Kentucky Administrative Regulations
Title 902 - CABINET FOR HEALTH AND FAMILY SERVICES - DEPARTMENT FOR PUBLIC HEALTH
Chapter 55 - Controlled Substances
Section 902 KAR 55:065 - Return of prescription drugs prohibited, exceptions
Universal Citation: 902 KY Admin Regs Service 55:065
Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO: KRS 217.005-217.215, 217.992
NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.125 authorizes the Cabinet for Human Resources to administer the provisions of KRS 217.005 to 217.215 and 217.992. The purpose of this administrative regulation is to prevent the dispensing of prescription drugs that may be adulterated or misbranded.
Section 1. Return of Prescription Drugs Prohibited; Exceptions.
(1) No pharmacist,
practitioner, or agent thereof shall accept the return of a prescription drug
for reuse or resale unless:
(a) The drug is
in a sealed container by which it can be readily determined by a pharmacist
employed by the dispensing pharmacy or by the dispensing practitioner that
entry or attempted entry by any means has not been made;
(b) The drug container meets the standards of
the United States Pharmacopoeia for storage conditions including temperature,
light sensitivity, moisture, chemical, and physical stability;
(c) The drug labeling and packaging has not
been altered or defaced and the identity of the drug, its potency, lot number,
and expiration date are legible;
(d) The drug does not require refrigeration;
and
(e) The drug is returned to a
pharmacist employed by the dispensing pharmacy or to the dispensing
practitioner within fourteen (14) days.
(2) Subsection (1)(d) and (e) of this section
shall be waived if all other conditions are met and if:
(a) The drug was dispensed for a patient in a
health care facility licensed by the Cabinet for Human Resources;
(b) The drug has not come into the physical
possession of the person for whom it was prescribed;
(c) The drug has been under the continuous
control of personnel in the health care facility who are trained and
knowledgeable in the storage and administration of drugs;
(d) The drug has been properly stored in an
area which is regularly inspected by a pharmacist; and
(e) The drug is not expired.
(3) Drugs distributed within an
acute care facility shall be exempt from the provisions of subsection (1)(a),
(d) and (e) of this section.
(4)
Nothing in this administrative regulation shall be construed to require a
pharmacist or practitioner to accept the return of a prescription
drug.
STATUTORY AUTHORITY: KRS 194.050, 211.090, 217.125
Disclaimer: These regulations may not be the most recent version. Kentucky may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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