CABINET FOR HEALTH AND FAMILY SERVICES

Office of Inspector General

Division of Audits and Investigations

(Amendment)

 

      902 KAR 55:015. Schedules of controlled substances [Schedule I substances].

 

      RELATES TO: KRS 217.005 -217.215, 218A.010, 218A.020, 218A.040, 218A.060, 218A.080, 218A.100, 218A.120[218A.010-218A.050], 21 C.F.R. 1308.11, 1308.12, 1308.13, 1308.14, 1308.15, 1308.35, 1308.49, 21 U.S.C. 301 – 399f, 801-971

      STATUTORY AUTHORITY: KRS[194A.050,] 218A.020(1), (3) [218A.250]

      NECESSITY, FUNCTION, AND CONFORMITY:[KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to protect the health of the individual citizens of the commonwealth, to operate programs and fulfill the cabinet’s responsibilities, or to implement federal law. KRS 218A.250 requires the cabinet to promulgate administrative regulations to carry out the provisions of KRS Chapter 218A.] KRS 218A.020(1) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations in order to add,[substances to or] 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[establishes] Schedule I, II, III, IV, and V drugs. This administrative regulation differs from the federal regulation 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 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[, 21 C.F.R. 1308.11, because it designates substances that are substantially similar to synthetic cannabinoids as Schedule I controlled substances].

 

      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 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(25)(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.[Opiates. The Cabinet for Health and Family Services hereby designates as Schedule I controlled substances, in addition to those specified by KRS 218A.050, any of the following opiates, including their isomers, optical isomers, esters, ethers, salts, salts of isomers, esters, and ethers, unless specifically excepted, if the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation:

(1) Alphacetylmethadol (except Levo-alphacetylmethadol LAAM);

(2) Acetyl-alpha-methylfentanyl, N-1-(1-methyl-2-phenethyl)-4-piperidinyl -N-phenylacetamide;

(3) Alpha-methylfentanyl, N-1-(alpha-methyl-beta-phenyl) ethyl-4-piperidyl propionanilide, 1-(1-methyl-2-phenylethyl)-4-(N-propanilido) piperidine);

(4) Alpha-methylthiofentanyl, N-1-methyl-2-(2-thienyl) ethyl-4-piperidinyl-N- phenylpropanamide;

(5) Benzylfentanyl, N-1-benzyl-4-piperidyl-N-phenylpro-panamide;

(6) Beta-hydroxyfentanyl, N-1-(2-hydroxy-2-phenethyl)-4-piperidinyl-N-phenypropanamide;

(7) Beta-hydroxy-3-methylfentanyl, N-1-(2-hydroxy-2phenethyl)-3-methyl-4-piperidinyl-N-phenylpropanamide;

(8) Difenoxin;

(9) 3-Methylfentanyl, N-3-methyl-1-(2-phenylethyl)-4-piperidyl-N-phenylpropanamide;

(10) 3-methylthiofentanyl N-3-methyl-1-(2-thienyl) ethyl-4-piperidinyl-N-phenylpropanamide;

(11) 1-methyl-4-phenyl-4-propionoxypiperidine (MPPP);

(12) Para-fluorofentanyl, N-(4-fluorophenyl)-N-(1-(2-phenethyl)-4-piperidinyl)propanamide;

(13) 1-(2-phenethyl)-4-phenyl-4-acetoxypiperidine (PEPAP);

(14) Thenylfentanyl, N-1-(2-thienyl) methyl-4-piperidyl-N-phenyl-propanamide;

(15) Thiofentanyl N-phenyl-N-1-(2-thienyl)ethyl-4-piperidinylpropan-amide;

(16) Tilidine; and

(17) U-47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methly-benzamide).

Section 2. Opium Derivatives. The Cabinet for Health and Family Services hereby designates as Schedule I controlled substances, in addition to those specified by KRS 218A.050, any of the following opium derivatives, their salts, optical isomers, isomers and salts of isomers, unless specifically excepted, if the existence of these salts, isomers, optical isomers, and salts of isomers is possible within the specific chemical designation:

(1) Drotebanol; and

(2) Etorphine (except hydrochloride salt).

