STATEMENT OF EMERGENCY

201 KAR 002:410E

This emergency administrative regulation is being promulgated to establish requirements that the Board of Pharmacy shall implement in order to comply with 85 Fed. Reg. 15198, 52136 (Third Amendment to the PREP Act Declaration) promulgated by the Department of Health and Human Services (HHS) as a federal emergency regulation to be in effect while a declaration of a public health emergency exists under 42 U.S.C. 247d..

The Third Amendment clarified that "covered countermeasures" include products that limit the harm that COVID19 might cause, and it amended the category of disease, health condition, and threat for which the HHS secretary recommends the administration or use of covered countermeasures to include the decrease in the rate of childhood immunizations during the pandemic. The Third Amendment included pharmacists as "qualified persons" to order and administer vaccinations to children between the ages of three and seventeen pursuant to certain requirements, and for pharmacist interns to be "qualified persons" to administer vaccinations to children ages three through seventeen pursuant to certain requirements. The Third Amendment preempts narrower state scope-of-practice laws for pharmacists and pharmacy interns who meet the requirements set forth in the Third Amendment. The Third Amendment does not affect broader state scope-of-practice laws.

This emergency administrative regulation is necessary, pursuant to KRS 13A.190(1)(a)3. and 4., to ensure state regulation meets federal floor requirements authorizing pharmacists to order and administer vaccines to children between the ages of three and seventeen and for pharmacist interns to be authorized to administer vaccinations to children between the ages of three and seventeen for the duration of the state of public health emergency. An ordinary administrative regulation is not a sufficient avenue to address the current emergency due to the time constraints of promulgating an ordinary administrative regulation. The federal regulation became effective on August 24, 2020, and without a change in state law, Kentucky does not comply with federal regulation. This emergency administrative regulation 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 state of emergency.

/s/_______________________

Andy Beshear Governor

/s/_______________________

Larry Hadley, Executive Director

Board of Pharmacy

__/s/___________________________________

Larry Hadley, Executive Director

Board of Pharmacy

Emergency Regulation Ordering and Administering Vaccinations

Frequently Asked Questions and Board Guidance

December 11, 2020

Kentucky Board of Pharmacy

Emergency Regulation: Ordering and Administering Vaccinations

Frequently Asked Questions and Board Guidance

December 11, 2020

The Kentucky Board of Pharmacy approved an emergency regulation 201 KAR 2:410E. Ordering and Administering Vaccinations in a Special Called Meeting on November 17, 2020. The regulation is in response to federal laws and guidance enacted during the COVID-19 pandemic.

These questions and answers will be monitored and updated as new information becomes available.

SECTIONS:

I. Overview(Updated 12/11/2020)

II. Vaccination via Prescription Drug Order(Updated 12/11/2020)

III. Vaccination via Prescriber-Approved Protocol Vaccination via Prescription Drug Order(Updated 12/11/2020)

IV. Vaccination via Pharmacist Order(Updated 12/11/2020)

V. Training and Continuing Education (CE)(Updated 12/11/2020)

VI. Kentucky Immunization Registry (KYIR)

I. Overview

1. What is an emergency regulation? When did the emergency regulation become effective? How long is it effective?

A: An emergency regulation is a regulation that has been adopted on an expedited, temporary basis because it has been determined to be necessary to protect public health, safety and welfare.

This regulation went into effect November 23, 2020, and will expire 270 days after that on August 20, 2021.

2. What does this emergency regulation address?

A: This emergency regulation, 201 KAR 2:410E Ordering and Administering Vaccinations, expands how a pharmacist may provide a vaccination and expands who may administer vaccines.

Prior to this emergency regulation, a vaccine may be administered by a pharmacist or a pharmacist intern pursuant to a prescription drug order and via a prescriber-approved protocol to individuals aged nine (9) and older. This practice may continue.

The emergency regulation allows pharmacists to expand prescriber-approved protocols down to individuals age three (3) to eight (8) and allows pharmacists to order and administer vaccines independent of a prescription drug order or prescriber-approved protocol to individuals aged three (3) and older.

The emergency regulation allows pharmacist interns to administer vaccines to individuals aged three (3) and older via pharmacist order, prescriber-approved protocol, or prescription drug order.

