On September 9, 2020, the Department of Health and Human Services (HHS) announced that it had published guidance authorizing state-licensed pharmacists to order and administer COVID-19 vaccinations to persons age 3 and up, subject to certain requirements. The authorization preempts any state and local laws that prohibit those who satisfy the HHS requirements from ordering or administering COVID-19 vaccines. These requirements include, among other things:
- The vaccine must be U.S. Food and Drug Administration (FDA)-authorized or licensed.
- The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendation.
- The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
- The licensed pharmacist must have a current certificate in basic CPR.
- The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each state licensing period.
- The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including reviewing the vaccine registry or other vaccination records prior to administering a vaccine.
- The licensed pharmacist must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.
- The licensed pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).