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IC 35-48-2-1
Considerations of board in determinations on substances;
controlled substances advisory committee; exclusion of a
nonnarcotic substance from schedule
Sec. 1. (a) The board shall administer this article and may
recommend to the general assembly the addition, deletion, or
rescheduling of all substances listed in the schedules in sections 4,
6, 8, 10, and 12 of this chapter by submitting in an electronic format
under IC 5-14-6 a report of such recommendations to the legislative
council. In making a determination regarding a substance, the board
shall consider the following:
(1) The actual or relative potential for abuse.
(2) The scientific evidence of its pharmacological effect, if
known.
(3) The state of current scientific knowledge regarding the
substance.
(4) The history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) The risk to public health.
(7) The potential of the substance to produce psychic or
physiological dependence liability.
(8) Whether the substance is an immediate precursor of a
substance already controlled under this article.
(b) After considering the factors enumerated in subsection (a), the
board shall make findings and recommendations concerning the
control of the substance if it finds the substance has a potential for
abuse.
(c) If the board finds that a substance is an immediate precursor,
substances which are precursors of the controlled precursor shall not
be subject to control solely because they are precursors of the
controlled precursor.
(d) If any substance is designated or rescheduled to a more
restrictive schedule as a controlled substance under federal law and
notice is given to the board, the board shall recommend similar
control of the substance under this article in the board's report to the
general assembly, unless the board objects to inclusion or
rescheduling. In that case, the board shall publish the reasons for
objection and afford all interested parties an opportunity to be heard.
At the conclusion of the hearing, the board shall publish its findings.
(e) If a substance is rescheduled to a less restrictive schedule or
deleted as a controlled substance under federal law, the substance is
rescheduled or deleted under this article. If the board objects to
inclusion, rescheduling, or deletion of the substance, the board shall
notify the chairman of the legislative council not more than thirty
(30) days after the federal law is changed and the substance may not
be rescheduled or deleted until the conclusion of the next complete
session of the general assembly. The notice from the board to the
chairman of the legislative council must be published.
(f) There is established a sixteen (16) member controlled
substances advisory committee to serve as a consultative and
advising body to the board in all matters relating to the classification,
reclassification, addition to, or deletion from of all substances
classified as controlled substances in schedules I to IV or substances
not controlled or yet to come into being. In addition, the advisory
committee shall conduct hearings and make recommendations to the
board regarding revocations, suspensions, and restrictions of
registrations as provided in IC 35-48-3-4. All hearings shall be
conducted in accordance with IC 4-21.5-3. The advisory committee
shall be made up of:
(1) two (2) physicians licensed under IC 25-22.5, one (1) to be
elected by the medical licensing board of Indiana from among
its members and one (1) to be appointed by the governor;
(2) two (2) pharmacists, one (1) to be elected by the state board
of pharmacy from among its members and one (1) to be
appointed by the governor;
(3) two (2) dentists, one (1) to be elected by the state board of
dentistry from among its members and one (1) to be appointed
by the governor;
(4) the state toxicologist or the designee of the state
toxicologist;
(5) two (2) veterinarians, one (1) to be elected by the state
board of veterinary medical examiners from among its members
and one (1) to be appointed by the governor;
(6) one (1) podiatrist to be elected by the board of podiatric
medicine from among its members;
(7) one (1) advanced practice nurse with authority to prescribe
legend drugs as provided by IC 25-23-1-19.5 who is:
(A) elected by the state board of nursing from among the
board's members; or
(B) if a board member does not meet the requirements under
IC 25-23-1-19.5 at the time of the vacancy on the advisory
committee, appointed by the governor;
(8) the superintendent of the state police department or the
superintendent's designee;
(9) three (3) members appointed by the governor who have
demonstrated expertise concerning controlled substances; and
(10) one (1) member appointed by the governor who is a
psychiatrist with expertise in child and adolescent psychiatry.
(g) All members of the advisory committee elected by a board
shall serve a term of one (1) year and all members of the advisory
committee appointed by the governor shall serve a term of four (4)
years. Any elected or appointed member of the advisory committee,
may be removed for cause by the authority electing or appointing the
member. If a vacancy occurs on the advisory committee, the
authority electing or appointing the vacating member shall elect or
appoint a successor to serve the unexpired term of the vacating
member. The board shall acquire the recommendations of the
advisory committee pursuant to administration over the controlled
substances to be or not to be included in schedules I to V, especially
in the implementation of scheduled substances changes as provided
in subsection (d).
(h) Authority to control under this section does not extend to
distilled spirits, wine, or malt beverages, as those terms are defined
or used in IC 7.1, or to tobacco.
