FDA holds off on enforcing compounded tirzepatide limits until court rules

On February 11, 2025, the FDA said it would hold off on enforcement action against compounders making copies of tirzepatide, the active ingredient in Mounjaro and Zepbound, until a federal district court rules on a request to block the agency's earlier decision ^[1][2].

The FDA removed tirzepatide from its drug shortage list in October 2024 ^[1]. Compounding groups sued. In a December 19, 2024 declaratory order, the FDA reaffirmed that determination and said it would exercise enforcement discretion — meaning it would refrain from acting — for 503A compounding pharmacies until February 18, 2025, and for 503B outsourcing facilities until March 19, 2025 ^[1].

The February 11 clarification extended both dates. Enforcement discretion will now run until the later of those original deadlines or the date the district court decides the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association v. FDA, filed in the Northern District of Texas ^[1]. If the court rules before the original deadlines, the FDA will keep to those original timeframes, according to a law firm summary of the litigation ^[2].

What changes after those dates: 503A pharmacies generally can no longer rely on the shortage exception to compound essentially copies of tirzepatide. To keep compounding such a product regularly — five or more units per calendar month — a pharmacy would need the compounded version to differ in dosage strength, route of administration, or another way a prescriber documents as a significant difference for an individual patient ^[1]. For 503B outsourcing facilities, the test turns on whether the product is identical or nearly identical in active ingredient, route of administration, dosage form, dosage strength and excipients, unless a prescriber documents a clinical difference for an individual patient ^[1].

Semaglutide, the ingredient in Ozempic, Wegovy and Rybelsus, followed a separate path. On February 21, 2025, the FDA revised its shortage listing and marked the semaglutide shortage resolved for all presentations of the drug ^[1]. Its declaratory order set enforcement discretion for 503A pharmacies until April 22, 2025, and for 503B facilities until May 22, 2025 ^[1][2]. On February 24, 2025, the Outsourcing Facilities Association filed a separate lawsuit challenging the semaglutide shortage resolution. The FDA has not commented on whether that filing will extend its enforcement discretion ^[1].

Liraglutide, another GLP-1 ingredient, remains in shortage ^[1]. Separately, Eli Lilly has petitioned the FDA to add tirzepatide to its Demonstrable Difficulties for Compounding list, and Novo Nordisk has nominated semaglutide for the same list. If granted, those petitions would bar pharmacists, physicians and outsourcing facilities from compounding the drugs ^[2]. No decision on either petition has been announced ^[2].

Why it matters for patients

The practical effect is timing. Compounded tirzepatide can remain available longer than the original February and March 2025 deadlines suggested, because a court has not yet ruled ^[1][2]. Compounded semaglutide faces the April 22 and May 22, 2025 cutoff unless the FDA changes course in response to the newer lawsuit ^[1].

That means the supply of compounded versions of these drugs can change on short notice, and a pharmacy that fills a prescription one month may not be able to fill it the next. The deadlines do not end all compounding. They end the shortcut that let pharmacies make near-copies of brand products because of a shortage, while leaving room for versions that a prescriber documents as meaningfully different for a given patient ^[1]. Patients who get a compounded version may need to move to an FDA-approved brand product, which can involve different costs and insurance coverage. Nothing in these filings changes what any individual patient's prescription should be; that is a question for the prescriber.

What happens next

• February 18, 2025 and March 19, 2025: the original 503A and 503B deadlines for compounded tirzepatide, now tied to the timing of the court's ruling ^[1].
• A ruling on the preliminary injunction in Outsourcing Facilities Association v. FDA. No date for that decision has been reported ^[1].
• April 22, 2025 and May 22, 2025: enforcement discretion ends for compounded semaglutide under 503A and 503B ^[1][2].
• The Outsourcing Facilities Association's semaglutide lawsuit, filed February 24, 2025, and the two petitions to place tirzepatide and semaglutide on the difficult-to-compound list, both still pending ^[1][2].