(Reuters) – Endo International Plc on Thursday filed a lawsuit against the U.S. Food and Drug Administration asking the court to declare the regulator’s current bulk compounding norms unlawful.
The lawsuit comes more than a month after the FDA said it was working on a new policy that would encourage more compounding pharmacies to register under the Drug Quality and Security Act of 2013.
The law, passed by Congress in the wake of a deadly 2012 meningitis outbreak, aims to bring more compounding pharmacies under FDA’s purview rather than the state pharmacy boards.
Compounding pharmacies make custom medications that are not FDA approved, and can only be used when prescribed by a doctor for a particular patient.
Such pharmacies can sell products in bulk to hospitals and physician practices without prescriptions.
The lawsuit also sought the immediate removal of vasopressin – an ingredient in the company’s blood pressure drug Vasostrict – from the Category 1 drug list.
Category 1 comprises substances eligible for inclusion on the list of bulk drug compounds.
The FDA declined to comment.
Endo filed the suit in the United States District Court for the District of Columbia.
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