(i) The board shall exclude any nonnarcotic substance from a
schedule if that substance may, under the Federal Food, Drug, and
Cosmetic Act or state law, be sold over the counter without a
prescription.
As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1977,
P.L.344, SEC.1; P.L.137-1985, SEC.17; P.L.200-1987, SEC.4;
P.L.188-1989, SEC.4; P.L.33-1993, SEC.73; P.L.163-1994, SEC.2;
P.L.177-1997, SEC.8; P.L.14-2000, SEC.77; P.L.107-2002, SEC.31;
P.L.28-2004, SEC.178.
IC 35-48-2-1.1
Repealed
(Repealed by P.L.2-1995, SEC.140.)
IC 35-48-2-1.5
Advisory committee; officers; meetings; rules; per diem; expenses
Sec. 1.5. (a) The advisory committee shall annually elect a
chairperson and any other officers that the advisory committee
determines necessary from among its members.
(b) Meetings of the advisory committee may be called by:
(1) the advisory committee chairperson; or
(2) a majority of the members of the advisory committee.
(c) Seven (7) members of the committee constitute a quorum.
(d) Notwithstanding IC 1-1-4-1, if at least a quorum of its
members are present at a meeting, the committee may take an action
by an affirmative vote of at least a majority of the members present
and voting.
(e) The advisory committee shall adopt rules under IC 4-22-2 to:
(1) set standards related to the registration and control of the
manufacture, distribution, and dispensing of controlled
substances, including record keeping requirements;
(2) set fees described in IC 25-1-8; and
(3) carry out its responsibilities under IC 35-48-2 through
IC 35-48-3.
(f) The Indiana professional licensing agency shall provide staff
and facilities to the advisory committee under IC 25-1-5.
(g) Each member of the committee who is not a state employee is
entitled to the minimum salary per diem provided by
IC 4-10-11-2.1(b). Such a member is also entitled to reimbursement
for traveling expenses and other expenses actually incurred in
connection with the member's duties, as provided in the state travel
policies and procedures established by the department of
administration and approved by the budget agency.
IC 35-48-2-2
Nomenclature
Sec. 2. Nomenclature. The controlled substances listed in the
schedules in sections 4, 6, 8, 10 and 12 of this chapter are included
by whatever official, common, usual, chemical, or trade name
designated. The number placed in brackets after each substance is its
federal Drug Enforcement Administration Controlled Substances
Code Number which is to be used for identification purposes on
certain certificates of registration.
As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1979,
P.L.303, SEC.2.
IC 35-48-2-3
Schedule I tests
Sec. 3. (a) The board shall recommend placement of a substance
in schedule I under this chapter if it finds that the substance:
(1) has high potential for abuse; and
(2) has no accepted medical use in treatment in the United
States or lacks accepted safety for use in treatment under
medical supervision.
(b) The board may recommend placement of a substance in
schedule I under this chapter if it finds that the substance is classified
as a controlled substance in schedule I under federal law.
As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.200-1987,
SEC.6.
IC 35-48-2-4
Schedule I
Sec. 4. (a) The controlled substances listed in this section are
included in schedule I.
(b) Opiates. Any of the following opiates, including their isomers,
esters, ethers, salts, and salts of isomers, esters, and ethers, unless
specifically excepted by rule of the board or unless listed in another
schedule, whenever the existence of these isomers, esters, ethers, and
salts is possible within the specific chemical designation:
Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4-
piperidinyl]-N-phenylacetamide) (9815)
Acetylmethadol (9601)
Allylprodine (9602)
Alpha-methylthiofentanyl (N-[1-methyl-2-(2-
thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide) (9832)
Alphacetylmethadol (9603)
IC 35-48-2-5
Schedule II tests
Sec. 5. (a) The board shall recommend placement of a substance
in schedule II under this chapter if it finds that:
(1) the substance has high potential for abuse;
(2) the substance has currently accepted medical use in
treatment in the United States, or currently accepted medical
use with severe restrictions; and
(3) the abuse of the substance may lead to severe psychological
or physical dependence.
(b) The board may recommend placement of a substance in
schedule II under this chapter if it finds that the substance is
classified as a controlled substance in schedule II under federal law.
As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.200-1987,
SEC.8.
compound, mixture, or preparation which contains any quantity of
the following substances:
(1) Immediate precursor to amphetamine and
methamphetamine: Phenylacetone (8501). Some trade or other
names: phenyl-2-propanone; P2P; benzyl methyl ketone; methyl
benzyl ketone.
(2) Immediate precursors to phencyclidine (PCP):
(A) 1-phenylcyclohexylamine (7460); or
(B) 1-piperidinocyclohexanecarbonitrile (PCC) (8603).
