Statutes and Regulations

Updated 10/20/2021


2021 KY Board of Pharmacy Regulatory Update​

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

Simultaneous Filing: Withdrawal of 201 KAR 2: 411E and Filing of​ 201 KAR 2:412 E. Ordering and administering vaccinations.

Filed October 12, 2021

Public Comment: Written comments may be submitted to the Board of Pharmacy through November 30, 2021. A public hearing will be held on November 30, 2021 at 9:00 a.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 emergency regulation authorizes pharmacists to prescribe and to administer routine ACIP-recommended childhood vaccinations to individuals eighteen and under, the COVID-19 vaccine to any individual pursuant to FDA authorization and the seasonal flu vaccine to individuals aged nineteen and over, pursuant to specific requirements. This administrative regulation also authorizes pharmacy technicians and pharmacist interns to administer vaccinations to these same individuals, pursuant to specific requirements. ​

201 KAR 2:030. License Transfer 

Filed September 14, 2021

Public Comment: Written comments can be submitted to the Board of Pharmacy through November 30, 2021. A public hearing will be held on November 30, 2021 at 9:00 a.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 Amendment conforms the regulation to the recently updated NABP application criteria for license transfer (reciprocity). 

201 KAR 2:074. Pharmacy Services in Hospitals

Filed September 14, 2021

Public Comment: Written comments can be submitted to the Board of Pharmacy through November 30, 2021. A public hearing will be held on November 30, 2021 at 9:00 a.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 Amendment removes “other organized health care facilities” from this regulation since long-term care facilities are now governed by 201 KAR 2:370. Moreover, this amendment substitutes “machine readable identifier that meets established industry standards as approved by the Board to ensure quality, performance and safety” where “bar code technology” was written. Lastly, this amendment modifies language to ensure that Board of Pharmacy inspectors are authorized to inspect all portions of hospital premises in which drugs are being dispensed by the hospital pharmacy through an automated pharmacy system. 

201 KAR 2:430, Emergency order and hearings.

Filed August 10, 2021

Public Comment: Written comments can be submitted to the Board of Pharmacy through October 31, 2021. A public hearing will be held on October 26, 2021 at 9:00 a.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 a new, ordinary administrative regulation that creates a process for immediate emergency suspension and restrictions of licenses, permits or registration pursuant to KRS 218A.205, KRS 315.131 and KRS 13B.125 to stop, prevent or avoid an immediate danger to the public health, safety, or welfare. 

201 KAR 2:076, Compounding.​

Filed August 10, 2021

Public Comment: Written comments can be submitted to the Board of Pharmacy through October 31, 2021. A public hearing will be held on October 26, 2021 at 9:00 a.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 Amendment allows for flavoring to be added to a drug without the addition being considered non-sterile compounding when certain conditions are met. Moreover, this amendment incorporates USP 825 for the preparation, compounding, dispensing and repackaging of radiopharmaceuticals. 

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

Filed August 3, 2021

Public Comment: Written comments can be submitted to the Board of Pharmacy through October 31, 2021. A public hearing will be held on October 26, 2021 at 9:00 a.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: The amendment increases the pharmacist license renewal fee and the delinquent renewal penalty for a pharmacist license by $25.



Regulations with a recent effective date

​201 KAR 2:360, Naloxone Dispensing​​ - Effective October 20, 2021

201 KAR 2:270, Expungement.​ - Effective October 20, 2021

201 KAR 2:420, Administration of Vaccines. - Effective October 20, 2021

201 KAR 2:061, Procedures followed by the Kentucky Board of Pharmacy in the investigation and hearing of complaints. - Effective August 26, 2021

201 KAR 2:171​, Computerized Recordkeeping - Effective July 21, 2021

201 KAR 2:205, Pharmacist-in-Charge - Effective July 21, 2021

201 KAR 2:040​, Registration of Pharmacist Interns - Effective July 21, 2021

201 KAR 2:390, Requirements for third-party logistic providers - Effective July 21, 2021

201 KAR 2:380, Board Authorized Protocols - Effective June 16, 2021

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

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Statutes and Regulations