Judge denies request to block FDA's tirzepatide compounding deadlines

A federal district court in Texas refused on March 5, 2025 to block the removal of tirzepatide from the national drug shortage list, denying a preliminary injunction that would have delayed the FDA's deadlines for compounded versions of the drug ^[1].

The ruling came in Outsourcing Facilities Association v. FDA, 4:24-cv-00953 (N.D. Tex.) ^[1]. With the injunction denied, the FDA's timeline for compounders moves forward as written ^[1]. For state-licensed pharmacies and physicians compounding tirzepatide under section 503A of the Food, Drug, and Cosmetic Act, the agency's period of enforcement discretion has ended ^[1]. For outsourcing facilities compounding under section 503B, the FDA does not intend to take action against compounders for violations of the law that depend on tirzepatide injection products being on the drug shortage list until March 19, 2025 ^[1].

The FDA determined on Dec. 19, 2024 that the tirzepatide injection shortage was resolved, after re-evaluating its October 2024 decision and based on what the agency described as its analysis of all the information before it ^[1]. Mounjaro and Zepbound are the brand-name tirzepatide injection products ^[1]. At that time, the agency set wind-down dates of Feb. 18, 2025 for 503A compounders and March 19, 2025 for 503B outsourcing facilities ^[1]. A Feb. 11, 2025 update said those periods would last until those dates "or until the date of the district court's decision on the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association (OFA) v. FDA, whichever is longer" ^[1].

Semaglutide is on a separate track. The FDA declared the semaglutide injection shortage resolved on Feb. 21, 2025, saying it had confirmed with the drug's manufacturer that stated product availability and manufacturing capacity can meet present and projected national demand ^[1]. The agency set its enforcement discretion periods for semaglutide at April 22, 2025 for 503A compounders and May 22, 2025 for 503B outsourcing facilities, or the date of the district court's decision on a separate preliminary injunction motion in OFA v. FDA, 4:25-cv-00174 (N.D. Tex.), whichever is later ^[1].

Even where that discretion applies, the FDA has said it may still act on violations of other statutory or regulatory requirements, such as findings that a product may be of substandard quality or otherwise unsafe ^[1]. Neither tirzepatide nor semaglutide appears on the FDA's drug shortage list, and neither appears on the agency's 503B bulks list ^[1]. Compounded drugs must also meet conditions for the exemptions: the agency considers a compounded product essentially a copy of an approved drug when it uses the same active ingredient in the same, similar or easily substitutable strength by the same route of administration, unless a prescriber documents a change that produces a significant difference for an identified patient ^[1]. Under 503B, outsourcing facilities may not compound from bulk drug substances unless the substance is on the 503B bulks list or the compounded drug is on the shortage list at the time of compounding, distribution and dispensing ^[1].

Why it matters for patients

For patients who have been receiving compounded tirzepatide from a state-licensed pharmacy, the exemption that covered that supply has narrowed. Under section 503A, a compounded product that is essentially a copy of a commercially available approved product does not qualify for the exemption, and the FDA's period of discretion for tirzepatide compounders operating under 503A has ended ^[1].

How quickly any individual pharmacy stops filling compounded tirzepatide prescriptions, and what it tells patients, has not been disclosed in the agency's statements. The FDA has also said patients and prescribers may still see intermittent and limited localized supply disruptions as products move from manufacturers and distributors to local pharmacies ^[1].

Compounded semaglutide operates on a later clock, with discretion running until April 22, 2025 for 503A compounders and May 22, 2025 for 503B facilities unless the court rules later on the pending motion ^[1]. Whether insurers or pharmacy benefit managers cover a switch between compounded and FDA-approved products is not addressed in the agency's statements ^[1].

What happens next

• March 19, 2025: End of the FDA's stated period of enforcement discretion for 503B outsourcing facilities compounding tirzepatide injection products, tied to the shortage list ^[1].
• April 22, 2025: End of that discretion for 503A state-licensed pharmacies and physicians compounding semaglutide injection products, or the date of the court's decision on the motion in 4:25-cv-00174, whichever is later ^[1].
• May 22, 2025: End of that discretion for 503B outsourcing facilities compounding semaglutide injection products, on the same conditional basis ^[1].

The FDA has said it continues to monitor drug availability and is working to determine whether demand or projected demand for each drug in shortage exceeds available supply ^[1].