Original reference · reviewed July 1, 2026
Peptide Regulatory Status Tracker
Where 24 peptides actually stand with the U.S. FDA — the 503A compounding categories, the 7 substances on the July 23–24, 2026 advisory-committee agenda, and the GLP-1 503B proposal. Every row links to its primary Federal Register or FDA.gov source. Filter it, search it, and download the data.
“Is this peptide FDA-approved? Is it legal to compound?” is one of the hardest questions to answer honestly, because the rules are changing month to month and most of what circulates online is either a retailer’s sales copy or a law firm’s prose. This tracker does one thing: it records the current regulatory status of each peptide from primary U.S. government documents, with the source linked on every row.
The conservative spine matters. Being on the 503A list is not the same as FDA approval. Only 5of the substances below are FDA-approved finished drugs. Most of the “wellness” peptides — BPC-157, CJC-1295, ipamorelin — are on no current 503A list at all; their nominations were withdrawn. And a spot on the July 2026 advisory-committee agenda is a review, not an approval. For the underlying biochemistry, see Is It a Peptide?; for the deeper compounding-law explainer, see FDA peptide compounding status.
The Tracker
Filter by status, search any peptide or brand, and export the full dataset as CSV or JSON (CC BY 4.0 — free to reuse with attribution). Status reflects the FDA 503A category list updated May 14, 2026 and Federal Register notices verified July 1, 2026.
Showing 24 of 24 substances
| Substance | Regulatory status | What that means | Most recent event | Source |
|---|---|---|---|---|
| BPC-157PCAC July 23, 2026 · use evaluated: Ulcerative colitis | Under PCAC review | Not FDA-approved and not currently on the 503A bulks list. Scheduled for FDA advisory-committee review as a bulk substance nominated for inclusion on the 503A list. | On the July 23, 2026 PCAC agenda (Federal Register notice, April 16, 2026). | Fed. Register (FDA-2025-N-6895)FDA.gov |
| Emideltidedelta sleep-inducing peptide (DSIP)PCAC July 24, 2026 · use evaluated: Opioid withdrawal, chronic insomnia, and narcolepsy | Under PCAC review | Not FDA-approved and not currently on the 503A bulks list. Nominated for the 503A list and scheduled for advisory-committee review. | On the July 24, 2026 PCAC agenda (Federal Register notice, April 16, 2026). | Fed. Register (FDA-2025-N-6895) |
| EpitalonepithalonPCAC July 24, 2026 · use evaluated: Insomnia | Under PCAC review | Not FDA-approved and not currently on the 503A bulks list. Nominated for the 503A list and scheduled for advisory-committee review. | On the July 24, 2026 PCAC agenda (Federal Register notice, April 16, 2026). | Fed. Register (FDA-2025-N-6895) |
| KPVPCAC July 23, 2026 · use evaluated: Wound healing and inflammatory conditions | Under PCAC review | Not FDA-approved and not currently on the 503A bulks list. Nominated for the 503A list and scheduled for advisory-committee review. | On the July 23, 2026 PCAC agenda (Federal Register notice, April 16, 2026). | Fed. Register (FDA-2025-N-6895) |
| MOTS-cPCAC July 23, 2026 · use evaluated: Obesity and osteoporosis | Under PCAC review | Not FDA-approved and not currently on the 503A bulks list. Nominated for the 503A list and scheduled for advisory-committee review. | On the July 23, 2026 PCAC agenda (Federal Register notice, April 16, 2026). | Fed. Register (FDA-2025-N-6895) |
| SemaxPCAC July 24, 2026 · use evaluated: Cerebral ischemia, migraine, and trigeminal neuralgia | Under PCAC review | Not FDA-approved and not currently on the 503A bulks list. Nominated for the 503A list and scheduled for advisory-committee review. | On the July 24, 2026 PCAC agenda (Federal Register notice, April 16, 2026). | Fed. Register (FDA-2025-N-6895) |
| TB-500thymosin beta-4 fragmentPCAC July 23, 2026 · use evaluated: Wound healing | Under PCAC review | Not FDA-approved and not currently on the 503A bulks list. Nominated for the 503A list and scheduled for advisory-committee review. | On the July 23, 2026 PCAC agenda (Federal Register notice, April 16, 2026). | Fed. Register (FDA-2025-N-6895) |
| GHK-Cu (topical / non-injectable)copper peptide | 503A Category 1 | Non-injectable GHK-Cu is on Category 1 (under evaluation; may be used in compounding while FDA completes its review). The injectable route is NOT — see the injectable row. | Removed from Category 1 on April 22, 2026 when nominations were withdrawn; after a May 5, 2026 clarification that only the injectable route was withdrawn, the non-injectable form was added back to Category 1. FDA intends to consult the PCAC on GHK-Cu before the end of February 2027. | FDA.gov |
| Vasoactive intestinal peptideVIP | 503A Category 1 | On Category 1 (under evaluation; may be used in compounding while FDA completes its review). Not FDA-approved as a finished drug. | Listed in Category 1 on the FDA 503A category list updated May 14, 2026. | FDA.gov |
