Federal Register - February 2, 2021

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Source: Federal Register

Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Notices
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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; 6
vii. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period;
viii. 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 6 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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provider when available, submitting the required immunization information to the State or local immunization information system vaccine registry, complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine;
ix. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate; and x. The licensed pharmacist and the licensed or registered pharmacy intern 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 vaccines.
e Healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are licensed or otherwise permitted to practice. When ordering and administering Covered Countermeasures by means of telehealth to patients in a state where the healthcare personnel are not already permitted to practice, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients by means of telehealth in the state where the healthcare personnel are permitted to practice. Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.7
Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services.
f Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or as authorized under the section Vd of this Declaration, who 7 See, e.g., Advisory Opinion 2002 on the Public Readiness and Emergency Preparedness Act and the Secretarys Declaration under the Act, May 19, 2020, available at https www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents/
advisory-opinion-20-02-hhs-ogc-prep-act.pdf last visited Jan. 24, 2021.

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prescribes, dispenses, or administers COVID19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID19 vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the COVID19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to: i Documentation of completion of the Centers for Disease Control and Prevention COVID19
CDC Vaccine Training Modules 8 and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID
19 vaccines to be administered; and g Any physician, advanced practice registered nurse, registered nurse, or practical nurse who has held an active license or certification to prescribe, dispense, or administer vaccines under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID19
vaccination effort by a federal, State, local, Tribal or territorial authority or by an institution in which the COVID19
vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector 8 See COVID19 Vaccine Training Modules, available at https www2.cdc.gov/vaccines/ed/
covid19/index.asp last visited Jan. 23, 2021
https www.cdc.gov/vaccines/covid-19/
training.html.

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Federal Register - February 2, 2021

TitoloFederal Register

PaeseStati Uniti

Data02/02/2021

Conteggio pagine145

Numero di edizioni7798

Prima edizione14/03/1936

Ultima edizione18/06/2026

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