FDA PCAC Review: July 23–24, 2026
UpcomingThe FDA Pharmacy Compounding Advisory Committee meets July 23–24, 2026 to review BPC-157, TB-500, MOTS-c, KPV, Semax, and Epithalon for reclassification from Category 2 to Category 1. Category 1 status allows 503A compounding pharmacies to produce these compounds for individual prescriptions.
View official FDA calendarPeptide Regulatory Status Registry
Real-time tracking of 20 peptides across FDA categories, compounding legality, and regulatory changes. Updated when FDA announcements are made.
Last updated: May 2, 2026
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Under FDA PCAC review for reclassification
Allowable for 503A compounding pharmacy production
Restricted — not allowed for compounding
Approved drug with labeled indication(s)
In clinical trials, not yet approved
No approved medical use; not available through pharmacies
BPC-157
Pending Review→ Expected Category 1Also: Body Protection Compound, Bepecin, PL 14736
FDA PCAC review scheduled July 23, 2026. Expected reclassification from Category 2 to Category 1, which would allow 503A compounding pharmacies to produce BPC-157 for individual prescriptions. Reclassification was driven by HHS Secretary RFK Jr.’s February 2026 directive.
TB-500 (Thymosin Beta-4 Fragment)
Pending Review→ Expected Category 1Also: TB500, Thymosin Beta-4, TB4-FRAG
Synthetic fragment of Thymosin Beta-4. Under PCAC review July 23, 2026 alongside BPC-157. Commonly stacked with BPC-157 for tissue repair protocols. Compounding pharmacies widely used TB-500 before Category 2 restrictions in 2023.
MOTS-c
Pending Review→ Expected Category 1Also: Mitochondrial Open Reading Frame
Mitochondria-derived peptide that activates AMPK and mimics exercise at the cellular level. Under PCAC review July 23, 2026. Search volume exploding +120% YoY as longevity researchers discover its exercise-mimetic properties.
KPV
Pending Review→ Expected Category 1Also: Lys-Pro-Val, Alpha-MSH tripeptide
Alpha-MSH-derived tripeptide with potent anti-inflammatory properties. Particularly researched for gut inflammation (IBD, Crohn’s). Available in oral, injectable, and topical forms. Under PCAC review July 23, 2026.
Semax
Pending Review→ Expected Category 1Also: ACTH 4-7 Pro8 Gly9 Pro10
Russian-developed neuropeptide that upregulates BDNF and improves cognitive processing. Used intranasally or via injection. Under PCAC review July 24, 2026. Growing +45% YoY in US searches, primarily from cognitive enhancement community.
Epithalon
Pending Review→ Expected Category 1Also: Epitalon, Tetrapeptide-2, Ala-Glu-Asp-Gly
Tetrapeptide with research suggesting telomere-lengthening effects via telomerase activation. Used in longevity protocols. Under PCAC review July 24, 2026. Primary research from Dr. Vladimir Khavinson at St. Petersburg Institute of Bioregulation.
Ipamorelin
Category 1Also: NNC 26-0161
GHRP (growth hormone releasing peptide) that selectively stimulates GH release without affecting cortisol or prolactin. Currently Category 1 — compoundable for prescriptions. Commonly combined with CJC-1295 for GH optimization protocols.
Selank
Category 1Also: TP-7
Anxiolytic peptide derived from tuftsin. Modulates serotonin, dopamine, and GABA. Used intranasally. Category 1 status allows compounding. Growing +45% YoY in US searches, primarily for anxiety and cognitive enhancement.
GHK-Cu (Copper Peptide)
Category 1Also: Copper tripeptide-1, GHK
Category 1 for topical and injectable compounding. Activates wound-healing genes, stimulates collagen synthesis, and has anti-inflammatory properties. FDA-approved in cosmetic contexts. Growing +35% YoY.
Thymosin Alpha-1 (TA-1)
Category 1Also: Thymasin α1, Zadaxin
FDA-approved (as Zadaxin) in 37 countries for hepatitis and immune conditions. Category 1 in the US for compounding. Extensive human clinical trial data for immune modulation. Growing +30% YoY in US searches.
