Endo files lawsuit to obtain FDA compliance with Drug Quality and Security Act of 2013

Ireland-incorporated Endo International (Nasdaq: ENDP) has revealed that two of its subsidiaries have filed suit in the US District Court for the District of Columbia against the Food and Drug Administration seeking a declaration that the FDA's current framework allowing for the bulk compounding of numerous products is unlawful under the Drug Quality and Security Act of 2013 (DQSA) amendments to the Federal Food, Drug, and Cosmetic Act (FDCA).

The lawsuit also seeks the immediate removal of vasopressin from the FDA's Category 1 nominations list to assure that non-sterile-to-sterile outsourcing facilities cannot engage in bulk compounding of vasopressin. Endo filed the suit based on legislative provisions contained in the DQSA amendments requiring FDA to implement a regulatory framework regarding bulk compounding that serves to protect the public health.