CABINET FOR HEALTH AND FAMILY SERVICES
Office of Inspector General
Division of Fraud, Waste, and Abuse,
Identification and Prevention
(Amendment)
902 KAR 55:030. Schedule IV substances.
RELATES TO: KRS 218A.010-218A.030, 218A.100, 218A.110, 21 C.F.R. 1308.14, 21 U.S.C. 801, 812
STATUTORY AUTHORITY: KRS 218A.020
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.020(1) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations 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 controlled under federal law. This administrative regulation designates Schedule IV controlled substances.
Section 1. Stimulants. The Cabinet for Health and Family Services designates as Schedule IV controlled substances, in addition to those specified by KRS 218A.110, a material, compound, mixture, or preparation which contains a quantity of the following substances, including their salts, isomers whether optical, position, or geometric, and salts of the isomers, if the existence of the salts, isomers, and salts of isomers is possible:
(1) Cathine ((+)-norpseudoephedrine);
(2) Diethylpropion;
(3) Fencamfamin;
(4) Fenproporex;
(5) Mazindol;
(6) Mefenorex;
(7) Modafinil;
(8) Pemoline, including organometallic complexes and chelates;
(9) Phentermine;
(10) Pipradrol;
(11) Sibutramine; and
(12) SPA ((-)-1-dimethylamino-1,2-diphenylethane).
Section 2. Depressants. The Cabinet for Health and Family Services designates as Schedule IV controlled substances, in addition to those specified by KRS 218A.110, a material, compound, mixture, or preparation which contains a quantity of the following substances, including its salts, isomers, and salts of isomers if the existence of the salts, isomers, and salts of isomers is possible within the specific chemical designation:
(1) Alprazolam;
(2) Bromazepam;
(3) Camazepam;
(4) Carisoprodol;
(5) Chlordiazepoxide;
(6) Clobazam;
(7) Clonazepam;
(8) Clorazepate;
(9) Clotiazepam;
(10) Cloxazolam;
(11) Delorazepam;
(12) Diazepam;
(13) Dichloralphenazone;
(14) Estazolam;
(15) Ethyl loflazepate;
(16) Fludiazepam;
(17) Flunitrazepam;
(18) Flurazepam;
(19) Halazepam;
(20) Haloxazolam;
(21) Ketazolam;
(22) Loprazolam;
(23) Lorazepam;
(24) Lormetazepam;
(25) Mebutamate;
(26) Medazepam;
(27) Methohexital;
(28) Midazolam;
(29) Nimetazepam;
(30) Nitrazepam;
(31) Nordiazepam;
(32) Oxazepam;
(33) Oxazolam;
(34) Pinazepam;
(35) Prazepam;
(36) Quazepam;
(37) Temazepam;
(38) Tetrazepam;
(39) Triazolam;
(40) Zaleplon;
(41) Zolpidem; and
(42) Zopiclone.
Section 3. Fenfluamine. The Cabinet for Health and Family Services designates as Schedule IV controlled substances, in addition to those specified by KRS 218A.110, a material, compound, mixture, or preparation which contains any quantity of the following substance, including its salts, isomers, whether optical, position, or geometric, and salts of such isomers, whenever the existence of such salts, isomers, and salts of isomers is possible: Fenfluramine.
Section 4. Narcotics. The Cabinet for Health and Family Services designates as Schedule IV controlled substances, in addition to those specified by KRS 218A.110, a material, compound, mixture, or preparation containing a quantity of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, as set forth below:
(1) Butorphanol;
(2) Dextropropoxyphene (Alpha-(+)-4-dimethylamino-1, 2-diphenyl-3-methyl-2-propionoxybutane);
(3) Not more than one (1) milligram of difenoxin and not less than twenty-five (25) micrograms of atropine sulfate per dosage unit; and
(4) Nalbuphine.
Section 5. Central Analgesics. The Cabinet for Health and Family Services designates as a Schedule IV controlled substance material, compound, mixture, or preparation which contains any quantity of Tramadol or its salts.
SADIQA REYNOLDS, ESQ, Inspector General
JANIE MILLER, Secretary
APPROVED BY AGENCY: May 12, 2008
FILED WITH LRC: May 12, 2008 at 3 p.m.
