PCAC Vote Complete — July 23–24, 2026
Results PostedThe FDA Pharmacy Compounding Advisory Committee voted to recommend six of seven peptides for the 503A Bulks List. The committee voted against its own FDA staff recommendations on every favorable outcome. These are advisory votes. The FDA is not bound by them. Formal Category 1 placement requires notice-and-comment rulemaking, typically 8 to 12 months. None of the six is compoundable yet.
BPC-157
8–6–1 ✓
TB-500
8–6–1 ✓
KPV
8–6–1 ✓
MOTS-c
7–5–2 ✓
Epitalon
7–4 ✓
Semax
8–5 ✓
Emideltide
6–7–1 ✗
Next PCAC
Before Feb 2027
Peptide 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: July 25, 2026
Get PCAC Results First
Be the first to know when BPC-157, TB-500, and others are officially reclassified. Influencers, researchers, and clinicians use this to stay ahead.
Committee recommended for 503A Bulks List — formal rulemaking required (8–12 months)
Committee voted against 503A inclusion — compounding access not recommended
On the 503A Bulks List — compoundable with a valid prescription
Restricted — not allowed for compounding
Approved drug with labeled indication(s)
In clinical trials, not yet approved
Scheduled for upcoming PCAC review
No approved medical use; not available through compounding pharmacies
BPC-157
PCAC RecommendedAlso: Body Protection Compound, Bepecin, PL 14736
FDA PCAC voted 8–6 to recommend BPC-157 for the 503A Bulks List on July 23, 2026, with one abstention. The committee voted against its own FDA staff’s written recommendation. The vote is advisory only. The FDA is not bound by it, and formal Category 1 placement requires notice-and-comment rulemaking, typically 8 to 12 months. BPC-157 was already removed from Category 2 on April 23, 2026, and is not currently restricted. Compounding pharmacy access is not yet open.
TB-500 (Thymosin Beta-4 Fragment)
PCAC RecommendedAlso: TB500, Thymosin Beta-4, TB4-FRAG
FDA PCAC voted 8–6 to recommend TB-500 for the 503A Bulks List on July 23, 2026, with one abstention, matching the BPC-157 tally exactly. FDA career scientists had recommended against inclusion, citing insufficient human clinical data. The advisory vote clears one of three required legal events. Formal rulemaking and Category 1 placement remain ahead. Removed from Category 2 on April 23, 2026.
KPV
PCAC RecommendedAlso: Lys-Pro-Val, Alpha-MSH tripeptide
FDA PCAC voted 8–6 to recommend KPV for the 503A Bulks List on July 23, 2026, with one abstention. FDA scientists noted the absence of any human clinical trial data for KPV specifically, but the committee found the broader safety and use profile sufficient for recommendation. Anti-inflammatory properties, particularly for gut conditions including IBD and Crohn’s disease, drove the nomination. Removed from Category 2 on April 23, 2026.
MOTS-c
PCAC RecommendedAlso: Mitochondrial Open Reading Frame
FDA PCAC voted 7–5 to recommend MOTS-c for the 503A Bulks List on July 23, 2026, with two abstentions. WADA prohibits MOTS-c in athletic competition, which factored into deliberations. The committee evaluated it for obesity and osteoporosis. FDA scientists recommended against inclusion. Two abstentions reflected the highest dissent rate of the July 23 compounds. Removed from Category 2 on April 23, 2026.
Epitalon
PCAC RecommendedAlso: Epithalon, Tetrapeptide-2, Ala-Glu-Asp-Gly
FDA PCAC voted 7–4 to recommend Epitalon for the 503A Bulks List on July 24, 2026, evaluated for insomnia. FDA scientists recommended against inclusion. The vote was the tightest favorable outcome of the two-day meeting. Primary human-use research originates from Dr. Vladimir Khavinson at the St. Petersburg Institute of Bioregulation. Formal rulemaking required before compounding access opens.
