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Federal Response to COVID-19: Therapeutics Clinical Implementation Guide (Outpatient Administration Guide for Healthcare Providers)

Clinical Implementation Guide Objectives

  • Review available outpatient COVID-19 therapeutics used to treat eligible non-hospitalized patients who have mild to moderate symptoms of COVID-19.
  • Summarize key information on COVID-19 therapeutics and support healthcare providers’ understanding of these therapies and how to implement their administration.
  • Describe process for obtaining and reporting COVID-19 therapeutics products purchased by HHS/ASPR, including collaboration with state and territorial health departments, as well as national healthcare and medical organizations and associations to ensure efficient and equitable distribution.

IMPORTANT NOTE: The Clinical Implementation Guide (CIG) is updated regularly following changes to COVID-19 therapeutic Emergency Use Authorizations (EUAs), approvals, or prescribing information of FDA approved therapeutics; however, there may be a lag in publishing updated versions. As such, it is important for healthcare providers to stay abreast of the latest changes to EUAs and prescribing information and their impact on distribution, and administration of COVID-19 therapeutics. 

 See the latest information on all FDA authorized products under EUA.

COVID-19 Therapeutics under Emergency Use Authorization (EUA)

  • In certain types of emergencies, the FDA can issue an emergency use authorization (EUA), to provide more timely access to critical medical products (including medicines and tests) that may help during the emergency when there are no adequate, approved, and available alternative options.
  • The EUA process is different than FDA approval, clearance, or licensing because the EUA standard may permit authorization based on significantly less data than would be required for approval, clearance, or licensing by the FDA. This enables the FDA to authorize the emergency use of medical products that meet the criteria within weeks rather than months to years. Since EUA products are not approved and, thus, do not have labeled indications, “off-label use” or the use of the product outside of the EUA authorization is not permitted.
  • EUAs are in effect until the emergency declaration ends but can be revised or revoked. The need will be evaluated during the emergency, availability of new data on the product’s safety and effectiveness, or as products meet the criteria to become approved, cleared, or licensed by the FDA.
  • Products packaged under the EUA must be prescribed/administered in accordance with the EUA even if the product receives FDA approval

HHS’s COVID-19 Therapeutics Homepage & Announcements