PUBLIC HEARING AND PUBLIC COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on June 23, 2008, at 9 a.m. in the Ombudsman Conference Room (1E-B) on the first floor of the Human Resources Building, 275 East Main Street, Frankfort, Kentucky. Individuals interested in attending this hearing shall notify this agency in writing by June 16, 2008, five (5) working days 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 cancelled. This hearing is open to the public. Any person who attends will be given an opportunity to comment on this 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 June 30, 2008. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to:
CONTACT PERSON: Jill Brown, Office of Legal Services, 275 East Main Street 5 W-B, Frankfort, Kentucky 40601, phone (502) 564-7905, fax (502) 564-7573.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person: Stephanie Brammer-Barnes, 502-564-2888
(1) Provide a brief summary of:
(a) What this administrative regulation does: This administrative regulation designates Schedule IV 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: KRS 218A.020 mandates that the Kentucky Cabinet for Health and Family Services add, delete, or reschedule substances enumerated in KRS Chapter 218A. This administrative regulation designates Schedule IV controlled substances.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: This administrative regulation designates Schedule IV controlled substances. This regulation is necessary to promote consistency of the state listing of Schedule IV controlled substances with the federal listing at 21 C.F.R. Section 1308.14.
(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 adds the central analgesic drug Tramadol to the Schedule IV controlled substances list.
(b) The necessity of the amendment to this administrative regulation: This amendment is necessary because Tramadol has significant abuse potential and inclusion of the Schedule IV list will help reduce risk to public health.
(c) How the amendment conforms to the content of the authorizing statutes: This amendment recognizes that central analgesic drug Tramadol has significant abuse potential and inclusion on the Schedule IV list will help reduce the risk to public health.
(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 assuring the Cabinet is carrying out its responsibility to establish and amend the schedule of controlled substances, based upon abuse potential.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: This administrative regulation affects each dispenser of controlled substances, including physicians, pharmacists, and retail pharmacies.
(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: The entities identified in question three will be required to lawfully dispense Tramadol and may be subject to penalties for the unauthorized, illegal dispensation of the Schedule IV drug.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): This amendment may only nominally and temporarily increase costs as the entities identified in question three need only to develop appropriate safeguards and protocols, as with all other Schedule IV drugs, for dispensation of Tramadol.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3): This amendment should decrease opportunities for abuse as it will create a disincentive for unauthorized use.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially: There will be no additional cost to implement this administrative regulation.
(b) On a continuing basis: There will be no additional cost associated with implementing this administrative regulation on an on-going basis.
(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 will be agency 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: Neither an increase in fees or 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 dispensers of controlled substances.
FISCAL NOTE ON STATE OR LOCAL GOVERNMENT
1. Does this administrative regulation relate to any program, service, or requirements of a state or local government (including cities, counties, fire departments, or school districts)? Yes
2. 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 the Cabinet for Health and Family Services, local law enforcement, and state Counties’ Attorney.
3. 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. 1308.13, 21 U.S.C. 801, 812
4. 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: This administrative regulation has no fiscal impact.
FEDERAL MANDATE ANALYSIS COMPARISON
1. Federal statute or regulation constituting the federal mandate. 21 C.F.R. Section 1308.14 establishes the federal listing of Schedule IV controlled substances. 21 U.S.C. 801 establishes congressional findings and declarations regarding controlled substances. 21 U.S.C. 812 establishes the five schedules of controlled substances.
2. State compliance standards. KRS 218A.020 permits the Cabinet for Health and Family Services to adopt a regulation to control a substance if it finds the substance has a potential for abuse.
3. Minimum or uniform standards contained in the federal mandate. The federal schedules of controlled substances are established in the federal mandate.
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 adds the central analgesic drug Tramadol to Kentucky’s Schedule IV controlled substances list. Tramadol is not listed on the federal listing of Schedule IV controlled substances.
5. Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements. This amendment recognizes that central analgesic drug Tramadol has significant abuse potential and inclusion on Kentucky’s Schedule IV list will help reduce the risk to public health.