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April 17, 2020

Health Law Daily

FDA Allows Compounders To Manufacture Drugs For Patients With Novel Coronavirus On Ventilators

  • April 17, 2020

STAT (4/16, Silverman) reports, “In response to shortages of medicines needed for Covid-19 patients on ventilators, the Food and Drug Administration is temporarily easing its rules so that compounders can start making some of the drugs.” As long as “the nationwide public health emergency is in effect, the agency will not take action against compounding pharmacies that make a medicine that is a copy of an approved drug, use bulk ingredients not on an approved list, or fail to meet good manufacturing requirements for stability testing.” The shift “applies only to so-called outsourcing facilities which, unlike smaller compounders that typically fill individual prescriptions, make and sell large quantities of medicines without requiring prescriptions.”