{"name":"Peptide Compounding Status Table","description":"The current FDA compounding status of the thirteen peptides and GLP-1 drugs on the FormBlends calculator, with the FDA source and its date for each.","snapshotId":"2026-09-04","updatedAt":"2026-09-04","cadence":"Weekly, and same day after any FDA list or PCAC change","license":"CC BY 4.0","methodology":["Status is read from FDA's 503A category list (PDF dated 05/14/2026), the Category 2 and withdrawn-nominations page (current 04/22/2026), the PCAC meeting pages, and FDA's GLP-1 concerns page (current 09/01/2026).","Removal from Category 2 means FDA no longer lists the substance as a significant safety risk. It does not add the substance to the 503A bulks list; that requires rulemaking. Rows say which is which.","Components of approved drugs (semaglutide, tirzepatide, tesamorelin, bremelanotide) may be compounded only when the result is not essentially a copy of the approved product, and only by licensed pharmacies for patient-specific prescriptions."],"columns":[{"key":"peptide","label":"Peptide","definition":"As named on the FormBlends calculator."},{"key":"compounding_status","label":"Compounding status","definition":"Plain-language status derived from the FDA source."},{"key":"detail","label":"Detail","definition":"What the source says and the dates that matter."},{"key":"fda_source","label":"FDA source","definition":"Document the status is read from."},{"key":"source_date","label":"Source date","definition":"Date printed on the source."},{"key":"calculator_url","label":"Calculator","definition":"Dosing arithmetic page for the peptide."}],"rows":[{"peptide":"Retatrutide","compounding_status":"Not eligible","detail":"FDA states retatrutide and cagrilintide cannot be used in compounding under federal law; investigational, not a component of any approved drug. Cited in warning letters on 09/09/2025, 03/31/2026 and 08/24/2026.","fda_source":"FDA GLP-1 concerns page","source_date":"2026-09-01","calculator_url":"https://formblends.com/tools/peptide-calculator/retatrutide"},{"peptide":"Semaglutide","compounding_status":"Eligible with limits","detail":"Component of approved drugs, so 503A compounding is allowed only when the product is not essentially a copy. Shortage resolved 02/21/2025; 503A enforcement deadline 04/22/2025. Salt forms (sodium, acetate) are not acceptable. FDA proposed excluding it from the 503B bulks list on 04/30/2026.","fda_source":"FDA declaratory order; GLP-1 concerns page; Federal Register 2026-08552","source_date":"2026-09-01","calculator_url":"https://formblends.com/tools/peptide-calculator/semaglutide"},{"peptide":"Tirzepatide","compounding_status":"Eligible with limits","detail":"Same essentially-a-copy constraint as semaglutide. Shortage resolved 12/19/2024. Fifth Circuit affirmed FDA's resolution determination on 08/27/2026. 503B exclusion proposed 04/30/2026.","fda_source":"FDA declaratory order; Fifth Circuit No. 25-10600","source_date":"2026-08-27","calculator_url":"https://formblends.com/tools/peptide-calculator/tirzepatide"},{"peptide":"BPC-157","compounding_status":"Not lawfully compoundable yet","detail":"Removed from Category 2 when its nomination was withdrawn (effective about 04/22/2026). PCAC voted 8-6-1 on 07/23/2026 to recommend adding it to the 503A bulks list. No rule has been issued, so it is not on the 503A list.","fda_source":"FDA Category 2 page; PCAC July 2026 page","source_date":"2026-07-23","calculator_url":"https://formblends.com/tools/peptide-calculator/bpc-157"},{"peptide":"TB-500","compounding_status":"Not lawfully compoundable yet","detail":"Same path as BPC-157: withdrawn from Category 2 in April 2026; PCAC recommended 8-6-1 on 07/23/2026; no rule yet.","fda_source":"FDA Category 2 page; PCAC July 2026 page","source_date":"2026-07-23","calculator_url":"https://formblends.com/tools/peptide-calculator/tb-500"},{"peptide":"MOTS-c","compounding_status":"Not lawfully compoundable yet","detail":"Withdrawn from Category 2 in April 2026; PCAC recommended 7-5-2 on 07/23/2026; no rule yet.","fda_source":"FDA Category 2 page; PCAC July 2026 page","source_date":"2026-07-23","calculator_url":"https://formblends.com/tools/peptide-calculator/mots-c"},{"peptide":"GHK-Cu","compounding_status":"Split by route","detail":"Non-injectable routes are in 503A Category 1 as of the 05/14/2026 list. Injectable GHK-Cu left Category 2 by withdrawal and is scheduled for the PCAC meeting before the end of February 2027.","fda_source":"FDA 503A category PDF","source_date":"2026-05-14","calculator_url":"https://formblends.com/tools/peptide-calculator/ghk-cu"},{"peptide":"CJC-1295","compounding_status":"Category 2 (safety risk)","detail":"Still listed on the Category 2 safety-risk table for immunogenicity