FDA clarifies tirzepatide compounding deadlines pending court ruling

The Food and Drug Administration said on February 11, 2025 that it has not changed its plans for compounded tirzepatide, and clarified how long it intends to hold off on enforcement. State-licensed pharmacies and physicians have until February 18, 2025, while outsourcing facilities have until March 19, 2025. In both cases, if a federal court rules on a pending preliminary injunction motion after those dates, the later date applies ^[1].

Tirzepatide is the active ingredient in the FDA-approved injection products Mounjaro and Zepbound ^[1].

The clarification follows the agency's December 19, 2024 decision that the tirzepatide injection shortage was resolved, based on its analysis of the information before it ^[1]. At that time, FDA set 60-day and 90-day windows for compounders — until February 18, 2025 for state-licensed pharmacies under section 503A of the federal Food, Drug and Cosmetic Act, and until March 19, 2025 for outsourcing facilities under section 503B. The agency said the windows were meant to avoid unnecessary disruption to patient treatment ^[1].

The enforcement discretion covers violations that depend on tirzepatide injection products being on FDA's drug shortage list ^[1]. In practice, that relates to the rule against compounded drugs that are "essentially a copy" of a commercially available product. FDA has said it considers a compounded product essentially a copy when it contains the same active ingredient in the same, similar or an easily substitutable strength and is given by the same route of administration as the approved product, unless a prescriber documents a change that produces a significant difference for an identified patient ^[1].

The agency also said it may still take action on other violations of statutory or regulatory requirements, including when a product may be of substandard quality or otherwise unsafe ^[1].

Why it matters for patients

Compounded tirzepatide has been one route to treatment for people who could not get, or could not afford, the FDA-approved versions. Once the enforcement windows close, FDA's stated intent not to act against compounders for shortage-related violations ends, which could mean some pharmacies stop selling compounded tirzepatide. How quickly individual pharmacies stop, and how much compounded supply they still hold, has not been reported ^[1].

The deadlines are not a guarantee that no action will be taken. FDA said it may still act on other violations, such as findings that a product may be substandard quality or otherwise unsafe ^[1].

What options remain for someone currently using a compounded tirzepatide product depends on their prescriber and pharmacy. Coverage and pricing of the FDA-approved products were not addressed in the February 11 update ^[1].

What happens next

• February 18, 2025: the window for state-licensed pharmacies and physicians ends, unless the court rules later ^[1].
• March 19, 2025: the window for outsourcing facilities ends, unless the court rules later ^[1].
• A preliminary injunction motion in Outsourcing Facilities Association v. FDA, in the Northern District of Texas, had not been decided as of the February 11 update ^[1]. If the court rules after either date, the later date is the deadline, the agency said ^[1].