FDA-approved, compounded, “research use only”: what the labels mean

FDA-approved

An approved drug has been through clinical trials sponsored by its maker, followed by an FDA review of safety, effectiveness and manufacturing quality. The approval covers a specific product, dose and use. Several peptides in our Sequence Explorer are in this group — for example semaglutide, tesamorelin, oxytocin and vasopressin.

Compounded

Compounding pharmacies prepare medications for an individual patient with a prescription. Under section 503A of the federal Food, Drug, and Cosmetic Act, they can only use certain bulk ingredients. The FDA is clear that compounded drugs are not FDA-approved: the agency does not verify their safety, effectiveness or quality before they are dispensed.

For peptide ingredients that were nominated for compounding, the FDA has used interim categories. Substances in “Category 2” were those it considered to raise significant safety risks, and BPC-157 was among the peptides placed there.

The July 2026 advisory vote

In 2026, a group of peptides was referred to the FDA’s Pharmacy Compounding Advisory Committee. On July 23, 2026, the committee narrowly voted to recommend allowing compounding of BPC-157, TB-500 and KPV (8–6 each) and MOTS-c (7–5), over objections from FDA scientists. These votes are advisory, not binding. The FDA still has to decide, and any change is expected to go through a formal rulemaking process. A vote to permit compounding is also not an approval: none of these peptides is an FDA-approved drug.

“Research use only”

Products labeled “for research use only” or “not for human consumption” are sold as laboratory chemicals. They are not approved drugs, are not made to drug-quality standards, and are not intended for people.

In sport

Anti-doping rules are separate from FDA rules. The U.S. Anti-Doping Agency notes that BPC-157 is prohibited at all times under the World Anti-Doping Agency’s category for non-approved substances.