Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
217.005-217.215,
218A.010,
218A.020,
218A.040,
218A.060,
218A.080,
218A.100,
218A.120,
218A.200,
21 C.F.R.
1308.11,
1308.12,
1308.13,
1308.14,
1308.15,
1308.35,
1308.49,
21 U.S.C.
301
¢â,¬o 399f, 801-971
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
218A.020(1) authorizes the
Cabinet for Health and Family Services to promulgate administrative regulations
in order to add, delete, or reschedule substances enumerated in KRS Chapter
218A. KRS
218A.020(3) authorizes the
Cabinet for Health and Family Services to promulgate administrative regulations
to control substances at the state level in the same numerical schedule
corresponding to the federal schedule or control a substance in a more
restrictive schedule than the federal schedule. This administrative regulation
designates Schedule I, II, III, IV, and V drugs. This administrative regulation
differs from the federal regulation,
21 C.F.R.
1308.11, because it designates tianeptine as
a Schedule I controlled substance. The Cabinet for Health and Family Services
recognizes that tianeptine has no accepted medical use in treatment and
inclusion on Kentucky's Schedule I list will help reduce the risk to public
health. This administrative regulation differs from the federal regulation,
21 C.F.R.
1308.14, because it designates pentazocine,
barbital, methylphenobarbital, and phenobarbital as a Schedule III controlled
substance. The federal regulation designates these substances as a Schedule IV
controlled substance. The Cabinet for Health and Family Services recognizes
that pentazocine and derivatives of barbituric acid or its salts have
significant abuse potential, and inclusion on Kentucky's Schedule III list will
help reduce the risk to public health. This administrative regulation further
differs from the federal regulation,
21 C.F.R.
1308.14-1308.15, because it
designates nalbuphine as a Schedule IV controlled substance and gabapentin as a
Schedule V controlled substance. The Cabinet for Health and Family Services
recognizes that nalbuphine and gabapentin have significant abuse potential, and
inclusion on Kentucky's controlled substances schedules will help reduce the
risk to public health.
Section 1.
Schedule I Controlled Substances.
(1) Each
substance that is scheduled or designated as a Schedule I controlled substance
under 21 C.F.R.
1308.11, including a substance temporarily
scheduled or designated under
21 C.F.R.
1308.11(h) or
1308.49, shall be scheduled or
designated at the state level as a Schedule I controlled substance.
(2) The Cabinet for Health and Family
Services designates the following as a Schedule I controlled substance:
tianeptine.
(3) The following shall
be exempt from control as a Schedule I substance:
(a) Cannabis plant material, and products
made therefrom, that contain tetrahydrocannabinols pursuant to the exemption
established in 21 C.F.R.
1308.35; and
(b) Any substance or product exempt from the
definition of marijuana pursuant to
KRS
218A.010(27)(a) -
(f).
Section
2. Schedule II Controlled Substances. Each substance that is
scheduled or designated as a Schedule II controlled substance under
21 C.F.R.
1308.12 shall be scheduled or designated at
the state level as a Schedule II controlled substance.
Section 3. Schedule III Controlled
Substances.
(1) Except as provided by
subsection (2) of this section, each substance that is scheduled or designated
as a Schedule III controlled substance under
21 C.F.R.
1308.13 shall be scheduled or designated at
the state level as a Schedule III controlled substance.
(2) The Cabinet for Health and Family
Services designates the following as Schedule III controlled substances:
(a) Pentazocine;
(b) Barbital;
(c) Methylphenobarbital; and
(d) Phenobarbital.
(3) This section shall not apply to any
material, compound, mixture, or preparation containing any quantity of an
anabolic steroid substance, or any isomer, ester, salt, or derivative thereof
that is:
(a) Expressly intended for
administration through implant to livestock or other nonhuman species;
and
(b) Approved by the United
States Food and Drug Administration for use as described in this
subsection.
Section
4. Schedule IV Controlled Substances.
(1) Except as provided by subsection (2) of
this section and Section 3(2) of this administrative regulation, each substance
that is scheduled or designated as a Schedule IV controlled substance under
21 C.F.R.
1308.14 shall be scheduled or designated at
the state level as a Schedule IV controlled substance.
(2) The Cabinet for Health and Family
Services designates the following as a Schedule IV controlled substance:
nalbuphine.
Section 5.
Schedule V Controlled Substances.
(1) Except
as provided by subsection (2) of this section, each substance that is scheduled
or designated as a Schedule V controlled substance under
21 C.F.R.
1308.15 shall be scheduled or designated at
the state level as a Schedule V controlled substance.
(2) The Cabinet for Health and Family
Services designates the following as a Schedule V controlled substance:
gabapentin.
Section 6.
Dispensing Without Prescription. A controlled substance listed in Schedule V,
which is not a prescription drug under the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C.
301 to
399f, may be dispensed by a
pharmacist without a prescription to a purchaser at retail, if:
(1) The medicinal preparation contains, in
addition to the controlled substances, some drug or drugs conferring upon it
medicinal qualities other than those possessed by the controlled substances
alone;
(2) Not more than 240cc
(eight (8) ounces) or more than forty-eight (48) dosage units of any controlled
substance containing opium is dispensed at retail to the same purchaser in any
given forty-eight (48) hour period;
(3) The labeling and packaging is in
accordance with the current requirements of
KRS
217.005 to
217.215,
21 U.S.C.
301 to
399f, and the United States
Pharmacopeia;
(4) The preparation
is dispensed or sold in good faith as a medicine and not for the purpose of
evading the provisions of KRS Chapter 218A;
(5) The preparation is not displayed in areas
open to the public;
(6) The
dispensing is made only by a pharmacist and not by a nonpharmacist employee
even if under the supervision of a pharmacist. After the pharmacist has
fulfilled his or her professional and legal responsibilities as set forth in
this section, the actual cash, credit transaction, or delivery may be completed
by a nonpharmacist;
(7) The
purchaser is at least eighteen (18) years of age;
(8) The pharmacist requires every purchaser
of a controlled substance under this section not known to the pharmacist to
furnish suitable identification, including proof of age if appropriate;
and
(9) The dispensing of exempt
controlled substances under this administrative regulation is recorded in a
bound book that shall be maintained in accordance with the recordkeeping
requirements of KRS
218A.200 and contain the:
(a) Name and address of the
purchaser;
(b) Name and quantity of
controlled substance purchased;
(c)
Date of each purchase; and
(d) Name
or initials of the pharmacist who dispensed the substance to the
purchaser.
STATUTORY AUTHORITY:
KRS
218A.020(1),
(3)
