CABINET FOR HEALTH AND FAMILY SERVICES
Office of Inspector General
Division of Audits and Investigations
(Amendment)
902
KAR 55:020. Schedule II substances.
RELATES
TO: KRS 218A.010-218A.030, 218A.060-218A.070, 21 C.F.R. 1308.12
STATUTORY
AUTHORITY: KRS 218A.060
NECESSITY,
FUNCTION, AND CONFORMITY: KRS 218A.020(1) authorizes the Cabinet for
Health and Family Services 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 under federal law. This administrative regulation designates
Schedule II controlled substances.
Section
1. Substances, Vegetable Origin or Chemical Synthesis.
The
Cabinet for Health and Family Services designates as a Schedule II controlled
substance any material, compound, mixture, or preparation which contains any
quantity of the following substances, except those narcotic drugs listed in
other schedules, whether produced directly or indirectly by extraction from
substances of vegetable origin, or independently by means of chemical
synthesis, or by combination of extraction and chemical synthesis:
(1)
Opium and opiate, and any salt, compound, derivative, or preparation of opium
or opiate;
(2)
Any salt, compound, isomer, derivative, or preparation thereof which is
chemically equivalent or identical with any of the substances referred to in subsection
(1) of this section, but not including the isoquinoline alkaloids of opium;
(3)
Opium poppy and poppy straw; and
(4)
Coca leaves and any salt, compound, derivative, or preparation of coca leaves,
including cocaine and ecgonine and their salts, isomers, derivatives and salts
of isomers and derivatives, and any salt, compound, isomer, derivative, or
preparation thereof which is chemically equivalent or identical with any of
these substances but not including decocainized coca leaves or extractions of
coca leaves which do not contain cocaine, ecgonine, or ioflupane.
Section
2. Opium and Derivatives. The Cabinet for Health and Family Services designates
as a Schedule II controlled substance, in addition to those specified by KRS
218A.070, opium and opiates, and a salt, compound, derivative, or preparation
of opium or opiate, excluding apomorphine, thebaine-derived butorphanol,
dextrorphan, nalbuphine, nalmefene, naloxegol, naloxone, and naltrexone, and
their respective salts, including the following:
(1)
Raw opium;
(2)
Opium extracts;
(3)
Opium fluid;
(4)
Powdered opium;
(5)
Granulated opium;
(6)
Tincture of opium;
(7)
Concentrate of poppy straw (the crude extract of poppy straw in either liquid,
solid, or powder form which contains the phenanthrene alkaloids of the opium
poppy);
(8)
Codeine;
(9)
Dihydroetorphine;
(10)
Ethylmorphine;
(11)
Etorphine hydrochloride;
(12)
Hydrocodone (dihydrocodeinone), including all hydrocodone combination products;
(13)
Hydromorphone;
(14)
Metopon;
(15)
Morphine;
(16)
Oripavine;
(17)
Oxycodone;
(18)
Oxymorphone; and
(19)
Thebaine.
Section
3. Opiates. The Cabinet for Health and Family Services designates as a Schedule
II controlled substance, in addition to those specified by KRS 218A.070, the
following opiates, including their isomers, esters, ethers, salts, and salts of
isomers, esters, and ethers if the existence of such isomers, esters, ethers,
or salts is possible within the specific chemical designation, dextrorphan and
levopropoxyphene except:
(1)
Alfentanil;
(2)
Alphaprodine;
(3)
Anileridine;
(4)
Bezitramide;
(5)
Bulk dextropropoxyphene, in nondosage forms;
(6)
Carfentanil;
(7)
Dihydrocodeine;
(8)
Diphenoxylate;
(9)
Fentanyl;
(10)
Isomethadone;
(11)
Levo-alphacetylmethadol (some other names include levo-alpha-acetylmethadol,
levomethadyl acetate, LAAM);
(12)
Levomethorphan;
(13)
Levorphanol;
(14)
Metazocine;
(15)
Methadone;
(16)
Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane;
(17)
Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic
acid;
(18)
Pethidine (meperidine);
(19)
Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine;
(20)
Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate;
(21)
Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid;
(22)
Phenazocine;
(23)
Piminodine;
(24)
Racemethorphan;
(25)
Racemorphan;
(26)
Remifentanil;
(27)
Sufentanil; and
(28)
Tapentadol.
