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Code · Kentucky · Chapter 315 — Pharmacists and pharmacies

315.404 Returns or exchanges of prescription drugs.

289 words·~1 min read·/ky/chapter-315/315-404

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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.
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