When did the tirzepatide shortage end?

FDA decided the shortage was resolved on December 19, 2024, after re-reviewing its earlier October 2, 2024 decision.

What is the difference between 503A and 503B?

503A pharmacies compound for individual patients with a prescription; 503B outsourcing facilities can make larger batches and register with FDA.

Does the HHS peptide draft policy change anything for tirzepatide?

No. The October 30, 2026 HHS item is a draft policy (proposed, not final) covering six research peptides, and tirzepatide is not one of them.

Are compounded tirzepatide products FDA-approved?

No. Compounded drugs are not FDA-approved, and FDA does not check them for safety, effectiveness or quality before sale.

FDA status

Is compounded tirzepatide still available?

Q: Is compounded tirzepatide still available?

Generally not as a routine copy of FDA-approved tirzepatide. FDA declared the tirzepatide injection shortage resolved on December 19, 2024. Its grace periods ended March 5, 2025 for state-licensed pharmacies and March 19, 2025 for outsourcing facilities. A pharmacy may still compound a version for an individual patient when a prescriber documents a significant medical difference from the approved drug. Compounded drugs are not FDA-approved.

Last checked: Nov 4, 2026. Educational only, not medical advice. PeptideX is not affiliated with any drug manufacturer.

Status box

FDA status: Shortage resolved (FDA decision Dec 19, 2024).
State-licensed pharmacies (503A): FDA's grace period ended Mar 5, 2025, after a federal court denied a preliminary injunction.
Outsourcing facilities (503B): FDA's grace period ended Mar 19, 2025.
FDA (Apr 2026): tirzepatide is not on the 503B bulks list or FDA's drug shortage list.
Compounded drugs are not FDA-approved.
Last checked: Nov 4, 2026.

Tirzepatide is the active ingredient in FDA-approved tirzepatide medicines. FDA approved tirzepatide for chronic weight management on Nov 8, 2023, and for moderate to severe obstructive sleep apnea in adults with obesity on Dec 20, 2024.

Tirzepatide injections were on FDA's drug shortage list from Dec 15, 2022. During a shortage, pharmacies have more room to make copies of an FDA-approved drug. On Dec 19, 2024, FDA re-reviewed the manufacturer's supply data and decided the shortage is resolved. FDA then gave compounders a wind-down period: Feb 18, 2025 for 503A pharmacies and Mar 19, 2025 for 503B outsourcing facilities, or until a court ruling in Outsourcing Facilities Association v. FDA, whichever was later. The court denied the injunction on Mar 5, 2025, so the 503A period ended then and the 503B period ended Mar 19, 2025.

What this means for you: a pharmacy generally can no longer make routine copies of FDA-approved tirzepatide based on the shortage. A pharmacy may still compound a version for an individual patient when a prescriber documents a significant medical difference from the approved drug. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they are sold. Talk with your clinician about your options.

Separate topic: On Oct 30, 2026 HHS published a draft policy (proposed, not final) about compounding six research peptides (BPC-157, TB-500, epitalon, KPV, MOTS-c, Semax). It does not cover tirzepatide.

FAQ

Sources (checked Nov 4, 2026)

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