A factual reference index of FDA approval and compounding status for GLP-1 drugs and commonly searched peptides, last verified September 3, 2026. Semaglutide, tirzepatide, liraglutide, dulaglutide, exenatide, orforglipron, and tesamorelin are FDA-approved; retatrutide, CagriSema, and cagrilintide are investigational and not legally compoundable. Compounded semaglutide and compounded tirzepatide left the FDA shortage list in February 2025 and December 2024 respectively, narrowing compounding to patient-specific 503A preparation, and an FDA proposal published May 1, 2026 (91 Fed. Reg. 23431) would exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. Sermorelin is the only peptide on the page that remains legally compoundable under 503A and 503B. BPC-157, TB-500, ipamorelin, CJC-1295, AOD-9604, GHK-Cu, and Melanotan II are not FDA-approved and not currently legal to compound. Compounded medications are not FDA-approved and are not therapeutically equivalent to FDA-approved products. Educational reference only, not medical or legal advice.
Approval means the drug passed the FDA's safety and efficacy review. Compounded versions have not, regardless of sharing the same active ingredient.
503A pharmacies compound patient-specific prescriptions; 503B outsourcing facilities compound larger batches under stricter cGMP standards. A drug can be permitted under one, both, or neither.
Compounding leeway expands during an official FDA shortage and contracts when it ends. Two lists get confused here: the FDA drug shortage database, which governs compounding legality, and the ASHP (University of Utah) shortage bulletins, which track real-world supply. Only the FDA list is the legal trigger. For instance, dulaglutide's ASHP bulletin is still open, but it is off the FDA list, so it cannot be legally compounded.
Under the FDA's interim policy, a bulk substance flagged Category 2 is effectively off-limits for compounding. A Category 1 substance may be compounded while the FDA continues to evaluate it. Neither is the same as approval of a finished drug.
Narrowly, yes. Routine \u201cessentially a copy\u201d compounding ended when the FDA declared the semaglutide shortage resolved in February 2025. What remains is patient-specific 503A compounding for a documented individual medical need. A pending FDA proposal would further restrict the 503B outsourcing pathway.
No. Compounded GLP-1s are not FDA-approved and are not therapeutically equivalent to brand-name drugs, even when they contain the same active ingredient. The FDA does not review compounded drugs for safety, effectiveness, or quality before they are sold, which is exactly why the agency has sent hundreds of warning letters to telehealth companies that implied otherwise.
Same picture as semaglutide. Tirzepatide came off the FDA shortage list on December 19, 2024, so routine compounding ended. Patient-specific 503A compounding may still be possible for a documented need, and the 503B route is subject to the pending bulks-list exclusion.
503A pharmacies compound patient-specific prescriptions under state regulation. 503B outsourcing facilities compound larger batches under FDA registration and stricter cGMP manufacturing standards. A drug can be legal to compound under one pathway, both, or neither.
The FDA determined that Novo Nordisk could meet current and projected national demand and issued a declaratory order on February 21, 2025 finding the shortage resolved. Tirzepatide was resolved earlier, on December 19, 2024.
The 503B bulks list identifies which bulk drug substances outsourcing facilities may use in compounding. Facilities generally cannot compound from bulk unless the substance is on this list or the drug is in shortage. The FDA's May 2026 proposal to exclude semaglutide, tirzepatide, and liraglutide from it would remove the last large-scale compounding pathway for the drugs already off the shortage list.
No. BPC-157 is not FDA-approved for any use and is not currently legal to compound. In July 2026 the FDA's advisory committee recommended adding it to the 503A Bulks List, and it was named in a February 2026 HHS announcement for intended reclassification, but no final FDA rule has been published, so it remains illegal to compound as of September 2026.
Not as a currently marketed product. Sermorelin was FDA-approved as Geref/Geref Diagnostic and voluntarily withdrawn in 2008 for commercial reasons, not safety. It has remained legally compoundable under 503A and 503B ever since, because it kept its Category 1 status through the 2023 peptide restrictions, unlike most other peptides sold online.
In February 2026, HHS announced intent to move roughly 14 of the peptides restricted in 2023 back to Category 1, including BPC-157, TB-500, CJC-1295, ipamorelin, AOD-9604, and GHK-Cu. In July 2026 the FDA's advisory committee separately recommended BPC-157, TB-500, KPV, MOTS-c, Semax, and Epitalon for the 503A Bulks List. Melanotan II, GHRP-2, GHRP-6, LL-37, and PEG-MGF are expected to stay restricted. None of these changes is final.