This maintained tracker follows peptides in PeptaHub's legal_status dataset that are currently marked reclassification-pending. It is built for readers who need a quick, citeable view of which compounds are still waiting on formal FDA movement, which ones have stronger caution flags, and what the current PeptaHub note says for each peptide.
The tracker is educational only. It does not provide dosing, sourcing, compounding instructions, or medical advice. Legal status can change quickly, and FDA publications, state board rules, pharmacy policies, and prescriber judgment all matter.
Reclassification table
Last updated: June 9, 2026. This YMYL tracker is generated from published PeptaHub peptide entries marked reclassification-pending.
| BPC-157 | Reclassification pending | Awaiting formal FDA or compounding-policy update | BPC-157 cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up BPC-157 on July 23, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding it to the Bulks List. PCAC is advisory: its vote is a recommendation rather than a binding decision, FDA must still decide whether to accept it, and formal rulemaking afterward typically takes 12 to 24 months. Many US suppliers paused sales in 2025-2026 pending regulatory clarity. Verify current federal and state rules before relying on access claims. |
| Dihexa | Reclassification pending | Awaiting formal FDA or compounding-policy update | Dihexa cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. Dihexa, which the FDA lists as dihexa acetate, was not among the seven peptides heard on July 23-24, 2026; the FDA has stated the Pharmacy Compounding Advisory Committee will reconvene before the end of February 2027 to consider it alongside GHK-Cu, Melanotan II, LL-37, and PEG-MGF. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. Dihexa is not FDA-approved for any indication, is otherwise sold as a research chemical, and is not scheduled. Verify current federal and state rules before relying on access claims. |
| DSIP | Reclassification pending | Awaiting formal FDA or compounding-policy update | DSIP cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up DSIP, which the FDA lists under the name emideltide, on July 24, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding it to the Bulks List. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. DSIP is not FDA-approved for any indication, is otherwise sold as a research peptide, and is not scheduled. Verify current federal and state rules before relying on access claims. |
| Epithalon | Reclassification pending | Awaiting formal FDA or compounding-policy update | Epithalon cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up the substance, which the FDA lists as Epitalon, on July 24, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding it to the Bulks List, citing inconsistent naming conventions among other concerns. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. Epithalamin (the natural extract) is approved in Russia as a pharmaceutical; the synthetic version is not FDA-approved and is otherwise sold as a research chemical internationally. Verify current federal and state rules before relying on access claims. |
| GHK-Cu | Reclassification pending | Awaiting formal FDA or compounding-policy update | This status describes injectable GHK-Cu, which cannot legally be compounded in the US today. Topical GHK-Cu is a separate matter: it is a long-established cosmetic ingredient (INCI: copper tripeptide-1), sold without restriction and regulated under cosmetic rather than drug authority, and nothing below affects it. On the injectable bulk drug substance: GHK-Cu is one of 12 peptides covered by the FDA's April 15, 2026 action on the interim 503A bulk drug substances list, effective within seven calendar days, taken because the original nominators withdrew their nominations. Note a detail specific to GHK-Cu — legal commentary indicates it was removed from Category 1 rather than Category 2, meaning it lost the enforcement discretion it previously had, while the other 11 were removed from Category 2. Either way the outcome is the same: the substance is not on the Section 503A Bulks List, enforcement discretion no longer applies, and it is not eligible for compounding. GHK-Cu was not among the seven peptides heard on July 23-24, 2026 (docket FDA-2025-N-6895); the FDA has stated the Pharmacy Compounding Advisory Committee will reconvene before the end of February 2027 to consider it alongside Melanotan II, LL-37, dihexa acetate, and PEG-MGF. PCAC recommendations are advisory only, and formal rulemaking afterward typically takes 12 to 24 months, so injectable compounding status is unlikely to change quickly. Injectable GHK-Cu sold as a research chemical is not FDA-approved for any indication. Verify current federal and state rules before relying on access claims. |
| KPV | Reclassification pending | Awaiting formal FDA or compounding-policy update | KPV cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up KPV-related bulk drug substances (KPV free base and KPV acetate) on July 23, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding them to the Bulks List. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. KPV is not FDA-approved for any indication and is otherwise sold as a research peptide. Verify current federal and state rules before relying on access claims. |
| LL-37 | Reclassification pending | Awaiting formal FDA or compounding-policy update | LL-37 cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. LL-37, which the FDA lists as cathelicidin, was not among the seven peptides heard on July 23-24, 2026; the FDA has stated the Pharmacy Compounding Advisory Committee will reconvene before the end of February 2027 to consider it alongside GHK-Cu, dihexa acetate, Melanotan II, and PEG-MGF. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months, so compounding status is unlikely to change quickly. LL-37 is not FDA-approved for any indication and is otherwise sold as a research peptide; it remains in clinical development for wound healing and infection applications. Verify current federal and state rules before relying on access claims. |
| Melanotan II | Reclassification pending | Awaiting formal FDA or compounding-policy update | Melanotan II cannot legally be compounded in the US today, is not FDA-approved for any indication, and is not legally marketed as a drug or cosmetic; it is sold as a research chemical outside any verified supply chain. The FDA, the Australian TGA, and the UK MHRA have all issued warnings against cosmetic use. It is not a scheduled controlled substance in most jurisdictions. On compounding: Melanotan II is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. Melanotan II was not among the seven peptides heard on July 23-24, 2026 (docket FDA-2025-N-6895); the FDA has stated the Pharmacy Compounding Advisory Committee will reconvene before the end of February 2027 to consider it alongside GHK-Cu, LL-37, dihexa acetate, and PEG-MGF. Industry commentary has generally expected Melanotan II to remain restricted. PCAC recommendations are advisory only, and formal rulemaking afterward typically takes 12 to 24 months. Two related melanocortin agonists are FDA-approved and legally available by prescription — bremelanotide (Vyleesi) and afamelanotide (SCENESSE) — but neither is Melanotan II. Verify current federal and state rules before relying on access claims. |
