503A compounding of tirzepatide copies loses its shortage protection

The FDA's 60-day grace period for state-licensed compounding pharmacies making copies of tirzepatide runs out today. Tirzepatide is the active ingredient in Eli Lilly's Mounjaro and Zepbound. After the agency declared the tirzepatide shortage resolved on December 19, 2024, it gave so-called 503A pharmacies until February 18, 2025 to wind down compounding, distributing or dispensing tirzepatide injections that are "essentially a copy" of the FDA-approved products ^[1][2].

How the wind-down was set up

FDA first removed tirzepatide from its shortage list in October 2024, then was ordered by a court to re-evaluate that call as part of litigation brought by the Outsourcing Facilities Association ^[2]. On December 19, 2024, the agency reached the same conclusion, finding that "supply meets or exceeds current demand, and . . . will also meet or exceed projected demand" ^[1]. FDA said it would keep monitoring and did not rule out putting tirzepatide back on the shortage list later if warranted ^[1].

To avoid abrupt disruption to treatment, FDA set two different clocks: 60 calendar days for 503A pharmacies and physicians, ending February 18, 2025, and 90 calendar days for 503B outsourcing facilities, ending March 19, 2025 ^[1][2]. In a February 11, 2025 clarification, FDA said the 503A period runs until February 18 "or until the date of the district court's decision on the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association (OFA) v. FDA (N.D. Tex.), whichever is longer" ^[2]. FDA later reported that the district court denied that preliminary injunction motion on March 5, 2025, and that the 503A enforcement discretion period had ended ^[2].

The legal mechanics differ by pharmacy type. Outsourcing facilities (503B) can only compound from a bulk drug substance if that substance is on the 503B bulks list or the drug is on FDA's shortage list at the time of compounding, distribution and dispensing — and tirzepatide is on neither ^[1][2]. Traditional 503A pharmacies can still compound in a narrow set of circumstances, such as documented medical necessity, but are barred from making products that are essentially copies of the commercially available drug ^[1].

FDA's guidance treats a compounded product as essentially a copy when it has the same active ingredient as a commercially available drug in the same, similar or easily substitutable strength, and the commercial product can be used by the same route of administration — unless a prescriber determines and documents that the compounded version has a change that produces a significant difference for a specific patient ^[2]. FDA has also said it may consider combination products, such as semaglutide mixed with vitamin B12, to be essentially copies when strengths are within 10% of the approved products ^[2].

Why it matters for patients

Many people have been getting tirzepatide through compounding pharmacies and telehealth platforms, often paying cash. Today's deadline means that source is no longer shielded by the shortage listing for 503A pharmacies, and the 503B channel closes on March 19, 2025 ^[1][2]. Some clinics may stop offering compounded tirzepatide, change what they offer, or point to a documented "significant difference" exception, which FDA guidance limits to an identified individual patient ^[1][2].

Supply on the ground may not feel resolved everywhere. The law firm Frier Levitt noted that the 503B lawsuit against FDA is ongoing and that shortages continued to be reported by pharmacies, so the situation could change ^[1]. FDA has also said patients and prescribers may still see intermittent and limited localized supply disruptions as products move through the supply chain ^[2].

Semaglutide is on a separate track. As of December 19, 2024, FDA still listed semaglutide injection as in shortage, along with dulaglutide and liraglutide, even though the manufacturer reported all semaglutide presentations available ^[2]. FDA notes that "available" reflects manufacturer information, not an agency determination that a shortage is resolved ^[2]. What individual pharmacies or telehealth companies will do in response to these deadlines is not something the sources describe.

What happens next

• March 19, 2025: the 90-day enforcement discretion window for 503B outsourcing facilities compounding tirzepatide injections expires ^[1][2].
• Ongoing: the OFA v. FDA litigation continues; FDA said on March 10, 2025 that the district court denied the preliminary injunction motion on March 5, 2025 ^[2].

Throughout, FDA has said it may still act on violations of other statutory or regulatory requirements, including findings that a product may be of substandard quality or otherwise unsafe ^[1][2].