The emergency regulation allows certified pharmacy technicians (CPhT) to administer vaccines to individuals aged three (3) and older via pharmacist order, prescriber-approved protocol or prescription drug order.

3. Are there additional requirements for this expansion of pharmacy practice?

A. Yes. If vaccinations are provided to an individual age three (3) to eight (8) or if vaccinations are provided via pharmacist order to an individual age three (3) and older, pharmacists and pharmacist interns must comply with specific training and reporting requirements.

If certified pharmacy technicians (CPhT) administer vaccines, the CPhT must comply with specific training requirements.

4. What is the PREP Act?

A. The Public Readiness and Emergency Preparedness (PREP) Act is a federal law that authorizes the Secretary of the Department of Health and Human Services (HHS) to issue a declaration that provides immunity from liability for covered persons in instances of public health emergencies and pre-empts state laws in order to address a public health emergency.

There was a declaration under the PREP Act issued March 17, 2020 to address the COVID-19 pandemic. PREP Act

5. How does the PREP Act apply to vaccination? (Updated 12/11/2020)

A. The third amendment to the HHS declaration issued August 24, 2020 authorized pharmacists to order and administer any vaccine that the CDC's Advisory Committee on Immunization Practices (ACIP) recommends to individuals aged three (3) to eighteen (18). August 24, 2020 Amendment to PREP Act declaration

The fourth amendment to the HHS declaration issued December 3, 2020 clarifies the training needed by pharmacists to order and/or administer any vaccine as well as adding an additional stipulation in order to receive immunity. Additionally, it incorporates the authorization of technicians to administer these vaccines under the supervision of a pharmacist whereas previously this was guidance and recommendation only. December 3, 2020 Amendment to PREP Act declaration

6. Will this emergency regulation apply to the COVID 19 vaccine(s) once available?

A. Yes. The emergency regulation applies to all FDA authorized or approved vaccines with an ACIP recommendation. There may be additional requirements for COVID 19 vaccinations. More information will be made available on a continual basis.

II. Vaccination via Prescription Drug Order (Updated 12/11/2020)

1. May a pharmacist administer a vaccine pursuant to a prescription drug order? (Updated 12/11/2020)

A. Yes. For individuals age nine (9) and older this practice has not changed. However, a pharmacist does not receive the immunity provided by the fourth amendment to the HHS PREP Act if all requirements of the amendment are not met.

For individuals age three (3) to eight (8) the pharmacist must:

• Complete an ACPE accredited practical training program that includes hands-on injection technique and recognition and treatment of emergency reactions to vaccines;

• Complete at least two (2) hours of immunization-related ACPE continuing education (CE) per licensing period;

• Possess a current certificate in basic cardiopulmonary resuscitation (CPR).

• Report the immunization to the Kentucky Immunization Registry (KYIR); and

• Notify the child's primary care provider of the immunization upon request of the child's parent or guardian.

• Inform childhood vaccination patients and adult caregivers about the importance of a well-child visit with their primary care provider and refer patients as appropriate.

2. May a pharmacist intern administer a vaccine pursuant to a prescription drug order? (Updated 12/11/2020)

A. Yes. For individuals age nine (9) and older this practice has not changed. However, a pharmacist intern does not receive the immunity provided by the fourth amendment to the HHS PREP Act if all requirements of the amendment are not met.

For individuals age three (3) to eight (8) the pharmacist intern must:

• Complete an ACPE accredited practical training program that includes hands-on injection technique and recognition and treatment of emergency reactions to vaccines; and

• Possess a current certificate in basic cardiopulmonary resuscitation (CPR).

If the vaccine is administered pursuant to a prescription drug order to a child age three (3) to eight (8), the immunization must be reported to the KYIR and notification sent to the child's primary care provider upon request of the child's parent or guardian.

Childhood vaccination patients and adult caregivers must be informed about the importance of a well-child visit with their primary care provider and refer patients as appropriate.

