Table 1.

Extraordinary federal authority within scope of COVID-19 emergency declarations under the Public Readiness and Emergency Preparedness (PREP) Act

Adapted from American Society of Consultant Pharmacists,32 Department of Health and Human Services,65 National Alliance of State Pharmacy Associations,42 and National Association of Chain Drug Stores66

On January 31, 2020, the Secretary of Health and Human Services declared a public health emergency for the entire United States to aid in the response of the nation’s health care community to the COVID-19 outbreak. On March 10, 2020, the Secretary issued a declaration under the PREP Act for medical countermeasures against COVID-19, amended several times subsequently. Other expansions took the form of DHHS General Counsel advisory opinions or DHHS guidance documents.

• DHHS Guidance—COVID-19 Testing, April 8, 2020, Office of the Assistant Secretary for Health

○ Authorizes pharmacists to order and administer FDA-authorized COVID-19 tests, including serology tests. Such pharmacists qualify as “covered persons” under the PREP Act, receiving immunity with respect to claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of such COVID-19 tests.

• Third Amendment to COVID-19 PREP Act Declaration—Childhood Vaccines, August 24, 2020, Secretary of the DHHS

○ Authorizes pharmacists to order and administer, and pharmacy interns to administer, ACIP-recommended childhood vaccines (ages 3-18 y).

• DHHS Guidance—COVID-19 Vaccines, September 3, 2020, Office of the Assistant Secretary for Health

○ Authorizes pharmacists to order and administer, and pharmacy interns to administer, COVID-19 vaccines.

• DHHS Guidance—Pharmacy Technicians and Interns Administer, October 20, 2020

○ Authorizes qualified pharmacy technicians and pharmacy interns (further clarifies pharmacy interns) to administer both childhood vaccines and COVID-19 vaccines.

• Seventh Amendment to COVID-19 PREP Act Declaration—Inactive, Expired, or Lapsed Licenses, March 11, 2021, Secretary of DHHS

○ Authorizes pharmacists and pharmacy interns/student pharmacists who have licenses that are inactive, expired, or lapsed in the past 5 y to prescribe, dispense, and/or administer COVID vaccines (based on previous PREP Act authority) provided the licensee was in good standing before inactivity, expiration, or lapse.

• Eighth Amendment to COVID-19 PREP Act Declaration—Authorization for Influenza Vaccine, August 4, 2021, Secretary of DHHS

○ Authorizes pharmacists and qualified pharmacy technicians and pharmacy interns to administer seasonal influenza vaccines under the supervision of a pharmacist to persons aged 19 y and older consistent with ACIP recommendations.

• Ninth Amendment (corrected) to COVID-19 PREP Act Declaration: Expanding Access to COVID Therapeutics, September 30, 2021, Secretary of DHHS

○ Authorizes pharmacists to both order and administer certain COVID-19 therapeutics and qualified pharmacy technicians and registered or licensed pharmacy interns to administer these products.

• Tenth Amendment to COVID-19 PREP Act Declaration—Seasonal Influenza Vaccine, December 30, 2021, Secretary of DHHS

○ Expands the scope of authority for licensed pharmacists to order and administer and qualified pharmacy interns to administer seasonal influenza vaccines.