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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices
situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declarations liability protections; made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID
19 pandemic among federal, state, local, and private-sector entities; revised the effective time period of the Declaration;
and republished the declaration in full.
85 FR 79190, December 9, 2020. On February 2, 2021, the Acting Secretary Norris Cochran amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID19 vaccines that are covered countermeasures under the Declaration 86 FR 7872, February 2, 2021. On February 16, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID19
vaccines that are covered countermeasures under the Declaration 86 FR 9516, February 16, 2021 and on February 22, 2021, the Department filed a notice of correction to the February 2
and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. 86 FR 10588, February 22, 2021. On March 11, 2021, the Acting Secretary amended the Declaration to add additional Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under the Declaration.
86 FR 14462 March 16, 2021.
Secretary Xavier Becerra now amends section V of the Declaration to revise subsections d and f to clarify that qualified pharmacy technicians are Qualified Persons covered by the Declaration, and to expand the scope of authority for qualified pharmacy technicians to administer seasonal influenza vaccines to adults within the state where they are authorized to practice and for interns to administer seasonal influenza vaccines to adults consistent with other terms and conditions of the Declaration.
Accordingly, subsection Vd authorizes:
d A State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by
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his or her State board of pharmacy,1 1
vaccines that the Advisory Committee on Immunization Practices ACIP
recommends to persons ages three through 18 according to ACIPs standard immunization schedule or 2 seasonal influenza vaccine administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIPs standard immunization schedule; or 3 FDA authorized or FDA
licensed COVID 19 vaccines to persons ages three or older. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons only if the following requirements are met:
i. The vaccine must be authorized, approved, or licensed by the FDA;
ii. In the case of a COVID19 vaccine, the vaccination must be ordered and administered according to ACIPs COVID19 vaccine recommendations;
iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIPs standard immunization schedule;
iv. In the case of seasonal influenza vaccine administered by qualified pharmacy technicians and interns, the vaccination must be ordered and administered according to ACIPs standard immunization schedule;
v. In the case of pharmacy technicians, the supervising pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician;
vi. The licensed pharmacist must have completed the immunization 1 Some states do not require pharmacy interns to be licensed or registered by the state board of pharmacy. As used herein, State-licensed or registered intern or equivalent phrases refers to pharmacy interns authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs. The authorization can, but need not, take the form of a license from, or registration with, the State board of pharmacy.
Similarly, states vary on licensure and registration requirements for pharmacy technicians. Some states require certain education, training, and/or certification for licensure or registration; others either have no prerequisites for licensure or registration or do not require licensure or registration at all. As used herein, to be a qualified pharmacy technician, pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a Certified Pharmacy Technician CPhT certification from either the Pharmacy Technician Certification Board or National Healthcareer Association. See Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID
19 Vaccines, and COVID19 Testing, OASH, Oct.
20, 2020 at 2, available at https www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments//prep-act-guidance.pdf last visited Jan.
24, 2021.

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training that the licensing State requires for pharmacists to order and administer vaccines. If the State does not specify training requirements for the licensed pharmacist to order and administer vaccines, the licensed pharmacist must complete a vaccination training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education ACPE to order and administer vaccines. Such a 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;
vii. The licensed or registered pharmacy intern and qualified pharmacy technician must complete a practical training program that is approved by the 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;
viii. The licensed pharmacist, licensed or registered pharmacy intern and qualified pharmacy technician must have a current certificate in basic cardiopulmonary resuscitation; 2
ix. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period;
x. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patients primary-care provider when available, submitting the required immunization information to the State or local immunization information system vaccine registry, 2 This requirement is satisfied by, among other things, a certification in basic cardiopulmonary resuscitation by an online program that has received accreditation from the American Nurses Credentialing Center, the ACPE, or the Accreditation Council for Continuing Medical Education. The phrase current certificate in basic cardiopulmonary resuscitation, when used in the September 3, 2020 or October 20, 2020 OASH
authorizations, shall be interpreted the same way.
See Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, available at https www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents//
licensed-pharmacists-and-pharmacy-internsregarding-covid-19-vaccines-immunity.pdf last visited Jan. 24, 2021; Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID19 Vaccines, and COVID19
Testing, OASH, Oct. 20, 2020, available at https
www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//prep-act-guidance.pdf last visited Jan. 24, 2021.

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