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Endo, Par Take Aim at Bulk Drug Compounding

Nov. 22, 2017, 2:09 PM

Bulk drug compounding could be facing a huge regulatory upheaval—one that could essentially shut down the industry.

Recently, drugmakers have raised concerns about whether compounders are complying with applicable Food and Drug Administration regulations and whether compounded drugs are safe and effective. Endo International Plc’s subsidiaries Endo Par Innovation Co. and Par Sterile Products LLC are suing the Food and Drug Administration, alleging the agency’s failure to strictly oversee compounding facilities is allowing unlawful and unsafe bulk compounding (Par Sterile Products LLC v. Hargan, D.D.C., No. 1:17-cv-02221, complaint filed 10/26/17).

The suit, which is the first one of ...

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