This week, I will appear before an FDA advisory committee to make a case that shouldn’t be controversial: patients ought to be able to get their peptide therapies from their licensed physicians or pharmacists, not an anonymous — and often foreign — website.

First, a quick primer, because “peptide” sounds more complicated than it is. A peptide is a short chain of amino acids, the same building blocks that form every protein in your body. Peptides occur naturally in the foods we eat, and peptide-based medicine is nothing new; insulin has treated patients for a century, with more than 100 peptide-based drugs approved since. These are well-understood molecules, not experimental compounds.

None of that is in dispute. What’s in dispute is who gets to provide them, and that’s the real question before the Pharmacy Compounding Advisory Committee when it meets July 23 and 24 to review seven peptides and recommend whether licensed compounding pharmacies can once again prepare them.

It will sound like a technical proceeding. It isn’t.

The recommendation will help determine whether these therapies are dispensed under a physician’s care or kept circulating in an unregulated gray market with no oversight.

So how did we get here? In 2023, the government restricted 14 of these peptides, the most widely used. The stated intent was patient safety. The result was the opposite. Physicians and pharmacists, the professionals trained to manage patient health, lost access to safe, regulated treatment options.

Demand didn’t disappear. It went underground.

Patients, disproportionately the 194 million Americans living with chronic illness, turned to online vendors and overseas suppliers, often with no sterility testing, no verified dosing, and no accountability. A policy meant to protect people stripped away their two best protections: a licensed pharmacy and a doctor’s supervision. This isn’t hypothetical. People have gotten sick from contaminated products they ordered online because their doctors could no longer legally prescribe the safer option.

The Food and Drug Administration began course correcting earlier this year, confirming that peptides previously banned from compounding would come off the restricted list. It was the right call, but incomplete and fragile. This week’s hearing decides whether these therapies earn durable status on the 503A bulk substances list or get shoved back into legal limbo.

The loudest opposition will come from pharmaceutical manufacturers, who argue that compounded access undermines drug approval. I’d take that argument more seriously if it were about safety rather than market share. Congress settled this decades ago: under Section 503A of the Federal Food, Drug, and Cosmetic Act, state-licensed pharmacies are explicitly authorized to prepare personalized medications under physician supervision. Compounding isn’t a loophole. It’s a deliberate feature of American healthcare.

Peptides are naturally occurring molecules that generally can’t be patented. No patent means no exclusivity, and no exclusivity means no company will spend hundreds of millions of dollars running them through clinical trials, however strong the science. That’s a gap in the research pipeline, not in the science. The molecules under review come from that same well-understood family.

And unlike the gray market, the compounding pathway comes with real oversight. Accredited 503A facilities answer to state boards of pharmacy and meet standards for sterility testing and potency verification. The anonymous vendors that have flourished since 2023 meet none of them. The only question is who’s accountable.

That’s the case I’ll bring to the committee, and it rests on a point the opposition avoids: peptides in regulated channels don’t just reach patients more safely, but they build the evidence base everyone claims to want. Route them through licensed pharmacies, and we can track outcomes, monitor side effects, and generate the real-world data the FDA wants.

That’s the market the American Academy of Peptide Medicine is building with regulators and industry: safe, quality-controlled, accountable. An anonymous website offers none of it.

The committee’s recommendation isn’t binding, but the FDA will take its cue from it. A second review is set for early next year, so Thursday is less a single verdict than a first move.

A well-intentioned rule three years ago pushed patients toward greater risk, not less. The FDA has spent this year walking it back. Thursday is the chance to finish it, to put these therapies where they belong — with the physicians and pharmacists patients trust, and to stop treating a prescription pad as the thing Americans need protection from.

This was never a hard call. Patients get their medicine from a licensed pharmacy and a doctor who knows them, or from a stranger on the internet who disappears when something goes wrong. On Thursday, the committee can make the right one.

Lee Rosebush is chairman and CEO of the American Academy of Peptide Medicine. He wrote this for InsideSources.com.