Peptlas — status changelogEvery recorded change in the regulatory status Peptlas tracks. A neutral, independent, source-linked reference tracking the U.S. and international regulatory status of named compounds under FDA process. Every entry is dated and links to its primary source. We sell nothing.https://peptlas.com/enSemaglutide (compounded): FDA proposed to permanently exclude semaglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound it from bulk. This is a proposal in a comment period, not a final change.https://peptlas.com/entries/semaglutidehttps://peptlas.com/entries/semaglutide#semaglutide-2026-04-30Semaglutide (compounded) — FDA proposed to permanently exclude semaglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound it from bulk. This is a proposal in a comment period, not a final change. (review scheduled). Primary source: https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federalThu, 30 Apr 2026 16:00:00 GMTreview_scheduledTirzepatide (compounded): FDA proposed to permanently exclude tirzepatide from the 503B bulks list, alongside semaglutide and liraglutide. This is a proposal in a comment period, not a final change.https://peptlas.com/entries/tirzepatidehttps://peptlas.com/entries/tirzepatide#tirzepatide-2026-04-30Tirzepatide (compounded) — FDA proposed to permanently exclude tirzepatide from the 503B bulks list, alongside semaglutide and liraglutide. This is a proposal in a comment period, not a final change. (review scheduled). Primary source: https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federalThu, 30 Apr 2026 16:00:00 GMTreview_scheduledGHK-Cu: Injectable GHK-Cu removed from Category 2 without being placed on the 503A list — removal did not authorize compounding.https://peptlas.com/entries/ghk-cuhttps://peptlas.com/entries/ghk-cu#ghk-cu-2026-04-22GHK-Cu — Injectable GHK-Cu removed from Category 2 without being placed on the 503A list — removal did not authorize compounding. (not legalized). Primary source: https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/Wed, 22 Apr 2026 16:00:00 GMTnot_legalizedMelanotan II: Moved out of Category 2 and slated for a later PCAC review — the change did not legalize compounding.https://peptlas.com/entries/melanotan-2https://peptlas.com/entries/melanotan-2#melanotan-2-2026-04-22Melanotan II — Moved out of Category 2 and slated for a later PCAC review — the change did not legalize compounding. (not legalized). Primary source: https://www.boesensnowlaw.com/blog/fda-advances-peptide-compounding-review-category-2-removals-announced-and-pcac-hearing-confirmed/Wed, 22 Apr 2026 16:00:00 GMTnot_legalizedTB-500 (Thymosin Beta-4): Removed from FDA Category 2 after nominations were withdrawn — but it was never in Category 1, so it is still not legal to compound.https://peptlas.com/entries/tb-500https://peptlas.com/entries/tb-500#tb-500-2026-04-22TB-500 (Thymosin Beta-4) — Removed from FDA Category 2 after nominations were withdrawn — but it was never in Category 1, so it is still not legal to compound. (not legalized). Primary source: https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-MeetingsWed, 22 Apr 2026 16:00:00 GMTnot_legalizedBPC-157: Placed on the July 23, 2026 FDA advisory committee agenda (Docket FDA-2025-N-6895); FDA's briefing proposes not adding it to the 503A list.https://peptlas.com/entries/bpc-157https://peptlas.com/entries/bpc-157#bpc-157-2026-04-16BPC-157 — Placed on the July 23, 2026 FDA advisory committee agenda (Docket FDA-2025-N-6895); FDA's briefing proposes not adding it to the 503A list. (review scheduled). Primary source: https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-requestThu, 16 Apr 2026 16:00:00 GMTreview_scheduledSemax: Placed on the July 24, 2026 FDA advisory committee agenda for possible inclusion on the 503A