Title 201 | Chapter 002 | Regulation 413E
This emergency administrative regulation establishes requirements that the Board of Pharmacy shall implement to comply with 42 U.S.C. 247d-6d, 85 Fed. Reg. 15198, 52136 and 86 Fed. Reg. 9516, 10588 and 14462. 85 Fed. Reg. 15198, 52136 and 86 Fed. Reg. 9516, 10588, 14462 and 41977 have been promulgated in response to the public health emergency invoked by 42 U.S.C. 247d-6d to address COVID-19. This emergency administrative regulation is necessary, pursuant to KRS 13A.190(1)(a)3 and 4, to ensure continued compliance with federal law and to ensure that Kentucky continues to have an ample pool of pharmacists available to order and administer the COVID-19 vaccine. Without this emergency regulation, many Kentucky-licensed pharmacists will become ineligible to order and to administer the COVID-19 vaccine because they do not meet federal training requirements. So long as the state has a training requirement, compliance with the state training requirement is sufficient to comply with federal law. Without this emergency administrative regulation, there is no state training requirement. This emergency administrative regulation will ensure that state law remains congruent with emergency federal regulations and responds to the current COVID-19 federal public health emergency. An ordinary administrative regulation is not a sufficient avenue to address the current emergency due to the COVID-19 pandemic being temporary. This emergency administrative regulation with regard to pharmacist authority will not be replaced by an ordinary administrative regulation due to the scope of the administrative regulation only existing and being needed for the duration of the federal public health emergency.
201 KAR 2:413E.Ordering and administering vaccinations.
Section 1.
Definitions.(1)
"Administer" is defined by KRS 315.010(1).(2)
"Pharmacist" is defined by KRS 315.010(17).(3)
"Pharmacist intern" is defined by KRS 315.010(18).(4)
"Pharmacy technician" is defined by KRS 315.010(21).(5)
"Prescribe" means to issue an original or new order from a pharmacist for an FDA-approved or authorized vaccination or medication, including but not limited to, epinephrine, diphenhydramine and corticosteroids to treat emergency reactions to vaccines.Section 2.
Pharmacist Requirements.(1)
A pharmacist may administer a vaccine to an individual pursuant to the Advisory Committee on Immunization Practices (ACIP) standard immunization schedule in accordance with KRS 315.010(22).(2)
A pharmacist may administer a vaccine to a child, age three (3) through eight (8), pursuant to a prescriber-approved protocol.(3)
A pharmacist may prescribe and administer a vaccine to an individual eighteen (18) and under, pursuant to the ACIP standard immunization schedule, a seasonal flu vaccine to any individual aged nineteen and over, a COVID-19 vaccine to any individual, and medications necessary for the emergency treatment of vaccine reactions, if the pharmacist:(a)
Completes or has completed practical training on administering vaccinations. This may include:1.
Completion of a practical training program from an education provider accredited by the Accreditation Council for Pharmacy Education (ACPE) that includes hands-on injection technique and the recognition and treatment of emergency reactions to vaccines;2.
Graduation from an ACPE accredited pharmacy school in which hands-on immunization training was part of the curriculum; or3.
Training via hands-on experience immunizing in current or previous pharmacy practice; and(b)
Possesses a current certificate in basic cardiopulmonary resuscitation.(4)
No provision in this regulation affects the ability of a pharmacist to administer a vaccination pursuant to a prescription drug order.Section 3.
Pharmacist Intern Requirements. A pharmacist intern under the general supervision of a pharmacist may administer a vaccine to an individual if the pharmacist intern:(1)
Completes, or has completed as part of pharmacy school curriculum, a practical training program accredited by the Accreditation Council for Pharmacy Education (ACPE) that includes hands-on injection technique and the recognition and treatment of emergency reactions to vaccines; and(2)
Possesses a current certificate in basic cardiopulmonary resuscitation.Section 4.
Pharmacy Technician Requirements. A pharmacy technician may administer a vaccine under the general supervision of a pharmacist to an individual, if the pharmacy technician:(1)
Completes a minimum of two (2) hours of immunization-related continuing education accredited by the Accreditation Council for Pharmacy Education (ACPE) per each state registration period;(2)
Completes, or has completed, a practical training program accredited by the Accreditation Council for Pharmacy Education (ACPE) that includes hands-on injection technique and the recognition and treatment of emergency reactions to vaccines; and(3)
Possesses a current certificate in basic cardiopulmonary resuscitation.Section 5.
Effective Date.(1)
This administrative regulation shall become effective at 5 p.m. on the date it is filed.(2)
In accordance with KRS 13A.190, this administrative regulation shall remain in effect until:(a)
Expiration of the time period established by KRS 13A.190; or(b)
Withdrawn in accordance with KRS 13A.190(12).(3)
The Board of Pharmacy shall regularly consult with the Governor's Office, the Centers for Disease Control and Prevention, and other public health authorities to determine if this administrative regulation shall be withdrawn prior to its expiration under KRS 13A.190.This emergency administrative regulation establishes requirements that the Board of Pharmacy shall implement to comply with 42 U.S.C. 247d-6d, 85 Fed. Reg. 15198, 52136 and 86 Fed. Reg. 9516, 10588 and 14462. 85 Fed. Reg. 15198, 52136 and 86 Fed. Reg. 9516, 10588, 14462 and 41977 have been promulgated in response to the public health emergency invoked by 42 U.S.C. 247d-6d to address COVID-19. This emergency administrative regulation is necessary, pursuant to KRS 13A.190(1)(a)3 and 4, to ensure continued compliance with federal law and to ensure that Kentucky continues to have an ample pool of pharmacists available to order and administer the COVID-19 vaccine. Without this emergency regulation, many Kentucky-licensed pharmacists will become ineligible to order and to administer the COVID-19 vaccine because they do not meet federal training requirements. So long as the state has a training requirement, compliance with the state training requirement is sufficient to comply with federal law. Without this emergency administrative regulation, there is no state training requirement. This emergency administrative regulation will ensure that state law remains congruent with emergency federal regulations and responds to the current COVID-19 federal public health emergency. An ordinary administrative regulation is not a sufficient avenue to address the current emergency due to the COVID-19 pandemic being temporary. This emergency administrative regulation with regard to pharmacist authority will not be replaced by an ordinary administrative regulation due to the scope of the administrative regulation only existing and being needed for the duration of the federal public health emergency.