Category 2 peptides: what FDA said, and where each one stands

Category 2 is part of FDA's interim policy for 503A pharmacies, explained on the 503A list page. FDA's label for it is "bulk drug substances that raise significant safety risks". Pharmacies are expected not to compound from anything in it. In September 2023 FDA placed a large group of peptides there. BioPharma Dive, summarising the decision in 2026, quoted FDA's 2023 wording that they posed "significant safety risks".

FDA keeps a page that sets out its stated concern for each substance, including those that have since left the category. The version current as of 22 April 2026 lists 17 peptides as "previously in category 2" and "withdrawn by the nominators". It gives no individual withdrawal dates.

FDA's stated concern, peptide by peptide

The quotations below are FDA's words from that page. "Immunogenicity" means the risk that the body mounts an immune response against the peptide or its impurities, which FDA raised for almost every injectable peptide.

Still in Category 2

FDA's 503A category list, updated 14 May 2026, has six entries in Category 2: cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, and quinacrine for intrauterine use. Kisspeptin-10, placed on 29 September 2023 for "limited safety information for proposed routes", is the only peptide among them. For 503B outsourcing facilities, GHRP-2 (injectable and nasal), GHRP-6, ipamorelin acetate and ibutamoren remain in Category 2.

How the withdrawals happened

There were two waves. In late September 2024 FDA updated its lists after several nominators withdrew. It then put some of the withdrawn substances before the committee anyway. The December 2024 briefing document notes, for CJC-1295, AOD-9604 and thymosin alpha-1, that each nomination "was withdrawn by the nominator. However, FDA is electing to proceed". The committee voted against all of them.

The second wave came on 15 April 2026. FDA announced it would take 12 peptides out of Category 2 within seven days because their nominators had withdrawn, and set committee dates for them. The FDA page shows the change as of 22 April 2026. The same update briefly removed GHK-Cu from Category 1 as well, until one nominator clarified on 5 May 2026 that it had meant to withdraw only the injectable route.

What leaving Category 2 means

It does not place a substance on the 503A list, and it does not move it to Category 1. Orrick, advising pharmacies the day after the announcement, called the 12 peptides' position a "regulatory gray area" and said pharmacies should not begin compounding them on the strength of the removal alone. Holland and Knight wrote in August 2026, after the committee vote, that the recommended peptides "still cannot be lawfully compounded" until FDA acts. Our July vote explainer covers what that means in practice.

The case for and against

FDA's reviewers, in their July 2026 briefing documents, recommended against listing every one of the seven peptides they evaluated, citing characterization, missing human safety data and lack of evidence of effectiveness. Supporters of wider access, including Rep. Diana Harshbarger in a November 2025 letter, argued that restrictions drive patients to "unregulated gray-market sources" and that a regulated pharmacy supply is safer. Both arguments are set out with their sources on the committee page. Individual compound pages, such as BPC-157, TB-500 and kisspeptin-10, cover the research itself.

Rules change faster than most people's records. If you are on a prescribed peptide, the dose log keeps each dose with the product, the pharmacy and the concentration, and bloodwork sits on the same timeline, so a change of product or source is easier to plan with your prescriber. The peptide library grades how much research exists behind each compound, and that grading does not move when a committee votes. The app is on iOS and Android.