Semax
PCAC RecommendedAlso: ACTH 4-7 Pro8 Gly9 Pro10
FDA PCAC voted 8–5 to recommend Semax for the 503A Bulks List on July 24, 2026, evaluated for cerebral ischemia, migraine, and trigeminal neuralgia. The committee’s margin was the clearest favorable vote of the second day. FDA scientists recommended against inclusion, citing limited and inconsistent human trial data. Used intranasally or via injection. Formal rulemaking required before compounding access opens.
Emideltide (DSIP)
PCAC RejectedAlso: Delta Sleep-Inducing Peptide, DSIP
FDA PCAC voted 6–7 against recommending Emideltide for the 503A Bulks List on July 24, 2026, with one abstention. Evaluated for insomnia, narcotic dependence, and opioid withdrawal. The rejection was the lone failure of the two-day meeting. The committee’s reasoning included a theoretical addictive potential from its endorphin-stimulating mechanism, and FDA scientists flagged inconsistent trial data. Emideltide was removed from Category 2 on April 23, 2026, and is not currently restricted. It is not on a compounding-accessible list. Available from research chemical suppliers only.
Ipamorelin
Category 1Also: NNC 26-0161
GHRP that selectively stimulates GH release without affecting cortisol or prolactin. Currently Category 1 — compoundable for valid prescriptions from 503A pharmacies. Commonly combined with CJC-1295 (without DAC) for GH optimization protocols. Not under PCAC review in 2026.
Selank
Category 1Also: TP-7
Anxiolytic peptide derived from tuftsin. Modulates serotonin, dopamine, and GABA. Used intranasally. Category 1 status allows compounding with a valid prescription. 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. A second PCAC meeting before February 2027 may review GHK-Cu for additional indications. 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, which distinguishes it from most compounds reviewed at the July 2026 PCAC meeting.
AOD-9604
Category 1Also: Anti-Obesity Drug 9604, hGH Fragment 177-191
Lipolytic fragment of human growth hormone. Category 1, compoundable. Targets fat metabolism without the appetite suppression side effects common to GLP-1 agonists. Growing +40% YoY as a GLP-1 alternative for patients who cannot tolerate nausea.
NAD+ (Injectable)
Category 1Also: Nicotinamide Adenine Dinucleotide, NAD
Category 1, compoundable for subcutaneous injection and IV infusion. Restores mitochondrial NAD+ levels that decline with age. Growing +50% YoY. High search volume for SubQ vs IV delivery comparison as patients prefer at-home administration.
Sermorelin
Category 1Also: Geref, GHRH 1-29
FDA-approved for diagnostic use in growth hormone deficiency testing. Category 1 for compounding in anti-aging and GH-optimization contexts. Considered the entry-level GHRH due to a well-established safety profile. Not under review in the July 2026 PCAC process.
LL-37
Pending Review→ Second PCAC meeting — before February 2027Also: Cathelicidin, human cathelicidin antimicrobial peptide
FDA has announced a second PCAC meeting before February 2027 that will review LL-37 alongside four other compounds. LL-37 is an endogenous antimicrobial peptide researched for wound healing, immune modulation, and anti-biofilm activity. Currently available from research chemical suppliers only. Formal review date not yet announced.
Dihexa
Pending Review→ Second PCAC meeting — before February 2027Also: PNB-0408, N-hexanoic-Tyr-Ile-(6) aminohexanoic amide
FDA-listed for review at the second PCAC meeting before February 2027. Researched for cognitive enhancement and neurological repair. Claims of potency far exceeding established nootropics circulate widely in the biohacking community. No human clinical trial data. Research chemical status. Not under any current FDA approval pathway.
Melanotan II
Pending Review→ Second PCAC meeting — before February 2027Also: MT-2, MTII
Listed for second PCAC review before February 2027. Melanocortin receptor agonist used for tanning and erectile dysfunction. PT-141 (bremelanotide) is the FDA-approved, more selective analog. Melanotan II has a broader receptor profile with a less predictable side effect range. Research chemical status in the US.
