FDA again says tirzepatide shortage is resolved and sets compounding deadlines

On December 19, 2024, the U.S. Food and Drug Administration determined again that the shortage of tirzepatide injection products is resolved, and set deadlines for compounding pharmacies and outsourcing facilities to stop making copies of the brand-name drugs Mounjaro and Zepbound ^[2][3].

The decision followed a court-ordered re-evaluation of the agency's October 2, 2024 determination. The new declaratory order revokes and replaces that earlier decision ^[1][3]. FDA said its conclusion rested on data from Eli Lilly, the maker of Mounjaro and Zepbound, showing that supply "meets or exceeds current demand" and will also meet or exceed projected demand ^[1][3]. Tirzepatide was first added to the shortage list on December 15, 2022 ^[3].

Under the order, FDA does not intend to take enforcement action against compounders for violations that depend on tirzepatide's place on the shortage list during two wind-down periods ^[2][3]:

• State-licensed pharmacies and physicians compounding under section 503A have 60 calendar days, until February 18, 2025 ^[1][2][3].
• Outsourcing facilities under section 503B have 90 calendar days, until March 19, 2025 ^[1][2][3].

FDA said it can still act on other violations of statutory or regulatory requirements, such as products found to be substandard quality or unsafe ^[1][2][3].

After those periods, 503B outsourcing facilities cannot compound tirzepatide because it appears on neither FDA's shortage list nor the 503B bulks list, according to the agency ^[1][2]. For 503A pharmacies, compounding that is "essentially a copy" of the commercial products is prohibited, though narrow circumstances — such as documentation of medical necessity — may still allow compounding ^[1].

Not everyone agrees the shortage is over. FDA said it received reports from patients and pharmacists who could not obtain the approved drugs, and acknowledged that "some individuals may still be currently encountering such challenges," which the agency attributed to dynamics in the supply chain between Lilly and local pharmacies rather than a national shortage ^[3]. The Alliance for Pharmacy Compounding said the announcement was not unexpected but "not necessarily the end of the story." Its CEO, Scott Brunner, said: "I'm just not persuaded that the data on which FDA is relying in this doubling-down on its shortage resolution decision is complete enough to say the shortage is really over" ^[4]. A Lilly spokesperson said anyone marketing or selling unapproved versions of tirzepatide must stop and begin transitioning patients to FDA-approved medicines ^[4].

The Outsourcing Facilities Association, which sued FDA in October over the earlier decision, is still in litigation. In a joint court filing on December 19, both sides said they were working to agree on a schedule, and FDA agreed not to take enforcement action while the court considers a motion to block the decision, if the association files one within two weeks ^[4].

As of December 19, FDA still listed dulaglutide injection, semaglutide injection and liraglutide injection as in shortage ^[1][2]. Reuters reported that Novo Nordisk's Wegovy, a semaglutide product, remained in shortage even though all doses were listed as available ^[4]. FDA notes that an "available" listing reflects the manufacturer's current information and is not an agency determination that a shortage is resolved ^[2].

Why it matters for patients

Compounded versions of tirzepatide have been a lower-cost route for patients, in part because insurers generally cover the brand-name drugs for diabetes but many do not cover them for weight loss, leaving many patients to pay out of pocket for compounded products ^[4]. The deadlines mean that compounded supply channel is scheduled to wind down: 503A pharmacies after February 18, 2025, and 503B facilities after March 19, 2025 ^[1][2][3].

FDA said patients and prescribers may still see "intermittent and limited localized supply disruptions" as products move from the manufacturer through distributors to local pharmacies, even with the shortage considered resolved nationally ^[3]. The agency said it will keep monitoring supply and demand and did not rule out adding tirzepatide back to the shortage list ^[1][3].

Whether patients currently using compounded tirzepatide will be able to move to an FDA-approved product, what they would pay, and whether any compounding continues has not been reported.

What happens next

• Within two weeks of December 19, 2024: the Outsourcing Facilities Association may ask the court to block FDA's decision; FDA has agreed not to enforce while the court considers such a motion ^[4].
• February 18, 2025: the 503A enforcement discretion period ends ^[1][2][3].
• March 19, 2025: the 503B enforcement discretion period ends ^[1][2][3].