PHARMACY ALERT: HHS Issues Guidance on PREP Act Preemption of State and Local Laws that Prohibit Licensed Pharmacists From Ordering and Administering FDA-approved COVID-19 Tests

On May 19, 2020, the Department of Health and Human Services (HHS) issued guidance clarifying whether the Public Readiness and Emergency Preparedness (PREP) Act preempts State licensing laws that restrict pharmacists and pharmacies from ordering and administering FDA-approved COVID-19 tests.  As we discussed in an earlier article, the Office of the Assistant Secretary of Health and Human Services (“OASH”) issued guidance on April 8, 2020 that authorized licensed pharmacists to order and administer FDA-approved COVID-19 tests under the PREP Act, and provided immunity against all claims of loss from the administration or use of those tests.  Consistent with that authorization, many states have recognized a pharmacist’s vital contribution to the fight against COVID-19 by allowing licensed pharmacists to order and administer FDA-authorized COVID-19 tests.  However, despite that guidance and the overwhelming need for widespread testing, some states still have laws prohibiting licensed pharmacists from ordering and administering those tests.  As a result, pharmacies and their pharmacists may be left wondering whether to follow state or federal law. 

HHS’s Advisory Opinion directly addresses that question.  In short, the Opinion explains that because the PREP Act contains an express preemption provision with respect to “qualified persons,” state and local authorities “may not prohibit or effectively prohibit ‘qualified persons’ from ordering and administering covered countermeasures.”[1]  In doing so, the opinion noted that on April 8, 2020, the HHS Secretary designated licensed pharmacists as “qualified persons” under the PREP Act to administer FDA-authorized COVID-19 tests, whether or not state law allowed them to do so.  The result is that state and local governments “may not establish, enforce, or continue in effect any legal requirement that prohibits or effectively prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests.”[1].  As a result, pharmacists and pharmacies should follow federal law and guidance with respect to the ordering and administering of FDA-approved COVID-19 tests. 

It is important to note that the PREP Act does not preempt all state and local requirements, only those that are different from or conflict with the PREP Act as explained above.  HHS has further advised that it is the responsibility of the person seeking PREP Act immunity to determine whether he/she is a covered person, and whether the products being used are covered under PREP Act Immunity.   

How Frier Levitt can help.

If you have questions regarding the licensing laws in your state, how the PREP Act applies to your practice, or any other questions related to your pharmacy or its reimbursements, contact Frier Levitt today.   


[1] Advisory Opinion 20-02, U.S. Dep’t H.H.S., Office of the Secretary.  May 19, 2020.  []

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