3. May a pharmacy technician administer a vaccine pursuant to a prescription drug order? (Updated 12/11/2020)

A. Yes, if the pharmacy technician meets the following requirements:

• Is a certified pharmacy technician (CPhT);

• Has completed an ACPE accredited practical training program that includes hands-on injection technique and recognition and treatment of emergency reactions to vaccines;

• Completes at least two (2) hours of immunization-related ACPE continuing education (CE) per state registration period; and

• Possess a current certificate in basic cardiopulmonary resuscitation (CPR).

If the vaccine is administered pursuant to a prescription drug order to a child age three (3) to eight (8), the immunization must be reported to the KYIR and notification sent to the child's primary care provider upon request of the child's parent or guardian.

Childhood vaccination patients and adult caregivers must be informed about the importance of a well-child visit with their primary care provider and refer patients as appropriate.

4. May a pharmacy technician administer medications, such as Vitamin B12, pursuant to a prescription drug order?

A. No. This emergency regulation only allows pharmacy technicians to administer vaccinations or medications to treat emergency reactions to vaccines.

5. Do immunizations administered via a prescription drug order have to be reported to the Kentucky Immunization Registry (KYIR)?

A. Immunizations administered pursuant to a prescription drug order to individuals age nine (9) or older are not required to be reported to the KYIR however, the Kentucky Department for Public Health (DPH) strongly recommends all vaccinations be reported to the KYIR.

Immunizations administered pursuant to a prescription drug order to children age three (3) to eight (8) are required to be reported to the KYIR.

For more information on the KYIR please read the September 2020 Board of Pharmacy Newsletter or visit the KYIR website.

September 2020 Board of Pharmacy Newsletter

KYIR website

6. What resources are available that address vaccination, including administration and storage?

A. Epidemiology and Prevention of Vaccine –Preventable Diseases The Pink Book

ACIP Vaccine Recommendations and Guidelines ACIP

ACIP Vaccine Administration Best Practice Guidelines Vaccine Administration

CDC Vaccine Storage and Handling Toolkit Vaccine Toolkit

III. Vaccination via Prescriber-Approved Protocols (Updated 12/11/2020)

1. May a pharmacist continue to use a prescriber-approved protocol to administer vaccines? (Updated December 11, 2020)

A. Yes. Pharmacists may continue to administer vaccines pursuant to a prescriber-approved protocol to individuals age nine (9) and older with no change to this practice. However, a pharmacist does not receive the immunity provided by the fourth amendment to the HHS PREP Act if all requirements of the amendment are not met.

2. If a prescriber-approved protocol is expanded to include children age three (3) to eight (8), what requirements must the pharmacist meet? (Updated December 11, 2020)

A. The pharmacist must:

• Complete an ACPE accredited practical training program that includes hands-on injection technique and recognition and treatment of emergency reactions to vaccines;

• Complete at least two (2) hours of immunization-related ACPE continuing education (CE) per licensing period;

• Possess a current certificate in basic cardiopulmonary resuscitation (CPR).

• Report the immunization to the Kentucky Immunization Registry (KYIR); and

• Notify the child's primary care provider of the immunization upon request of the child's parent or guardian.

• Inform childhood vaccination patients and adult caregivers about the importance of a well-child visit with their primary care provider and refer patients as appropriate.

3. May a pharmacist intern administer a vaccine pursuant to a prescriber-approved protocol? (Updated December 11, 2020)

A. Yes.

If the protocol is for individuals age nine (9) and older, the pharmacist intern may continue based on current practice.

If the protocol is expanded to include children age three (3) to eight (8), the pharmacist intern must:

• Complete an ACPE accredited practical training program that includes hands-on injection technique and recognition and treatment of emergency reactions to vaccines; and

• Possess a current certificate in basic cardiopulmonary resuscitation (CPR).

The immunization must be reported to the KYIR and notification sent to the child's primary care provider upon request of the child's parent or guardian.

Childhood vaccination patients and adult caregivers must be informed about the importance of a well-child visit with their primary care provider and refer patients as appropriate.

4. May a pharmacy technician administer a vaccine pursuant to a prescriber-approved protocol? (Updated December 11, 2020)

A. Yes, if the pharmacy technician meets the following requirements:

• Is a certified pharmacy technician (CPhT);

• Has completed an ACPE accredited practical training program that includes hands-on injection technique and recognition and treatment of emergency reactions to vaccines;

• Completes at least two (2) hours of immunization-related ACPE continuing education (CE) per state registration period; and

• Possess a current certificate in basic cardiopulmonary resuscitation (CPR).

