Tag Archives: hhs

U.S. Pharmacists and Pharmacies Authorized to Order 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.

To read the full text of this Duane Morris Alert, please visit the firm website.

HHS Clarifies Broad Scope of Immunity Protection Under the PREP Act

The Department of Health & Human Services (HHS) has provided an omnibus advisory opinion in response to various requests for clarification of the scope of tort immunity provided by the declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act declaration provides immunity from tort liability for various persons, products and activities in response to COVID-19, as explained in our March 17, 2020, Alert. The Coronavirus Aid, Relief and Economic Security Act (CARES Act) subsequently expanded these protections.

To read the full text of this Duane Morris Alert, please visit the firm website.

Immunity Protections Expanded Under CARES Act for Covered Countermeasures and Healthcare Volunteers

As discussed in our March 18 Alert, the Secretary of Health and Human Services has issued a declaration authorizing drugs, devices and biologics used to treat or mitigate COVID-19 as covered countermeasures under the Public Readiness and Emergency Preparedness (PREP) Act. Following Secretary Azar’s declaration of a public health emergency, covered persons may obtain immunity under federal law for all claims arising from manufacturing, distributing or administering covered countermeasures, subject to the conditions laid out at 42 U.S.C. § 247d-6d, the declaration and other applicable regulations.

Subsequent to our previous Alert, President Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (CARES Act), which expanded the covered countermeasure protections offered by the PREP Act.

To read the full text of this Duane Morris Alert, please visit the firm website.