HHS Sends Peptide Compounding Policy to White House for Review

The Department of Health and Human Services sent a peptides "interim access policy" to the Office of Management and Budget, according to a Thursday posting on a government website. That office reviews federal rules with the potential for significant economic impact. The filing gives no specifics, and HHS officials did not immediately respond to requests for comment, according to the Associated Press (reporter Matthew Perrone), whose story STAT carried.

Two people familiar with the plan told the Associated Press it is intended to let specialty pharmacies temporarily compound some of the most popular peptides, including BPC-157. That compound is promoted for building muscle and healing injuries. The people spoke anonymously because the deliberations are confidential.

The mechanism matters for businesses. According to those sources, the policy would use "enforcement discretion." That means the FDA would choose not to act against pharmacies that make certain peptides. It would not formally change the rules. Formally adding peptides to the FDA's list of drugs safe for compounding would require rulemaking with public comment. That process could take years, and it is unclear whether the administration still plans to pursue it.

For companies, that difference is a risk factor. A policy of non-enforcement can plausibly be set quickly and may be reversed more easily than a formal rule. This is our interpretation; the source does not say how durable the policy would be, and this is the weakest part of the analysis.

The FDA currently lists BPC-157 and more than a dozen other injectable peptides as too risky for pharmacies to compound. It cites possible contamination, allergic reactions and tumor growth. The uses driving demand, such as bulking up, looking younger and boosting energy, are not FDA approved. Most of the data on these peptides comes from animal studies.

The expert views are also divided. In July, an outside FDA advisory panel recommended dropping restrictions on six of the seven peptides it reviewed. FDA staff scientists reached a different conclusion. They said none of the peptides had been studied enough to establish safety and effectiveness. The panel was selected by HHS and included doctors, pharmacists and consultants who work in the peptide field, according to the Associated Press.

Commercial interest is already visible. Telehealth providers Hims & Hers and Noom have each announced plans to offer peptides to customers if the federal government eases access. Wall Street analysts estimate the market at $2 billion to $3 billion. Some prominent figures in the Make America Healthy Again movement also sell peptide injections and supplements.

Compounding pharmacies would be the first to gain, since they would get assurance they will not be targeted. Large telehealth firms could then add a new product line. The source does not say how any company would price or market these products.

Health Secretary Robert F. Kennedy Jr. has argued that Americans are turning to "gray market" peptides made in China and other countries. Those products remain widely available online, including through TikTok. A legal U.S. channel could compete with that supply. The source does not say whether it would reduce it.

Wellness clinic operator Brigham Buhler, who sells peptides, praised the move on X. "This is huge," he wrote. He called the issue one of "MEDICAL FREEDOM."

What to watch next

Whether the White House clears the policy, what the published text says about which peptides and how long the access lasts, and whether HHS also starts the formal rulemaking process.

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