Peptide Regulatory Status Tracker
Where 24 peptides actually stand with the U.S. FDA — the 503A compounding categories, the 7 substances the advisory committee voted on July 23–24, 2026 (it recommended 6 for the 503A list and rejected one), 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of the “wellness” peptides — BPC-157, CJC-1295, ipamorelin — are on no current 503A list at all; their nominations were withdrawn.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 favorable July 2026 advisory-committee vote is a recommendation, not an approval — the list itself has not changed. For what the committee actually decided, see Did the FDA approve BPC-157?; 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 24, 2026.
Showing 24 of 24 substances
| Substance | Regulatory status | What that means | Most recent event | Source |
|---|---|---|---|---|
| BPC-157PCAC July 23, 2026 · recommended for inclusion 8–6 (1 abstention) · use evaluated: Ulcerative colitis | PCAC recommended for inclusionreported | Still not FDA-approved and still not on the 503A bulks list. On July 23, 2026 the FDA Pharmacy Compounding Advisory Committee voted 8–6 (1 abstention) to recommend adding it to the 503A list for the use it evaluated. The recommendation is non-binding; FDA must complete formal rulemaking before it changes what a pharmacy may compound. | PCAC recommended inclusion on the 503A bulks list, 8–6 with 1 abstention, July 23, 2026. Tally per contemporaneous reporting of the public meeting; FDA minutes not yet posted. | Fed. Register (FDA-2025-N-6895)FDA.govFDA.gov |
| EpitalonepithalonPCAC July 24, 2026 · recommended for inclusion 7–4 · use evaluated: Insomnia | PCAC recommended for inclusionreported | Still not FDA-approved and still not on the 503A bulks list. On July 24, 2026 the FDA Pharmacy Compounding Advisory Committee voted 7–4 to recommend adding it to the 503A list for the use it evaluated. The recommendation is non-binding; FDA must complete formal rulemaking before it changes what a pharmacy may compound. | PCAC recommended inclusion on the 503A bulks list, 7–4, July 24, 2026. Tally per contemporaneous reporting of the public meeting; FDA minutes not yet posted. | Fed. Register (FDA-2025-N-6895)FDA.gov |
| KPVPCAC July 23, 2026 · recommended for inclusion 8–6 (1 abstention) · use evaluated: Wound healing and inflammatory conditions | PCAC recommended for inclusionreported | Still not FDA-approved and still not on the 503A bulks list. On July 23, 2026 the FDA Pharmacy Compounding Advisory Committee voted 8–6 (1 abstention) to recommend adding it to the 503A list for the use it evaluated. The recommendation is non-binding; FDA must complete formal rulemaking before it changes what a pharmacy may compound. | PCAC recommended inclusion on the 503A bulks list, 8–6 with 1 abstention, July 23, 2026. Tally per contemporaneous reporting of the public meeting; FDA minutes not yet posted. | Fed. Register (FDA-2025-N-6895)FDA.gov |
| MOTS-cPCAC July 23, 2026 · recommended for inclusion 7–5 (2 abstentions) · use evaluated: Obesity and osteoporosis | PCAC recommended for inclusionreported | Still not FDA-approved and still not on the 503A bulks list. On July 23, 2026 the FDA Pharmacy Compounding Advisory Committee voted 7–5 (2 abstentions) to recommend adding it to the 503A list for the use it evaluated. The recommendation is non-binding; FDA must complete formal rulemaking before it changes what a pharmacy may compound. | PCAC recommended inclusion on the 503A bulks list, 7–5 with 2 abstentions, July 23, 2026. Tally per contemporaneous reporting of the public meeting; FDA minutes not yet posted. | Fed. Register (FDA-2025-N-6895)FDA.gov |
| SemaxPCAC July 24, 2026 · recommended for inclusion 8–5 · use evaluated: Cerebral ischemia, migraine, and trigeminal neuralgia | PCAC recommended for inclusionreported | Still not FDA-approved in the United States and still not on the 503A bulks list. On July 24, 2026 the FDA Pharmacy Compounding Advisory Committee voted 8–5 to recommend adding it to the 503A list for the use it evaluated. The recommendation is non-binding; FDA must complete formal rulemaking before it changes what a pharmacy may compound. | PCAC recommended inclusion on the 503A bulks list, 8–5, July 24, 2026. Tally per contemporaneous reporting of the public meeting; FDA minutes not yet posted. | Fed. Register (FDA-2025-N-6895)FDA.gov |
