Washington, DC—After receiving requests from pharmacists, pharmacies, and a trade association, the Department of Health and Human Services has issued an advisory opinion saying that qualified pharmacists can order and administer COVID-19 diagnostic tests even in states that would otherwise prohibit those types of actions.
Specifically, HHS announced that its Office of the General Counsel (OGC) determined that the Public Readiness and Emergency Preparedness (PREP) Act preempts state licensing laws that restrict the ability of pharmacists to order and administer the tests.
“For the reasons and subject to the limitations set forth below, we conclude that the PREP Act, in conjunction with the Secretary’s March 10, 2020 declaration, preempts any state or local requirement that prohibits or effectively prohibits a pharmacist from ordering and administering a COVID-19 diagnostic test that the Food and Drug Administration (FDA) has authorized,” according to an HHS press release.
On April 8, 2020, the Office of the Assistant Secretary for Health issued guidance “authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized,” citing the PREP Act.
HHS Secretary Alex M. Azar II explained that Americans would have easier access to COVID-19 testing if pharmacists were given the authorization to order and administer it.
The agency points out that, consistent with that authorization, numerous states have made clear that licensed pharmacists may order and administer FDA-authorized COVID-19 tests, noting, “Some of those states—including Alaska, New Mexico, and Virginia—relied on the HHS guidance when authorizing their licensed pharmacists to order and administer FDA-authorized COVID-19 tests.”
OGC issued an Advisory Opinion on the PREP Act discussing, among other things, that licensed pharmacists “are covered as qualified persons (and hence as covered persons) even if they may not be licensed or authorized by the State to prescribe the tests pursuant to § 247d-6d(i)(8)(A), because they fit within the alternative definition of ‘qualified persons’ pursuant to § 247d-6d(i)(8)(B), as provided by the Secretary in the declaration.”
Subsequent to that, OGC was asked whether, under the PREP Act, licensed pharmacists may order and administer COVID-19 tests even in states that prohibit licensed pharmacists from ordering and administering those tests.
HHS cautions that, while the advisory opinion address the questions and includes the current views of OGC, it is not a final agency action or a final order and does not bind HHS or the federal courts.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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Specifically, HHS announced that its Office of the General Counsel (OGC) determined that the Public Readiness and Emergency Preparedness (PREP) Act preempts state licensing laws that restrict the ability of pharmacists to order and administer the tests.
“For the reasons and subject to the limitations set forth below, we conclude that the PREP Act, in conjunction with the Secretary’s March 10, 2020 declaration, preempts any state or local requirement that prohibits or effectively prohibits a pharmacist from ordering and administering a COVID-19 diagnostic test that the Food and Drug Administration (FDA) has authorized,” according to an HHS press release.
On April 8, 2020, the Office of the Assistant Secretary for Health issued guidance “authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized,” citing the PREP Act.
HHS Secretary Alex M. Azar II explained that Americans would have easier access to COVID-19 testing if pharmacists were given the authorization to order and administer it.
The agency points out that, consistent with that authorization, numerous states have made clear that licensed pharmacists may order and administer FDA-authorized COVID-19 tests, noting, “Some of those states—including Alaska, New Mexico, and Virginia—relied on the HHS guidance when authorizing their licensed pharmacists to order and administer FDA-authorized COVID-19 tests.”
OGC issued an Advisory Opinion on the PREP Act discussing, among other things, that licensed pharmacists “are covered as qualified persons (and hence as covered persons) even if they may not be licensed or authorized by the State to prescribe the tests pursuant to § 247d-6d(i)(8)(A), because they fit within the alternative definition of ‘qualified persons’ pursuant to § 247d-6d(i)(8)(B), as provided by the Secretary in the declaration.”
Subsequent to that, OGC was asked whether, under the PREP Act, licensed pharmacists may order and administer COVID-19 tests even in states that prohibit licensed pharmacists from ordering and administering those tests.
HHS cautions that, while the advisory opinion address the questions and includes the current views of OGC, it is not a final agency action or a final order and does not bind HHS or the federal courts.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
« Click here to return to Weekly News Update.
