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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices
specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F3i8A of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law.
The plain language of the PREP Act makes clear that there is preemption of state law as described above.
Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by COVID19 as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID19 countermeasure program.
Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID19.
Section V of the March 10, 2020
Declaration under the PREP Act for medical countermeasures against COVID19, as amended April 10, 2020, June 4, 2020, August 19, 2020, as amended and republished on December 3, 2020, and as amended on February 2, 2021, and as amended March 11, 2021, is further amended pursuant to section 319F3b4 of the PHS Act as described below. All other sections of the Declaration remain in effect as republished at 85 FR 79190 December 9, 2020.
1. Covered Persons, section V, delete in full and replace with:

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V. Covered Persons 42 U.S.C. 247d6di2, 3, 4, 6, 8A
and B
Covered Persons who are afforded liability immunity under this Declaration are manufacturers, distributors, program planners, qualified persons, and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. Order as used herein and in guidance issued by the Office of the Assistant Secretary for Health 7 means a provider 7 See Guidance for Licensed Pharmacists, COVID
19 Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at https
www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19tests.pdf last visited Jan. 24, 2021; 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-pharmacistsand-pharmacy-interns-regarding-covid-19-vaccinesimmunity.pdf last visited Jan. 24, 2021.

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medication order, which includes prescribing of vaccines, or a laboratory order, which includes prescribing laboratory orders, if required. In addition, I have determined that the following additional persons are qualified persons:
a Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII
below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an Emergency, as that term is defined in Section VII of this Declaration; 8
b Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act;
c Any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act;
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 his or her State board of pharmacy,9 1 vaccines 8 See, e.g., Guidance for Licensed Pharmacists, COVID19 Testing, and Immunity Under the PREP
Act, OASH, Apr. 8, 2020, available at https
www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19tests.pdf last visited Jan. 24, 2021; Guidance for PREP Act Coverage for COVID19 Screening Tests at Nursing Homes, Assisted-Living Facilities, LongTerm-Care Facilities, and other Congregate Facilities, OASH, Aug. 31, 2020, available at https www.hhs.gov/guidance/sites/default/files/
hhs-guidance-documents/prep-act-coverage-forscreening-in-congregate-settings.pdf last visited Jan. 24, 2021; 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/hhsguidance-documents//licensed-pharmacists-andpharmacy-interns-regarding-covid-19-vaccinesimmunity.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/hhs-guidance-documents//prepact-guidance.pdf last visited Jan. 24, 2021; PREP
Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures, Oct. 29, 2020, available at https www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments//prep-act-authorization-pharmaciesadministering-covered-countermeasures.pdf last visited Jan. 24, 2021 collectively, OASH PREP Act Authorizations. Nothing herein shall suggest that, for purposes of the Declaration, the foregoing are the only persons authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction.
9 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
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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 Statelicensed 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 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 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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