concerns; not among the twelve peptides withdrawn in April 2026; not in Category 1.","fda_source":"FDA Category 2 page","source_date":"2026-04-22","calculator_url":"https://formblends.com/tools/peptide-calculator/cjc-1295-ipamorelin"},{"peptide":"Ipamorelin","compounding_status":"Category 2 (safety risk)","detail":"Ipamorelin acetate is 503B Category 2 (added 09/29/2023) and appears on the 503A risk table. It was not among the twelve withdrawn peptides, contrary to some industry trackers.","fda_source":"FDA Category 2 page","source_date":"2026-04-22","calculator_url":"https://formblends.com/tools/peptide-calculator/cjc-1295-ipamorelin"},{"peptide":"Sermorelin","compounding_status":"No current FDA listing found","detail":"Absent from every category list in the 05/14/2026 PDF. Industry use relies on the approval history of Geref (NDA 020443, discontinued for commercial reasons). No 2025-2026 FDA statement located.","fda_source":"FDA 503A category PDF (absence)","source_date":"2026-05-14","calculator_url":"https://formblends.com/tools/peptide-calculator/sermorelin"},{"peptide":"Tesamorelin","compounding_status":"Component of an approved drug","detail":"Component of Egrifta; compounding must avoid essentially-a-copy products. Named as an unapproved-drug product in the 08/24/2026 Peptide Partners warning letter (research-vendor context).","fda_source":"FDA warning letter 735063","source_date":"2026-08-24","calculator_url":"https://formblends.com/tools/peptide-calculator/tesamorelin"},{"peptide":"PT-141 (bremelanotide)","compounding_status":"Component of an approved drug","detail":"Component of Vyleesi; same essentially-a-copy constraint; cited in the 08/24/2026 Peptide Partners letter.","fda_source":"FDA warning letter 735063","source_date":"2026-08-24","calculator_url":"https://formblends.com/tools/peptide-calculator/pt-141"},{"peptide":"NAD+","compounding_status":"Category 1 (under evaluation)","detail":"Nicotinamide adenine dinucleotide and NADH are in 503A Category 1: nominated with adequate support, under FDA evaluation, with enforcement discretion while pending.","fda_source":"FDA 503A category PDF","source_date":"2026-05-14","calculator_url":"https://formblends.com/tools/peptide-calculator/nad-plus"}],"sources":[{"id":"fda-glp1-concerns-2026-09","title":"FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 09/01/2026)","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","accessedAt":"2026-09-04","sourceType":"regulatory"},{"id":"fda-503a-category-pdf-2026-05","title":"503A bulk drug substances category list (updated May 14, 2026)","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/media/94155/download","accessedAt":"2026-09-04","sourceType":"regulatory"},{"id":"fda-category2-page-2026-04","title":"Certain bulk drug substances for use in compounding that may present significant safety risks (content current as of 04/22/2026)","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","accessedAt":"2026-09-04","sourceType":"regulatory"},{"id":"fda-pcac-2026-07","title":"July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting","publisher":"U.S. Food and Drug Administration","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","accessedAt":"2026-09-04","sourceType":"regulatory"},{"id":"ca5-25-10600","title":"Fifth Circuit opinion, No. 25-10600 (tirzepatide shortage case), affirmed August 27, 2026","publisher":"U.S. Court of Appeals for the Fifth Circuit","url":"https://www.ca5.uscourts.gov/opinions/unpub/25/25-10600.0.pdf","accessedAt":"2026-09-04","sourceType":"primary"}],"findings":[{"id":"finding-1","text":"Of the thirteen substances, one is explicitly not eligible for compounding (retatrutide), two are eligible only when not essentially a copy of an approved drug (semaglutide, tirzepatide), three left Category 2 but have no rule yet (BPC-157, TB-500, MOTS-c), two remain in Category 2 (CJC-1295, ipamorelin acetate), and one is Category 1 under evaluation (NAD+).","url":"https://formblends.com/report/data/peptide-compounding-status#finding-1"},{"id":"finding-2","text":"GHK-Cu is split by route: non-injectable forms are Category 1, injectable forms await a PCAC meeting due before the end of February 2027.","url":"https://formblends.com/report/data/peptide-compounding-status#finding-2"},{"id":"finding-3","text":"Sermorelin appears on no FDA category list; its use rests on the approval history of a discontinued product, Geref.","url":"https://formblends.com/report/data/peptide-compounding-status#finding-3"}],"caveats":["Status can change with a single FDA posting; check the source date on each row.","This table describes FDA's compounding framework, not state law, which can be stricter."],"attribution":"FormBlends Research, Peptide Compounding Status Table, snapshot 2026-09-04"}