# Most peptides leave FDA's Category 2 list

> FDA's Category 2 list now names only kisspeptin-10 and ibutamoren from this site. BPC-157, TB-500 and others left after nominators withdrew.

- Canonical URL: https://livingpluspeptides.com/news/fda-category-2-peptides-withdrawn-2026/
- Last updated: October 26, 2026
- Publisher: Living+

Published October 26, 2026.

FDA's Category 2 list is much shorter in 2026. Category 2 is where FDA puts nominated compounding ingredients that raise significant safety risks. On FDA's 503A list updated May 14, 2026, it names six substances: cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, and quinacrine hydrochloride for intrauterine use [1]. The only entries covered on this site are [kisspeptin](/peptides/kisspeptin/) and ibutamoren ([MK-677](/peptides/mk-677/)) [1].

## Who left, and why

FDA's safety risks page, current as of April 22, 2026, lists 17 substances that were previously in Category 2 and whose nominations were withdrawn by the nominators [2]. They include [BPC-157](/peptides/bpc-157/), [TB-500](/peptides/tb-500-thymosin-beta-4/), [KPV](/peptides/kpv/), [MOTS-c](/peptides/mots-c/), [Semax](/peptides/semax/), [Epitalon](/peptides/epitalon/), [LL-37](/peptides/ll-37/), [Melanotan II](/peptides/melanotan-ii/), [selank](/peptides/selank/), [thymosin alpha-1](/peptides/thymosin-alpha-1/), [CJC-1295](/peptides/cjc-1295/), [ipamorelin](/peptides/ipamorelin/), [AOD-9604](/peptides/aod-9604/), emideltide (DSIP) and GHK-Cu for injectable routes [2]. The page still describes the safety risks FDA found for these substances [2].

## What withdrawal does not change

Leaving Category 2 is not the same as being cleared for compounding. Under section 503A, a pharmacy may compound with a bulk ingredient only if it has a USP or NF monograph, is a component of an FDA-approved drug, or appears on the 503A Bulks List that FDA sets by regulation [3]. None of the withdrawn peptides is in Category 1, the group FDA lets pharmacies use while it reviews them, on the May 14, 2026 list [1].

## GHK-Cu's round trip

GHK-Cu for non-injectable routes was removed from Category 1 on April 22, 2026, because its nominators withdrew [1]. On May 5, 2026, one nominator clarified that it meant to withdraw only the injectable route [1]. FDA says [GHK-Cu](/peptides/ghk-cu/) for non-injectable routes will be added back to Category 1, and that it intends to consult its Pharmacy Compounding Advisory Committee before the end of February 2027 [1].

## What came next

FDA chose to review seven of the withdrawn peptides itself. It scheduled its advisory committee for July 23 and 24, 2026, to discuss BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax and Epitalon for the 503A Bulks List [4]. We cover that meeting in [FDA advisers review seven peptides for compounding](/news/pcac-july-2026-peptides/) [4]. The current status of every peptide is on the [Status Tracker](/regulation/tracker/) [1].

## Sources

1. [FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (updated May 14, 2026)](https://www.fda.gov/media/94155/download)
2. [FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
3. [FDA: Briefing Document Introduction, Pharmacy Compounding Advisory Committee, July 23-24, 2026](https://www.fda.gov/media/193342/download)
4. [Federal Register: Pharmacy Compounding Advisory Committee; Notice of Meeting (April 16, 2026)](https://www.federalregister.gov/d/2026-07361)

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