It depends on which peptide, how you got it, where you live, and what you plan to do with it.
On April 15, 2026 the FDA took two coordinated actions. It cleared 12 peptides out of Category 2 (“significant safety concerns”) and scheduled fresh PCAC reviews of those substances.
Compounding status today is unchanged. None of the affected peptides is currently legally compoundable under §503A, the section of the Federal Food, Drug, and Cosmetic Act (codified at 21 U.S.C. §353a) that governs traditional pharmacy compounding. To be compoundable under §503A, a bulk substance must either have a USP monograph, be a component of an FDA-approved drug, or appear on the FDA’s “503A Bulks List.” None of these 12 peptides currently does.
The substantive decisions are coming in three buckets:
7 peptides being formally evaluated for inclusion on the §503A Bulks List. Each with a specific indication FDA reviewed.
5 peptides removed from Category 2 but parked. Review comes later in the calendar.
Significant-safety-concerns list narrowed sharply. 2 peptide-adjacent substances remain consumer-relevant:
Five things to know before you go further. Each links to where the full detail lives on this page.
FDA-approved peptide + valid Rx = legal.
Ozempic, Wegovy, Mounjaro, Zepbound, Vyleesi. Off-label use is at your physician’s discretion.
Compoundable peptide + licensed pharmacy = legal.
Sermorelin, gonadorelin, VIP, NAD+. Must come from a licensed §503A or §503B pharmacy with a valid prescription.
“Research use only” peptides sit in a gray zone.
BPC-157, TB-500, CJC-1295, ipamorelin, Melanotan II. Legal for labs. Not legal when marketed to individuals — that zone is narrowing fast.
40+ state attorneys general are actively enforcing.
Connecticut, Alabama, New York, California leading in 2025-26. “Research use only” labels are no longer providing the legal cover they once did.
Your state matters. A lot.
Federal law sets the floor. States layer on their own enforcement. What’s permissive in Florida or Texas is actively prosecuted in Connecticut or New York. Jump to the map →
Every peptide you might encounter falls into one of three legal buckets. The category — not the molecule — determines what’s legal.
Have been through clinical trials and received FDA approval. Fully legal to prescribe, dispense, and use for approved indications. Off-label prescribing is at the physician’s discretion.
Semaglutide (Ozempic, Wegovy) · Tirzepatide (Mounjaro, Zepbound) · Liraglutide · Leuprolide · Tesamorelin · Bremelanotide (Vyleesi)
Not themselves FDA-approved, but eligible under §503A/503B compounding. They appear on the Category 1 bulks list, have USP monographs, or are active ingredients in approved drugs. Legal with a valid prescription through a licensed pharmacy.
Sermorelin · Gonadorelin · GHK-Cu (topical) · VIP · NAD+
Not FDA-approved and not legally compoundable. Sold as “research chemicals” or “for research use only.” Selling for genuine lab research is legal. Marketing for human consumption is not — a distinction state AGs are now enforcing aggressively.
BPC-157 · TB-500 · CJC-1295 · Ipamorelin · AOD-9604 · Melanotan II · Selank · Semax · KPV · Epitalon
More than 40 state attorneys general sent a coordinated letter to the FDA on peptide sales. Connecticut forced a seller to cease operations and accept a monetary judgment. Alabama obtained a temporary restraining order in November. “Research use only” labels are no longer providing the legal cover they once did.
Federal law sets the floor. States layer on their own rules — and, increasingly, their own enforcement. Tap a state to read its posture. States shown in grey default to the federal framework with no state-specific guidance documented.
Pick a scenario. Two or three questions walk the federal regulatory framework. For state-specific enforcement, see the map above.
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