| IbutamorenMK-677 (a growth-hormone secretagogue, often marketed alongside peptides) | 503A Category 2 | On Category 2 — FDA identified a significant safety risk, so it should not be used in 503A compounding. Not FDA-approved. (Chemically a small molecule, not a peptide, but frequently sold under the "peptide" umbrella.) | Listed in Category 2 (as ibutamoren mesylate) on the FDA 503A category list updated May 14, 2026. | FDA.gov |
| Kisspeptin-10 | 503A Category 2 | On Category 2 — FDA identified a significant safety risk, so it should not be used in 503A compounding. Not FDA-approved. | Listed in Category 2 on the FDA 503A category list updated May 14, 2026. | FDA.gov |
| CibinetideARA-290 | 503A Category 3 | On Category 3 — nominated without adequate supporting information for FDA to evaluate. Not FDA-approved. | Listed in Category 3 on the FDA 503A category list updated May 14, 2026. | FDA.gov |
| AOD-9604 | Not on the 503A list | Not on any current 503A category list and not FDA-approved. Its nomination for the 503A bulks list was withdrawn. | Not present on the FDA 503A category list updated May 14, 2026. | FDA.gov |
| CJC-1295 | Not on the 503A list | Not on any current 503A category list and not FDA-approved. Its nomination for the 503A bulks list was withdrawn. | Not present on the FDA 503A category list updated May 14, 2026. | FDA.gov |
| GHK-Cu (injectable)copper peptide | Not on the 503A list | The injectable route of GHK-Cu is not on any 503A category list; its nomination was withdrawn and not reinstated. Not FDA-approved. | Injectable-route nomination withdrawn April 22, 2026; not added back (clarified May 5, 2026). | FDA.gov |
| Ipamorelin | Not on the 503A list | Not on any current 503A category list and not FDA-approved. Its nomination for the 503A bulks list was withdrawn. | Not present on the FDA 503A category list updated May 14, 2026. | FDA.gov |
| Selank | Not on the 503A list | Not on any current 503A category list and not FDA-approved. Its nomination for the 503A bulks list was withdrawn. | Not present on the FDA 503A category list updated May 14, 2026. | FDA.gov |
| Sermorelin | Not on the 503A listreported | A sermorelin finished drug (Geref) was historically FDA-approved but the brand is discontinued; sermorelin is not on any current 503A category list. Its compounding eligibility rests on prior-approval history and is not settled here. | Not present on the FDA 503A category list updated May 14, 2026. (Prior Geref approval history reported; the exact discontinuation date is not confirmed here.) | FDA.govFDA.gov |
| Thymosin alpha-1 | Not on the 503A list | Not on any current 503A category list and not FDA-approved in the U.S. (approved in some other countries). Its U.S. nomination for the 503A bulks list was withdrawn. | Not present on the FDA 503A category list updated May 14, 2026. | FDA.gov |
| BremelanotidePT-141, Vyleesi | FDA-approved drugreported | The finished drug Vyleesi is FDA-approved. Compounded "PT-141" is not the approved product and is not FDA-approved. | Vyleesi FDA-approved finished drug (approval reported 2019). | FDA.gov |
| LiraglutideVictoza, Saxenda | FDA-approved drug | FDA-approved as branded finished drugs. Separately, FDA has proposed NOT to add liraglutide to the 503B outsourcing-facility bulks list; the comment period on that notice runs through July 30, 2026. | Named in the FDA 503B clinical-need notice proposing exclusion (Federal Register, May 1, 2026; comment period extended to July 30, 2026). | Fed. Register (FDA-2018-N-3240)Fed. Register (FDA-2018-N-3240) |
| SemaglutideOzempic, Wegovy, Rybelsus | FDA-approved drug | FDA-approved as branded finished drugs. Separately, FDA has proposed NOT to add semaglutide to the 503B outsourcing-facility bulks list; the comment period on that notice runs through July 30, 2026. Shortage-based compounding has ended. | Named in the FDA 503B clinical-need notice proposing exclusion (Federal Register, May 1, 2026; comment period extended to July 30, 2026). | Fed. Register (FDA-2018-N-3240)Fed. Register (FDA-2018-N-3240) |
| TesamorelinEgrifta | FDA-approved drugreported | FDA-approved as a finished drug (Egrifta), a growth-hormone-releasing-hormone analog. This is an approved product, distinct from the compounding lists above. | FDA-approved finished drug (approval reported 2010). | FDA.gov |
| TirzepatideMounjaro, Zepbound | FDA-approved drug | FDA-approved as branded finished drugs. Separately, FDA has proposed NOT to add tirzepatide to the 503B outsourcing-facility bulks list; the comment period on that notice runs through July 30, 2026. Shortage-based compounding has ended. | Named in the FDA 503B clinical-need notice proposing exclusion (Federal Register, May 1, 2026; comment period extended to July 30, 2026). | Fed. Register (FDA-2018-N-3240)Fed. Register (FDA-2018-N-3240) |
How this is built:Rows marked as primary were read directly from the Federal Register full text (PCAC meeting notice, docket FDA-2025-N-6895; and the 503B clinical-need notice, docket FDA-2018-N-3240) and the FDA 503A category list PDF. Rows marked “reported” rest on secondary reporting and are labeled as such. FDA lists change — always confirm against the linked source at time of use.
