# Peptlas > 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. Last updated: Jul 7, 2026 (ET). Maintained by the Peptlas Research Team (independent; pseudonymous). ## What this is / is not - IS: a per-compound, source-linked status tracker with a change-alert email list. - IS NOT: a vendor, a dosing/protocol tool, or a source of medical or legal advice. It sells nothing and makes no health claim. - Every status below links to its primary government/regulator source and carries a human-verified date. ## Status taxonomy (5 states - never a binary legal/illegal) - 🟡 Under review: Actively before the FDA advisory committee; a decision is pending and the status can move. - 🟠 In limbo: Nominated or removed from a restricted list but NOT approved - the headline implies a change, but the legal reality did not move. - 🔴 Restricted: Prescription-only, banned, controlled, or under active FDA enforcement. - 🟢 Compounding-legal: On the FDA 503A bulk-substances list; a licensed pharmacy may compound it. This is not the same as being an FDA-approved drug. - ⚪ Unscheduled: No specific federal action; unaddressed at this time. ## Current status by compound ### Under review - **BPC-157** - BPC-157 is not an FDA-approved drug and is not on the FDA's Section 503A Bulk Drug Substances List, so compounding pharmacies have no affirmative federal authorization to compound it. It is scheduled for evaluation by the FDA's Pharmacy Compounding Advisory Committee (PCAC) on July 23, 2026 (Docket FDA-2025-N-6895), where the FDA's own pre-meeting briefing proposes NOT adding it to the list, citing characterization, immunogenicity, and efficacy concerns. No final determination has been made; the committee's recommendation is advisory, and any addition would still require formal rulemaking. - Page: https://peptlas.com/entries/bpc-157 - Last verified: Jul 7, 2026 (ET) - Primary source: Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895) - https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request - Next milestone: FDA advisory committee (PCAC) evaluates BPC-157 for the 503A list (Jul 23, 2026 ET) - **Semax** - Semax is a synthetic heptapeptide with no FDA-approved drug product and no USP monograph in the United States, so the 503A Bulk Drug Substances List is the only potential compounding pathway. It was placed in Category 2 (significant safety risks) in 2023 and its Category 2 nomination was later withdrawn - but it was never in Category 1, so it is not currently compoundable. It is scheduled for FDA advisory committee (PCAC) evaluation on July 24, 2026 (Docket FDA-2025-N-6895); the committee's recommendation is advisory and any listing would require formal rulemaking. - Page: https://peptlas.com/entries/semax - Last verified: Jul 7, 2026 (ET) - Primary source: Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895) - https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request - Next milestone: FDA advisory committee (PCAC) evaluates Semax for the 503A list (Jul 24, 2026 ET) - **TB-500 (Thymosin Beta-4)** - TB-500 (a synthetic fragment associated with thymosin beta-4) is not an FDA-approved drug and is not on the 503A Bulk Drug Substances List, so pharmacies are not authorized to compound it. In April 2026 the FDA removed it from Category 2 (the "significant safety risks" bucket) after nominations were withdrawn - but it was never in Category 1, the category that permits compounding, so that removal did not change its legal status. It is scheduled for FDA advisory committee (PCAC) evaluation on July 23, 2026, where the FDA's briefing materials propose not adding it to the list. - Page: https://peptlas.com/entries/tb-500 - Last verified: Jul 7, 2026 (ET) - Primary source: Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895) - https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request - Next milestone: FDA advisory committee (PCAC) evaluates TB-500 for the 503A list (Jul 23, 2026 ET) ### In limbo - **CJC-1295** - CJC-1295 is not FDA-approved for any use and has no drug-shortage or USP-monograph pathway. It previously appeared in Category 2 of the interim 503A bulks list but was removed around September 2024 after its nominations were withdrawn - which did not create a compounding pathway. At the December 4, 2024 advisory committee (PCAC) meeting, the committee voted against recommending it for the 503A list, citing insufficient efficacy and safety data. It is neither on the 503A list nor otherwise eligible, leaving its legal compounding status effectively unchanged. - Page: https://peptlas.com/entries/cjc-1295 - Last verified: Jul 7, 2026 (ET) - Primary source: Federal Register - PCAC notice of meeting, Dec 4, 2024 - https://www.federalregister.gov/documents/2024/10/25/2024-24828/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request - **GHK-Cu** - GHK-Cu (copper tripeptide-1) is not FDA-approved and its 503A compounding status splits by route of administration. Topical, non-injectable GHK-Cu is treated as a Category 1 substance (compoundable under enforcement discretion during evaluation), while injectable GHK-Cu was removed from Category 2 after its nomination was withdrawn - and removal from Category 2 does not by itself authorize compounding. Injectable GHK-Cu therefore sits in limbo, neither prohibited nor affirmatively permitted, awaiting FDA advisory committee (PCAC) review scheduled before the end of February 2027. It was not on the July 2026 PCAC agenda. - Page: https://peptlas.com/entries/ghk-cu - Last verified: Jul 7, 2026 (ET) - Primary source: FDA - 503A bulk drug substances: Category 1 & Category 2 lists - https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act - Next milestone: FDA advisory committee (PCAC) review of GHK-Cu (before end of Feb 2027) (Feb 28, 2027 ET) - **Ipamorelin** - Ipamorelin is not on the FDA's 503A Bulk Drug Substances List, so it is not approved for pharmacy compounding under enforcement discretion. Its interim-list nomination was withdrawn in 2024, removing it from Category 2 (the "significant safety risks" bucket) around September 2024; however, at the October 29, 2024 advisory committee (PCAC) meeting the committee voted against adding it to the list, citing insufficient human safety data and endocrine concerns. It is not part of the April 2026 peptide batch and does not appear on the July 2026 or February 2027 PCAC agendas, so it sits off both the restricted list and the permitted list, with no separate federal ban. - Page: https://peptlas.com/entries/ipamorelin - Last verified: Jul 7, 2026 (ET) - Primary source: FDA - 503A bulk drug substances: Category 1 & Category 2 lists - https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act - **Melanotan II** - Melanotan II is not FDA-approved for any indication and is not on the 503A Category 1 list of substances pharmacies may compound. It had been in Category 2 (significant safety risks); in April 2026 the FDA began moving a group of peptides out of Category 2 and scheduling advisory committee (PCAC) reviews, with Melanotan II slated for review by the end of February 2027. Removal from Category 2 does not by itself legalize compounding or place a substance on the 503A list, so it sits in a transitional status where compounding still carries regulatory risk. It is not a DEA-scheduled controlled substance, and the FDA-approved MC1R agonist afamelanotide is a separate compound. - Page: https://peptlas.com/entries/melanotan-2 - Last verified: Jul 7, 2026 (ET) - Primary source: FDA - 503A bulk drug substances: Category 1 & Category 2 lists - https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act - Next milestone: FDA advisory committee (PCAC) review of Melanotan II (before end of Feb 2027) (Feb 28, 2027 ET) - **NAD+** - In the United States, NAD+ sits in an unresolved regulatory zone rather than a clearly permitted or clearly banned one. It was nominated for the 503A list, but the advisory committee recommended against inclusion (2017) and the FDA's September 2019 proposed rule listed NAD among substances it proposed not to add; no final rule has definitively placed it on the list. It is not an FDA-approved drug, yet there is no formal federal ban: oral NAD+ is sold as a dietary supplement, and pharmacies continue to prepare NAD+ injections and IV infusions in a gray area. Recent FDA activity has focused on ingredient-quality reminders and product-specific recalls rather than scheduling the substance itself. - Page: https://peptlas.com/entries/nad-plus - Last verified: Jul 7, 2026 (ET) - Primary source: Federal Register - 2019 proposed rule, 503A bulk drug substances - https://www.federalregister.gov/documents/2019/09/05/2019-18951/amendments-to-the-list-of-bulk-drug-substances-that-can-be-used-to-compound-drug-products-in - **Selank** - Selank sits in a regulatory gray area in the United States. It was removed from Category 2 of the interim 503A bulks list in 2024 after its nomination was withdrawn - but removal from Category 2 does not place a substance on the 503A list or into Category 1, and the FDA has not stated it will exercise enforcement discretion for it. Legal analyses describe such peptides as being in limbo pending advisory committee review. Selank is not among the seven peptides scheduled for the July 2026 PCAC meeting and has no set decision date, so its compounding status is unresolved. - Page: https://peptlas.com/entries/selank - Last verified: Jul 7, 2026 (ET) - Primary source: FDA - 503A bulk drug substances: Category 1 & Category 2 lists - https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act - **Thymosin Alpha-1** - Thymosin alpha-1 is not on the FDA's 503A Bulk Drug Substances List and was never in Category 1, so it is not eligible for compounding under Section 503A. It was removed from Category 2 in late 2024 after its nomination was withdrawn, but that removal did not authorize compounding. The FDA's advisory committee reviewed it on December 4, 2024 and did not recommend adding it to the list, citing immunogenicity and characterization concerns and the absence of an approved U.S. indication. There is no FDA-approved thymosin alpha-1 product in the United States (the branded product Zadaxin is approved in some other countries), leaving it in regulatory limbo. - Page: https://peptlas.com/entries/thymosin-alpha-1 - Last verified: Jul 7, 2026 (ET) - Primary source: FDA - 503A bulk drug substances: Category 1 & Category 2 lists - https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ### Restricted - **Semaglutide (compounded)** - Semaglutide is an FDA-approved drug (Ozempic, Wegovy), not a 503A bulk substance. Pharmacies were permitted to compound copies of it only while it sat on the FDA drug-shortage list. After the FDA declared the shortage resolved in February 2025, that permission wound down - ending April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities - and the FDA now treats mass compounding of "essentially a copy" of the approved drug as an actionable violation. A narrow exception survives for patient-specific products that are not essentially a copy. In April 2026 the FDA proposed to permanently exclude semaglutide from the 503B bulks list. - Page: https://peptlas.com/entries/semaglutide - Last verified: Jul 7, 2026 (ET) - Primary