FDA ISSUES 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.  The FDA has issued a guidance explaining a temporary policy regarding state-licensed pharmacies and federal facilities compounding certain human drugs for hospitalized patients during the COVID-19 public health emergency. This guidance helps address reported issues with accessing certain FDA-approved drugs used for hospitalized patients with COVID-19.

FDA recognizes that during the COVID-19 public health emergency, even with the recent temporary regulatory flexibility provided to outsourcing facilities, the supply of FDA-approved drugs and drugs compounded by outsourcing facilities may not be sufficient to meet urgent needs for drugs used to treat hospitalized COVID-19 patients.  As a temporary measure, with regard to drugs listed in Appendix A, FDA does not intend to take action against state-licensed pharmacies and federal facilities under the circumstances outlined in the guidance for:

  • compounding a drug that is essentially a copy of a commercially available drug, or
  • providing a drug to a hospital without first obtaining a patient-specific prescription

Hospitals that cannot obtain FDA-approved drugs and seek to use compounded drugs for their hospitalized patients should first contact outsourcing facilities that produce compounded drugs under more robust quality standards than those made by state- licensed pharmacies or federal facilities.