Statutes and Regulations

Updated 4/30/2021


Kentucky Pharmacy Lawbook

This document is not the official copy of the Statutes and Regulations listed. Please note that legislation may change at any time, please see the links below for the official listing of the current Statutes and Regulations.
Links to related pharmacy laws and regulations:
201 KAR 9:016 - Restrictions on use of amphetamine and amphetamine-like anorectic controlled substances.
 
KRS 320.240 - Board's meetings, officers, powers, and duties -- Licensure and classification of optometrists -- Board to have sole authority over practice of optometry -- Authorization to administer and prescribe pharmaceutical agents and certain oral medications.
 
KRS 314.011 - Definitions for chapter.
 
KRS 314.042 - License to practice as an advanced practice registered nurse -- Application -- Renewal -- Reinstatement -- Use of "APRN" -- Prescriptive authority under CAPA-NS and CAPA-CS -- Exemption from CAPA-NS requirement.
 
KRS 311.560 - Prohibition against practice of medicine or osteopathy without license -- Exceptions.​​

Filed Regulations

201 KAR 2:061, Procedures followed by the Kentucky Board of Pharmacy in the investigation and hearing of complaints.

Filed April 13, 2021
Public Comment: Written comments can be submitted to the Board of Pharmacy through June 30, 2021. A public hearing will be held on June 22, 2021 at 1:00 p.m. eastern. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing.
Summary: This is an amendment to 201 KAR 2:061. In the amendment, changes are made to the grievance process and the corresponding procedures afforded to licensees, permit holders and registrants. Moreover, provisions have been added to comply with the FDA’s memorandum of understanding on compounding that the Board of Pharmacy will be signing once this amended regulation is effective.

201 KAR 2171, Computerized Recordkeeping

Filed March 11, 2021
Public Comment: Written comments can be submitted to the Board of Pharmacy through May 31, 2021. A public hearing shall be held May 25, 2021. Individuals interested in being heard at the hearing shall notify the agency in writing at least five workdays prior to the hearing of their intent to attend.
Summary: 201 KAR 2:171 creates requirements for computerized recordkeeping within a pharmacy. 201 KAR 2:171 was drafted to replace 201 KAR 2:170 when it expired. The requirements for computerized recordkeeping are the same requirements that were included in 201 KAR 2:170.

201 KAR 2:040, Registration of Pharmacist Interns.

Filed March 10, 2021
Public Comment: Written comments can be submitted to the Board of Pharmacy through May 31, 2021. A public hearing shall be held May 25, 2021. Individuals interested in being heard at the hearing shall notify the agency in writing at least five workdays prior to the hearing of their intent to attend.
Summary: This amendment removes the requirement for pharmacy students to provide a passport photo on their intern application. This amendment also updates the application removing the photograph requirement and spelling out FPGEC to foreign pharmacy graduate examination committee.

201 KAR 2:205, Pharmacist-in-Charge.

Filed March 9, 2021
Public Comment: Written comments can be submitted to the Board of Pharmacy through May 31, 2021. A public hearing shall be held May 25, 2021. Individuals interested in being heard at the hearing shall notify the agency in writing at least five workdays prior to the hearing of their intent to attend.
Summary: 201 KAR 2:205 has proposed amendments to update the applications incorporated by reference to include the $25 fee increase that became effective with the amendment to 201 KAR 2:050 on February 4, 2021. Moreover, it contains an amendment to ensure that a PIC for a non-resident pharmacy is licensed in the state of Kentucky pursuant to KRS 315.0351.

201 KAR 2:390, Requirements for third-party logistic providers

Filed February 26, 2021
Public Comment: Written comments can be submitted to the Board of Pharmacy through May 31, 2021. A public hearing shall be held May 25, 2021. Individuals interested in being heard at the hearing shall notify the agency in writing at least five workdays prior to the hearing of their intent to attend.
Summary: This amendment conforms the regulation of third-party logistics providers to the DSCSA and conforms 201 KAR 2:390 to mirror new legal requirements found in 201 KAR 2:105 and 201 KAR 2:320.

201 KAR 2:380, Board Authorized Protocols

Filed December 14, 2020
Public Comment: Written comments can be submitted to the Board of Pharmacy through February 28, 2021. A public hearing shall be held February 23, 2021. Individuals interested in being heard at this hearing shall notify the agency in writing at least five workdays prior to the hearing of their intent to attend.
Summary: This amendment authorizes new conditions for Board-authorized protocols to include alcohol use disorder, colorectal cancer prevention and screening, HCV infection screening, HIV infection prophylaxis (pre and post exposure), HIV infection screening and acute cutaneous fungal infection.

Regulations with a recent effective date

201 KAR 2:050, Licenses and permits; fees - Effective, February 4, 2021

201 KAR 2:105, Requirements for wholesalers, medical gas wholesalers, wholesaler distributors, and virtual wholesale distributors - Effective, February 4, 2021

201 KAR 2:106, Licensed or permitted facility closures - Effective, February 4, 2021

201 KAR 2:225, Special limited pharmacy permit - Medical gas - Effective, February 4, 2021

201 KAR 2:240, Special limited pharmacy permit - Charitable - Effective, February 4, 2021

201 KAR 2:320, Requirements for manufacturers and virtual manufacturers - Effective, February 4, 2021

201 KAR 2:410E, Ordering and administering vaccinations -  Effective February 22, 2021