The FDA Peptide Reclassification, Explained
The current legal status of every peptide we cover, plus the regulatory actions and timeline behind it.
On April 30, 2026, the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list — closing the remaining legal pathway for large-scale GLP-1 compounding. Public comment runs through June 29, 2026. This is the GLP-1 compounding track tightening, separate from the Category 2 peptide reclassification track. The tracker shows current status for every compound we cover, plus full regulatory timeline.
Peptide Regulatory Tracker
Current FDA compounding status for all tracked compounds.
Last Updated: May 8, 2026
| Compound▲ | Current Status | Compoundable Now? | Indication |
|---|---|---|---|
| PT-141 | FDA-approved for HSDD in premenopausal women (Vyleesi). Available via compounding for off-label uses. | Yes (via compounding) | HSDD |
| Semaglutide | FDA-approved for multiple indications. Compounding effectively prohibited; FDA proposes excluding from 503B bulks list (April 30, 2026). Public comment through June 29, 2026. | Compounding restricted | Type 2 diabetes, chronic weight management |
| Tirzepatide | FDA-approved for multiple indications. Compounding effectively prohibited; FDA proposes excluding from 503B bulks list (April 30, 2026). Public comment through June 29, 2026. | Compounding restricted | Type 2 diabetes, chronic weight management |
| BPC-157 | Removed from Category 2 effective April 22, 2026. PCAC review scheduled July 23, 2026. | No | Ulcerative colitis |
| Dihexa | Removed from Category 2 effective April 22, 2026. PCAC review scheduled at the second of two PCAC meetings, to be held before February 2027 — alongside GHK-Cu, LL-37, Melanotan II, and PEG-MGF. | No | Cognitive enhancement |
| DSIP | Removed from Category 2 effective April 22, 2026. PCAC review scheduled July 24, 2026. | No | Opioid withdrawal, chronic insomnia, narcolepsy |
| Epitalon | Removed from Category 2 effective April 22, 2026. PCAC review scheduled July 24, 2026. | No | Insomnia |
| GHK-Cu | Removed from Category 2 effective April 22, 2026. PCAC review scheduled at second meeting before February 2027. | No | Skin regeneration, wound healing |
| KPV | Removed from Category 2 effective April 22, 2026. PCAC review scheduled July 23, 2026. | No | Wound healing, inflammatory conditions |
| LL-37 (Cathelicidin)* | Removed from Category 2 effective April 22, 2026. PCAC review scheduled at second meeting before February 2027. | No | Antimicrobial, immune defense |
| Melanotan II* | Removed from Category 2 effective April 22, 2026. PCAC review scheduled at second meeting before February 2027. | No | Skin pigmentation |
| MOTS-C | Removed from Category 2 effective April 22, 2026. PCAC review scheduled July 23, 2026. | No | Obesity, osteoporosis |
| PEG-MGF* | Removed from Category 2 effective April 22, 2026. PCAC review scheduled at second meeting before February 2027. | No | Muscle tissue repair |
| Semax | Removed from Category 2 effective April 22, 2026. PCAC review scheduled July 24, 2026. Approved as a pharmaceutical in Russia since 2011. | No | Cerebral ischemia, migraine, trigeminal neuralgia |
| TB-500 | Removed from Category 2 effective April 22, 2026. PCAC review scheduled July 23, 2026. | No | Wound healing |
| AOD-9604 | Category 2. PCAC reviewed December 4, 2024 and voted against 503A inclusion. | No | Obesity |
| CJC-1295 / Ipamorelin | Category 2. PCAC reviewed both in late 2024 and voted against 503A inclusion (Ipamorelin October 2024, CJC-1295 December 2024). | No | Growth hormone deficiency, postoperative ileus |
| Thymosin Alpha-1 | FDA orphan drug designation for melanoma, hepatitis B/C, DiGeorge syndrome. Approved as Zadaxin in 35+ countries. Referred to PCAC September 2024; the committee voted against inclusion on the 503A bulks list in December 2024. | No | Hepatitis B/C, HIV, oncology, vaccine response |
| PE-22-28 | Category 2. No current path to compounding — not on PCAC review agenda and not removed from Category 2 in the April 2026 reclassifications. | No | Depression |
| Selank | Category 2. Referred to PCAC September 2024; not scheduled for either of the two announced PCAC meetings. No active review pathway. | No | Anxiolytic |
* Profile coming soon.
The FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. The agency explicitly clarified that supply, affordability and cost are not part of the clinical-need analysis — a notable line in the sand.
If finalized, this closes the remaining legal pathway for large-scale 503B compounding of these drugs. 503A patient-specific compounding isn't directly affected by this proposal but remains constrained by the “essentially a copy” rule.
This is the GLP-1 track tightening, separate from the Category 2 peptide reclassification, which is moving in the opposite direction through PCAC review. Two tracks, opposite directions.
What to do: If you're currently using a compounded GLP-1 medication, talk to your prescribing provider about transition options. Public comment runs through June 29, 2026.
Source: FDA proposal April 30, 2026; Federal Register 91 Fed. Reg. 23431, May 1.
GLP-1s are on a separate regulatory track
Semaglutide and tirzepatide are FDA-approved drugs facing compounding restrictions, not Category 2 peptides awaiting reclassification. The two stories are moving in opposite directions and shouldn't be conflated. See the semaglutide profile and tirzepatide profile for current compounding status and details.
FAQ
Category 1 substances have adequate safety and usage data and can be compounded by licensed pharmacies with a valid prescription. Category 2 substances have been flagged as potentially presenting safety risks and are effectively prohibited from compounding. Category 1 is not FDA approval — it means pharmacies may compound the substance with a prescription.
On April 22, 2026, 12 peptides were removed from Category 2: BPC-157, TB-500, KPV, MOTS-C, DSIP (Emideltide), Semax, Epitalon, LL-37, Dihexa, GHK-Cu, PEG-MGF and Melanotan II. Seven of these go before PCAC on July 23–24, 2026 (BPC-157, KPV, TB-500, MOTS-C on Day 1; DSIP, Semax, Epitalon on Day 2). The remaining five (GHK-Cu, Melanotan II, LL-37, Dihexa, PEG-MGF) will be reviewed at a second PCAC meeting before February 2027. Five other peptides — CJC-1295, Ipamorelin, AOD-9604, Thymosin Alpha-1 and Selank — were referred to PCAC in September 2024, but PCAC voted against four of them (CJC-1295, Ipamorelin, AOD-9604, Tα1) at meetings in October and December 2024. Selank has not been scheduled for review at either of the two announced PCAC meetings.
Not yet. BPC-157 was removed from Category 2 effective April 22, 2026 and is scheduled for PCAC review on July 23, 2026. Removal from Category 2 is not the same as authorization to compound — the FDA must add BPC-157 to the 503A bulks list through formal rulemaking after the PCAC review before licensed compounding pharmacies can legally produce it. When that happens, BPC-157 will be available via prescription, not over the counter and will not be FDA-approved.
The Pharmacy Compounding Advisory Committee (PCAC) is the FDA advisory committee that reviews substances for inclusion on the 503A bulk drug substances list. The evaluation process has four steps: (1) FDA refers the substance to PCAC, (2) PCAC schedules a public meeting and reviews the safety and efficacy evidence, (3) PCAC votes to recommend for or against adding the substance to the bulks list, (4) the FDA conducts notice-and-comment rulemaking before any substance is formally added. PCAC’s vote is advisory and non-binding; the FDA can decide differently than PCAC recommends. The full process typically takes a year or longer from referral to final rulemaking. Recent examples: PCAC voted against adding CJC-1295, Ipamorelin, AOD-9604 and Thymosin Alpha-1 in October and December 2024. PCAC will review BPC-157, KPV, TB-500, MOTS-C, DSIP, Semax and Epitalon on July 23–24, 2026.
503A pharmacies are traditional compounding pharmacies filling individual prescriptions. 503B outsourcing facilities operate under stricter FDA oversight and can produce larger batches. Both can legally compound Category 1 substances.
No. Removal from Category 2 means the FDA no longer flags those substances as raising significant safety concerns based on prior review. It does not authorize compounding. To legally compound a peptide under Section 503A, the substance must be on the 503A bulks list, in a USP/NF monograph or a component of an FDA-approved drug. None of the 12 meets those criteria today. Don’t buy “research peptides” from gray-market vendors based on the headlines — purity, sterility and dosing are not assured. The legitimate pathway is opening but it’s worth waiting for.