AOD-9604
Category 1Also: Anti-Obesity Drug 9604, hGH Fragment 177-191
Lipolytic fragment of human growth hormone. Category 1, compoundable. Growing as GLP-1 alternative — +40% YoY. Targets fat metabolism without the appetite suppression side effects of GLP-1 agonists.
NAD+ (Injectable)
Category 1Also: Nicotinamide Adenine Dinucleotide, NAD
Category 1, compoundable for subcutaneous injection and IV infusion. Restores mitochondrial NAD+ levels which decline with age. Growing +50% YoY. High search intent for SubQ vs. IV comparison.
Sermorelin
Category 1Also: Geref, GHRH 1-29
FDA-approved for diagnostic use (growth hormone deficiency testing). Category 1 for compounding in anti-aging and GH-optimization contexts. Considered the “beginner-friendly” GHRH due to its safety profile and straightforward protocol.
Semaglutide
FDA ApprovedAlso: Ozempic, Wegovy, Rybelsus
FDA-approved for T2D (Ozempic) and obesity (Wegovy). Compounded versions remain available despite FDA shortage resolution. Oral form (Wegovy 25mg/50mg pill) launched 2025. Stable market with 8% of all US prescriptions as of March 2026.
Tirzepatide
FDA ApprovedAlso: Mounjaro, Zepbound
FDA-approved dual GIP/GLP-1 agonist. Compounded versions remain in high demand despite brand availability. PCAC compounding legality is contested — the largest search query in the GLP-1 category. Injectable only (no oral form approved).
Tesamorelin
FDA ApprovedAlso: Egrifta, Egrifta SV
FDA-approved for HIV-associated lipodystrophy (visceral fat reduction). Used off-label for visceral fat reduction in non-HIV populations. High search intent for off-label use. Category 1 for compounding.
PT-141 (Bremelanotide)
FDA ApprovedAlso: Vyleesi
FDA-approved (as Vyleesi) for hypoactive sexual desire disorder (HSDD) in premenopausal women. Used off-label by men for erectile dysfunction and libido. Compounded versions widely available. SubQ injection or nasal spray.
Retatrutide
InvestigationalAlso: LY3437943
Phase 3 trials ongoing. Triple agonist (GLP-1, GIP, glucagon receptors) — dubbed ‘Godzilla of weight loss drugs’ in community. NOT FDA approved; only available from research chemical suppliers. Explosive +300% YoY search growth as Phase 3 nears completion.
CJC-1295 (with DAC)
Category 2Also: Drug Affinity Complex CJC, CJC-1295 DAC
Category 2 restriction remains in effect for CJC-1295 with DAC due to pharmacokinetic concerns around its extended 6-9 day half-life. NOT under PCAC review in July 2026. CJC-1295 without DAC is Category 1 and remains available for compounding.
MK-677 (Ibutamoren)
Research ChemicalAlso: Ibutamoren, Numalin
Not FDA approved. Oral GH secretagogue. Banned by WADA for athletic competition. Available as a research chemical. High search volume for side effects, particularly blood sugar elevation and water retention. NOT legally available through compounding pharmacies.
Understanding the 2026 FDA Reclassification
In February 2026, HHS Secretary Robert F. Kennedy Jr. directed the FDA to review its classification of peptides on the bulk drug substances list. The primary change involves moving several peptides from Category 2 (prohibited from compounding) back to Category 1 (allowable for compounding).
Category 1 designation allows 503A compounding pharmacies — traditional compounding pharmacies that compound for individual patient prescriptions — to produce these peptides. This means patients with valid prescriptions from licensed physicians can legally obtain these compounds from compounding pharmacies, rather than from research chemical suppliers.
The July 23–24, 2026 PCAC meeting is the formal review process for this reclassification. The committee will evaluate six peptides: BPC-157, TB-500 (Thymosin Beta-4), MOTS-c, KPV, Semax, and Epithalon. The expected outcome is Category 1 reclassification, though the committee's recommendation is advisory and the final decision rests with the FDA Commissioner.