FDA declared the tirzepatide shortage resolved, then reaffirmed it after a court remand

The FDA declared the tirzepatide injection shortage resolved on October 2, 2024, removing Mounjaro and Zepbound from its national drug shortage list and ending a shortage that began December 15, 2022 ^[3][4]. The decision was then remanded to the agency for re-evaluation on October 22, 2024 as part of litigation, and reaffirmed on December 19, 2024 in a new order that revoked and replaced the October decision ^[1][3].

In the December 19 order, the FDA said tirzepatide maker Eli Lilly provided detailed production and inventory data, including stock reports for all strengths, cumulative quantities supplied and demanded in 2024, projected supply and demand for future months, and wholesaler inventory data ^[3]. The agency concluded Lilly's supply "is currently meeting or exceeding demand for these drug products" and "will meet or exceed projected demand" ^[3].

The FDA acknowledged it received reports that some patients and pharmacists could not obtain the approved drugs and that "a substantial amount of tirzepatide compounding is occurring," but said that information had "important limitations" and did not outweigh Lilly's data ^[3]. The agency said such intermittent problems were most likely explained by the supply chain between the manufacturer and individual customers, not a continuing national shortage, and that patients and prescribers "may still see intermittent localized supply disruptions" ^[1][3]. The law firm Frier Levitt, which advises compounders, noted the FDA said it would keep monitoring and did not rule out adding tirzepatide back to the shortage list if warranted ^[2].

To avoid disrupting patient treatment, the FDA said it does not intend to take action against state-licensed pharmacies or physicians compounding under section 503A for 60 days from the December 19 order, until February 18, 2025, or against outsourcing facilities under section 503B for 90 days, until March 19, 2025 ^[1][3]. The agency said it may still act on other violations, such as products that may be substandard or unsafe ^[1][2]. Frier Levitt wrote that 503A pharmacies may still compound tirzepatide in narrow circumstances, such as documentation of medical necessity, but cannot compound copies of the approved products ^[2]. A 503B facility may use a bulk drug substance only if it is on the 503B bulks list or the drug is on the FDA's shortage list at the time of compounding, distribution and dispensing; the FDA says tirzepatide and semaglutide appear on neither list ^[1]. One trade publication's October 3 account of the initial decision said small compounding pharmacies had to stop immediately while larger 503B compounders had a 60-day grace period, which differs from the FDA's later description of 60 days for 503A and 90 days for 503B ^[1][3][4].

Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, said in a release that "plenty of patients taking compounded tirzepatide are going to be caught flat-footed by this. They are being cut-off cold-turkey, their prescription no longer fillable" ^[4]. He said that if many of those patients move to the FDA-approved versions "if they can afford them, of course," it could push tirzepatide injection back into shortage ^[4]. FiercePharma reported that shares of Hims & Hers Health, a telehealth seller of prescription drugs, had fallen 14% by mid-morning on October 3 ^[4]. Lilly's president of cardiometabolic health, Patrik Jonsson, said the company "invested significantly to expand manufacturing and bring new options to the market," and Lilly said that "there may be many reasons why a particular pharmacy does not have a particular dose of the medicine in stock" ^[4]. Lilly announced a $4.5 billion manufacturing and research facility in Lebanon, Indiana, due for completion by the end of 2027, part of $13 billion earmarked for its LEAP district there ^[4].

Why it matters for patients

Compounded tirzepatide became a widely used, often cheaper alternative while the drug was on the shortage list, and the shortage designation was what allowed compounders to make copies of the approved products ^[4]. With that designation gone, the FDA's stated wind-down periods set the point at which compounding of these copies is no longer covered by the agency's enforcement discretion ^[1][3]. Patients who get tirzepatide from a compounding pharmacy face a change in where their medication comes from, and Brunner's statement describes prescriptions that can no longer be filled ^[4]. On cost, Lilly sells Zepbound through its LillyDirect pharmacy at a 50% discount to the list price of other GLP-1 medicines ^[4]. As of December 19, 2024, semaglutide injection (Ozempic and Wegovy), dulaglutide injection and liraglutide injection were still listed as in shortage, so compounded versions of those drugs were not yet affected by this decision ^[1][2]. How many patients were using compounded tirzepatide, and how insurers will handle coverage if they switch, has not been reported in these sources.

What happens next

• February 18, 2025: the FDA's stated period of enforcement discretion for 503A state-licensed pharmacies and physicians ends ^[1][3].
• March 19, 2025: the corresponding period for 503B outsourcing facilities ends ^[1][3].
• The FDA later declared the semaglutide injection shortage resolved on February 21, 2025, with its own wind-down dates of April 22, 2025 for 503A compounders and May 22, 2025 for 503B facilities ^[1].