The FDA peptide crackdown: every action from 2023 to today.
Category 2 designations, 503A and 503B compounding cutoffs, warning letters to research-peptide vendors, shortage resolutions, and the 2026 HHS reclassification proposal — dated, cited, updated as rulings land.
Feb 27, 2026 · Reclassification
HHS announces proposed removal of 14 peptides from Category 2
HHS Secretary RFK Jr. announced that 14 of 19 peptides on the FDA's Category 2 list — including BPC-157, GHK-Cu, CJC-1295, ipamorelin, MOTS-c, thymosin alpha-1, and others — would be proposed for removal. Removal does not automatically return a substance to Category 1. Each peptide still requires Pharmacy Compounding Advisory Committee (PCAC) review and a final FDA determination before 503A or 503B pharmacies can legally compound with it. The July 2026 FDA Advisory Committee hearing is the next procedural milestone.
May 22, 2025 · Compounding ruling
503B semaglutide compounding discretion ends
Final cutoff for 503B outsourcing facilities to compound semaglutide. With tirzepatide already off the table, mid-2025 marked the effective end of the compounded GLP-1 era in the United States for most patients.
Mar 19, 2025 · Compounding ruling
503B tirzepatide compounding discretion ends
Final cutoff for 503B outsourcing facilities to compound tirzepatide. After this date, compounded tirzepatide produced by 503B facilities became generally unlawful.
Feb 21, 2025 · Shortage status
FDA declares semaglutide shortage resolved
The FDA declared semaglutide's shortage resolved. 503A compounding discretion ended April 22, 2025; 503B by May 22, 2025. This was the larger of the two GLP-1 shortage resolutions by patient volume — by most estimates several hundred thousand patients had been receiving compounded semaglutide and needed to transition to branded Wegovy/Ozempic or discontinue.
Dec 19, 2024 · Shortage status
FDA declares tirzepatide shortage resolved
The FDA announced that the tirzepatide shortage had been resolved. Under Section 503A, compounding pharmacies lost discretion to compound tirzepatide by February 18, 2025. 503B outsourcing facilities had until March 19, 2025. After these dates, compounded tirzepatide became broadly illegal except in narrow edge cases.
Dec 10, 2024 · Warning letter
FDA issues warning letters to Summit Research Peptides and others
The FDA issued warning letters to Summit Research Peptides, Prime Peptides, Xcel Peptides, and SwissChems for selling semaglutide, tirzepatide, and retatrutide as unapproved drugs. The agency explicitly rejected the vendors' 'research use only' labeling when the totality of the marketing (dosing information on product pages, related sales of bacteriostatic water, therapeutic claims) implied human use.
Sep 7, 2023 · Reclassification
FDA places 19 peptide substances on Category 2 list
The FDA added 19 peptide bulk drug substances to its Category 2 list — substances the agency identified as potentially raising significant safety risks for compounding. The list includes AOD-9604, BPC-157, LL-37, CJC-1295, Dihexa, DSIP, Epitalon, GHK-Cu (injectable), Ibutamoren (MK-677), Ipamorelin, Kisspeptin-10, KPV, Melanotan II, PEG-MGF, MOTS-c, Selank, Semax, Thymosin Alpha-1, and Thymosin Beta-4 fragment. Category 2 placement means these substances may not be compounded under Section 503A or 503B while under review.
What's next
The July 2026 FDA Advisory Committee hearing is the next procedural milestone. The PCAC will weigh in on whether the 14 proposed peptides should be moved off Category 2, which peptides should remain, and what conditions (labeling, testing, prescribing) should apply if they return to Category 1. We're tracking this live at the FDA peptide tracker and will update this timeline within 24 hours of material decisions.