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McBrayer Blogs
Showing 2 posts in Drug Quality and Security Act (“DQSA”).
Controlling Compounding: The Drug Quality and Security Act, Part II
Posted In Compounding, Drug Quality and Security Act (“DQSA”), Health Care Law, House Bill 3204, New England Compounding Center ("NECC"), Pharmacists
Earlier this week we discussed the new Drug Quality and Security Act (“DQSA”) that establishes and regulates a new class of compounding pharmacies called “outsourcing facilities.” To qualify as an “outsourcing facility”, the entity must compound sterile drugs with or without patient prescriptions and comply with the DQSA’s new rules, including registering with the FDA. An outsourcing facility is not required to be a licensed pharmacy. Registering as an outsourcing facility is completely voluntary, but entities that do not register may be prohibited from compounding drugs for office use and will be required to obtain prescriptions for individual patients. More >
Controlling Compounding: The Drug Quality and Security Act
Posted In Compounding, Drug Quality and Security Act (“DQSA”), Health Care Law, House Bill 3204, New England Compounding Center ("NECC"), Outsourcing facility, Pharmacists
In October 2012, a fatal meningitis outbreak killed 64 people in the United States and infected more than 750 in 20 states. The outbreak was traced back to contaminated vials of an injectable painkilling steroid that was compounded by the New England Compounding Center (“NECC”). More >
