Title XXVI, Occupations and Professions

(1) (a) A wholesale distributor may receive prescription drug returns or exchanges from a pharmacy, pharmacy warehouse, or other person authorized to distribute a prescription drug to an end user under the terms and conditions of an agreement between the parties. (b) Returns of e…

- Administrative regulations. (1) (a) As of the date specified by an administrative regulation promulgated by the board pursuant to KRS Chapter 13A, each person or entity engaged in the wholesale distribution of prescription drugs that leave or that have ever left the normal dist…

(1) The board shall not require the use of an electronic track and trace system to initiate, provide, receive, or maintain a pedigree by a person or entity licensed to possess, distribute, dispense, or administer prescription drugs for use by an end user until the FDA develops an…

(1) The board shall issue an order to the appropriate person or entity, including but not limited to wholesale distributors or retailers, to immediately cease distribution of prescription drugs within the Commonwealth if there are reasonable grounds to believe: (a) 1. The distrib…

(1) Each facility of a third-party logistics provider located within Kentucky shall be licensed by the board prior to shipping a prescription drug: (a) Within the borders of Kentucky; or (b) To a location outside the borders of Kentucky. (2) Licenses issued under subsection (1) o…

logistics provider. (1) An applicant for licensure as a third-party logistics provider shall submit a satisfactorily completed board-approved application along with the required fee. New applicants shall provide, at minimum, the following: (a) The applicant's full name, all trade…

logistics provider. (1) The board shall consider, at a minimum, the following factors in determining the eligibility for initial licensure and renewal of third-party logistics providers: (a) A finding by a law enforcement agency or regulatory agency that the applicant or any owne…

logistics provider subject to board inspection -- Persons disqualified from being owner or designated representative. (1) Third-party logistics providers shall establish and maintain for board inspection a list of each partner, limited liability company member, and corporate offi…

regulations -- Inspection access required -- Penalty for noncompliance. (1) A third-party logistics provider shall operate in compliance with all applicable federal, state, and local laws and regulations, including but not limited to: (a) The Drug Supply Chain Security Act of 201…

(1) A person engaged in the wholesale distribution of prescription drugs who unknowingly violates any provision of KRS 315.400 to 315.410 may be fined not more than five thousand dollars ($5,000). (2) A person engaged in the wholesale distribution of prescription drugs who acts w…

For the purposes of KRS 315.450 to 315.460: (1) "Controlled substance" has the same meaning as in KRS 218A.010; (2) "Dispense" has the same meaning as in KRS 217.015; (3) "Health care provider" has the same meaning as in KRS 304.17A-005; (4) "Health facility" has the same meaning…

Permitted donations -- Voluntary participation -- Handling fee -- Distribution. (1) The board shall establish and maintain a legend drug repository program to support the donation of a legend drug or supplies needed to administer a legend drug for use by an individual who meets t…

administration supplies. (1) A legend drug or supplies used to administer a legend drug may be accepted and dispensed under the program established in KRS 315.452 only if the following requirements are met: (a) The legend drug or supplies needed to administer the legend drug is i…

(1) Unless the manufacturer of a legend drug or supply needed to administer a legend drug exercises bad faith or fails to exercise ordinary care, the manufacturer of a legend drug or supply shall not be subject to criminal or civil liability for injury, death, or loss to a person…

The board shall promulgate administrative regulations to establish: (1) The requirements for health facilities and pharmacies to accept and dispense donated legend drugs or supplies needed to administer legend drugs under KRS 315.452 and 315.454, including all of the following: (…

Drugs that shall only be dispensed to a patient registered with the drug's manufacturer in accordance with federal Food and Drug Administration requirements shall not be accepted or distributed under the provisions of the program.

Executive order -- Time limit -- Actions authorized -- Extension. (1) When the Governor declares a state of emergency pursuant to KRS 39A.100, the Governor may issue an executive order for a period of up to thirty (30) days giving pharmacists emergency authority. The executive or…

315.500(1). The Kentucky Board of Pharmacy may promulgate administrative regulations in accordance with KRS Chapter 13A to allow pharmacists to effectuate the authority granted in KRS 315.500(1).

(1) Except for the provisions of KRS 315.320, any person violating any provision of KRS Chapter 315 shall be fined for each offense not less than one hundred dollars ($100) nor more than one thousand dollars ($1,000) or imprisoned in the county jail for not more than six (6) mont…