Federal Actions Under the PREP Act Affecting the Practice of Pharmacy
The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. There are several active PREP Act declarations related to COVID-19, as well as various General Counsel advisory opinions and HHS guidances. Some of those declarations and guidances have a significant impact on practice authority for pharmacists, pharmacy interns, and pharmacy technicians:
- HHS Guidance – COVID Testing
- Authorizes pharmacists to order and administer FDA-authorized COVID-19 tests
- [April 8, 2020]
- Third Amendment – Childhood Vaccines
- Authorizes pharmacists to order and administer, and interns to administer, childhood vaccines (ages 3 – 18)
- [August 24, 2020]
- HHS Guidance – COVID Vaccines
- Authorizes pharmacists to order and administer, and interns to administer, COVID vaccines
- [September 3, 2020]
- HHS Guidance – Pharmacy Technicians & Interns Administer
- Authorizes pharmacy technicians and interns (further clarifies interns) to administer both childhood vaccines and COVID vaccine
- [October 20, 2020]
- Seventh Amendment – Inactive, Expired, or Lapsed Licenses
- Authorizes pharmacists and pharmacy interns/student pharmacists who have licenses that are inactive, expired, or lapsed in the past 5 years 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
- [March 11, 2021]
- Eighth Amendment – Authorization for Influenza Vaccine
- Authorizes qualified pharmacy technicians and interns to administer seasonal influenza vaccines under the supervision of a pharmacist to persons aged 19 and older consistent with ACIP recommendations.
- [August 4, 2021]
- Ninth Amendment (corrected) – Expanding Access to Covid Therapeutics
- Authorizes licensed pharmacists to both order and administer certain COVID-19 therapeutics, and qualified pharmacy technicians and registered or licensed interns to administer these products.
- [September 30, 2021]
- Tenth Amendment – Seasonal Influenza Vaccine
- Authorizes licensed pharmacists to order and administer and qualified pharmacy interns to administer seasonal influenza vaccines.
- [December 30, 2021]
- Emergency Use Authorization (EUA) for Paxlovid
- Authorizes state-licensed pharmacists to prescribe Paxlovid to expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19.
- [July 6, 2022]
For more information on pharmacist state-based vaccination authority beyond temporary federal authority granted during the COVID-19 pandemic, please visit our Pharmacist Immunization Authority resource page.