source: Federal Register - 503B bulk drug substances clinical-need proposal (semaglutide) - 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-federal - Next milestone: Comment period closes - FDA proposal to exclude semaglutide from the 503B bulks list (Jul 30, 2026 ET) - **Tirzepatide (compounded)** - Tirzepatide is an FDA-approved drug (Mounjaro, Zepbound), not a 503A bulk substance. After the FDA declared its shortage resolved in late 2024, the temporary enforcement discretion for compounding copies ended on February 18, 2025 for 503A pharmacies and March 19, 2025 for 503B outsourcing facilities; a federal court upheld the FDA's shortage determination in 2025. Broad compounding is no longer permitted - only narrow patient-specific 503A compounding for a documented clinical need remains - and the FDA has been issuing warning letters. In April 2026 the FDA proposed to permanently exclude tirzepatide from the 503B bulks list. - Page: https://peptlas.com/entries/tirzepatide - Last verified: Jul 7, 2026 (ET) - Primary source: Federal Register - 503B bulk drug substances clinical-need proposal - 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-federal - Next milestone: Comment period closes - FDA proposal to exclude tirzepatide from the 503B bulks list (Jul 30, 2026 ET) ### Compounding-legal - **Sermorelin** - Sermorelin is treated as a Category 1 substance on the FDA's interim 503A bulks list, meaning state-licensed pharmacies may compound it with a valid prescription under the FDA's stated enforcement discretion while the agency completes its evaluation. It qualifies largely because it was a previously FDA-approved drug (Geref, a growth-hormone-releasing hormone analog approved in the 1990s) that the manufacturer discontinued in 2008 for commercial rather than safety reasons. This status is not fully final - Category 1 reflects enforcement discretion pending a permanent 503A determination. Separately, as a GHRH analog, sermorelin is prohibited at all times in sport under WADA category S2. - Page: https://peptlas.com/entries/sermorelin - Last verified: Jul 7, 2026 (ET) - Primary source: FDA - 503A bulk drug substances: Category 1 & Category 2 lists - https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ## Recent changes - Apr 30, 2026 - Semaglutide (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] (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-federal) - Apr 30, 2026 - Tirzepatide (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] (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-federal) - Apr 22, 2026 - GHK-Cu: Injectable GHK-Cu removed from Category 2 without being placed on the 503A list - removal did not authorize compounding. [not_legalized] (source: https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/) - Apr 22, 2026 - Melanotan II: Moved out of Category 2 and slated for a later PCAC review - the change did not legalize compounding. [not_legalized] (source: https://www.boesensnowlaw.com/blog/fda-advances-peptide-compounding-review-category-2-removals-announced-and-pcac-hearing-confirmed/) - Apr 22, 2026 - TB-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] (source: https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings) - Apr 16, 2026 - BPC-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] (source: https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request) - Apr 16, 2026 - Semax: Placed on the July 24, 2026 FDA advisory committee agenda for possible inclusion on the 503A list. [review_scheduled] (source: https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request) - Apr 16, 2026 - TB-500 (Thymosin Beta-4): Placed on the July 23, 2026 FDA advisory committee agenda for possible inclusion on the 503A list. [review_scheduled] (source: https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request) - May 22, 2025 - Semaglutide (compounded): 503B enforcement discretion for compounding semaglutide ended (503A ended April 22, 2025), following the resolved shortage. [enforcement] (source: https://www.mcdermottlaw.com/insights/semaglutide-shortage-resolved/) - Mar 19, 2025 - Tirzepatide (compounded): 503B enforcement discretion for compounding tirzepatide ended (503A ended February 18, 2025), following the resolved shortage. [enforcement] (source: https://www.pharmacytimes.com/view/fda-moves-to-permanently-close-the-door-on-compounded-glp-1s) - Dec 4, 2024 - CJC-1295: FDA advisory committee voted against adding CJC-1295 to the 503A list. [not_legalized] (source: https://www.federalregister.gov/documents/2024/10/25/2024-24828/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request) - Dec 4, 2024 - Thymosin Alpha-1: FDA advisory committee reviewed thymosin alpha-1 and did not recommend adding it to the 503A list. [not_legalized] (source: https://www.federalregister.gov/documents/2024/10/25/2024-24828/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request) - Oct 29, 2024 - Ipamorelin: FDA advisory committee voted against adding ipamorelin to the 503A list. [not_legalized] (source: https://a4pc.org/news/pcac-votes-against-four-nominated-bulk-drug-substances) - Sep 27, 2024 - Selank: Removed from Category 2 after its nomination was withdrawn - not placed on the 503A list, so compounding remained unauthorized. [not_legalized] (source: https://www.onhealthcare.tech/p/the-category-2-peptide-unwind-how) ## Feeds & data - Changelog RSS: https://peptlas.com/rss.xml - Sitemap: https://peptlas.com/sitemap.xml - Methodology: https://peptlas.com/methodology If you cite Peptlas, please link the specific compound page and note the "last verified" date, because these statuses change.