Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO: 21 C.F.R. Part 1317
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
218A.250 requires the Cabinet for Health and
Family Services to promulgate administrative regulations for carrying out the
provisions of KRS Chapter 218A. This administrative regulation establishes
safe, secure, and responsible methods for the disposal of unused or unwanted
prescription controlled substances by long-term care facilities and other
cabinet-licensed facilities with custodial control of patient-owned controlled
substance medications.
Section 1.
Methods of Disposal. A long-term care facility or other cabinet-licensed
facility with custodial control of patient-owned controlled substance
medications shall:
(1) Dispose of all
expired, abandoned, or otherwise unwanted controlled substances in accordance
with 21 C.F.R. Part 1317; and
(2)
Develop and implement written policies and procedures for the disposal of
controlled substances. Disposal methods shall include:
(a) On-site destruction that renders the
controlled substance unrecoverable and beyond reclamation so that the
medication cannot be diverted; or
(b) Transfer of the controlled substance to
an authorized collection receptacle maintained by a:
1. Law enforcement agency; or
2. Pharmacy.
Section 2. Procedures for
Disposal.
(1) If a patient's controlled
substance medication has expired, been abandoned, or is otherwise unwanted,
either the facility's responsible person or the director of nursing and a
witness who is employed by the facility shall perform and document:
(a) Removal of the patient's controlled
substances from the medication cart or storage area;
(b) Transfer of the medications to a separate
secure storage area; and
(c) Use of
a disposal method established by Section 1(2) of this administrative regulation
no later than thirty (30) days from the date the patient's controlled
substances are removed from the medication cart or storage area.
(2) The facility shall maintain a
readily retrievable record of controlled substances removed from the medication
cart or other area of storage. The record shall:
(a) Be maintained for a minimum of eighteen
(18) months from the date of disposal;
(b) Be made available upon request by the
cabinet for purposes of inspection; and
(c) Contain the following information:
1. Amount of controlled substances destroyed
on-site or transferred to a collection receptacle;
2. Disposal method;
3. Date of disposal;
4. Patient name;
5. Drug name;
6. Drug strength; and
7. Name of the responsible person or director
of nursing and witness responsible for the transfer and disposal of the
medications.
(3) Controlled substances shall not be
destroyed by flushing into a sewage treatment system unless disposal by
flushing is permitted by:
(a) Instructions on
the label;
(b) The patient
information leaflet with the medication; or
(c) The U.S. Food and Drug Administration's
(FDA) flush list posted on the FDA webpage:
https://www.fda.gov/media/85219/download.
(4) The cabinet shall take adverse
action against a facility's license in accordance with
902 KAR
20:008, Section 8, or
908
KAR 1:370, Section 20, if the cabinet finds that there
has been a substantial failure by the facility to comply with the provisions of
this administrative regulation.
STATUTORY AUTHORITY:
KRS
218A.250