Section
4. Stimulants. The Cabinet for Health and Family Services designates as a
Schedule II controlled substance a material, compound, mixture, or preparation
which contains any quantity of the following substances having a stimulant
effect on the central nervous system, including their salts, isomers (whether
optical position or geometric), and salts of those isomers if the existence of
the salts, isomers, or salts of isomers is possible within the specific
chemical designation:
(1)
Amphetamine;
(2)
Methamphetamine;
(3)
Phenmetrazine;
(4)
Methylphenidate; and
(5)
Lisdexamfetamine.
Section
5. Depressants. (1) Except as provided in subsection (2) of this section,
the Cabinet for Health and Family Services designates as a
Schedule II controlled substance[substances], in addition to
those specified by KRS 218A.070, a material, compound, mixture, or preparation
which contains a quantity of the following substances:
(a)
Amobarbital;
(b)
Glutethimide;
(c)
Pentobarbital;[and]
(d)
Phencyclidine; and
(e)
Secobarbital.
(2)
A suppository dosage form containing amobarbital, secobarbital, or
pentobarbital or any of their salts, which has been approved by the United States
Food and Drug Administration for marketing only as a suppository, shall be in
Schedule III.
Section
6.[2.] Immediate Precursors. The Cabinet for Health and Family
Services designates as a Schedule II controlled substance[substances],
in addition to those specified by KRS 218A.070, a material, compound, mixture,
or preparation which contains a quantity of the following substances:
(1)
Immediate precursors to amphetamine and methamphetamine and substances:
(a)
Phenylacetone;
(b)
Phenyl-2-propanone;
(c)[(b)]
P2P;
(d)[(c)]
Benzyl methyl ketone; and
(e)[(d)]
Methyl benzyl ketone;[and]
(2)
Immediate precursors to phencyclidine:
(a)
1-phenylcyclohexylamine; and
(b)
1-piperidinocyclohexanecarbonitrile, also known as PCC; and
(3)
Immediate precursors of fentanyl, 4-anilino-N-phenethyl-4-piperidine (ANPP).
Section
7.[3.] Hallucinogenic Substances. The Cabinet for Health and
Family Services designates as a Schedule II controlled substance[substances],
in addition to those specified by KRS 218A.070, a material, compound, mixture,
or preparation which contains a quantity of the following substances: Nabilone,
also known as (plus or minus) -
trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzo{b,d}pyran-9-one.
[Section
4. Opium and Derivatives. The Cabinet for Health Services designates as
Schedule II controlled substances, in addition to those specified by KRS
218A.070, opium and opiates, and a salt, compound, derivative, or preparation
of opium or opiate, excluding apomorphine, dextrorphan, nalbuphine, nalmefene, naloxone,
and naltrexone, and their respective salts, but including the following:
(1)
Raw opium;
(2)
Opium extracts;
(3)
Opium fluid;
(4)
Powdered opium;
(5)
Granulated opium;
(6)
Tincture of opium;
(7)
Codeine;
(8)
Ethylmorphine;
(9)
Etorphine hydrochloride;
(10)
Hydrocodone;
(11)
Hydromorphone;
(12)
Metopon;
(13)
Morphine;
(14)
Oxycodone;
(15)
Oxymorphone; and
(16)
Thebaine.
Section
5. Opiates. The Cabinet for Health Services designates as Schedule II
controlled substances, in addition to those specified by KRS 218A.070, the
following opiates, including their isomers, esters, ethers, salts and salts of
isomers, esters, and ethers if the existence of such isomers, esters, ethers,
or salts is possible within the specific chemical designation, dextrorphan and
levopropoxyphene excepted:
(1)
Alfentanil;
(2)
Bulk dextropropoxyphene, in nondosage forms;
(3)
Carfentanil;
(4)
Levo-alphacetylmethadol (LAAM);
(5)
Remifentanil; and
(6)
Sufentanil.]
MARYELLEN
B. MYNEAR, Inspector General
AUDREY
TAYSE HAYNES, Secretary
APPROVED
BY AGENCY: October 28, 2015
FILED
WITH LRC: November 4, 2015 at 4 p.m.