| MOTS-c | Reclassification pending | Awaiting formal FDA or compounding-policy update | MOTS-c cannot legally be compounded in the US today, and it is not FDA-approved or approved as a pharmaceutical or supplement ingredient in any country. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up MOTS-c-related bulk drug substances (MOTS-c free base and MOTS-c acetate) on July 23, 2026 (docket FDA-2025-N-6895), alongside BPC-157, TB-500, and KPV, with emideltide (DSIP), Semax, and Epitalon heard on July 24. FDA staff briefing documents recommended against inclusion for all seven, concluding that none satisfied the criteria in 21 CFR 216.23(c) and citing inadequate substance characterization, inconsistent naming, missing quality data, insufficient human clinical evidence, and immunogenicity safety flags. PCAC is advisory: its vote is a recommendation rather than a binding decision, FDA must still decide whether to accept it, and formal rulemaking typically takes a further 12 to 24 months. Verify the current docket record and federal and state rules before relying on access claims. |
| PEG-MGF | Reclassification pending | Awaiting formal FDA or compounding-policy update | PEG-MGF cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. PEG-MGF, which the FDA lists as pegylated mechano growth factor, was not among the seven peptides heard on July 23-24, 2026; the FDA has stated the Pharmacy Compounding Advisory Committee will reconvene before the end of February 2027 to consider it alongside GHK-Cu, Melanotan II, LL-37, and dihexa acetate. Industry commentary has generally expected PEG-MGF to remain restricted. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. PEG-MGF is not FDA-approved, is otherwise sold by research peptide suppliers as a laboratory compound, and is prohibited by WADA in competitive sport. Verify current federal and state rules before relying on access claims. |
| Semax | Reclassification pending | Awaiting formal FDA or compounding-policy update | Semax cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up Semax on July 24, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding it to the Bulks List. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. Semax is approved as a prescription drug in Russia and Ukraine but is not FDA-approved in the US, where it is otherwise sold as a research peptide and is not scheduled. Verify current federal and state rules before relying on access claims. |
| TB-500 | Reclassification pending | Awaiting formal FDA or compounding-policy update | TB-500 cannot legally be compounded in the US today. It is one of 12 peptides the FDA removed from Category 2 of the interim 503A bulk drug substances list on April 15, 2026, effective within seven calendar days, because the original nominators withdrew their nominations. Removal from Category 2 is not the same as being added to the Section 503A Bulks List or placed in Category 1, and the FDA has been explicit that it does not by itself make a substance eligible for compounding — enforcement discretion extends only to Category 1, and these substances were never in Category 1. The Pharmacy Compounding Advisory Committee took up TB-500-related bulk drug substances (TB-500 free base and TB-500 acetate) on July 23, 2026 (docket FDA-2025-N-6895); FDA staff briefing documents recommended against adding them to the Bulks List, citing inconsistent naming conventions among other concerns. PCAC is advisory and formal rulemaking afterward typically takes 12 to 24 months. Previously sold as a research chemical, and widely used in veterinary medicine. Verify current federal and state rules before relying on access claims. |
How to read this tracker
The table below pulls directly from PeptaHub peptide profile data where legal_status equals reclassification-pending. The current status column translates that dataset flag into reader-facing language. The reclassification status column summarizes the review posture without implying that FDA has approved, cleared, or authorized a peptide unless the source data says so.
The note column is the current legal_notes field from the peptide dataset. It is intentionally concise: this page is a maintained tracker, not a replacement for FDA source documents, pharmacy counsel, or the full peptide profile pages.
Tracker maintenance policy
PeptaHub updates this page when the underlying peptide dataset changes, when FDA publishes relevant bulk-substance or compounding guidance, or when a peptide's market status materially changes. Each update should preserve the table shape so journalists, community moderators, and researchers can compare the same compounds over time.
If a peptide leaves reclassification-pending status in the dataset, it should drop out of this table on the next page update and be handled in the appropriate profile, comparison, or regulatory timeline entry.
Editorial caution
Reclassification-pending is not the same thing as FDA approval, prescription access, or legal availability. It means PeptaHub has tagged the compound as awaiting a clearer FDA or compounding-policy outcome. Readers should not treat inclusion in this table as a signal to buy, compound, prescribe, or use a peptide.
This topic is YMYL because it touches regulated health products. PeptaHub frames the page as a status tracker and citation aid only.
Cite this tracker
PeptaHub Editorial Team. FDA Peptide Reclassification Tracker 2026. PeptaHub. Updated June 9, 2026. https://peptahub.com/guides/fda-reclassification-2026
Frequently asked questions
No. Reclassification-pending means PeptaHub's dataset marks the peptide as awaiting a clearer FDA or compounding-policy outcome. It does not mean the peptide is FDA-approved, available by prescription, or legally available from a compounding pharmacy.
The table is generated from PeptaHub's peptide dataset by filtering for entries where legal_status is reclassification-pending. The status notes come from each peptide's legal_notes field.
It should be updated whenever the source peptide dataset changes, when FDA publishes relevant compounding or bulk-substance guidance, or when a peptide's practical market status changes materially.
No. This page is educational only and does not provide dosing, sourcing, compounding, prescribing, or treatment instructions.