If the vaccine is administered pursuant to an expanded prescriber-approved protocol to include children age three (3) to eight (8), the immunization must be reported to the KYIR and notification sent to the child's primary care provider upon request of the child's parent or guardian.

Childhood vaccination patients and adult caregivers must be informed about the importance of a well-child visit with their primary care provider and refer patients as appropriate.

5. May technicians begin administering vaccines pursuant to the pharmacy's current prescriber-approved protocol?

A. Yes, if the technician meets the requirements of the emergency regulation. Pharmacists should review the language of their current protocol for any potential conflict.

6. Do immunizations administered via a prescriber-approved protocol have to be reported to the Kentucky Immunization Registry (KYIR)?

A. Immunizations administered pursuant to a prescriber-approved protocol for individuals age nine (9) and older are not required to be reported to the KYIR however, the Kentucky Department for Public Health (DPH) strongly recommends all vaccinations be reported to the KYIR.

Immunizations administered pursuant to an expanded prescriber-approved protocol for children age three (3) to eight (8) must be reported to the KYIR.

For more information on the KYIR and how to report to the KYIR please read the September 2020 Board of Pharmacy Newsletter or visit the KYIR website.

September 2020 Board of Pharmacy Newsletter

KYIR website

7. What resources are available that address vaccination, including administration and storage?

A. Epidemiology and Prevention of Vaccine –Preventable Diseases The Pink Book

ACIP Vaccine Recommendations and Guidelines ACIP

ACIP Vaccine Administration Best Practice Guidelines Vaccine Administration

CDC Vaccine Storage and Handling Toolkit Vaccine Toolkit

IV. Vaccination via Pharmacist Order

1. What medications may a pharmacist order?

A. This emergency regulation allows a pharmacist to order any FDA approved or authorized vaccine for an individual age three (3) or older, pursuant to the Advisory Committee on Immunization Practices' (ACIP) immunization schedule. The pharmacist may also order an FDA approved or authorized medication to treat emergency reactions to vaccines, including epinephrine.

2. What requirements must a pharmacist meet to be able to order and administer a vaccine? (Updated December 11, 2020)

A. The pharmacist must:

• Complete an ACPE accredited practical training program that includes hands-on injection technique and recognition and treatment of emergency reactions to vaccines;

• Complete at least two (2) hours of immunization-related ACPE continuing education (CE) per licensing period;

• Possess a current certificate in basic cardiopulmonary resuscitation (CPR).

• Report the vaccination to the Kentucky Immunization Registry (KYIR); and

• Notify the individual's primary care provider of the immunization upon request of the individual or child's parent or guardian.

• Inform childhood vaccination patients and adult caregivers about the importance of a well-child visit with their primary care provider and refer patients as appropriate.

3. May a pharmacist intern administer a vaccine pursuant to a pharmacist's order? (Updated December 11, 2020)

A. Yes, if the pharmacist intern:

• Completed an ACPE accredited practical training program that includes hands-on injection technique and recognition and treatment of emergency reactions to vaccines; and

• Possesses a current certificate in basic cardiopulmonary resuscitation (CPR).

The immunization must be reported to the KYIR and notification sent to the individual's primary care provider upon request of the individual or child's parent or guardian.

Childhood vaccination patients and adult caregivers must be informed about the importance of a well-child visit with their primary care provider and refer patients as appropriate.

4. May a pharmacy technician administer a vaccine pursuant to a pharmacist's order? (Updated December 11, 2020)

A. Yes, if the pharmacy technician meets the following requirements:

• Is a certified pharmacy technician (CPhT);

• Has completed an ACPE accredited practical training program that includes hands-on injection technique and recognition and treatment of emergency reactions to vaccines;

• Completes at least two (2) hours of immunization-related ACPE continuing education (CE) per state registration period; and

• Possess a current certificate in basic cardiopulmonary resuscitation (CPR).

The immunization must be reported to the KYIR and notification sent to the individual's primary care provider upon request of the individual or child's parent or guardian.

