Reviewed by: TRT Locator's Medical Advisory Board.
> This article summarizes and credits content from the Diary of a CEO interview with Dr. Alex Tatem, hosted by Stephen Bartlett. All regulatory claims, clinical commentary, and statistics cited here are drawn from that interview. We strongly recommend watching the original for full context.
In 2023, the FDA moved 19 commonly prescribed peptides into "Category 2," effectively barring compounding pharmacies from manufacturing them. That decision cut off legal access to compounds like BPC-157, TB500, and Epitalon for millions of patients who had been using them under physician supervision. In July 2026, the FDA is scheduled to reconsider seven of those peptides for reinstatement to Category 1 — a move that could restore legal compounding access within months. Dr. Alex Tatem, a urologist and men's health specialist, laid out exactly what is at stake in a recent interview on the Diary of a CEO podcast (Diary of a CEO, 2024).
What the FDA's Category 2 decision actually did
To understand the ban, it helps to understand how compounding pharmacies fit into the US drug system. Compounding pharmacies legally produce customized medications — at doses, concentrations, or delivery formats not available commercially — but only from substances on an approved "Category 1" list. When the FDA reclassifies a substance to Category 2, it signals that the agency has determined there is "insufficient safety data" to allow its continued compounding. The practical effect is immediate: pharmacies must stop producing the compound, and physicians can no longer prescribe it through those channels.
The 2023 reclassification swept up 19 peptides that had been widely used in men's health clinics, longevity practices, and sports medicine. The FDA's stated rationale was that the compounds lacked sufficient human clinical trial data to meet compounding eligibility standards (Diary of a CEO, 2024).
Why Dr. Tatem thinks the FDA got it wrong
Dr. Tatem's argument is not that patient safety concerns are irrelevant — it is that the FDA applied a selective standard that happens to serve pharmaceutical industry interests. The compounds most affected by the 2023 reclassification are naturally occurring molecules. Because they cannot be patented, no pharmaceutical company has financial motivation to fund the expensive clinical trials the FDA requires for drug approval. The research gap, in Tatem's view, is a product of economics rather than evidence of danger.
The irony, as he frames it: the same compounds that were being prescribed by board-certified physicians at licensed compounding pharmacies are now being purchased by patients from unregulated websites labeled "for research use only." The ban did not eliminate demand. It redirected it toward sources with no quality control, no dosing accuracy, and no physician oversight (Diary of a CEO, 2024).
Searches for peptides have increased by 400 percent in recent years. Revenue from just two peptides — semaglutide and tirzepatide — is expected to exceed $55 billion this year, approaching the entire AI industry's annual revenue. The regulatory and commercial forces in this space are not small (Diary of a CEO, 2024).
The peptides under review and what they do
BPC-157, TB500, and Epitalon are among the seven peptides the FDA is scheduled to evaluate for return to Category 1 in July 2026. Understanding what each does helps explain why patient advocates and physicians are pressing for reinstatement.
BPC-157 (Body Protection Compound) is naturally present in human gastric juices. In animal models it has shown a striking ability to promote tissue repair — including, in one well-documented study, the spontaneous healing of severed Achilles tendons. Its mechanism involves promoting blood vessel growth (angiogenesis) and recruiting fibroblasts to injury sites. It has been used clinically for muscle, ligament, and tendon injuries.
TB500 is derived from thymosin beta-4, a protein secreted by the thymus. It promotes stem cell proliferation and the growth of extracellular matrix, which supports wound healing with reduced scarring. It is often paired with BPC-157 in clinical recovery protocols.
Epitalon is a synthetic version of a peptide secreted by the pineal gland. Animal studies suggest it may influence telomerase activity, potentially slowing cellular aging, and may help regulate circadian rhythms through melatonin pathways. Dr. Tatem is candid about the limits of the evidence: he is interested in the data but skeptical of claims that frame it as a straightforward longevity drug (Diary of a CEO, 2024).
The "gas station sushi" problem with buying outside a clinic
Tatem uses a blunt analogy for patients who source peptides online: it is "gas station sushi." The gray market for research-labeled peptides is large, unregulated, and operating in a legal gray zone specifically because the 2023 reclassification pushed patients out of the clinic and into the internet. Contamination with lipopolysaccharide (LPS), a bacterial byproduct that triggers serious immune responses, is a documented risk in unregulated peptide products. Dosing accuracy is not guaranteed. There is no physician reviewing your bloodwork or adjusting your protocol.
The FDA's category system was designed to protect patients. The perverse outcome of the 2023 decision is that it removed the safest legal pathway and left the riskiest one intact. If the July 2026 review reinstates these compounds, it would restore the physician-supervised compounding route and reduce reliance on unregulated sources.
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What the broader peptide landscape looks like right now
Not all therapeutic peptides are under regulatory pressure. Several remain on Category 1 and are actively prescribed through licensed compounding pharmacies.
Tesamorelin (sold commercially as Egrifta) is FDA-approved and specifically indicated for visceral abdominal fat reduction in HIV patients. Physicians use it off-label for metabolic health. GLP-1 drugs — semaglutide and tirzepatide — are fully FDA-approved for obesity and type 2 diabetes and represent the fastest-growing sector of the pharmaceutical market. Retatrutide, a next-generation GLP-1/GIP/glucagon triple agonist, has shown 20 to 25 percent body weight reduction in clinical trials and is advancing through the approval pipeline.
PT-141 (Vyleesi) is FDA-approved for female hypoactive sexual desire disorder and is legally prescribed off-label by men's health physicians for erectile and sexual dysfunction. Semax and Selank, intranasal peptides used for cognitive recovery and anxiety, occupy a different part of the regulatory landscape and are used in clinical contexts outside the US.
The point Dr. Tatem makes repeatedly: the peptide world is not monolithic. Some compounds have strong clinical data and FDA approval. Others have promising but incomplete data and are awaiting the clinical investment that economic incentives don't currently favor. Treating all peptides as equivalent — either equivalently dangerous or equivalently safe — misrepresents what the science and regulation actually show (Diary of a CEO, 2024).
