HHS Sends a Peptide Compounding Policy to the White House. It Would Be Permission, Not Approval.
The Oct. 14 filing would reportedly let pharmacies temporarily compound BPC-157 and other popular peptides under enforcement discretion. FDA staff scientists have said none has been studied enough to establish safety and effectiveness.
On Oct. 14, the Department of Health and Human Services and the Food and Drug Administration sent an "Interim Access Policy for Compounding Using Certain Peptides" to the White House Office of Management and Budget for review, according to a Holland & Knight analysis. The policy has not been issued, and its text is not public. The filing itself gives no specifics.
The Associated Press, in a report carried by local outlets and by STAT, said two people familiar with the plan, speaking anonymously, described it as letting pharmacies temporarily compound some of the most popular peptides, including BPC-157. HHS officials did not immediately respond to the AP's requests for comment.
What enforcement discretion means
The AP described the approach as enforcement discretion: FDA would choose not to act against compounding pharmacies making certain peptides. Holland & Knight expects the interim policy would likely move peptides into Category 1 of FDA's interim bulks policy, so the agency would not act against 503A pharmacies compounding them for individual patients, subject to conditions. In the firm's reading, that would not approve any product or change the statute. It would not reach research-use-only products, supplements or 503B outsourcing facilities, and it could be withdrawn without formal rulemaking.
The permanent route is slower. Adding peptides to the 503A bulks list requires federal rulemaking, which the AP said could take years and multiple rounds of public comment. Holland & Knight notes that FDA's 2016 proposed rule on 10 bulk substances was not finalized until 2019.
Compounding permission is not approval. No efficacy or safety standard has been applied to these products.
The record so far
FDA placed BPC-157 and more than a dozen other peptides in Category 2 of its interim bulks policy in 2023, a designation for substances the agency believes raise significant safety risks, according to Holland & Knight. The AP listed possible risks including contamination, allergic reactions and tumor growth. On April 15, 2026, FDA said it would remove 12 peptides from Category 2 after their nominations were withdrawn, a step that did not make any of them eligible for compounding.
On June 29, FDA staff recommended against adding any of the seven peptides under review to the bulks list, and the agency announced a reconstituted Pharmacy Compounding Advisory Committee. On July 23 and 24 the committee voted to recommend six. BPC-157, KPV and TB-500 each passed 8 to 6 with one abstention, per Holland & Knight, which did not report counts for MOTS-c, Epitalon and Semax. Emideltide failed 6 to 7. The votes are advisory. The AP reported that the panel was selected by Kennedy's health department and included doctors, pharmacists and consultants who work in the peptide field, and that FDA staff scientists reiterated that none of the peptides had been studied enough to establish safety and effectiveness.
Enforcement is also tightening
Holland & Knight lists five FDA warning letters to online peptide vendors on Aug. 24, and a Sept. 18 warning letter to a compounder of GLP-1 products that also questioned prescriptions generated through preselected options on third-party telehealth platforms. It also cites more than two dozen illnesses in at least four states, reported by FDA and the Centers for Disease Control and Prevention, linked to compounded glutathione injections made with supplement-grade ingredients contaminated with endotoxin.
What it means in clinic
Patients are likely to ask, and some may already be using gray-market products. Ask what they are injecting and where it came from, and document it. If you are considering prescribing, remember that state pharmacy rules still govern, that none of these peptides has an FDA-approved indication, and that the policy may change before it is issued, if it is. Avoid describing any of these products as approved or cleared. Telehealth prescribing is drawing scrutiny too; see our note on planning around uncertain telehealth policy.
Reported, fact-checked and edited by The Script Pad's editorial staff.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
