watch for a public notice or agency statement that distinguishes any temporary enforcement discretion from a formal change to the FDA’s compounding rules. Until those details appear, the plan remains under review and the reported scope rests on anonymous sources familiar with the deliberations.
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Key Questions
What has the Trump administration done?
HHS submitted an interim peptide access policy to the White House Office of Management and Budget for review on October 15, 2026. Submission is not approval.
Which peptides might be covered?
The filing does not list them. Two people familiar with the plan told MedPage Today that it could include BPC-157 and other popular peptides, but the administration has not confirmed the scope publicly.
Would the proposal make peptides FDA-approved?
No such change is confirmed. The reported approach would involve enforcement discretion for certain compounding pharmacies, not formal FDA approval of a peptide or its use for muscle building, injury recovery or other wellness purposes.
What safety concerns has the FDA raised?
The FDA has cited potential contamination, allergic reactions and tumor growth among concerns about compounding certain injectable peptides. The report says available research is limited, with much of it based on animal studies.
What happens next?
The policy is under OMB review. Its timing, final terms and whether the administration will also pursue formal rulemaking have not been announced.
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