FDA Week - 03/09/2018

503B Compounder Targeted By DOJ Fights Back, Says FDA Won't Reinspect

March 08, 2018
The 503B compounding pharmacy that FDA and the Department of Justice are asking a federal judge to shut down is fighting back, using its bankruptcy to request a temporary restraining order that would halt any government action for 45 days. The company argues it has implemented the changes sought by FDA and that the agency has refused to reinspect the facility. A "he said, she said" situation has arisen, where consultants for the compounder argue the company is up to...

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