RELATES TO:

KRS 217.005-217.215, 217.992

STATUTORY AUTHORITY:

KRS 194A.050, 211.090, 217.125, 315.300

CERTIFICATION STATEMENT:

NECESSITY, FUNCTION, AND CONFORMITY:

KRS 315.300 authorizes the Cabinet for Health Services to promulgate administrative regulations that implement the possession of certain drugs by a hospice or home health agency. The purpose of this administrative regulation is to establish criteria that a pharmacy, hospice or home health agency must meet in order to insure that drugs belonging to a pharmacy, that are stored in a hospice or home health agency, are safe and effective for administration to patients.

1. Section 1. Authorized Employees. A pharmacy may place a legend drug listed in KRS 315.300 with an authorized employee of a hospice or a home health agency if the pharmacy maintains a record of the license that authorizes the employee to administer legend drugs.
2. Section 2. Written Agreement. Each party to a written agreement between a pharmacy and a home health agency or a pharmacy and a hospice shall maintain a copy of the written agreement.

3. Section 3. Protocol.

   1. (1) A protocol required by KRS 315.300 may be included in the written agreement or may be a separate document.
   2. (2) If the protocol is a separate document, a copy shall be maintained by the pharmacy and by the hospice or home health agency.
   3. (3) The protocol shall be reviewed not less than annually and modified if necessary.

4. Section 4. Records.

   1. (1) The pharmacy record of a drug placed with authorized employees of a hospice or home health agency shall be retained for five (5) years.
   2. (2) The record of a drug administered by authorized employees of a hospice or home health agency shall be retained by the pharmacy for five (5) years.

History

(902 KAR 055:115. 25 Ky.R. 723; 1369; eff. 12-16-1998; Crt eff. 1-11-2019; Crt eff. 11-24-2025.)