Last updated September 23, 2026 · Reviewed by Jason D. Wright, D.O.
Peptide regulation is changing quickly, and patients often find conflicting information online. This page tracks the current U.S. regulatory status of the peptides we are most often asked about, based on FDA announcements and advisory committee records. It is updated as the status of each peptide changes.
Some peptides are FDA-approved drugs. Others are prepared by licensed compounding pharmacies for individual patients with a prescription. Your physician will review which options fit your health, goals, and history.
How to read the status column
- FDA-approved: a finished drug approved by the FDA for a specific condition.
- Available through compounding pharmacies: prepared by a licensed pharmacy for an individual patient with a prescription.
- Recommended by FDA advisory committee: the FDA’s Pharmacy Compounding Advisory Committee voted in favor of adding it to the compounding list; the FDA’s final rule is the next step.
- Scheduled for FDA review: on the agenda for an upcoming advisory committee meeting.
- Not currently on FDA compounding lists: not currently listed, with no FDA review announced.
| Peptide | Current status | Latest action | Next step |
|---|---|---|---|
| FDA-approved | |||
| Semaglutide | FDA-approved (Ozempic, Wegovy) | Brand products widely available. Compounded versions prescribed based on individual medical need. FDA proposal on outsourcing-facility compounding pending; comment period closed July 30, 2026. | FDA final decision on proposal |
| Tirzepatide | FDA-approved (Mounjaro, Zepbound) | Brand products widely available. Compounded versions prescribed based on individual medical need. Included in the same pending FDA proposal. | FDA final decision on proposal |
| Tesamorelin | FDA-approved (Egrifta) | Approved for reduction of abdominal fat in HIV-associated lipodystrophy. | None scheduled |
| Bremelanotide (PT-141) | FDA-approved (Vyleesi) | Approved for hypoactive sexual desire disorder in premenopausal women. | None scheduled |
| Oxytocin | FDA-approved (Pitocin) | Approved as an IV injection for labor. Nasal spray and troches prepared by compounding pharmacies. | None scheduled |
| Methylene blue | FDA-approved (ProvayBlue) | Approved as an IV injection for methemoglobinemia. Oral capsules prepared by compounding pharmacies. | None scheduled |
| Clomiphene | FDA-approved (Clomid) | Approved for ovulation induction; used off-label in men to raise testosterone. | None scheduled |
| Available through compounding pharmacies | |||
| Sermorelin | Available by prescription through compounding pharmacies | Previously marketed as an FDA-approved brand (Geref). | None scheduled |
| Glutathione | Available by prescription through compounding pharmacies | Established pharmaceutical ingredient. | None scheduled |
| NAD+ | Available by prescription through compounding pharmacies | Widely prescribed through compounding pharmacies. | None scheduled |
| Recommended by FDA advisory committee | |||
| BPC-157 | Recommended for compounding list | Removed from FDA restricted category April 2026. Advisory committee voted in favor, July 23, 2026. | FDA final rule |
| TB-500 | Recommended for compounding list | Removed from FDA restricted category April 2026. Advisory committee voted in favor, July 23, 2026. | FDA final rule |
| KPV | Recommended for compounding list | Removed from FDA restricted category April 2026. Advisory committee voted in favor, July 23, 2026. | FDA final rule |
| MOTS-c | Recommended for compounding list | Removed from FDA restricted category April 2026. Advisory committee voted in favor, July 23, 2026. | FDA final rule |
| Semax | Recommended for compounding list | Removed from FDA restricted category April 2026. Advisory committee voted in favor, July 24, 2026. | FDA final rule |
| Epitalon | Recommended for compounding list | Removed from FDA restricted category April 2026. Advisory committee voted in favor, July 24, 2026. | FDA final rule |
| Scheduled for FDA review | |||
| GHK-Cu | Scheduled for advisory committee review | Removed from FDA restricted category April 2026. | Review before end of February 2027 |
| LL-37 | Scheduled for advisory committee review | Removed from FDA restricted category April 2026. | Review before end of February 2027 |
| Melanotan II | Scheduled for advisory committee review | Removed from FDA restricted category April 2026. | Review before end of February 2027 |
| Ibutamoren (MK-677) | Not currently listed | FDA’s 2024 review analysis recommended against adding it to the compounding list. | FDA action pending |
| ARA-290 (cibinetide) | Not currently listed; no review scheduled | Investigational; studied in small human trials for nerve pain. | None announced |
| Not currently on FDA compounding lists | |||
| CJC-1295 | Not currently listed; no review scheduled | Removed from FDA restricted category 2024. | None announced |
| Ipamorelin | Not currently listed; no review scheduled | Removed from FDA restricted category 2024. | None announced |
| AOD-9604 | Not currently listed; no review scheduled | Removed from FDA restricted category 2024. | None announced |
| Selank | Not currently listed; no review scheduled | Removed from FDA restricted category 2024. | None announced |
| Thymosin alpha-1 | Not currently listed; no review scheduled | Removed from FDA restricted category 2024. Approved as a medication in several countries outside the U.S. | None announced |
| SS-31 (elamipretide) | Not currently listed; no review scheduled | FDA-approved brand (Forzinity) available for Barth syndrome. | None announced |
| Melanotan I (afamelanotide) | Not currently listed; no review scheduled | FDA-approved implant (Scenesse) available for erythropoietic protoporphyria. | None announced |
| GHRP-2, GHRP-6, hexarelin, IGF-1 LR3, kisspeptin, 5-Amino-1MQ | Not currently listed; no review scheduled | No recent FDA action. | None announced |
| Not available through compounding | |||
| Emideltide (DSIP) | Not recommended by advisory committee | Advisory committee voted against, July 24, 2026. | FDA final action |
| Enclomiphene | Not recommended by advisory committee | Advisory committee voted against adding it to the compounding list, June 2022. Never FDA-approved. | FDA final action |
| Retatrutide | Investigational | In clinical trials; not eligible for compounding. | Manufacturer FDA application |
| Cagrilintide | Investigational | In clinical trials; not eligible for compounding. | Manufacturer FDA application |
| hCG | FDA-approved brands only | Regulated as a biologic since 2020, so it cannot be compounded. Available as FDA-approved brand products (such as Pregnyl) by prescription. | None scheduled |
This page is for education only and is not medical advice. Regulatory status can change; talk with your physician before starting any treatment. Compounded medications are not FDA-approved.