FDA Releases Declaratory Order Regarding Tirzepatide Shortage
By EsqSocial Corporation 23/12/24
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...
By: Quarles & Brady LLP