Statutes and Regulations

Updated 8/31/2023


Kentucky Pharmacy Lawbook

​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 Amendments to Regulations and New Regulations

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    201 KAR 2:040, Registration of Pharmacist Interns​

Filed August 14, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through October 31, 2023. A public hearing will be held on October 24th at 9 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. If no request is made to be heard at the public hearing, the hearing will be cancelled.

Summary: This amendment aligned regulatory language with statutory language by removing section five which prevented an applicant from being registered as an intern if they were not currently enrolled in a college or school of pharmacy. This amendment also removed language from the intern application, incorporated by reference, requiring certification that the applicant's student loans were not in default.


201 KAR 2:020, Examination​

Filed June 7, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through August 31, 2023. A public hearing will be held on August 30, 2023 at 10:00 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. [No comments received/hearing cancelled] 

​Summary: This amendment changes the initial pharmacist application to add a question regarding employment location and incorporates by reference the pharmacist renewal application which removed a provision regarding student loan default. 


201  KAR 2:050, Licenses and permits; fees.​

Filed June 7, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through August 31, 2023. A public hearing will be held on August 30, 2023 at 10:00 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. [No comments received/hearing cancelled] 

​Summary: This amendment increases the license/permit initial and renewal fees by $25 for pharmacies, wholesalers and manufacturers. This amendment also ensures the fee for change of address or change of ownership is congruent with the initial license/permit fee since those changes require a new application. The resident and nonresident pharmacy permit applications have been incorporated by reference here instead of 201 KAR 2:205. The resident and nonresident pharmacy applications have been amended for reformatting and including additional questions regarding website, registration status with the Secretary of State, date of last controlled substance inventory, stocking of emergency medication kits, stocking long-term care facilities, using automation for prescription dispensing and if compounding is being performed and if so, what type. For the non-resident application, pursuant to KRS 315.0351(1)(b), a question has been added to collect the names of all pharmacists who are dispensing prescription drugs to residents in the Commonwealth. 

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201 KAR 2:076. Compounding.

Filed June 7, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through August 31, 2023. A public hearing will be held on August 30, 2023 at 10:00 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. [No comments received/hearing cancelled] 

​Summary: 201 KAR 2:076 has been amended to ensure congruence with federal law, 21 U.S.C. 353a, and 2022 revisions to the USP. The amendment requires compliance with the 2022 revision of USP 795 and 797. Waiver provisions and a two-year period of enforcement discretion are included in the amendment. 


201 KAR 2:105. Requirements for wholesalers, medical gas wholesalers, wholesale distributors, and virtual wholesale distributors​.

Filed June 7, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through August 31, 2023. A public hearing will be held on August 30, 2023 at 10:00 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. [No comments received/hearing cancelled] 

​Summary: The wholesaler initial and renewal forms have been amended to include the proposed fee increase and to make other formatting changes. 


201 KAR 2:205. Pharmacist-in-charge.​

Filed June 7, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through August 31, 2023. A public hearing will be held on August 30, 2023 at 10:00 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. [No comments received/hearing cancelled] 

​​Summary: 201 KAR 2:205 was amended to remove the pharmacy initial and renewal applications from the materials incorporated by reference.


201 KAR 2:225. Special Limited pharmacy permit - medical gas.

Filed June 7, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through August 31, 2023. A public hearing will be held on August 30, 2023 at 10:00 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. [No comments received/hearing cancelled] 

​Summary:  201 KAR 2:225 has been amended to reflect the proposed fee increase in 201 KAR 2:050 and to add non-resident initial and renewal applications for the special limited pharmacy permit—medical gas. Formatting changes were also made to the resident initial and renewal applications incorporated by reference.  


201 KAR 2:240. Special limited pharmacy permit – Charitable.​

Filed June 7, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through August 31, 2023. A public hearing will be held on August 30, 2023 at 10:00 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. [No comments received/hearing cancelled] 

​Summary: This amendment revises the fee listed in the applications to be congruent with the proposed fee increase in 201 KAR 2:050. This amendment also incorporates non-resident applications for charitable pharmacy permits and makes formatting changes to all applications.


201 KAR 2:320. Requirements for Manufacturers and Virtual Manufacturers.​

Filed June 7, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through August 31, 2023. A public hearing will be held on August 30, 2023 at 10:00 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. [No comments received/hearing cancelled] 

​Summary: This amendment revises the fee amount listed in the applications to be congruent with the proposed change in 201 KAR 2:050. This amendment also makes formatting changes. 


201 KAR 2:340. Special Limited Pharmacy Permit—Clinical Practice.

Filed June 7, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through August 31, 2023. A public hearing will be held on August 30, 2023 at 10:00 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. [No comments received/hearing cancelled] 

​Summary: This amendment revises the fee amount listed in the applications to be congruent with the proposed amendment in 201 KAR 2:050. This amendment also makes formatting changes and includes non-resident applications. 


201 KAR 2:390. Requirements for third-party logistics providers.

Filed June 7, 2023

Public Comment: Written comments may be submitted to the Board of Pharmacy through August 31, 2023. A public hearing will be held on August 30, 2023 at 10:00 a.m. eastern via zoom teleconference. Individuals interested in being heard at the hearing must notify the board in writing at least five business days prior to the hearing. [No comments received/hearing cancelled] 

​Summary:  This amendment increases the fee for third-party logistics providers to $400. This amendment also makes formatting changes to the applications.




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Recently Effective Regulations and Amendments​

201 KAR 2:450. Unprofessional Conduct of a Pharmacy Permit Holder​ ​ Effective March 9, 2023

201 KAR 2:360 Naloxone dispensing Effective March 9, 2023

201 KAR 2:050, Licenses and permits; fees Effective August 25, 2022

201 KAR 2:020, Examination. Effective August 25, 2022

201 KAR 2:225, Special limited pharmacy permit – Medical Gas. Effective August 25, 2022

201 KAR 2:440, Legend Drug Repository​. Effective July 20, 2022

     201 KAR 2:380. Board Authorized Protocols Effective June 21, 2023

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Statutes and Regulations