Table 2.

Scope of authorization of EUAs granted by FDA

Treatment	FDA Scope of Authorization
Remdesivir	Distribution of the authorized Veklury will be controlled by the U.S. Government for use consistent with the terms and conditions of the EUA. Gilead will supply Veklury to authorized distributors, or directly to a U.S. government agency, who will distribute to hospitals and other healthcare facilities as directed by the U.S. Government, in collaboration with state and local government authorities, as needed. Veklury covered by this authorization will be used only to treat adults and children with suspected or laboratory confirmed COVID-19 administered in an in-patient hospital setting via IV infusion by a healthcare provider. The use of Veklury covered by this authorization should be in accordance with the dosing regimens as detailed in the authorized Facts Sheets.
Convalescent plasma	The scope of the authorization is limited to the use of the authorized COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. The emergency use of the authorized COVID-19 convalescent plasma under the EUA must be consistent with, and may not exceed, the terms of the letter of authorization, including the scope and the conditions of authorization set by the letter.
Fresenius Propoven 2% Emulsion	Fresenius Propoven 2% Emulsion will be used only to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation. Fresenius Propoven 2% Emulsion will be administered only by a licensed healthcare provider in an ICU setting. Fresenius Propoven 2% Emulsion will NOT be administered to pregnant women, unless there are no FDA-approved products available to maintain sedation for these patients should they require mechanical ventilation in an ICU setting. Fresenius Propoven 2% Emulsion will be used only in accordance with the dosing regimens as detailed in the authorized Fact Sheets.
Hydroxychloroquine (REVOKED)	FDA-approved hydroxychloroquine sulfate that is approved by FDA for other uses and accompanied by its FDA-approved labeling and authorized Fact Sheets. The hydroxychloroquine sulfate must be administered by a healthcare provider pursuant to a valid prescription of a licensed practitioner. The hydroxychloroquine sulfate may only be used to treat adult and adolescent patients who weigh 50 kg or more, hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible.
Bamlanivimab	Distribution of the authorized bamlanivimab will be controlled by the U.S. Government for use consistent with the terms and conditions of the EUA. Lilly will supply bamlanivimab to authorized distributors, who will distribute to healthcare facilities or healthcare providers as directed by the U.S. Government, in collaboration with state and local government authorities. The bamlanivimab covered by this authorization will be used only by healthcare providers to treat mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab is not authorized for use in the following patient populations: Adults or pediatric patients who are hospitalized due to COVID-19, adults or pediatric patients who require oxygen therapy due to COVID19, adults or pediatric patients who require an increase in baseline oxygen flow rate due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity. Bamlanivimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the EMS, as necessary. The use of bamlanivimab must be in accordance with the dosing regimens as detailed in the authorized Fact Sheets.
Baricitinib	The baricitinib covered by the authorization will be used only by healthcare providers, in combination with remdesivir, to treat suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or ECMO. The use of baricitinib covered by this authorization must be in accordance with the dosing regimens as detailed in the authorized Fact Sheets.
Casirivimab and Imdevimab	Distribution of the authorized casirivimab and imdevimab will be controlled by the U.S. Government for use consistent with the terms and conditions of the EUA. Regeneron will supply casirivimab and imdevimab to authorized distributor(s), who will distribute to healthcare facilities or healthcare providers as directed by the U.S. Government, in collaboration with state and local government authorities, as needed. The casirivimab and imdevimab will be used only by healthcare providers to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Casirivimab and imdevimab may only be administered together. Casirivimab and imdevimab is not authorized for use in the following patient populations: adults or pediatric patients who are hospitalized due to COVID-19, adults or pediatric patients who require oxygen therapy due to COVID19, adults or pediatric patients who require an increase in baseline oxygen flow rate due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity. Casirivimab and imdevimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. The use of casirivimab and imdevimab must be in accordance with the dosing regimens as detailed in the authorized Fact Sheets.