Section 3. Hallucinogenic Substances. The Cabinet for Health and Family Services hereby designates as Schedule I controlled substances, in addition to those specified by KRS 218A.050, any material, compound, mixture, or preparation that contains any quantity of the following hallucinogenic substances, their salts, isomers and salts of isomers if the existence of these salts: isomers, including the optical position and geometric isomers; and salts of isomers is possible within the specific chemical designation:

(1) alpha-ethyltryptamine (alpha-ethyl-1H-indole-3-ethanamine,3-(2-aminobutyl)indole);

(2) 4-bromo-2, 5-dimethoxy-amphetamine (4-bromo-2,5-DMA,4-bromo-2,5-dimethoxy-alpha-methylphenethylamine);

(3) 2, 5-dimethoxyamphetamine (2,5-DMA);

(4) 2, 5-dimethoxy-4-ethylamphetamine (DOET);

(5) Ethylamine analog of phencyclidine (N-ethyl-1-phenylcy-clohexylamine, cyclohexamine, (1-phenylcyclohexyl) ethylamine, N-(1-phenylcyclohexyl) ethylamine, PCE);

(6) 3, 4-methylenedioxymethamphetamine (MDMA);

(7) 4-methoxyamphetamine (PMA, 4-methoxy-alphamethylphen-ethylamine, paramethoxyamphetamine);

(8) 3, 4-methylenedioxy-N-ethylamphetamine (N-ethyl-alpha-methyl-3, 4(methylenedioxy)phenethylamine, N-ethyl MDA, MDE, MDEA);

(9) N-hydroxy-3, 4-methylenedioxyamphetamine (N-hydroxy-alpha-methyl-3, 4(methylenedioxy)phenethylamine, N-hydroxy MDA);

(10) Parahexyl (Synhexyl, 3-Hexyl-1-hydroxy-7, 8, 9, 10-tetrahydro-6, 6, 9-trimethyl-6H-dibenzo b,d pyran);

(11) Pyrrolidine analog of phencyclidine (1-(1-phenylcyclohexyl)-pyrrolidine, PCPy, PHP);

(12) Thiophene analog of phencyclidine (1-(1-(2-thienyl)cyclo-hexyl)piperidine, TCP, TPCP);

(13) 1-1-(2-thienyl) cyclohexylpyrrolidine (TCPy);

(14) 2-(2,5-dimethoxyphenyl)-N-{(2-methoxypheny)methyl}ethanamine (2,5H-NBOMe);

(15) 2-(4-iodo-2,5-dimethoxyphenyl)-N-{(2-methoxyphenyl)methyl}ethanamine (2,5I-NBOMe);

(16) 2-(4-bromo-2,5-dimethoxyphenyl)-N-{(2-methoxyphenyl)methyl}ethanamine (2,5B-NBOMe); and

(17) 2-(4-chloro-2,5-dimethoxyphenyl)-N-{(2-methoxyphenyl)methyl}ethanamine (2,5C-NBOMe).

      Section 4. Depressants. The Cabinet for Health and Family Services hereby designates as Schedule I controlled substances, in addition to those specified by KRS 218A.050, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including their salts, isomers, and salts of isomers if the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Mecloqualone; and

(2) Methaqualone.

Section 5. Stimulants. The Cabinet for Health and Family Services hereby designates as Schedule I controlled substances, in addition to those specified by KRS 218A.050, any 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, and salts of isomers if the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Aminorex (aminoxaphen, 2-amino-5-phenyl-2-oxazoline, 4,5-dihydro-5-phenyl-2-oxazolamine);

(2) Cathinone (2-amino-1-phenyl-1-propanone, alpha-aminopro-piophenone, 2-aminopropiophenone, and norephedrone);

(3) (±) cis-4-methylaminorex ((±) cis-4,5-dihydro-4methyl-5-phenyl-2-oxazolamine);

(4) N,N-dimethylamphetamine (N,N-alpha-trimethyl-benzeneetha-namine, N,N,alpha-trimethylphenethylamine), its salts, optical isomers and salts of optical isomers;

(5) N-ethylamphetamine;

(6) Fenethylline;

(7) Methcathinone (2-(methylamino)-propiophenone, alpha (methylamino)-propiophenone, alpha (methylamino)-propiophenone, 2-(methylamino)-1-phenylpropan-1-one, alpha-N-methylaminopropiophe-none, monomethylpropion, ephedrone, N-methylcathinone, methylcathinone, AL-464, AL-422, AL-463 and UR1431), its salts, optical isomers and salts of optical isomers;

(8) Paramethoxymethamphetamine (PMMA); and

(9) Paramethoxyamphetamine (PMA).

