Peptide Regulatory Tracker 2026
FDA compounding categories group nominated substances while the agency reviews them; they are not drug approvals. Category 1 concerns substances nominated with sufficient information for review; Category 2 identifies substances with safety concerns. PCAC is the Pharmacy Compounding Advisory Committee: it advises the FDA, but its votes are not final FDA decisions. The 503A bulks list is the FDA's formal list of bulk drug substances evaluated for that compounding framework. This tracker summarizes our published reporting, not a live government status database.
Definitions source: Our 503A vs. 503B framework article.
2026 timeline
Dates below identify reported events or dated coverage, not independent confirmation. Where a post cites no event-specific primary source, that gap is shown rather than filled with an unrelated link.
- — Confirmed notices, reported dates and remaining uncertainties. 2026 vendor closures report. Event-specific primary source: not cited in this post.
- — Our coverage reports a proposed peptide interim access policy sent to OMB and distinguishes it from FDA approval. RFK Jr. Just Changed the Peptide Industry Forever. Here's What It Actually Means.. Event-specific primary source: not cited in this post.
- — Our Apex follow-up separates reported search developments from confirmed public charges and discusses FDA warning-letter context. Apex Peptides Update 2026: What We Know Nearly Two Weeks After the Federal Raid. Event-specific primary source: not cited in this post.
- — Our reporting describes the September 23 federal search involving Apex and distinguishes an investigation from a finding of wrongdoing. Apex Peptides, Federal Agents, and What the September 23 Raid Actually Tells Us About the RUO Sector. Event-specific primary source: not cited in this post.
- — Our explainer describes Lilly's retatrutide classification dispute with the FDA and the Seventh Circuit appeal. Retatrutide Biologic Lawsuit: Lilly v. FDA Explained. Cited primary-source context
- — Our report covers the proposed PEPTIDES for Veterans Act, not enacted access or FDA approval. PEPTIDES for Veterans Act 2026: Nancy Mace, the VA, and How Everything Changed. Cited primary-source context
- — Our Apex follow-up cites FDA warning letters dated August 24 as separate enforcement context, not proof about the Apex search. Apex Peptides Update 2026: What We Know Nearly Two Weeks After the Federal Raid. Cited primary-source context
- — Our post-vote road map distinguishes advisory recommendations, proposed rules and final FDA action. The FDA Voted. Now What? The Complete Road Map to What Happens After the PCAC Peptide Decision. Event-specific primary source: not cited in this post.
- — Our Day 2 report records favorable recommendations for Semax and Epitalon and a negative recommendation for Emideltide. FDA Advisory Panel Day 2 Results: Semax and Epitalon Recommended, Emideltide Rejected: Full Two-Day Scorecard. Event-specific primary source: not cited in this post.
- — Our Day 1 report records recommendations for BPC-157, TB-500, KPV and MOTS-c and notes that the FDA makes the final decision. FDA Advisory Panel Votes to Recommend BPC-157, TB-500, KPV, and MOTS-c for Compounding (2026). Event-specific primary source: not cited in this post.
- — Our compounding-framework article reports the April removal of selected peptides from Category 2 and distinguishes that step from automatic Category 1 placement. 503A vs. 503B: How Peptides Fit Into the U.S. Compounding Framework in 2026 and Beyond. Event-specific primary source: not cited in this post.
Status by compound
Peptide laws by state. These fields summarize dated published coverage; they are not automatic current legal determinations.
| Compound | FDA compounding category | PCAC review and vote | 503A bulks list status | FDA-approved drug | WADA status | Last reviewed |
|---|---|---|---|---|---|---|
| BPC-157 | Reported removed from Category 2 effective April 22, 2026. This report does not establish a later Category 1 placement. Source post Reviewed: 2026-10-17 | July 23, 2026: recommended for inclusion, 8–6. The vote is advisory, not FDA approval. Source post Reviewed: 2026-10-17 | The cited coverage describes an advisory recommendation, not completed FDA rulemaking or a final bulks-list addition. Source post Reviewed: 2026-10-17 | No FDA-approved form of BPC-157, according to the cited published explainer. Source post Reviewed: 2026-10-17 | Listed in our 2026 WADA coverage as prohibited under S0. Source post Reviewed: 2026-10-17 | 2026-10-17 |
| DSIP | Not yet reviewed | July 24, 2026: Emideltide (DSIP) was not recommended for inclusion. The vote is advisory. Source post Reviewed: 2026-10-17 | The July 24 coverage reports a negative advisory recommendation, not a final FDA bulks-list decision. Source post Reviewed: 2026-10-17 | Not yet reviewed | Not yet reviewed | 2026-10-17 |
| Epitalon | Reported removed from Category 2 effective April 22, 2026. This report does not establish a later Category 1 placement. Source post Reviewed: 2026-10-17 | July 24, 2026: recommended for inclusion, 7–5 with one abstention. The vote is advisory. Source post Reviewed: 2026-10-17 | The cited coverage describes an advisory recommendation, not completed FDA rulemaking or a final bulks-list addition. Source post Reviewed: 2026-10-17 | Not yet reviewed | Listed in our 2026 WADA coverage as prohibited under S0. Source post Reviewed: 2026-10-17 | 2026-10-17 |
