Title 201 | Chapter 002 | Regulation 465REG
PROPOSED
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PREVIOUS VERSION
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BOARDS AND COMMISSIONS
Board of Pharmacy
(Amended at ARRS Committee)
201 KAR 2:465.Non-resident pharmacy applications and waivers.
Section 1.
Inspection Requirements.(1)
Each pharmacy shall provide to the board and(2)
If an(3)
If anSection 2.
Pharmacist-in-Charge.(1)
The pharmacist-in-charge shall directly and timely respond to any lawful request for information from the board or law enforcement authorities.(2)
The pharmacist-in-charge shall be responsible for receiving and maintaining publications distributed by the board.(3)
The pharmacist-in-charge shall be responsible for answering the toll-free telephone service six (6) days a week and a minimum of forty (40) hours per week. The toll-free telephone number shall be present on the label of each prescription dispensed by the pharmacy to a Kentucky resident. If the pharmacist-in-charge is unavailable, a staff pharmacist with access to patient records may answer the call, but the staff pharmacist shall notify the pharmacist-in-charge of the call and provide the pharmacist-in-charge with a callback number for the patient. If the staff pharmacist is unable to resolve the patient's question, the pharmacist-in-charge shall return the call of the patient within forty-eight (48) hours.Section 3.
Waiver.(1)
The board may grant a waiver from the permitting requirements of this section to any nonresident pharmacy which limits dispensing activity to isolated transactions.(2)
An isolated transaction isSection 4.
Applications.(1)
To receive(a)
A copy of a valid license, permit, or registration issued by the regulatory or licensing agency of the state in which the pharmacy is located; and(b)
A letter from the regulatory or licensing agency of the state in which the pharmacy is located that certifies the pharmacy is in good standing. If the licensing agency does not provide a letter, primary source verification may be utilized.(2)
Each applicant shall(a)
1.
Names and license numbers of all pharmacists and pharmacist-managers dispensing prescription legend drugs to an ultimate user in Kentucky, the names and, if available, the license or registration numbers of all supportive personnel employed by the out-of-state pharmacy who assist pharmacists in the2.(b)
Names, locations, titles, social security number, and date of birth of all principal corporate officers or members, if incorporated; and3.(c)
If the pharmacy is owned by a partnership or sole proprietorship, the name, location, title, social security number, and date of birth of any partner or owner of the pharmacy.(b)(d)
A report containing this information shall be made on an annual basis and within thirty (30) days of each change for any principal office, pharmacist manager, corporate officer, partner, or owner of the pharmacy.(3)
Each non-resident pharmacy shall develop and provide the board with a policy and procedure manual that sets forth:(a)
Normal delivery protocols and times;(b)
The procedure to be followed if the patient's medication is not available at the out-of-state pharmacy, or if delivery will be delayed beyond normal delivery time;(c)
The procedure to be followed upon receipt of a prescription for an acute illness, which shall include a procedure for delivery of the medication to the patient from the out-of-state pharmacy at the earliest possible time, or an alternative that ensures(d)
The procedure to be followed when the out-of-state pharmacy is advised that the patient's medication has not been received within the normal delivery time and that the patient is out of medication and requires interim dosage until mail prescription drugs become available(e)
(4)
(a)
An applicant for an out-of-state pharmacy permit shall(b)
An(c)
All legal process in any action or proceeding against the(d)
(e)
An(5)
Any entity who ships, mails, or delivers prescription drugs to Kentucky residents from more than one (1) out-of-state pharmacy shall register each pharmacy separately.(6)
An out-of-state pharmacy shall report to the disciplinary action taken by another state or jurisdiction against the pharmacy or pharmacy staff within thirty (30) days of final case resolution.(7)
An applicant shall submit photographs of the exterior of the pharmacy building and working areas.(8)
Section 5.
A nonresident pharmacy permit applicant shall submit:(1)
An initial or renewal application for a nonresident pharmacy permit on either the:(a)
Application for Non-Resident Pharmacy Permit; or(b)
Application for Non-Resident Pharmacy Permit Renewal; and(2)
As appropriate, the:(a)
Initial application fee established by 201 KAR 2:050, Section 1(8); or(b)
Renewal fee established by 201 KAR 2:050, Section 1(9).Section 6.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
"Application for Non-Resident Pharmacy Permit", 04/2024; and(b)
"Application for Non-Resident Pharmacy Permit Renewal", 04/2024.(2)
This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Board of Pharmacy, State Office Building Annex, Suite 300, 125 Holmes Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m. This material is also available on the board's Web site at https://pharmacy.ky.gov/Businesses/Pages/Non-Resident-Pharmacy-Permit-Information.aspx.FILED WITH LRC: December 9, 2024
CONTACT PERSON: Christopher Harlow, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Christopher.harlow@ky.gov.
BOARDS AND COMMISSIONS
Board of Pharmacy
(Amended at ARRS Committee)
201 KAR 2:465.Non-resident pharmacy applications and waivers.
Section 1.
Inspection Requirements.(1)
Each pharmacy shall provide to the board and maintain, in readily retrievable form, the record of a satisfactory inspection conducted within the previous twenty-four (24) month period by the licensing entity of the state where the pharmacy is located.(2)
If an inspection record as established in subsection (1) of this Section is not readily available, the record of the satisfactory inspection conducted at the expense of the pharmacy within the previous twenty-four (24) months by a third-party recognized by the board to inspect may be accepted.(3)
If an inspection has not been performed within the previous twenty-four (24) months, the board shall conduct or contract with a third party recognized by the board to inspect the pharmacy, for which all costs shall be borne by the applicant.Section 2.
