Alerts and Updates

U.S. Pharmacists and Pharmacies Authorized to Order and Administer COVID-19 Diagnostic Tests

May 27, 2020

Accordingly, pharmacists and pharmacies are authorized to purchase and administer COVID-19 diagnostic tests. 

In further clarification to pharmacists and pharmacies around the country, on May 19, 2020, the Department of Health and Human Services (HHS) issued an advisory opinion determining that pharmacies in the United States, regardless of state or local requirements, are authorized to order and administer COVID-19 diagnostic tests under the Public Readiness and Emergency Preparedness (PREP) Act.

On April 8, 2020, pharmacists and pharmacies, through general guidance issued by the Office of the Assistant Secretary of Health, were authorized to offer and administer COVID-19 tests. This authorization was based on Secretary Alex Azar’s March 10, 2020, declaration invoking the PREP Act and declaring pharmacists as “qualified persons” to administer such testing.

The PREP Act, enacted in 2005, amended the Public Health Services Act and specifically addressed liability immunity regarding claims related to the manufacture, distribution, administration or use of medication countermeasures under a declaration of the PREP Act. An exception to liability under the PREP is for claims alleging “willful misconduct.”

The April 8 guidance was followed by a number of states clearly stating that licensed pharmacists may order and administer FDA-authorized COVID-19 tests, most of which relied on HHS guidance in permitting such authorization for licensed pharmacists and pharmacies.

Despite HHS guidance, however, in order to bridge the information gap between certain state guidance and HHS declarations, numerous pharmacists and pharmacies requested clarification from HHS on their ability to order and administer COVID-19 tests under the PREP Act.

In the May 19 advisory opinion, HHS clarified that the PREP Act preempts state licensing laws that place restrictions on pharmacists’ ability to order and administer COVID-19 tests. The advisory opinion specifically noted that the PREP Act declaration allows the HHS secretary to designate a “qualified person” to use and administer countermeasures even when that person is not authorized to do so under state law; that it expressly preempts any state or local legal requirement that prohibits a qualified person from ordering and administering a covered countermeasure pursuant to the secretary’s declaration; and that states and localities cannot challenge in court the secretary’s designation of persons authorized to order and administer countermeasures. Accordingly, pharmacists and pharmacies are authorized to purchase and administer COVID-19 diagnostic tests and, under the PREP Act, are immune from related claims, except for claims involving willful misconduct.

However, the advisory opinion notes that it is not a final agency action or a final order, does not bind the HHS or federal courts and does not have the force or effect of law. It is based upon the PREP declaration, which the HHS secretary is authorized to issue during times of emergency, and it will endure for the period that the declaration is enacted and is not a permanent authorization.

Duane Morris attorneys will continue to monitor developments in this area and other related issues and report on the key details for our clients and others in the industry.

About Duane Morris

Duane Morris has created a COVID-19 Strategy Team to help organizations plan, respond to and address this fast-moving situation. Contact your Duane Morris attorney for more information. Prior Alerts on the topic are available on the team’s webpage.

For More Information

If you have any questions about this Alert, please contact Jonathan L. Swichar, Bradley A. Wasser, any of the attorneys in our Pharmacy Litigation Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.