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Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Notices
qualified persons under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized COVID19
diagnostic tests.2 The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as qualified persons would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of qualified persons 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 complete preemption of state law as described above. Furthermore, preemption of State law is justified to respond to the nationwide 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 vaccination program.
Amendments to Declaration
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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, and August 19, 2020 and amended and republished on December 2 Department of Health and Human Services General Counsel Advisory Opinion on the Public Readiness and Emergency Preparedness Act, May 19, 2020, available at: https www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments/prep-act-advisory-opinion-hhs-ogc.pdf/
last visited Jan. 24, 2021. See also, Department of Justice Office of Legal Counsel Advisory Opinion for Robert P. Charrow, General Counsel of the Department of Health and Human Services, January 12, 2020, available at: https www.justice.gov/sites/
default/files/opinions/attachments/2021/01/19/
2021-01-19-prep-act-preemption.pdf last visited Jan. 24, 2021.

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3, 2020 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:
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 3
means a provider 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; 4
3 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.
4 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/hhs-

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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 who administer if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy,5 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 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 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.
guidance-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.
5 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. 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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