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Pharmaceuticals / Regulatory Affairs

Endo Resumes Lawsuit Against FDA Over Bulk Drug Compounding Decree

Aug. 20, 2018

Endo lifted its stay of litigation against the FDA and is going ahead with a lawsuit challenging the agency’s policy on bulk drug compounding.

Two Endo subsidiaries, Par Sterile Products and Endo Par Innovation, filed the initial lawsuit against the FDA last October, seeking to halt compounding involving the API vasopressin.

They claimed the agency’s handling of bulk compounding laws violates the 2013 Drug Quality and Security Act, treating the laws as non-binding guidance rather than a legal mandate. Congress passed the law after a 2012 meningitis outbreak that originated with illegal bulk manufacturing of a compounded drug. The lawsuit claims the FDA ignored the law and instead operated under a less rigorous “interim” program.

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