902 Kar 55:020. Schedule Ii Substances

Link to law: http://www.lrc.ky.gov/kar/902/055/020reg.htm
Published: 2015

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.
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