PUBLIC
HEARING AND PUBLIC COMMENT PERIOD: A public hearing on this administrative
regulation shall, if requested, be held on December 21, 2015, at 9:00 a.m. in
Conference Suite B, Health Services Building, First Floor, 275 East Main
Street, Frankfort, Kentucky. Individuals interested in attending this hearing
shall notify this agency in writing by December 14, 2015, five (5) workdays
prior to the hearing, of their intent to attend. If no notification of intent
to attend the hearing is received by that date, the hearing may be canceled. The
hearing is open to the public. Any person who attends will be given an
opportunity to comment on the proposed administrative regulation. A transcript
of the public hearing will not be made unless a written request for a
transcript is made. If you do not wish to attend the public hearing, you may
submit written comments on the proposed administrative regulation. You may
submit written comments regarding this proposed administrative regulation until
close of business, January 4, 2016. Send written notification of intent to
attend the public hearing or written comments on the proposed administrative
regulation to:
CONTACT
PERSON: Tricia Orme, Office of Legal Services, 275 East Main Street 5 W-B,
Frankfort, Kentucky 40621, phone (502) 564-7905, fax (502) 564-7573, email tricia.orme@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact
Person: Stephanie Brammer-Barnes
(1)
Provide a brief summary of:
(a)
What this administrative regulation does: This administrative regulation
designates Schedule II controlled substances.
(b)
The necessity of this administrative regulation: This administrative regulation
is needed to designate Schedule II controlled substances.
(c)
How this administrative regulation conforms to the content of the authorizing
statutes: This administrative regulation conforms to the content of KRS 218A.020
which allows the Cabinet for Health and Family Services to add substances to or
delete or reschedule all substances enumerated in the schedules set forth in
KRS Chapter 218A.
(d)
How this administrative regulation currently assists or will assist in the
effective administration of the statutes: This administrative regulation will
assist in the effective administration of the statutes by designating Schedule
II controlled substances.
(2)
If this is an amendment to an existing administrative regulation, provide a
brief summary of:
(a)
How the amendment will change this existing administrative regulation: On
August 22, 2014, the US Drug Enforcement Administration (DEA) published a final
rule in the Federal Register reclassifying hydrocodone combination products
(HCP) from Schedule III to Schedule II. Therefore, to ensure consistency with
the DEA’s rescheduling of these painkillers, this amendment adds HCPs to
Kentucky’s list of Schedule II drugs. In addition, this amendment adds other
drugs to Kentucky’s list of Schedule II drugs to ensure consistency with the federal
Schedule II regulations.
(b)
The necessity of the amendment to this administrative regulation: This
amendment is necessary to promote consistency between the state listing of
Schedule II drugs and the federal listing of Schedule II drugs at 21 C.F.R.
1308.12. This amendment further assures that the Cabinet is carrying out its
responsibility to establish and amend the state’s list of Schedule II controlled
substances based upon high potential for abuse, currently accepted medical use,
as well as potential for psychic or physical dependence if abused.
(c)
How the amendment conforms to the content of the authorizing statutes: This
amendment conforms to the content of KRS 218A.020 which allows the Cabinet for
Health and Family Services to add substances to or delete or reschedule
substances enumerated in the schedules set forth in KRS Chapter 218A.
(d)
How the amendment will assist in the effective administration of the statutes: This
amendment will assist in the effective administration of the statutes by
ensuring the Cabinet is carrying out its responsibility to establish and amend
the state’s list of Schedule II controlled substances based upon high potential
for abuse, currently accepted medical use, as well as potential for psychic or
physical dependence if abused.
(3)
List the type and number of individuals, businesses, organizations, or state
and local governments affected by this administrative regulation: This
administrative regulation affects Kentucky’s pharmacists who rely on state and
federal regulations for information regarding Scheduled drugs as well as law
enforcement agencies and prosecutors who use this administrative regulation to
charge individuals for crimes related to controlled substances, including HCPs,
under KRS Chapter 218A.