Scope & compliance: This is regulatory-status information, not medical or legal advice. It contains no doses and makes no efficacy claims. Nothing here should be read as encouragement to use any unapproved substance.
What’s Happening July 23–24, 2026
The FDA Pharmacy Compounding Advisory Committee (PCAC) meets over two days to consider peptides nominated for the 503A bulks list. On July 23 the committee discusses BPC-157, KPV, TB-500, and MOTS-c; on July 24 it discusses emideltide (delta sleep-inducing peptide), semax, and epitalon. The committee reviews the specific use each was nominated for, hears from nominators, and votes a recommendation — which is non-binding. FDA still has to complete formal rulemaking before anything changes. The public docket is FDA-2025-N-6895.
Frequently Asked Questions
Is BPC-157 FDA-approved or legal to compound in 2026?
No. As of the FDA 503A category list updated May 14, 2026, BPC-157 is not FDA-approved and is not on the 503A bulks list. It is scheduled for review by the FDA Pharmacy Compounding Advisory Committee (PCAC) on July 23, 2026, as a substance nominated for possible inclusion on that list. Being on a meeting agenda is not approval and does not make a substance compoundable.
What is the FDA doing about peptides in July 2026?
The FDA Pharmacy Compounding Advisory Committee meets July 23–24, 2026 to discuss whether several nominated peptides should be added to the 503A bulks list. July 23 covers BPC-157, KPV, TB-500, and MOTS-c; July 24 covers emideltide (DSIP), semax, and epitalon. The committee's recommendation is non-binding — FDA still has to complete formal rulemaking afterward. The public docket is FDA-2025-N-6895.
What does "503A Category 1, 2, or 3" mean?
These are the FDA's working categories for bulk substances nominated for use in pharmacy compounding under section 503A. Category 1 means "under evaluation" — a substance may generally be used in compounding while FDA finishes its review. Category 2 means FDA identified a significant safety risk, so it should not be compounded. Category 3 means the nomination lacked adequate supporting information. A substance on none of these lists was either never nominated or had its nomination withdrawn.
Can compounding pharmacies still make semaglutide or tirzepatide?
Generally no. Compounding of the GLP-1 drugs was permitted only while they were on the FDA drug-shortage list; those shortages resolved, ending that basis. Separately, in a Federal Register notice published May 1, 2026 (docket FDA-2018-N-3240), FDA proposed NOT to add semaglutide, tirzepatide, or liraglutide to the 503B outsourcing-facility bulks list. The comment period on that notice was extended to July 30, 2026.
Which peptides are actually FDA-approved?
Only a handful of peptide DRUGS are FDA-approved as finished products, and that is a completely different pathway from the compounding lists. Approved examples include semaglutide, tirzepatide, and liraglutide (GLP-1 drugs), tesamorelin (Egrifta), and bremelanotide (Vyleesi). Most peptides marketed by wellness brands — BPC-157, CJC-1295, ipamorelin, and so on — are not FDA-approved.
Is this legal advice?
No. This tracker reports the regulatory status of peptides as recorded in public FDA and Federal Register documents. It is educational information, not medical or legal advice, and the underlying FDA lists change. Verify the current status against the linked primary source before relying on it, and consult a licensed professional for your situation.
Primary Sources
- FDA — Pharmacy Compounding Advisory Committee; Notice of Meeting (July 23–24, 2026). Federal Register, published April 16, 2026. — Docket FDA-2025-N-6895.
- FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Category 1 / 2 / 3 list). Updated May 14, 2026.
- FDA — Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (program hub).
- FDA — List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B (proposes NOT to include semaglutide, tirzepatide, liraglutide). Federal Register, published May 1, 2026. — Docket FDA-2018-N-3240.
- FDA — Extension of Comment Period for the 503B clinical-need notice (comment period extended to July 30, 2026). Federal Register, published June 26, 2026. — Docket FDA-2018-N-3240.
- FDA — Human Drug Compounding Laws (conditions for the 503A and 503B exemptions).
Reviewed by Dr. Charles Kamen, MD — LiveNow Longevity, Las Vegas. This reference is educational and is not medical or legal advice.
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