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Tirzepatide: Status and What Changed

Grade A, brand productCompounding closed

The short version

  • A dual GIP and GLP-1 receptor agonist, FDA approved with strong trial evidence.
  • Shortage resolved October 2024, closing the compounding exemption.
  • FDA moved in April 2026 to remove it from the 503B bulks list entirely.
  • Under patent. Lilly runs an active enforcement programme against sellers.
  • We do not offer compounded tirzepatide.

The position now

Tirzepatide sits in the same place as semaglutide, slightly earlier on the same timeline. The shortage that permitted mass compounding ended in October 2024. Since then, compounding copies has run against the "essentially a copy" prohibition, and FDA has acted on it at scale.

There is an additional layer here: tirzepatide is under patent, and the patent holder litigates. Regulatory exposure and civil exposure are separate problems and a seller can face both at once.

Why the price gap is so large

Gray market tirzepatide is cheap because the input cost is genuinely low. What you are not paying for is the manufacturing standard, the sterility and endotoxin testing, the supply chain accountability, and anyone who is answerable if something goes wrong. Independent testing has found problems in roughly 30 percent of gray market peptide vials. See our safety page.

Related

Full library · Safety and sourcing · Reconstitution calculator · Compound index

Regulatory status current as of the page date. This area is changing quickly and this page is reviewed monthly. [set review reminder]