Childhood vaccination patients and adult caregivers must be informed about the importance of a well-child visit with their primary care provider and refer patients as appropriate.

5. Do immunizations administered pursuant to a pharmacist's order have to be reported to the Kentucky Immunization Registry (KYIR)?

A. Yes. For more information on the KYIR and how to report to the KYIR please read the September 2020 Board of Pharmacy Newsletter or visit the KYIR website.

September 2020 Board of Pharmacy Newsletter

KYIR website

6. What resources are available that address vaccination, including administration and storage?

A. Epidemiology and Prevention of Vaccine –Preventable Diseases The Pink Book

ACIP Vaccine Recommendations and Guidelines ACIP

ACIP Vaccine Administration Best Practice Guidelines Vaccine Administration

CDC Vaccine Storage and Handling Toolkit Vaccine Toolkit

V. Training and Continuing Education (CE) (Updated December 11, 2020)

1. Does the ACPE practical training program have to be through APhA? Does the program have to be twenty (20) hours? Is there a time frame in which it must be completed?

A. The ACPE practical training program does not have to be through APhA and there is not a designated hour criteria for the program. The training program must be ACPE accredited and must be completed at least once prior to immunizing pursuant to the emergency regulation. Pharmacists, pharmacist interns and certified pharmacy technicians must be able to show proof of completion of a training program.

2. When must the immunization–related CE be completed?

A. The minimum two (2) hours of immunization-related ACPE CE must be completed in the calendar year (between January 1 and December 31) starting in 2021.

3. Does a new graduate have to complete the immunization –related CE?

A. A pharmacist licensed by the board in the same calendar year as graduation from an ACPE accredited college of pharmacy does not have to complete the two (2) hours of immunization-related ACPE CE for that year.

4. Does the basic cardiopulmonary resuscitation (CPR) training for pharmacists, pharmacist interns, and certified pharmacy technician (CPhT) have to be completed in person? (Updated December 11, 2020)

A. No, it may be completed in person or online. If completed online, the course must be accredited by ACPE, the American Nurses Credentialing Center or the Accreditation for Continuing Medical Education.

VI. Kentucky Immunization Registry (KYIR)

1. Which immunizations must be reported to the Kentucky Immunization Registry (KYIR)?

A. A pharmacist must report administration of vaccines by pharmacists, pharmacist interns or certified pharmacy technicians (CPhT):

• To any individual age three (3) to eight (8); and

• To any individual age nine (9) and older vaccinated via pharmacist order.

The Kentucky Department for Public Health (DPH) strongly recommends all vaccinations be reported to the KYIR.

2. What is the Kentucky Immunization Registry (KYIR)? How do I report vaccinations to the KYIR?

A. Please read the September 2020 Board of Pharmacy Newsletter or visit the KYIR website for details on the KYIR and how to report immunizations.

September 2020 Board of Pharmacy Newsletter

KYIR website

BOARDS AND COMMISSIONS

Board of Pharmacy

(New Emergency Administrative Regulation)

201 KAR 002:410E. Ordering and Administering Vaccinations.

RELATES TO: KRS 39A.180, 315.010, 315.020, 315.050, 315.065, 315.135, 315.205, 315.500, 42 U.S.C. 247d-6d, 85 Fed. Reg. 15198, 52136