(4)
Provide an analysis of how the entities identified in question (3) will be
impacted by either the implementation of this administrative regulation, if
new, or by the change, if it is an amendment, including:
(a)
List the actions that each of the regulated entities identified in question (3)
will have to take to comply with this administrative regulation or amendment: Under
this amendment, Kentucky’s law enforcement agencies and prosecutors will use
this administrative regulation to charge individuals for crimes related to
controlled substances under KRS Chapter 218A. No additional action needed for
pharmacists.
(b)
In complying with this administrative regulation or amendment, how much will it
cost each of the entities identified in question (3): No costs will be incurred
by any entity identified in question (3).
(c)
As a result of compliance, what benefits will accrue to the entities identified
in question (3): By making this administrative regulation consistent with the
federal regulations for Schedule II substances, this amendment reduces
confusion for pharmacists, law enforcement agencies, and prosecutors who rely
on state and federal regulations for scheduling information.
(5)
Provide an estimate of how much it will cost the administrative body to
implement this administrative regulation:
(a)
Initially: No costs are necessary to implement this amendment.
(b)
On a continuing basis: No costs are necessary to implement this amendment.
(6)
What is the source of the funding to be used for the implementation and
enforcement of this administrative regulation: The source of funding used for
the implementation and enforcement of this administrative regulation is from
state general funds.
(7)
Provide an assessment of whether an increase in fees or funding will be
necessary to implement this administrative regulation, if new, or by the change
if it is an amendment: No fees or additional funding will be necessary to
implement this administrative regulation.
(8)
State whether or not this administrative regulation established any fees or
directly or indirectly increased any fees: This administrative regulation does
not establish any fees.
(9)
TIERING: Is tiering applied? Tiering is not applicable as compliance with this
administrative regulation applies equally to all individuals or entities
regulated by it.
FISCAL NOTE ON STATE OR LOCAL GOVERNMENT
1.
What units, parts or divisions of state or local government (including cities,
counties, fire departments, or school districts) will be impacted by this
administrative regulation? This administrative regulation affects Kentucky’s
pharmacists who rely on state and federal regulations for information regarding
Scheduled drugs as well as law enforcement agencies and prosecutors who use
this administrative regulation to charge individuals for crimes related to
controlled substances, including HCPs, under KRS Chapter 218A.
2.
Identify each state or federal statute or federal regulation that requires or
authorizes the action taken by the administrative regulation. KRS 218A.020, KRS
218A.060, KRS 218A.070, 21 C.F.R. 1308.12
3.
Estimate the effect of this administrative regulation on the expenditures and
revenues of a state or local government agency (including cities, counties,
fire departments, or school districts) for the first full year the
administrative regulation is to be in effect.
(a)
How much revenue will this administrative regulation generate for the state or
local government (including cities, counties, fire departments, or school
districts) for the first year? There will be no additional revenue generated
for state or local government for the first year that this administrative
regulation is in effect.
(b)
How much revenue will this administrative regulation generate for the state or
local government (including cities, counties, fire departments, or school
districts) for subsequent years? There will be no additional revenue generated
for state or local government during subsequent years after this administrative
regulation becomes effective.
(c)
How much will it cost to administer this program for the first year? There will
be no additional cost to administer this program for the first year.
(d)
How much will it cost to administer this program for subsequent years? There
will be no additional cost to administer this program in subsequent years.
Note:
If specific dollar estimates cannot be determined, provide a brief narrative to
explain the fiscal impact of the administrative regulation.
Revenues
(+/-):
Expenditures
(+/-):
Other
Explanation:
FEDERAL MANDATE ANALYSIS COMPARISON
1.
Federal statute or regulation constituting the federal mandate. 21 C.F.R.
1308.12
2.
State compliance standards. KRS 218A.020
3.
Minimum or uniform standards contained in the federal mandate. 21 C.F.R.
1308.12 lists controlled substances that have been classified by the DEA as
Schedule II drugs.
4.
Will this administrative regulation impose stricter requirements, or additional
or different responsibilities or requirements, than those required by the
federal mandate? This administrative regulation does not impose stricter
requirements than those required by federal mandate.
5.
Justification for the imposition of the stricter standard, or additional or
different responsibilities or requirements. Not applicable.
