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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
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, 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
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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 2
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; 3
2 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.
3 See, e.g., Guidance for Licensed Pharmacists, COVID19 Testing, and Immunity Under the PREP
Act, OASH, Apr. 8, 2020, available at https

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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,4 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
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.
4 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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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.
iii. In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIPs standard immunization schedule;
iv. The licensed pharmacist must have completed the immunization training that the licensing State requires in order 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;
v. The licensed or registered pharmacy intern 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;
vi. The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation; 5
5 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

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