OASH Authorizes Licensed Pharmacists to Order and Administer COVID-19 Testing, Granting Federal Immunity under the PREP Act

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A critical aspect of the response to the COVID-19 public-health crisis in the United States is the rapid expansion of testing capabilities across the country.  Given that almost all Americans live in close proximity to retail or community-based pharmacies, pharmacists are well-positioned to assist in that expansion and play a bigger role in the response to the coronavirus.

Accordingly, on April 8, 2020, in an effort to further increase access to COVID-19 testing, the Office of the Assistant Secretary for Health (OASH) issued new guidance under the Public Readiness and Emergency Preparedness Act (PREP Act),[1] authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.

The PREP Act authorizes the Secretary of Health and Human Services (HHS) to declare that certain “covered persons” are immune from liability for taking certain “covered countermeasures” that are necessary to combat a public-health emergency such as COVID-19. On March 10, 2020, Secretary of HHS Alex Azar issued such a declaration, effective February 4, 2020.

Under the OASH’s new guidance, pharmacists will qualify as “covered persons” under the PREP Act, meaning they may receive immunity with respect to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of FDA-authorized COVID-19 tests. This is a welcome development, as granting immunity to pharmacists who order and administer COVID-19 tests should allow easier access to testing for those in need.

“Giving pharmacists the authorization to order and administer COVID-19 tests to their patients means easier access to testing for Americans who need it,” said HHS Secretary Alex Azar in a statement today.  “Pharmacists play a vital role in delivering convenient access to important public health services and information. The Trump Administration is pleased to give pharmacists the chance to play a bigger role in the COVID-19 response, alongside all of America's heroic healthcare workers.”

For more information on Secretary Azar’s declaration and the immunities afforded by the PREP Act, see our previous post here.

We will continue to monitor coronavirus-related developments under the PREP Act and encourage pharmacists and other health care providers to reach out to Seyfarth’s health care team with any questions.

Jesse M. Coleman is a partner in the Houston Office of Seyfarth Shaw, LLP and is co-chair of the firm’s Health Care, Life Sciences and Pharmaceuticals Practice Group.

Drew del Junco is a litigation associate in Seyfarth’s Houston Office.

[1] See 85 Fed. Reg. 15,198, 15,202 (March 17, 2020); see also Pub. L. No. 109-148, Public Health Service Act § 319F-3, 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e