HHS Authorizes Pharmacists to Order, Administer COVID-19 Tests

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HHS Authorizes Pharmacists to Order, Administer COVID-19 Tests

Noting that, because of proximity to most Americans, pharmacies can significantly increase the availability and convenience of COVID-19 testing, the Department of Health and Human Services has authorized licensed pharmacists to order and administer novel coronavirus testing approved by the FDA. Here is more information.

WASHINGTON, DC – Licensed pharmacists have been authorized to order and administer COVID-19 tests approved by the Food and Drug Administration.

The news came from the Office of the Assistant Secretary for Health, who cited the Public Readiness and Emergency Preparedness Act in expanding pharmacists’ role in the novel coronavirus outbreak.

Brett P. Giroir, MD, who announced the change, explained, “In an effort to expand testing capabilities, we are authorizing licensed pharmacists to order and administer COVID-19 tests to their patients. The accessibility and distribution of retail and independent community-based pharmacies make pharmacists the first point of contact with a healthcare professional for many Americans. This will further expand testing for Americans, particularly our healthcare workers and first responders who are working around the clock to provide care, compassion and safety to others."

"Giving pharmacists the authorization to order and administer COVID-19 tests to their patients means easier access to testing for Americans who need it,” added Health & Human Services Secretary Alex Azar. “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."

The order states, “Therefore, as an Authority Having Jurisdiction under the Secretary’s March 10, 2020 declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), OASH issues this guidance authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized. 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.1 By doing so, such pharmacists will qualify as “covered persons” under the PREP Act. And they may receive immunity under the PREP Act 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. 42 U.S.C. § 247d-6d(a)(1).”

Approved tests are listed here - PDF.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

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