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HHS Allows Pharmacists to Conduct COVID-19 Testing

In what has been considered a huge win for community pharmacists, the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) issued an Advisory Opinion on May 19, 2020.

The Advisory Opinion concluded that the Public Readiness and Emergency Preparedness (PREP) Act preempts certain state licensure laws that would otherwise prevent pharmacists from ordering and administering COVID-19 diagnostic tests.

The OGC held that both the PREP Act and the HHS Secretary’s March 10, 2020 declaration under the PREP Act specifically designate licensed pharmacists as “qualified persons” and that by doing so, “the Secretary has also authorized licensed pharmacists to order and administer FDA-authorized COVID-19 tests in states where the licensed pharmacists are not authorized to do so.” The Advisory Opinion concludes that:

any state or local law or legal requirement that prohibits or effectively prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests are different from or in conflict with the declaration—and therefore, a legal requirement under the PREP Act. So during the effective period of the PREP Act declaration, a state or locality cannot establish, enforce, or continue any such legal requirements under the PREP Act’s preemption provision.

An Advisory Opinion does not have the force or effect of law, and does not bind HHS, or the federal courts. However, some states, like Alaska, New Mexico, Virginia, and California, already have waived laws that might otherwise limit a pharmacist’s ability to order and administer COVID-19 tests.

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