FDA Issues Temporary Guidance for Human Health Compounding

FDA has issued an Emergency Guidance for Industry, “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health.” 

It allows traditional compounding pharmacies, known as 503A pharmacies, to compound 13 specific human-health medications for hospital use with inpatients, when they are in short supply by their manufacturers and not available from so-called 503B Outsourcing Facilities. The policy went into effect immediately and will remain in place “for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, or for such shorter time as FDA may announce through updated guidance.”