PEG-MGF
Pending Review→ Second PCAC meeting — before February 2027Also: Pegylated Mechano Growth Factor, IGF-1 Ec
Pegylated form of Mechano Growth Factor, a splice variant of IGF-1. Extended half-life from PEGylation allows less frequent dosing. Researched for muscle repair and satellite cell activation. Listed for second PCAC review before February 2027. WADA-prohibited. Research chemical status.
Semaglutide
FDA ApprovedAlso: Ozempic, Wegovy, Rybelsus
FDA-approved for type 2 diabetes (Ozempic) and obesity (Wegovy). Oral form (Wegovy 25mg/50mg tablet) launched 2025. Compounded versions remain available despite FDA shortage resolution. Accounts for approximately 8% of all US prescriptions as of March 2026. Not reviewed at PCAC, as it is FDA-approved.
Tirzepatide
FDA ApprovedAlso: Mounjaro, Zepbound
FDA-approved dual GIP/GLP-1 agonist for type 2 diabetes (Mounjaro) and obesity (Zepbound). Compounded versions remain in high demand despite brand availability. Injectable only. No oral form approved. Legal status of compounded tirzepatide remains contested. Not reviewed at PCAC.
Tesamorelin
FDA ApprovedAlso: Egrifta, Egrifta SV
FDA-approved for HIV-associated lipodystrophy. Used off-label for visceral fat reduction in the general population. Category 1 for compounding. High search intent for the off-label indication. The most clinically validated GHRH in the compounding space.
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. Compounded versions widely available. Available as SubQ injection or nasal spray. The more selective, safer cousin of Melanotan II, which is pending PCAC review.
Retatrutide
InvestigationalAlso: LY3437943
Phase 3 trials ongoing. Triple agonist targeting GLP-1, GIP, and glucagon receptors simultaneously. Not FDA approved. Available from research chemical suppliers only, with no prescription or clinical oversight pathway. Search volume growing +300% YoY as Phase 3 data circulates. Not reviewed at PCAC.
CJC-1295 (with DAC)
Category 2Also: Drug Affinity Complex CJC, CJC-1295 DAC
Category 2 restriction remains in effect for CJC-1295 with DAC. The extended 6 to 9 day half-life raises pharmacokinetic concerns that kept it out of the July 2026 PCAC review. Not on the docket for the upcoming February 2027 meeting either. CJC-1295 without DAC is Category 1 and remains compoundable.
MK-677 (Ibutamoren)
Research ChemicalAlso: Ibutamoren, Numalin
Oral GH secretagogue. Not FDA approved. WADA-prohibited in athletic competition. Not on any PCAC agenda. Available from research chemical suppliers. High search volume for side effects, including blood glucose elevation and water retention. Not legally available through compounding pharmacies.
What the PCAC Vote Means — and What It Does Not
The vote is advisory. The headlines are already blurring this, so it is worth stating plainly: a PCAC recommendation is one of three distinct legal events the market tends to treat as one. The first was April 23, 2026, when all seven compounds were removed from Category 2 (restricted from compounding). The second was this week’s committee vote. The third is formal rulemaking, which has not started yet and typically takes 8 to 12 months when it does.
What the vote means: the committee, voting against its own FDA staff’s written recommendations on every favorable outcome, signaled that it believes access to these compounds through licensed compounding pharmacies is appropriate. That signal carries political weight under an HHS Secretary who has publicly advocated for broader peptide access. It does not, by itself, open a compounding pharmacy pathway.
What comes next: the FDA reviews the recommendations and decides whether to initiate rulemaking. If it does, there is a public comment period and a formal review before any final rule takes effect. Compounds that received favorable votes remain in the same legal state they have been in since April 23, 2026 — off the restricted list, available from research chemical suppliers, but not yet on the 503A Bulks List that would allow compounding pharmacies to fill prescriptions for them.
Emideltide (DSIP) was the lone rejection, narrowly failing 6 to 7 with one abstention. It remains off Category 2 but has no PCAC recommendation. A second PCAC meeting before February 2027 will review LL-37, GHK-Cu, Dihexa, Melanotan II, and PEG-MGF.