STATUTORY AUTHORITY: KRS 315.500, 315.505

NECESSITY, FUNCTION, AND CONFORMITY: The Third Amendment to the Department of Health and Human Services Declaration under the PREP Act, 85 Fed. Reg. 15198, 85 Fed. Reg. 52136, requires the Board of Pharmacy to promulgate an administrative regulation to conform state law to federal law during the period of this public health emergency. KRS 315.010(22) does not authorize pharmacists to order vaccinations. KRS 315.010(22) also does not authorize the use of prescriber-approved protocols for pharmacists or pharmacist interns to administer vaccinations to children under the age of nine (9). The third amendment of 85 CFR 15198, 85 Fed. Reg. 52136, requires that state-licensed pharmacists be authorized to order and administer vaccinations to children between the ages of three (3) and seventeen (17) and that state-registered pharmacist interns and pharmacy technicians be authorized to administer vaccinations to children between the ages of three (3) and seventeen (17). Department of Health & Human Services Guidance issued on October 20, 2020 authorizes pharmacy technicians to administer vaccinations if they meet specific federal requirements listed in the federal guidance. The Prep Act (42 U.S.C. 247d-6d(8)) preempts any state law that would prohibit or effectively prohibit activities authorized by the Secretary in a PREP Act Declaration, including pharmacists ordering and administering vaccinations and pharmacist interns administering vaccinations to children between the ages of three (3) and seventeen (17). According to Department of Health and Human Services Advisory Opinion 20-03, issued on October 22, 2020, state law does not need to mirror federal requirements; however, state law shall allow for pharmacists to be able to order and to administer vaccinations to children between the ages of three (3) and seventeen (17), and pharmacist interns shall be able to administer vaccinations to children between the ages of three (3) and seventeen (17). This administrative regulation establishes requirements for Kentucky to comply with 85 Fed. Reg. 52136.

Section 1. Definitions. (1) "Administer" is defined by KRS 315:010(1).

(2) "Certified Pharmacy Technician" is an individual who: (a) Has successfully completed the Pharmacy Technician Certification Exam administered by the Pharmacy Technician Certification Board (PTCB) or the examination for the Certification of Pharmacy Technicians by the National Healthcareer Association (NHA);

(b) The certificate issued by the PTCB or NHA is current.

(3) "Order" means an original or new order from a pharmacist for an FDA approved or authorized vaccination or medication to treat emergency reactions to vaccines, including epinephrine.

(4) "Pharmacist" is defined by KRS 315.010(17).

(5) "Pharmacist intern" is defined by KRS 315.010(18).

(6) "Pharmacy technician" is defined by KRS 315.010(21).

Section 2. Pharmacist Requirements. A pharmacist may order and administer a vaccine to an individual, age three (3) or older, pursuant to the Advisory Committee on Immunization Practices' (ACIP) standard immunization schedule, if the pharmacist:

(1) Reports the administration of each vaccination by the pharmacist, pharmacist intern, or pharmacy technician to the Kentucky Immunization Registry administered by the Cabinet for Health and Family Services;

(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;

(3) Completes a minimum of two (2) hours of immunization-related continuing education accredited by ACPE per each licensing period;

(4) Provides notification of the immunization to the individual's primary care provider upon the request of the individual or the individual's parent or guardian, if the individual:

(a) Is under eighteen (18) years of age; or

(b) Has a court-appointed guardian; and

(5) Possesses a current certificate in basic cardiopulmonary resuscitation.

Section 3. Pharmacist Intern Requirements. A pharmacist intern may administer a vaccine ordered by a pharmacist, or pursuant to a prescriber-approved protocol or prescription drug order, to an individual, aged three (3) or older, if the pharmacist intern:

(1) 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

(2) Possesses a current certificate in basic cardiopulmonary resuscitation. Section 4. Pharmacy Technician Requirements. A pharmacy technician may administer a vaccine ordered by a pharmacist or pursuant to prescriber-approved protocol or prescription drug order to an individual, aged three (3) or older, if the pharmacy technician:

(1) Is a certified pharmacy technician;

(2) 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;

(3) 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

(4) Possesses a current certificate in basic cardiopulmonary resuscitation. Section 5. Prescriber-approved Protocols. (1) A pharmacist may utilize prescriber-approved protocols or a prescription drug order as a means to provide a vaccine for individuals aged nine (9) and older pursuant to KRS 315.010 (22), while the vaccine may be administered by a pharmacist, pharmacist intern or pharmacy technician. The pharmacy technician shall meet the conditions established in section 4 of this administrative regulation, if administering a vaccination that has been provided by prescription drug order or prescriber-approved protocol.

(2) A pharmacist may utilize prescriber approved protocols or a prescription drug order as a means to provide a vaccine for individuals aged three (3) to eight (8), while the vaccine may be administered by a pharmacist, pharmacist intern or pharmacy technician. The pharmacist, pharmacist intern or pharmacy technician shall meet the conditions established in section 2, 3 or 4, respectively, of this administrative regulation.

Section 6. 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.