Tirzepatide: FDA and compounding status

Quick answer

Tirzepatide is an FDA-approved drug and is not on FDA's 503A Bulks List. Section 503A records it as "Not nominated" (May 14, 2026) and section 503B as "Proposed for exclusion" (May 1, 2026). No PCAC recommendation is on file and the committee is advisory; verified September 16, 2026.

By Peptides.NYC Editorial TeamPublished September 16, 2026

Verified against FDA's bulk substances page on September 16, 2026. Every field below links the document it came from.

Current status

Tirzepatide

FDA approval

FDA approved

FDA approved MOUNJARO (tirzepatide injection) under NDA 215866 on May 13, 2022 as a new molecular entity, under priority review.

Sources

Drugs@FDA, NDA 215866 (MOUNJARO, tirzepatide injection) (U.S. Food and Drug Administration, retrieved 2026-09-16)

Section 503A

Not nominated

As stated on the cited document, dated May 14, 2026.

The substance appears in none of the categories on that nomination document, as of the document's own date.

Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.

Sources

FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)

Section 503B

Proposed for exclusion

As stated on the cited document, dated May 1, 2026.

FDA considered the nomination and published a Federal Register notice proposing not to include the substance on the list, having found no clinical need.

FDA considered the nominations and proposes NOT to include tirzepatide on the 503B Bulks List, finding no clinical need for outsourcing facilities to compound it from bulk substances. Comments closed June 30, 2026; a final determination had not been published as of the verification date.

Sources

List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the FD&C Act, Doc. 2026-08552, published May 1, 2026; comments closed June 30, 2026 (Office of the Federal Register, retrieved 2026-09-16)
FDA, FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List, April 30, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)

Verified against FDA's bulk substances page on September 16, 2026.

Timeline

Every dated event on file for Tirzepatide, newest first, with the document it came from.

August 27, 2026Status change
In Outsourcing Facilities Ass'n v. FDA, No. 25-10758, the Fifth Circuit affirmed for the same reasons it had affirmed the district court's judgment in the companion Eli Lilly appeal over compounded tirzepatide.
Sources
- Outsourcing Facilities Ass'n v. FDA, No. 25-10758 (5th Cir. Aug. 27, 2026; opinion revised Sept. 1, 2026) (U.S. Court of Appeals for the Fifth Circuit, retrieved 2026-09-16)
May 1, 2026Status change
FDA published a Federal Register notice proposing not to include tirzepatide on the 503B Bulks List; the notice records a comment close date of June 30, 2026.
Sources
- List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the FD&C Act, Doc. 2026-08552, published May 1, 2026; comments closed June 30, 2026 (Office of the Federal Register, retrieved 2026-09-16)
April 30, 2026Status change
FDA announced it was proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need, and invited comments through June 29, 2026.
Sources
- FDA, FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List, April 30, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)
May 13, 2022Status change
FDA approved MOUNJARO (tirzepatide injection) under NDA 215866.
Sources
- Drugs@FDA, NDA 215866 (MOUNJARO, tirzepatide injection) (U.S. Food and Drug Administration, retrieved 2026-09-16)

Related guides

Frequently asked questions

Is Tirzepatide legal to compound?

On FDA's section 503A list, Tirzepatide is recorded as "Not nominated" as of May 14, 2026. On FDA's section 503B list, Tirzepatide is recorded as "Proposed for exclusion" as of May 1, 2026. Tirzepatide is not on FDA's 503A Bulks List: that list is established by notice-and-comment rulemaking, and none of the categories above is inclusion on it. Compounding is governed by federal and state law together, and a pharmacy or outsourcing facility answers to both. This page reports what FDA has published; it is not legal or medical advice.

Was Tirzepatide reviewed by PCAC?

This tracker cites no Pharmacy Compounding Advisory Committee record for Tirzepatide. PCAC's role is advisory: FDA must still complete notice-and-comment rulemaking before anything is added to the 503A Bulks List.

Is Tirzepatide FDA-approved?

FDA approved MOUNJARO (tirzepatide injection) under NDA 215866 on May 13, 2022 as a new molecular entity, under priority review.

Disclaimer: This page is a record of what regulators have published about Tirzepatide. It is for educational purposes only, it is not medical or legal advice, and it is not a recommendation to use or compound any substance. Regulatory status changes; check the linked primary sources and consult your healthcare provider.