BPC-157, TB-500 and other peptides leave FDA's category 2 list after nominations are withdrawn

FDA keeps a page listing bulk drug substances placed in category 2 under its interim compounding policies, meaning substances where the agency identified potential significant safety risks while reviewing nominations ^[1]. In the version dated 22 April 2026, the page has two tables. The first is category 2 itself. The second is headed "Bulk drug substances nominated but withdrawn", and FDA describes it as substances "previously in category 2" that were withdrawn by the nominators ^[1].

The withdrawn table lists 17 entries: AOD-9604, BPC-157, cathelicidin LL-37, CJC-1295, dihexa acetate, emideltide (DSIP), epitalon, GHK-Cu for injectable routes, ipamorelin acetate, KPV, pegylated mechano growth factor (PEG-MGF), melanotan II, MOTs-C, selank acetate, Semax, thymosin beta-4 fragment (LKKTETQ), which FDA notes is also known as TB-500, and thymosin alpha-1 ^[1]. Among the peptides we track, that covers AOD-9604, GHK-Cu, melanotan II, LL-37 and thymosin alpha-1 as well as the three named above.

What stays in category 2 is shorter. The table lists 14 substances, including kisspeptin-10 (503A), GHRP-2 for injectable and nasal routes (503B), GHRP-6 (503B), ibutamoren mesylate (both) and ipamorelin acetate (503B) ^[1]. Ipamorelin is the one peptide that appears in both tables: FDA notes it is still in category 2 under the 503B interim policy ^[1].

The page does not say FDA has re-examined these substances and found them safe. For each withdrawn peptide it keeps the same safety summary it gave in category 2. For BPC-157, FDA says compounded products may pose a risk of immunogenicity and that it "lacks sufficient information" to know whether the drug would cause harm in humans ^[1]. For CJC-1295 it cites serious adverse events including increased heart rate and a systemic vasodilatory reaction ^[1]. For melanotan II it points to published case reports of melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism ^[1].

The interim policy only protects compounding with category 1 substances. FDA says it does not intend to take action against compounders using category 1 substances if the policy's conditions are met, while category 2 and category 3 substances are outside that policy ^[2]. The withdrawn table is a separate list, not category 1. FDA also says it does not intend to place substances nominated on or after 7 January 2025 into these categories at all ^[2].

The permanent 503A bulks list, in 21 CFR 216.23, still names six substances and no peptides ^[3]. A 503A pharmacy may use a bulk substance only if it has a USP or NF monograph, is a component of an FDA-approved drug, or is on that list ^[2]. None of the withdrawn peptides meets any of those tests on FDA's current pages.

No part of the change makes BPC-157 legal to compound, sell or market for human use in the United States. The wider answer depends on the country and on what is being done with the product, and our US legal status guide sets out the federal position. In short, BPC-157 is not an FDA-approved drug, and it is not on the 503A list ^[3].

The same applies to the other entries. Is GHK-Cu FDA approved? Nothing on FDA's pages indicates that it is. It was nominated for the 503A list, a route meant for substances that have no monograph and are not components of approved drugs ^[2], and it is not on that list ^[3]. Its withdrawn entry covers injectable routes only ^[1]. CJC-1295 FDA approval status and AOD-9604 FDA approval status are unchanged for the same reasons: both went through the nomination route, neither is on the 503A list, and moving to the withdrawn table did not alter that.

Much of the online discussion of BPC 157 FDA status claims that FDA "banned" or "unbanned" it. Neither describes what happened. FDA placed it in category 2 because of safety concerns, and the nominators then withdrew their nominations ^[1].

Withdrawal did not end FDA's review. The briefing document for the July 2026 Pharmacy Compounding Advisory Committee meeting records that the nominations for BPC-157, KPV, TB-500, MOTs-C, emideltide, epitalon and Semax had been withdrawn by the nominators, and that FDA elected to present them to the committee anyway ^[4].

For each of those substances, in both free base and acetate form, FDA's briefing document states that the agency was proposing the substance not be included on the 503A bulks list ^[4]. FDA has not published a final decision since the meeting.

BPC-157 is still not approved by FDA, and FDA's safety summary for it is unchanged. Products sold online as research peptides were never within the compounding system in the first place. If you are comparing sellers, the BPC-157 price comparison shows listings, and our guides on third-party peptide testing and how to spot a fake peptide supplier explain what a certificate of analysis can and cannot show. The overview of legal status by country covers the UK, Canada, Australia and New Zealand, where the rules differ again.