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315.404 Returns or exchanges of prescription drugs.
(1)
(2)
(3)
(4)
(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.
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.
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.
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.
Effective:July 15, 2008
History: Created 2008 Ky. Acts ch. 124, sec. 5, effective July 15, 2008.
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