Pharmacist-in-Charge.(1)
The pharmacist-in-charge shall directly and timely respond to any lawful request for information from the board or law enforcement authorities.(2)
The pharmacist-in-charge shall be responsible for receiving and maintaining publications distributed by the board.(3)
The pharmacist-in-charge shall be responsible for answering the toll-free telephone service six (6) days a week and a minimum of forty (40) hours per week. The toll-free telephone number shall be present on the label of each prescription dispensed by the pharmacy to a Kentucky resident. If the pharmacist-in-charge is unavailable, a staff pharmacist with access to patient records may answer the call, but the staff pharmacist shall notify the pharmacist-in-charge of the call and provide the pharmacist-in-charge with a callback number for the patient. If the staff pharmacist is unable to resolve the patient's question, the pharmacist-in-charge shall return the call of the patient within forty-eight (48) hours.Section 3.
Waiver.(1)
The board may grant a waiver from the permitting requirements of this section to any nonresident pharmacy which limits dispensing activity to isolated transactions.(2)
An isolated transaction is a transaction in which dispensing is limited to an established patient of the dispensing pharmacy no more than three (3) times per calendar year.Section 4.
Applications.(1)
To receive a permit as an out-of-state pharmacy, the facility shall be in good standing in the state where it is located and submit evidence consisting of:(a)
A copy of a valid license, permit, or registration issued by the regulatory or licensing agency of the state in which the pharmacy is located; and(b)
A letter from the regulatory or licensing agency of the state in which the pharmacy is located that certifies the pharmacy is in good standing. If the licensing agency does not provide a letter, primary source verification may be utilized.(2)
Each applicant shall disclose the:(a)
1.
Names and license numbers of all pharmacists and pharmacist-managers dispensing prescription legend drugs to an ultimate user in Kentucky, the names and, if available, the license or registration numbers of all supportive personnel employed by the out-of-state pharmacy who assist pharmacists in the dispensing;2.
Names, locations, titles, social security number, and date of birth of all principal corporate officers or members, if incorporated; and3.
If the pharmacy is owned by a partnership or sole proprietorship, the name, location, title, social security number, and date of birth of any partner or owner of the pharmacy.(b)
A report containing this information shall be made on an annual basis and within thirty (30) days of each change for any principal office, pharmacist manager, corporate officer, partner, or owner of the pharmacy.(3)
Each non-resident pharmacy shall develop and provide the board with a policy and procedure manual that sets forth:(a)
Normal delivery protocols and times;(b)
The procedure to be followed if the patient's medication is not available at the out-of-state pharmacy, or if delivery will be delayed beyond normal delivery time;(c)
The procedure to be followed upon receipt of a prescription for an acute illness, which shall include a procedure for delivery of the medication to the patient from the out-of-state pharmacy at the earliest possible time, or an alternative that ensures the patient the opportunity to obtain medication at the earliest possible time; and(d)
The procedure to be followed when the out-of-state pharmacy is advised that the patient's medication has not been received within the normal delivery time and that the patient is out of medication and requires interim dosage until mail prescription drugs become available.(4)
(a)
An applicant for an out-of-state pharmacy permit shall designate a resident agent in Kentucky for service of process.(b)
An out-of-state pharmacy that does not designate a resident agent shall be deemed to have appointed the Secretary of State of the State of Kentucky to be its true and lawful attorney upon whom process may be served.(c)
All legal process in any action or proceeding against the pharmacy arising from shipping, mailing, or delivering prescription drugs in Kentucky shall be served on the resident agent.(d)
A copy of the service of process shall be mailed to the out-of-state pharmacy by certified mail, return receipt requested, at the address of the out-of-state pharmacy as designated on the registration form filed with the board.(e)
An out-of-state pharmacy which does not register in this state, shall be deemed to have consented to service of process on the Secretary of State as sufficient service.(5)
Any entity who ships, mails, or delivers prescription drugs to Kentucky residents from more than one (1) out-of-state pharmacy shall register each pharmacy separately.(6)
An out-of-state pharmacy shall report to the disciplinary action taken by another state or jurisdiction against the pharmacy or pharmacy staff within thirty (30) days of final case resolution.(7)
An applicant shall submit photographs of the exterior of the pharmacy building and working areas.Section 5.
A nonresident pharmacy permit applicant shall submit:(1)
An initial or renewal application for a nonresident pharmacy permit on either the:(a)
Application for Non-Resident Pharmacy Permit; or(b)
Application for Non-Resident Pharmacy Permit Renewal; and(2)
As appropriate, the:(a)
Initial application fee established by 201 KAR 2:050, Section 1(8); or(b)
Renewal fee established by 201 KAR 2:050, Section 1(9).Section 6.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
"Application for Non-Resident Pharmacy Permit", 04/2024; and(b)
"Application for Non-Resident Pharmacy Permit Renewal", 04/2024.(2)
This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Board of Pharmacy, State Office Building Annex, Suite 300, 125 Holmes Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m. This material is also available on the board's Web site at https://pharmacy.ky.gov/Businesses/Pages/Non-Resident-Pharmacy-Permit-Information.aspx.FILED WITH LRC: December 9, 2024
CONTACT PERSON: Christopher Harlow, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Christopher.harlow@ky.gov.