list.https://peptlas.com/entries/semaxhttps://peptlas.com/entries/semax#semax-2026-04-16Semax — Placed on the July 24, 2026 FDA advisory committee agenda for possible inclusion on the 503A list. (review scheduled). Primary source: https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-requestThu, 16 Apr 2026 16:00:00 GMTreview_scheduledTB-500 (Thymosin Beta-4): Placed on the July 23, 2026 FDA advisory committee agenda for possible inclusion on the 503A list.https://peptlas.com/entries/tb-500https://peptlas.com/entries/tb-500#tb-500-2026-04-16TB-500 (Thymosin Beta-4) — Placed on the July 23, 2026 FDA advisory committee agenda for possible inclusion on the 503A list. (review scheduled). Primary source: https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-requestThu, 16 Apr 2026 16:00:00 GMTreview_scheduledSemaglutide (compounded): 503B enforcement discretion for compounding semaglutide ended (503A ended April 22, 2025), following the resolved shortage.https://peptlas.com/entries/semaglutidehttps://peptlas.com/entries/semaglutide#semaglutide-2025-05-22Semaglutide (compounded) — 503B enforcement discretion for compounding semaglutide ended (503A ended April 22, 2025), following the resolved shortage. (enforcement). Primary source: https://www.mcdermottlaw.com/insights/semaglutide-shortage-resolved/Thu, 22 May 2025 16:00:00 GMTenforcementTirzepatide (compounded): 503B enforcement discretion for compounding tirzepatide ended (503A ended February 18, 2025), following the resolved shortage.https://peptlas.com/entries/tirzepatidehttps://peptlas.com/entries/tirzepatide#tirzepatide-2025-03-19Tirzepatide (compounded) — 503B enforcement discretion for compounding tirzepatide ended (503A ended February 18, 2025), following the resolved shortage. (enforcement). Primary source: https://www.pharmacytimes.com/view/fda-moves-to-permanently-close-the-door-on-compounded-glp-1sWed, 19 Mar 2025 16:00:00 GMTenforcementCJC-1295: FDA advisory committee voted against adding CJC-1295 to the 503A list.https://peptlas.com/entries/cjc-1295https://peptlas.com/entries/cjc-1295#cjc-1295-2024-12-04CJC-1295 — FDA advisory committee voted against adding CJC-1295 to the 503A list. (not legalized). Primary source: https://www.federalregister.gov/documents/2024/10/25/2024-24828/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-requestWed, 04 Dec 2024 16:00:00 GMTnot_legalizedThymosin Alpha-1: FDA advisory committee reviewed thymosin alpha-1 and did not recommend adding it to the 503A list.https://peptlas.com/entries/thymosin-alpha-1https://peptlas.com/entries/thymosin-alpha-1#thymosin-alpha-1-2024-12-04Thymosin Alpha-1 — FDA advisory committee reviewed thymosin alpha-1 and did not recommend adding it to the 503A list. (not legalized). Primary source: https://www.federalregister.gov/documents/2024/10/25/2024-24828/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-requestWed, 04 Dec 2024 16:00:00 GMTnot_legalizedIpamorelin: FDA advisory committee voted against adding ipamorelin to the 503A list.https://peptlas.com/entries/ipamorelinhttps://peptlas.com/entries/ipamorelin#ipamorelin-2024-10-29Ipamorelin — FDA advisory committee voted against adding ipamorelin to the 503A list. (not legalized). Primary source: https://a4pc.org/news/pcac-votes-against-four-nominated-bulk-drug-substancesTue, 29 Oct 2024 16:00:00 GMTnot_legalizedSelank: Removed from Category 2 after its nomination was withdrawn — not placed on the 503A list, so compounding remained unauthorized.https://peptlas.com/entries/selankhttps://peptlas.com/entries/selank#selank-2024-09-27Selank — Removed from Category 2 after its nomination was withdrawn — not placed on the 503A list, so compounding remained unauthorized. (not legalized). Primary source: https://www.onhealthcare.tech/p/the-category-2-peptide-unwind-howFri, 27 Sep 2024 16:00:00 GMTnot_legalized