FDA Releases Declaratory Order Regarding Tirzepatide Shortage

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The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of history, on October 2, 2024 the FDA determined the tirzepatide shortage was resolved and compounders could no longer rely on the shortage to compound the product. Shortly thereafter, a compounding trade association sued the FDA arguing that its abrupt decision to deem the shortage resolved led to patient safety concerns, relying upon a continuity of care argument and arguing that there was not enough commercial product in the system to serve all patients. As a result, FDA agreed to reconsider its decision. Thus, even though the FDA found that the shortage was technically resolved, compounding pharmacies and 503B facilities were still permitted to compound with tirzepatide while the FDA took a second look.

On December 19, 2024, the FDA released a new decision determining that the tirzepatide shortage has formally been resolved, including all strengths of Mounjaro (2.5 mg, 5.0 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg) and Zepbound (2.5 mg, 5.0 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg). However, to address any concerns regarding patient continuity of care, the FDA established a grace period for 503A compounding pharmacies, compounding physicians and 503B outsourcing facilities. As such, the FDA does not plan to take any action against the following entities when compounding commercially available tirzepatide drug products:

  • State-licensed 503A compounding pharmacies and physicians compounding under Section 503A may compound, distribute or dispense tirzepatide injections within 60 calendar days from yesterday’s [December 19, 2024] announcement, until February 18, 2025.
  • Outsourcing 503B facilities may compound, distribute or dispense tirzepatide injections within 90 calendar days from yesterday’s [December 19, 2024] announcement, until March 19, 2025.

The FDA explained that a longer time was given to 503B facilities because they are registered with FDA and are subject to cGMP requirements, and also that they invest more resources and time before they can produce products due to a shortage because of those standards. What they did not explain, however, were the practical implications. For example, if a 503A can compound until February 18th, is it prohibited from dispensing that compounded product on February 19th? Can a 503A dispense a 503B compounded product after February 18th since 503Bs can compound until mid-March? Also, some members within the industry have contemplated whether the FDA’s Declaratory Order will re-ignite litigation from the compounding trade association that filed suit in October, potentially causing the FDA’s decision to remanded again. We will keep an eye on the litigation, the FDA’s webpage regarding this matter found here, and the declaratory order found here to see if any updates are provided.

If you have any questions regarding the FDA statement on the tirzepatide shortage please contact your Quarles attorney or:

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