Most peptides leave FDA's Category 2 list

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 and ibutamoren (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page, current as of April 22, 2026, lists 17 substances that were previously in Category 2 and whose nominations were withdrawn by the nominators ^[2].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, TB-500, KPV, MOTS-c, Semax, Epitalon, LL-37, Melanotan II, selank, thymosin alpha-1, CJC-1295, ipamorelin, 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 None of the withdrawn peptides is in Category 1, the group FDA lets pharmacies use while it reviews them, on the May 14, 2026 list ^[1].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 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FDA chose to review seven of the withdrawn peptides itself.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 ^[4]. The current status of every peptide is on the Status Tracker ^[1].

Peptides in this update

• BPC-157: FDA status, research and uses
• TB-500 and Thymosin Beta-4: FDA status, research and uses
• KPV: FDA status, research and uses
• MOTS-c: FDA status, research and uses
• Semax: FDA status, research and uses
• Epitalon: FDA status, research and uses
• GHK-Cu: FDA status, research and uses
• LL-37: FDA status, research and uses
• Melanotan II: FDA status, research and uses
• Selank: FDA status, research and uses
• Thymosin Alpha-1: FDA status, research and uses
• CJC-1295: FDA status, research and uses
• Ipamorelin: FDA status, research and uses
• AOD-9604: FDA status, research and uses
• Kisspeptin: FDA status, research and uses
• MK-677 (Ibutamoren): FDA status, research and uses

More news

• DEA telemedicine flexibilities run through 2026
• FDA advisers review seven peptides for compounding
• FDA proposes keeping GLP-1s off the 503B bulks list
• FDA warns 30 telehealth firms over compounded GLP-1 ads
• HHS interim policy covers 6 peptides for compounding
• WADA 2027 List names peptides as S0 examples

Status of every peptide

• FDA Peptide Status Tracker

Sources

1. FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (updated May 14, 2026)
2. FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
3. FDA: Briefing Document Introduction, Pharmacy Compounding Advisory Committee, July 23-24, 2026
4. Federal Register: Pharmacy Compounding Advisory Committee; Notice of Meeting (April 16, 2026)

Updated October 26, 2026. Educational information, not medical advice.