FDA sets March 19 end date for compounded tirzepatide from outsourcing facilities

The FDA has confirmed that its period of enforcement discretion for compounded tirzepatide injections is ending, after a federal court in Texas declined to block the agency's timeline ^[1]. For outsourcing facilities, the agency said it does not intend to take action against compounders for violations of federal law that depend on tirzepatide injection products having been on the FDA drug shortage list until March 19, 2025 ^[1].

The March 10, 2025 update followed a March 5, 2025 ruling in which the district court denied the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:24-cv-00953 (N.D. Tex.) ^[1].

Federal compounding rules split compounders into two groups. State-licensed pharmacies and physicians compound under section 503A of the Food, Drug, and Cosmetic Act, which generally requires that a drug be made for an identified patient based on a prescription and that it not be essentially a copy of a commercially available product ^[1]. Larger outsourcing facilities compound under section 503B, which restricts them from using bulk drug substances unless the substance is on the FDA's 503B bulks list or the drug is on the shortage list at the time it is compounded, distributed and dispensed ^[1].

For tirzepatide, FDA said the 503A enforcement discretion period has ended ^[1]. The earlier deadline was February 18, 2025, or the date of the court's decision on the injunction motion, whichever was longer; the court's March 5 denial closed that window ^[1]. The remaining 503B period runs through March 19, 2025 ^[1].

The update also restated the semaglutide schedule, which was not changed by the tirzepatide ruling. For state-licensed pharmacies and physicians compounding under 503A, enforcement discretion runs until April 22, 2025, or until the district court decides a preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.), whichever is later ^[1]. For 503B outsourcing facilities, it runs until May 22, 2025, or the court's decision, whichever is later ^[1]. The March 10 update describes that semaglutide motion as forthcoming, so those dates could be pushed later depending on how the court rules ^[1].

The deadlines follow FDA's determinations that the shortages are over. FDA said on December 19, 2024 that the tirzepatide injection shortage was resolved ^[1]. On February 21, 2025, it said the semaglutide injection shortage was resolved, after semaglutide injections had been in shortage since 2022 ^[1]. FDA said it confirmed with the manufacturer that stated product availability and manufacturing capacity can meet present and projected national demand, though patients and prescribers may still see intermittent and limited localized supply disruptions as products move from manufacturers and distributors to local pharmacies ^[1].

The agency also said it may still act on other violations, such as findings that a compounded product is substandard or otherwise unsafe ^[1].

Why it matters for patients

Compounded versions of GLP-1 drugs became widely used during the shortage, when brand-name supply was limited. With the shortage designations removed, the legal room for compounders to make near-copies of those products is narrowing on a fixed schedule ^[1].

The practical effect depends on which drug and which type of pharmacy a patient uses. Compounded tirzepatide from a state-licensed pharmacy or physician is now outside the discretion period, while outsourcing facilities have until March 19, 2025 ^[1]. Compounded semaglutide has later dates: April 22, 2025 for 503A compounders and May 22, 2025 for 503B facilities ^[1]. Patients who receive compounded injections could find that a pharmacy stops filling those prescriptions as the dates pass.

FDA's update does not address what patients pay, whether insurance will cover brand-name products, or how quickly any individual pharmacy will stop. Those details have not been reported. FDA has said localized supply disruptions are still possible even though national supply is considered adequate ^[1].

What happens next

• March 19, 2025: the 503B enforcement discretion period for compounded tirzepatide injections ends ^[1].
• April 22, 2025: the 503A discretion period for compounded semaglutide injections ends, unless a later court decision extends it ^[1].
• May 22, 2025: the 503B discretion period for compounded semaglutide injections ends, unless a later court decision extends it ^[1].
• A ruling on the semaglutide preliminary injunction motion in OFA v. FDA, 4:25-cv-00174, had not been issued as of the March 10 update ^[1].