Section 6. Synthetic Cannabinoids. The Cabinet for Health and Family Services hereby designates as Schedule I controlled substances, in addition to those specified by KRS 218A.050, any substance, compound, mixture, or preparation which contains any quantity of any synthetic cannabinoid and is not an FDA approved drug, including the following:

(1) (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144);

(2) (1-(5-fluoropentyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (XLR-11);

(3) 1-(5-fluoropentyl)-1H-indazol-3-yl(naphthalen-1-yl)methanone (THJ-2201);

(4) 1-naphthalenyl(1-pentyl-1H-indazol-3-yl)-methanone (THJ-018);

(5) (1-(5-fluoropentyl)-1H-benzoimidazol-2-yl)(naphthalen-1-yl)methanone (AM2201-benzimidazole analog, FUBIMINA);

(6) Indole-3-carboxylate esters: Any compound containing a 1H-indole-3-carboxylate ester structure with the ester oxygen bearing a napthyl, quinolinyl, isoquinolinyl, or adamantyl group and substitution at the one (1) position of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, benzyl, N-methyl-2-piperidinylmethyl, or 2-(4-morpholinyl)ethyl group, whether or not further substituted on the indole ring to any extent and whether or not further substituted on the naphthyl, quinolinyl, isoquinolinyl, adamantyl, or benzyl groups to any extent. Examples of this structural class include PB-22 and 5F-PB-22; and

(7) Indazole-3-carboxamides: Any compound containing a 1H-indazole-3-carboxamide structure with substitution at the nitrogen of the carboxamide by a naphthyl, quinolinyl, isoquinolinyl, adamantyl, or 1-amino-1-oxoalkan-2-yl group and substitution at the one (1) position of the indazole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, benzyl, N-methyl-2-piperidinylmethyl, or 2-(4-morpholinyl)ethyl group, whether or not further substituted on the indazole ring to any extent and whether or not futher substituted on the naphthyl, quinolinyl, isoquinolinyl, adamantyl, 1-amino-oxoalkan-2-yl, or benzyl groups to any extent. Examples of this structural class include AB-FUBINACA and AB-CHMINACA.

      Section 7. Control of Substances Scheduled under Federal Law. If a substance not identified in Section 1 through Section 6 of this administrative regulation is temporarily scheduled or designated as a Schedule I controlled substance under the federal Controlled Substances Act, 21 U.S.C. 801-971, or 21 C.F.R. 1308.11, the substance shall be considered to be controlled at the state level as a Schedule I controlled substance.]

 

ROBERT S. SILVERTHORN, JR., Inspector General

VICKIE YATES BROWN GLISSON, Secretary

      APPROVED BY AGENCY: June 7, 2017

      FILED WITH LRC: June 9, 2017 at 2 p.m.

      PUBLIC HEARING AND PUBLIC COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on July 21, 2017, at 9:00 a.m. in Suites A & B, Health Services Building, First Floor, 275 East Main Street, Frankfort, Kentucky 40621. Individuals interested in attending this hearing shall notify this agency in writing by July 14, 2017, 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 this proposed administrative regulation until July 31, 2017. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to:

      CONTACT PERSON: Tricia Orme, Administrative Specialist, Office of Legal Services, 275 East Main Street 5 W-B, Frankfort, Kentucky 40621, (502) 564-7905, fax (502) 564-7573, email tricia.orme@ky.gov.

 

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

 

Contact Persons: Stephanie Brammer-Barnes, Internal Policy Analyst, Office of Inspector General, email stephanie.brammer@ky.gov., phone 502-564-2888., and Tricia Orme

      (1) Provide a brief summary of:

      (a) What this administrative regulation does: This administrative regulation designates Kentucky’s schedules of controlled substances.

      (b) The necessity of this administrative regulation: This administrative regulation is necessary to comply with KRS 218A.020.

      (c) How this administrative regulation conforms to the content of the authorizing statutes: This administrative regulation conforms to the content of KRS 218A.020(3), which 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.

      (d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: This administrative regulation assists in the effective administration of the statutes by designating Kentucky’s schedules of 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: This amendment aligns Kentucky’s schedules of controlled substances with the federal schedules of controlled substances except for the following: This administrative regulation differs from the federal regulation because Kentucky designates pentazocine, barbital, methylphenobarbital, and phenobarbital as a Schedule III controlled substance. The federal regulation designates these substances as a Schedule IV controlled substance. This administrative regulation also differs from the federal regulation because Kentucky designates nalbuphine as a Schedule IV controlled substance and gabapentin as a Schedule V controlled substance. These substances are not scheduled at the federal level.

      (b) The necessity of the amendment to this administrative regulation: Consistent with the passage of HB 158 during the 2017 legislative session, this amendment is necessary to align Kentucky's schedules of controlled substances with the federal schedules.

      (c) How the amendment conforms to the content of the authorizing statutes: This amendment conforms to the content of KRS 218A.020 by controlling substances at the state level in the same numerical schedule corresponding to the federal schedule unless Kentucky controls a substance in a more restrictive schedule than the federal schedule as noted above.