(g) Hallucinogenic substances:
Nabilone (7379). Other name: (+/-)-trans-3-
(1,1-dimethylheptyl)-6, 6a, 7, 8, 10, 10a-hexahydro-1-hydroxy
-6, 6-dimethyl-9H-dibenzo [b,d] pyran-9-one.
As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1979,
P.L.303, SEC.4; Acts 1981, P.L.170, SEC.3; P.L.333-1983, SEC.2;
P.L.77-1984, SEC.13; P.L.327-1985, SEC.2; P.L.156-1986, SEC.5;
P.L.329-1987, SEC.1; P.L.31-1998, SEC.9; P.L.22-2008, SEC.2.
IC 35-48-2-7
Schedule III tests
Sec. 7. (a) The board shall recommend placement of a substance
in schedule III under this chapter if it finds that:
(1) the substance has a potential for abuse less than the
substances listed in schedule I and II under this chapter;
(2) the substance has currently accepted medical use in
treatment in the United States; and
(3) abuse of the substance may lead to moderate or low physical
dependence or high psychological dependence.
(b) The board may recommend placement of a substance in
schedule III under this chapter if it finds that the substance is
classified as a controlled substance in schedule III under federal law.
As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.200-1987,
SEC.9.
IC 35-48-2-8
Schedule III
Sec. 8. (a) The controlled substances listed in this section are
included in schedule III.
(b) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation
which contains any quantity of the following substances having a
stimulant effect on the central nervous system, 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 within the specific chemical designation:
(1) Those compounds, mixtures, or preparations in dosage unit
form containing any stimulant substances listed in schedule II
which compounds, mixtures, or preparations were listed on
April 1, 1986, as excepted compounds under 21 CFR 1308.32,
and any other drug of the quantitative composition shown in
that list for those drugs or that is the same except that it
contains a lesser quantity of controlled substances (1405).
(2) Benzphetamine (1228).
(3) Chlorphentermine (1645).
(4) Clortermine (1647).
(5) Phendimetrazine (1615).
(c) Depressants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation
which contains any quantity of the following substances having a
depressant effect on the central nervous system:
(1) Any compound, mixture, or preparation containing:
(A) amobarbital (2126);
(B) secobarbital (2316);
(C) pentobarbital (2271); or
(D) any of their salts;
and one (1) or more other active medicinal ingredients which
are not listed in any schedule.
(2) Any suppository dosage form containing:
(A) amobarbital (2126);
(B) secobarbital (2316);
(C) pentobarbital (2271); or
(D) any of their salts;
and approved by the Food and Drug Administration for
marketing only as a suppository.
(3) Any substance which contains any quantity of a derivative
of barbituric acid, or any salt thereof (2100).
(4) Chlorhexadol (2510).
(5) Embutramide (2020).
(6) Lysergic acid (7300).
(7) Lysergic acid amide (7310).
(8) Methyprylon (2575).
(9) Sulfondiethylmethane (2600).
(10) Sulfonethylmethane (2605).
(11) Sulfonmethane (2610).
(12) A combination product containing Tiletamine and
Zolazepam or any salt thereof (Telazol) (7295).
(13) Any drug product containing gamma-hydroxybutyric acid,
including its salts, isomers, and salts of isomers, for which an
application is approved under section 505 of the federal Food,
Drug and Cosmetic Act, 21 U.S.C. 301 et seq. (2012).
(d) Nalorphine (a narcotic drug) (9400).
(e) Narcotic Drugs. Unless specifically excepted or unless listed
in another schedule, any material, compound, mixture, or preparation
containing any of the following narcotic drugs, or their salts
calculated as the free anhydrous base or alkaloid, in the following
limited quantities:
(1) Not more than 1.8 grams of codeine, per 100 milliliters or
not more than 90 milligrams per dosage unit, with an equal or
greater quantity of an isoquinoline alkaloid of opium (9803).
(2) Not more than 1.8 grams of codeine, per 100 milliliters or
not more than 90 milligrams per dosage unit, with one (1) or
more active, nonnarcotic ingredients in recognized therapeutic
amounts (9804).
(3) Not more than 300 milligrams of dihydrocodeinone, per 100
milliliters or not more than 15 milligrams per dosage unit, with
a fourfold or greater quantity of an isoquinoline alkaloid of
opium (9805).
(4) Not more than 300 milligrams of dihydrocodeinone, per 100
milliliters or not more than 15 milligrams per dosage unit, with
one (1) or more active nonnarcotic ingredients in recognized
therapeutic amounts (9806).
