HHS Issues New Testing Guidance

May 29, 2020
ADVISORY OPINION 20-02 ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT
AND THE SECRETARY’S DECLARATION UNDER THE ACT

MAY 19, 2020

We have received requests from pharmacists, pharmacies, and one trade association asking the Office of the General Counsel (OGC) whether the Public Readiness and Emergency Preparedness (PREP) Act preempts state licensing laws that restrict the ability of pharmacists to order and administer COVID-19 diagnostic tests where the Department of Health and Human Services (HHS) has expressly authorized pharmacists, under the PREP Act, to order and administer those tests. For the reasons and subject to the limitations set forth below, we conclude that the PREP Act, in conjunction with the Secretary’s March 10, 2020 declaration, preempts any state or local requirement that prohibits or effectively prohibits a pharmacist from ordering and administering a COVID-19 diagnostic test that the Food and Drug Administration (FDA) has authorized.  READ THE LETTER