| KPV | Reported removed from Category 2 effective April 22, 2026. This report does not establish a later Category 1 placement. Source post Reviewed: 2026-10-17 | July 23, 2026: recommended for inclusion, 8–6. The vote is advisory. Source post Reviewed: 2026-10-17 | The cited coverage describes an advisory recommendation, not completed FDA rulemaking or a final bulks-list addition. Source post Reviewed: 2026-10-17 | Not yet reviewed | Not yet reviewed | 2026-10-17 |
| MOTS-c | Reported removed from Category 2 effective April 22, 2026. This report does not establish a later Category 1 placement. Source post Reviewed: 2026-10-17 | July 23, 2026: recommended for inclusion, 7–5. The vote is advisory. Source post Reviewed: 2026-10-17 | The cited coverage describes an advisory recommendation, not completed FDA rulemaking or a final bulks-list addition. Source post Reviewed: 2026-10-17 | Not yet reviewed | Not yet reviewed | 2026-10-17 |
| Semaglutide | Not yet reviewed | Not yet reviewed | Not yet reviewed | The cited GLP-1 comparison identifies semaglutide as FDA approved (Ozempic and Wegovy). Source post Reviewed: 2026-10-17 | Included in the 2026 Monitoring Program; described as monitored, not prohibited. Source post Reviewed: 2026-10-17 | 2026-10-17 |
| Semax | Reported removed from Category 2 effective April 22, 2026. This report does not establish a later Category 1 placement. Source post Reviewed: 2026-10-17 | July 24, 2026: recommended for inclusion, 8–5. The vote is advisory. Source post Reviewed: 2026-10-17 | The cited coverage describes an advisory recommendation, not completed FDA rulemaking or a final bulks-list addition. Source post Reviewed: 2026-10-17 | Not yet reviewed | Not yet reviewed | 2026-10-17 |
| TB-500 | Reported removed from Category 2 effective April 22, 2026. This report does not establish a later Category 1 placement. Source post Reviewed: 2026-10-17 | July 23, 2026: recommended for inclusion, 8–6. The vote is advisory. Source post Reviewed: 2026-10-17 | The cited coverage describes an advisory recommendation, not completed FDA rulemaking or a final bulks-list addition. Source post Reviewed: 2026-10-17 | Not yet reviewed | Not yet reviewed | 2026-10-17 |
| Tirzepatide | Not yet reviewed | Not yet reviewed | Not yet reviewed | The cited GLP-1 comparison identifies tirzepatide as FDA approved (Mounjaro and Zepbound). Source post Reviewed: 2026-10-17 | Included in the 2026 Monitoring Program; described as monitored, not prohibited. Source post Reviewed: 2026-10-17 | 2026-10-17 |
Not yet eligible for a status page
A page requires at least two sourced fields; absence of a page does not imply any regulatory status.
- 5-Amino-1MQ — 0 sourced fields
- 9-ME-BC — 0 sourced fields
- Adalank — 0 sourced fields
- Adamax — 0 sourced fields
- Adrafinil — 0 sourced fields
- Agmatine Sulfate — 0 sourced fields
- AHK-Cu — 0 sourced fields
- AICAR — 0 sourced fields
- ALCAR (Acetyl-L-Carnitine) — 0 sourced fields
- Alpha-GPC — 0 sourced fields
- Alpha-Lipoic Acid — 0 sourced fields
- Aniracetam — 0 sourced fields
- AOD-9604 — 0 sourced fields
- ARA-290 — 0 sourced fields
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- Bacopa Monnieri — 0 sourced fields
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- Berberine — 0 sourced fields
- BPC-157/TB-500 (Wolverine) — 0 sourced fields
- BPC-157/TB-500/KPV (Phoenix) — 0 sourced fields
- Bromantane — 0 sourced fields
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- CDP-Choline (Citicoline) — 0 sourced fields
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- HGH (Somatropin) — 0 sourced fields
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- Huperzine A — 0 sourced fields
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- Ipamorelin — 0 sourced fields
- Kisspeptin — 0 sourced fields
- Klotho — 0 sourced fields
- KLOW — 0 sourced fields
- L-Carnitine — 0 sourced fields
- LGD-4033 (Ligandrol) — 0 sourced fields
- Lion's Mane — 0 sourced fields
- Liraglutide (Victoza) — 0 sourced fields
- Livagen — 0 sourced fields
- LL-37 — 0 sourced fields
- Mazdutide — 0 sourced fields
- Melanotan I — 0 sourced fields
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- MGF — 0 sourced fields
- MK-2866 (Ostarine) — 0 sourced fields
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- NMN (Nicotinamide Mononucleotide) — 0 sourced fields
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- NR (Nicotinamide Riboside) — 0 sourced fields
- NSI-189 (NSI-189 Phosphate) — 0 sourced fields
- Orforglipron (Foundayo) — 0 sourced fields
- Ovagen — 0 sourced fields
- Oxiracetam — 0 sourced fields
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- Quercetin — 0 sourced fields
- RAD-140 (Testolone) — 0 sourced fields
- Rapamycin (Sirolimus) — 0 sourced fields
- Resveratrol — 0 sourced fields
- Retatrutide — 1 sourced fields
- Rhodiola Rosea — 0 sourced fields
- S23 — 0 sourced fields
- S4 (Andarine) — 0 sourced fields
- Selank — 0 sourced fields
- Sermorelin — 0 sourced fields
- Shilajit — 0 sourced fields
- SLU-PP-332 — 0 sourced fields
- SNAP-8 — 0 sourced fields
- Spermidine — 0 sourced fields
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- Thymulin — 0 sourced fields
- Tongkat Ali — 0 sourced fields
- Triptorelin — 0 sourced fields
- TRT — 0 sourced fields
- Vasopressin (ADH) — 0 sourced fields
- Ventfort — 0 sourced fields
- Vesilute — 0 sourced fields
- Vesugen — 0 sourced fields
- Vilon — 0 sourced fields
- VIP — 0 sourced fields
- YK-11 — 0 sourced fields
Research use only. Not for human consumption. This page summarizes public regulatory information and is not legal advice.