FDA removes epinephrine from the lists of drugs for temporary compounding during the COVID-19 public health emergency

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FDA removes epinephrine from the lists of drugs for temporary compounding during the COVID-19 public health emergency

The FDA removed epinephrine from the lists of drugs for temporary compounding by outsourcing facilities and state-licensed pharmacies or federal facilities not registered as outsourcing facilities during the COVID-19 public health emergency. This removal is based on increased supplies of FDA-approved epinephrine products used to treat hospitalized COVID-19 patients. The updated lists are referenced in the following guidances: Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry Hospitals that cannot obtain adequate supplies of FDA-approved drugs and are considering the use of compounded drugs for their hospitalized patients should first contact outsourcing facilities, which are subject to more robust quality standards than state-licensed pharmacies, or federal facilities that do not register with FDA as outsourcing facilities. The guidance for temporary compounding of certain drugs by outsourcing facilities during the COVID-19 public health emergency includes timely product reporting by outsourcing facilities compounding drugs covered by the guidance. Hospitals can use this product information to help determine which outsourcing facilities are compounding drugs used for hospitalized patients with COVID-19.