Title 902 | Chapter 055 | Regulation 065


902 KAR 55:065.Return of prescription drugs prohibited, exceptions.

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.

HISTORY: (15 Ky.R. 1618; 1853; eff. 3-15-1989; 20 Ky.R. 2226; eff. 3-14-1994; Crt eff. 1-11-2019.)

7-Year Expiration: 1/11/2026

Last Action: 12/15/2021


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