Open dataset · Weekly, and same day after any FDA list or PCAC change
Peptide Compounding Status Table
Which peptides are lawfully compoundable, which are eligible only with limits, which sit in Category 2, and which are not eligible at all, as of the dated FDA sources listed.
Key findings from FormBlends Research
FormBlends Research finding 1
#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+).
FormBlends Research finding 2
#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.
FormBlends Research finding 3
#Sermorelin appears on no FDA category list; its use rests on the approval history of a discontinued product, Geref.
The data
| Peptide | Compounding status | Detail | FDA source | Source date | Calculator |
|---|---|---|---|---|---|
| Retatrutide | Not eligible | 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 GLP-1 concerns page | 2026-09-01 | formblends.com/tools/peptide-calculator/retatrutide |
| Semaglutide | Eligible with limits | 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 declaratory order; GLP-1 concerns page; Federal Register 2026-08552 | 2026-09-01 | formblends.com/tools/peptide-calculator/semaglutide |
| Tirzepatide | Eligible with limits | 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 declaratory order; Fifth Circuit No. 25-10600 | 2026-08-27 | formblends.com/tools/peptide-calculator/tirzepatide |
| BPC-157 | Not lawfully compoundable yet | Removed from Category 2 when its nomination was withdrawn (effective about 04/22/2026).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 Category 2 page; PCAC July 2026 page | 2026-07-23 | formblends.com/tools/peptide-calculator/bpc-157 |
| TB-500 | Not lawfully compoundable yet | 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 Category 2 page; PCAC July 2026 page | 2026-07-23 | formblends.com/tools/peptide-calculator/tb-500 |
| MOTS-c | Not lawfully compoundable yet | Withdrawn from Category 2 in April 2026; PCAC recommended 7-5-2 on 07/23/2026; no rule yet. | FDA Category 2 page; PCAC July 2026 page | 2026-07-23 | formblends.com/tools/peptide-calculator/mots-c |
| GHK-Cu | Split by route | 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 503A category PDF | 2026-05-14 | formblends.com/tools/peptide-calculator/ghk-cu |
| CJC-1295 | Category 2 (safety risk) | 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 Category 2 page | 2026-04-22 | formblends.com/tools/peptide-calculator/cjc-1295-ipamorelin |
| Ipamorelin | Category 2 (safety risk) | 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 Category 2 page | 2026-04-22 | formblends.com/tools/peptide-calculator/cjc-1295-ipamorelin |
| Sermorelin | No current FDA listing found | 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 503A category PDF (absence) | 2026-05-14 | formblends.com/tools/peptide-calculator/sermorelin |
| Tesamorelin | Component of an approved drug | 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 warning letter 735063 | 2026-08-24 | formblends.com/tools/peptide-calculator/tesamorelin |
| PT-141 (bremelanotide) | Component of an approved drug | Component of Vyleesi; same essentially-a-copy constraint; cited in the 08/24/2026 Peptide Partners letter. | FDA warning letter 735063 | 2026-08-24 | formblends.com/tools/peptide-calculator/pt-141 |
| NAD+ | Category 1 (under evaluation) | Nicotinamide adenine dinucleotide and NADH are in 503A Category 1: nominated with adequate support, under FDA evaluation, with enforcement discretion while pending. | FDA 503A category PDF | 2026-05-14 | formblends.com/tools/peptide-calculator/nad-plus |
Methodology
- 1. 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).
- 2. 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.
- 3. 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.
Limits
- • 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.
Source ledger
regulatory · accessed 2026-09-04
U.S. Food and Drug Administration
FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 09/01/2026)
regulatory · accessed 2026-09-04
U.S. Food and Drug Administration
503A bulk drug substances category list (updated May 14, 2026)
regulatory · accessed 2026-09-04
U.S. Food and Drug Administration
Certain bulk drug substances for use in compounding that may present significant safety risks (content current as of 04/22/2026)
regulatory · accessed 2026-09-04
U.S. Food and Drug Administration
July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting
primary · accessed 2026-09-04
U.S. Court of Appeals for the Fifth Circuit
Fifth Circuit opinion, No. 25-10600 (tirzepatide shortage case), affirmed August 27, 2026