The FDA has sent an "interim access policy for compounding using certain peptides" to the White House for review, according to a report on Yahoo Health citing Reuters. If it moves forward, the temporary policy could let pharmacies compound certain unapproved peptides, including BPC-157, while the agency works on permanent rules.

Peptides are short chains of amino acids that act as messengers for things like appetite, healing and hormone release. Some are FDA-approved drugs: insulin is a peptide, and so is semaglutide, the active ingredient in Ozempic and Wegovy. BPC-157, nicknamed "Wolverine" and marketed online for injury recovery, is not, and neither are the peptides sold for muscle, sleep and anti-aging.

What enforcement discretion actually means

Compounding pharmacies can normally only use bulk ingredients that meet strict federal criteria. In July, FDA advisers recommended adding six peptides to that list, including BPC-157, TB-500 and MOTS-c, per an analysis from Holland & Knight, but the vote was nonbinding and formal rulemaking could take years.

The interim policy would fill that gap by having the agency decline to act against qualifying pharmacies, with possible conditions including state licensure, valid prescriptions and adverse event reporting, according to Buchanan Ingersoll & Rooney. That is a very different thing from approval, and the experts quoted are unusually blunt about the distinction. "Just because something is under 'enforcement discretion' does not mean it's FDA approved. Nor does it mean it's safe to use," said Danny Barnes, PharmD, a board-certified sterile compounding pharmacist. Shawn Hamilton, MD, an internist, put it this way: "Enforcement discretion means they have other fish to fry."

The safety record on BPC-157

The FDA has already spelled out concerns about compounded BPC-157, saying it "may pose risk for immunogenicity" and has "no, or only limited, safety-related information" for the ways people use it. Career staff at the agency have reportedly pushed back on the policy over patient safety.

Henry Legere, MD, an immunologist, described the early research as promising but limited. "Preclinical studies, primarily in animal models, have demonstrated promising effects on tendon healing, tissue repair, inflammation and blood vessel formation," he said. "However, we need to distinguish promising biological mechanisms from proven clinical benefits."

The research-use-only loophole

Many peptides sold online carry a "research use only" label. The FDA is not treating that as a defense: on Aug. 24 it sent warning letters to four online sellers, treating their products as unapproved new drugs despite the disclaimers, according to an analysis by the law firm Sheppard.

Bottom line

A policy that makes something easier to obtain is not a policy that says it works. Legere's framing is the one worth keeping: changes in compounding policy "should not be interpreted as proof of safety or effectiveness."