| TB-500thymosin beta-4 fragmentPCAC July 23, 2026 · recommended for inclusion 8–6 (1 abstention) · use evaluated: Wound healing | PCAC recommended for inclusionreported | Still not FDA-approved and still not on the 503A bulks list. On July 23, 2026 the FDA Pharmacy Compounding Advisory Committee voted 8–6 (1 abstention) to recommend adding it to the 503A list for the use it evaluated. The recommendation is non-binding; FDA must complete formal rulemaking before it changes what a pharmacy may compound. | PCAC recommended inclusion on the 503A bulks list, 8–6 with 1 abstention, July 23, 2026. Tally per contemporaneous reporting of the public meeting; FDA minutes not yet posted. | Fed. Register (FDA-2025-N-6895)FDA.gov |
| Emideltidedelta sleep-inducing peptide (DSIP)PCAC July 24, 2026 · recommended against inclusion 6–7 · use evaluated: Opioid withdrawal, chronic insomnia, and narcolepsy | PCAC recommended against inclusionreported | Not FDA-approved and not on the 503A bulks list. On July 24, 2026 the FDA Pharmacy Compounding Advisory Committee voted 6–7 against recommending it for the 503A list — the only substance of the seven heard that the committee declined to recommend. The recommendation is non-binding, but nothing about the vote moves it toward compounding eligibility. | PCAC recommended against inclusion on the 503A bulks list, 6–7, July 24, 2026. Tally per contemporaneous reporting of the public meeting; FDA minutes not yet posted. | Fed. Register (FDA-2025-N-6895)FDA.gov |
| 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 the PCAC Decided on July 23–24, 2026
The FDA Pharmacy Compounding Advisory Committee (PCAC) met over two days and voted on seven peptides nominated for the 503A bulks list. It recommended six of them for inclusion and rejected one. On July 23: BPC-157 8–6 (1 abstention), KPV 8–6 (1 abstention), TB-500 8–6 (1 abstention), and MOTS-c 7–5 (2 abstentions). On July 24: epitalon 7–4 and semax 8–5 were recommended, while emideltide (delta sleep-inducing peptide) was voted down 6–7. FDA’s own review scientists had argued against easing restrictions, in part because several of these substances are not chemically well-characterized. The public docket is FDA-2025-N-6895.
Two things this vote was not. It was not FDA approval — all seven remain unapproved drugs, and approval is a separate, finished-drug pathway. And it was not the lifting of a ban: these substances came off 503A Category 2 back in April 2026 when their nominations were withdrawn. This week’s vote was about adding them to the 503A list, a later and different step. The recommendation is non-binding, and FDA must complete formal rulemaking before what a pharmacy may legally compound actually changes. Full breakdown: Did the FDA approve BPC-157?
Vote tallies are from contemporaneous reporting of the public meeting; FDA has not yet posted minutes. The seven affected rows in the tracker are therefore labelled “reported” rather than primary-sourced; they will be upgraded when the official minutes publish.
Where the reporting disagrees: Epitalon — Reporting on this tally differs. STAT published 7–4; Regulatory Focus (RAPS) published 7–5 with one abstention. The figure shown here follows STAT. FDA minutes will settle it. Emideltide — Both STAT and Regulatory Focus (RAPS) report the 6–7 outcome, but RAPS additionally reports one abstention that STAT does not mention. The figure shown here follows STAT.
Frequently Asked Questions
Is BPC-157 FDA-approved or legal to compound in 2026?
No. BPC-157 is not FDA-approved, and as of the FDA 503A category list updated May 14, 2026 it is not on the 503A bulks list. On July 23, 2026 the FDA Pharmacy Compounding Advisory Committee voted 8–6 (1 abstention) to recommend adding it to that list for the use it evaluated, ulcerative colitis. That recommendation is non-binding and is not approval: FDA must still complete formal rulemaking before the list itself changes.
What did the FDA advisory committee decide in July 2026?
The FDA Pharmacy Compounding Advisory Committee met July 23–24, 2026 and voted on seven nominated peptides. It recommended six for addition to the 503A bulks list — BPC-157 (8–6, 1 abstention), KPV (8–6, 1 abstention), TB-500 (8–6, 1 abstention) and MOTS-c (7–5, 2 abstentions) on July 23; epitalon (7–4) and semax (8–5) on July 24. It voted 6–7 against emideltide (DSIP), the only rejection. Every recommendation is non-binding — FDA must still complete formal rulemaking, and all seven substances remain unapproved drugs. Public docket FDA-2025-N-6895. Vote tallies are from contemporaneous reporting of the public meeting; FDA minutes are not yet posted.
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 — Pharmacy Compounding Advisory Committee: meeting materials, roster, minutes, and webcast archive (July 23–24, 2026 meeting).
- 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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