      (d) How the amendment will assist in the effective administration of the statutes: This amendment assists in the effective administration of the statutes by aligning Kentucky’s schedules of controlled substances with the federal schedules.

      (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 and prescribing practitioners who rely on state and federal regulations for information regarding scheduled drugs as well as state and local law enforcement agencies and the Department of Corrections.

      (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: No additional action is needed to comply with this administrative regulation.

      (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): Law enforcement and medical providers have traditionally been required to review three sources (federal regulation, state law, and state administrative regulation) to determine how a drug is scheduled. However, these laws are often in conflict. Although the federal and state schedules do not match for some drugs because Kentucky has up-scheduled a controlled substance, the reason the schedules do not line up is the difficulty in keeping Kentucky’s administrative regulations and state laws up-to-date with the federal schedules. To resolve this concern, the recent passage of HB 158 amended KRS 218A.020(3) to clarify that any drug controlled at the federal level shall also be controlled at the state level in the same numerical schedule unless the state elects to up-schedule a drug due to its abuse potential. In addition to amending KRS 218A.020, HB 158 also repealed KRS 218A.030, 218A.050, 218A.070, 218A.090, 218A.110, and 218A.130, thereby deleting the state schedules from statute and instead relying on the authority of Kentucky’s administrative regulations to align with the federal regulations in an effort to streamline the controlled substance schedules.

      (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 to be used for the implementation and enforcement of this administrative regulation is from 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 increase in fees or funding will be necessary to implement this amended administrative regulation.

      (8) State whether or not this administrative regulation established any fees or directly or indirectly increased any fees: The amendment to this administrative regulation will not establish or increase 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 and prescribing practitioners who rely on state and federal regulations for information regarding scheduled drugs as well as state and local law enforcement agencies and the Department of Corrections.

      2. Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation. KRS 218A.020, 21 C.F.R. 1308.11, 1308.12, 1308.13, 1308.14, 1308.15, 1308.35, 1308.49      

      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? This amendment will not generate additional revenue for state or local government during the first year.

      (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? This amendment will not generate additional revenue for state or local government during subsequent years.

      (c) How much will it cost to administer this program for the first year? No additional costs are necessary to administer this program during the first year.

      (d) How much will it cost to administer this program for subsequent years? No additional costs are necessary to administer this program for 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. 1308.11, 1308.12, 1308.13, 1308.14, 1308.15, 1308.35, 1308.49

      2. State compliance standards. KRS 218A.020

      3. Minimum or uniform standards contained in the federal mandate. 21 C.F.R. 1308.11 lists controlled substances that have been classified by the DEA as Schedule I drugs. 21 C.F.R. 1308.12 lists controlled substances that have been classified by the DEA as Schedule II drugs. 21 C.F.R. 1308.13 lists controlled substances that have been classified by the DEA as Schedule III drugs. 21 C.F.R. 1308.14 lists controlled substances that have been classified by the DEA as Schedule IV drugs. 21 C.F.R. 1308.15 lists controlled substances that have been classified by the DEA as Schedule IV drugs. 21 C.F.R. 1308.35 exempts certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols from scheduling. 21 C.F.R. 1308.49 allows the DEA to place a substance into Schedule I on a temporary basis if such action is necessary to avoid an imminent hazard to the public safety.

      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 differs from the federal regulation because it designates pentazocine, barbital, methylphenobarbital, and phenobarbital as a Schedule III controlled substance in Kentucky. The federal regulation designates these substances as a Schedule IV controlled substance. NOTE: Designating pentazocine, barbital, methylphenobarbital, and phenobarbital as a Schedule III controlled substance is not a new change to Kentucky’s schedules of controlled substances. This administrative regulation also differs from the federal regulation because it designates nalbuphine as a Schedule IV controlled substance and gabapentin as a Schedule V controlled substance. However, the federal regulation does not designate nalbuphine or gabapentin as a controlled substance. NOTE: Designating nalbuphine and gabapentin as a Schedule IV and Schedule V controlled substance respectively is not a new change made by this amendment to Kentucky’s schedules of controlled substances.

      5. Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements. The Cabinet for Health and Family Services recognizes that pentazocine and derivatives of barbituric acid or its salts have significant abuse potential, and inclusion as a Schedule III controlled substance in Kentucky will help reduce the risk to public health. The Cabinet for Health and Family Services also recognizes that nalbuphine and gabapentin have significant abuse potential and inclusion in Kentucky’s controlled substance schedules will help reduce the risk to public health.