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The Department of Health and Human Services has submitted an interim peptide access policy to the White House’s Office of Management and Budget for review. People familiar with the proposal say it would let specialty pharmacies temporarily compound some popular peptides, but the filing does not identify which compounds or spell out the policy. The move comes amid FDA safety concerns and a broader review of restrictions on these products.
The Department of Health and Human Services has sent a proposed interim policy on peptide access to the White House Office of Management and Budget for review, a government website posting showed Thursday. Two people familiar with the plan told MedPage Today it is intended to let specialty pharmacies temporarily compound some popular peptides, including BPC-157; the filing itself does not specify which substances would be covered.
The proposal concerns compounded peptides—customized preparations made by pharmacies—rather than approved drugs produced through the conventional drug approval process. The sources said the policy would use enforcement discretion, under which the Food and Drug Administration could choose not to enforce certain restrictions against pharmacies producing specified peptides. The sources spoke anonymously because the government deliberations are confidential.
The plan is at an early review stage. The White House posting says HHS submitted an “interim access policy” to OMB, which reviews federal rules and regulations that could have significant economic effects. HHS did not immediately respond to MedPage Today’s request for comment. The filing offers no public details about the compounds, conditions, or duration that might be covered.
The FDA previously placed BPC-157 and more than a dozen other injectable peptides on a list of substances it considers too risky for compounding. The agency has cited potential hazards including contamination, allergic reactions and tumor growth. The products have been promoted for goals such as muscle building, injury recovery, looking younger and boosting energy, but those uses are not FDA-approved, and much of the available research is from animal studies.
A Shift in Pharmacy Enforcement
If adopted as described by people familiar with the plan, the policy could make some peptide products easier to obtain through specialty pharmacies without formally establishing that they are safe or effective. That distinction matters: non-enforcement would not equal FDA approval, and it would not amount to a finding that the products work for the uses promoted by wellness sellers.
The proposal could also affect a market that has attracted wellness businesses and larger telehealth companies. MedPage Today reported that Hims & Hers and Noom have announced plans to offer peptides if federal access rules ease. Wall Street analysts cited in the report estimate the market could reach $2 billion to $3 billion.
For patients and consumers, the immediate issue is that wider pharmacy access could change where and how these injections are sold while the evidence and regulatory status remain unsettled. The potential risks identified by the FDA are relevant to that decision, particularly because the products at issue have not undergone the same review as approved medicines.
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Kennedy’s Review of Peptide Rules
Robert F. Kennedy Jr. had criticized FDA restrictions on peptides before becoming health secretary. In office, he said U.S. compounding pharmacies should be allowed to sell them as Americans increasingly turn to products from what he called a “gray market”, including products made in China and other countries. Such products have remained available through online platforms, according to the report.
Earlier in 2026, Kennedy directed the FDA to reconsider restrictions on a short list of peptides promoted by wellness influencers and fitness figures. In July, an external FDA advisory panel recommended removing restrictions on six of the seven peptides it considered. That recommendation differed from the position of FDA staff scientists, who said the substances had not been studied enough to establish safety and effectiveness.
The advisory panel was selected by Kennedy’s health department and included doctors, pharmacists and consultants who work in the peptide field, MedPage Today reported. A formal change to the FDA’s compounding list would require federal rulemaking, including public comment, and could take years. It is not known whether the administration intends to pursue that route alongside the interim policy.
““FDA’s war” on peptides and other wellness products would soon end.”
— Robert F. Kennedy Jr., before becoming health secretary, as quoted in the report
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Policy Details Still Undisclosed
The White House filing does not state which peptides would be included, how long any temporary policy would last, or what safeguards pharmacies would have to follow. The reported inclusion of BPC-157 comes from two people familiar with the plan, not from the public filing, and the administration has not confirmed those details.
It is also unclear whether OMB will approve the policy as submitted, whether HHS or FDA will revise it, or when a decision might be made. The proposal’s relationship to formal rulemaking is unsettled. Nor does the available information establish whether the policy would change the FDA’s assessment of the evidence or the potential risks.
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OMB Review and FDA Decisions
The next procedural step is review by the Office of Management and Budget. The administration has not published the proposed policy’s full terms. Any subsequent announcement or document would be needed to confirm which peptides, pharmacies and conditions are covered.
Kennedy previously directed the FDA to reconsider peptide restrictions, and an external advisory panel recommended removing restrictions on six of the seven peptides it considered. A formal change to the FDA’s compounding list would require federal rulemaking, including public comment, and could take years. Until the interim proposal’s terms are clarified, it should be understood as a policy under review—not as a final rule, an FDA approval of the peptides, or confirmation that the products are safe and effective.
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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. The filing confirms the submission, but does not disclose the policy’s detailed terms.
Would pharmacies be allowed to compound BPC-157?
Two people familiar with the plan told MedPage Today that it is intended to allow temporary compounding of some popular peptides, including BPC-157. The public filing does not name the substances, and the administration has not confirmed that detail.
Does the proposal mean peptides have FDA approval?
No. The reported approach would use enforcement discretion, not grant FDA approval. It would not establish that the peptides are safe or effective for wellness uses such as muscle building or injury recovery.
What safety concerns has the FDA raised?
The FDA has cited possible contamination, allergic reactions and tumor growth among concerns about certain injectable peptides. FDA staff scientists have also said the substances have not been studied enough to establish their safety and effectiveness.
When will the policy take effect?
No effective date has been announced. The proposal is still under OMB review, and the public filing does not provide a timeline for a decision.
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