HHS Issues Fifth and Sixth Amendments to Prep Act

February 19, 2021

On January 28, the US Department of Health and Human Services (HHS) issued the fifth amendment to the Public Readiness and Emergency Preparedness (PREP) Act, which provides immunity from losses related to the use or administration of a covered countermeasure. The amendment enlarges the categories of “qualified persons” that are authorized to prescribe, dispense, and administer covered COVID-19 vaccines. Those additional “qualified persons” are: (1) health care professionals and individuals who are currently authorized to prescribe, dispense, or administer vaccines in a state other than the state where the license or certification is held; and (2) physicians, advanced practice registered nurses, registered nurses, or practical nurses who within the past five years held but no longer hold a license or certification to prescribe, dispense, or administer vaccines, who now do so in association with a governmental, territorial, or institutional COVID-19 vaccination effort. Training is required and previously licensed/certified health care professionals are required to be observed and their competency confirmed. Prior license suspension, revocation, surrender, or being on the exclusion list maintained by the Office of Inspector General may disqualify individuals from this grant of authority.

On February 10, HHS issued a sixth amended declaration under the PREP Act. The amendment expands the categories of “qualified persons” to include any Federal government employee, contractor, or volunteer who prescribes, administers, delivers, distributes, or dispenses a covered countermeasure. A person is only a “qualified person” if the executive department or agency that engaged the person has or could have authorized the aforementioned activities.