Emergency Use Authorization Declaration: drugs and biological products

The record

Jurisdiction

United States

Level

Federal

Authority

FD&C Act § 564

Issued

2020-03-27 Mar. 27, 2020

Effective

2020-03-27

End

through the § 564 emergency (read as 2021-09-30)

In force

Mar. 27, 2020 to Sept. 30, 2021

Quarters

2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3

2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3

Limitation types

Emergency declarationHealth care orders

Addressees

• FDA; drug and biologic manufacturers (the basis of the vaccine EUAs, FED-185 to FED-187)

Functions reached

• context: legal basis of every COVID-19 vaccine and therapeutic EUA

Collection

Federal health, safety and transport layer FED-A

Operative words

On March 27, 2020, on the basis of my determination of a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the novel (new) coronavirus, I declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic

Enforcement

Notes