KRS 315.404: Returns or exchanges of prescription drugs.

(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 expired, damaged, recalled, or otherwise nonsalable prescription

drugs shall be distributed by the receiving wholesale distributor only to the

original manufacturer, a third -party returns processor, or a reverse distributor

licensed as a wholesale distributor.

(c) Returns or exchanges of prescription drugs that may or may not be salable,

including any redistribution by a receiving wholesaler, shall not be subject to

the requirements of KRS 315.406 if they are exempt from the pedigree

requirements of the federal regulations for the federal Prescription Drug

Marketing Act of 1987 as amended by the Prescription Drug Amendments of

1992 and any amendments thereto.

(2) A manufacturer or wholesale distributor shall supply prescription drugs only to a

person or entity licensed to possess or distribute prescription drugs to an end user.

(3) Prescription drugs supplied by a manufacturer or wholesale distributor shall be

delivered only to the business address of the licensee or the address listed on the

license, to the address of a health -care entity authorized by the licensee, or to an

authorized person or agent of the licensee at the premises of the manufacturer or

wholesale distributor if the identity and authority of the authorized agent is

established.

(4) A licensed wholesale distributor, pharmacy, or other person authorized by law to

furnish prescription drugs to an end user shall be accountable for their returns

process and shall ensure that all aspects of their operations are secure and do not

permit the entry of adulterated or counterfeit prescription drugs.