(5) Not more than 1.8 grams of dihydrocodeine, per 100
milliliters or not more than 90 milligrams per dosage unit, with
one (1) or more active, nonnarcotic ingredients in recognized
therapeutic amounts (9807).
(6) Not more than 300 milligrams of ethylmorphine, per 100
milliliters or not more than 15 milligrams per dosage unit, with
one (1) or more active, nonnarcotic ingredients in recognized
therapeutic amounts (9808).
(7) Not more than 500 milligrams of opium per 100 milliliters
or per 100 grams or not more than 25 milligrams per dosage
unit, with one (1) or more active, nonnarcotic ingredients in
recognized therapeutic amounts (9809).
(8) Not more than 50 milligrams of morphine, per 100
milliliters or per 100 grams with one (1) or more active
nonnarcotic ingredients in recognized therapeutic amounts
(9810).
(9) Buprenorphine (9064).
(f) Anabolic steroid (as defined in 21 U.S.C. 802(41)(A) and 21
U.S.C. 802(41)(B)).
(g) The board shall except by rule any compound, mixture, or
preparation containing any stimulant or depressant substance listed
in subsections (b) through (e) from the application of any part of this
article if the compound, mixture, or preparation contains one (1) or
more active medicinal ingredients not having a stimulant or
depressant effect on the central nervous system, and if the admixtures
are included therein in combinations, quantity, proportion, or
concentration that vitiate the potential for abuse of the substances
which have a stimulant or depressant effect on the central nervous
system.
(h) Any material, compound, mixture, or preparation which
contains any quantity of Ketamine (7285).
(i) Hallucinogenic substances:
Dronabinol (synthetic) in sesame oil and encapsulated in a soft
gelatin capsule in a United States Food and Drug
Administration approved drug product (7369).
As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1977,
P.L.2, SEC.86; Acts 1979, P.L.303, SEC.5; Acts 1981, P.L.170,
SEC.4; P.L.333-1983, SEC.3; P.L.200-1987, SEC.10; P.L.48-1991,
SEC.76; P.L.1-1994, SEC.171; P.L.31-1998, SEC.10; P.L.288-2001,
SEC.16; P.L.22-2008, SEC.3.
IC 35-48-2-9
Schedule IV tests
Sec. 9. (a) The board shall recommend placement of a substance
in schedule IV under this chapter if it finds that:
(1) the substance has a low potential for abuse relative to
substances in schedule III under this chapter;
(2) the substance has currently accepted medical use in
treatment in the United States; and
(3) abuse of the substance may lead to limited physical
dependence or psychological dependence relative to the
substances in schedule III under this chapter.
(b) The board may recommend placement of a substance in
schedule IV under this chapter if it finds that the substance is
classified as a controlled substance in schedule IV under federal law.
As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.200-1987,
SEC.11.
IC 35-48-2-10
Schedule IV
Sec. 10. (a) The controlled substances listed in this section are
included in schedule IV.
(b) Narcotic drugs. Unless specifically excepted in a rule adopted
by the board or unless listed in another schedule, any material,
compound, mixture, or preparation containing any of the following
narcotic drugs, or their salts calculated as the free anhydrous base or
alkaloid, in the following limited quantities:
(1) Not more than 1 milligram of difenoxin (9618) and not less
than 25 micrograms of atropine sulfate per dosage unit.
(2) Dextropropoxyphene (alpha- (+)-4-dimethylamino-1,2-
diphenyl-3-methyl-2-propionoxybutane (9278).
(c) Depressants. Unless specifically excepted in a rule adopted by
the board or unless listed in another schedule, any material,
compound, mixture, or preparation which contains any quantity of
the following substances, including its salts, isomers, and salts of
isomers whenever the existence of such salts, isomers, and salts of
isomers is possible within the specific chemical designation:
Alprazolam (2882).
Barbital (2145).
Bromazepam (2748).
Camazepam (2749).
Carisoprodol.
Chloral betaine (2460).
Chloral hydrate (2465).
Chlordiazepoxide (2744).
Clobazam (2751).
Clonazepam (2737).
Clorazepate (2768).
Clotiazepam (2752).
nervous system, 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
within the specific chemical designation:
Cathine ((+)-norpseudoephedrine) (1230).
Diethylpropion (1610).
Fencamfamin (1760).
Fenproporex (1575).
Mazindol (1605).
Mefenorex (1580).
Modafinil (1680).
Phentermine (1640).
Pemoline (including organometallic complexes and chelates
thereof) (1530).
Pipradrol (1750).
Sibutramine (1675).
SPA ((-)-1-dimethylamino-1,2-diphenylethane (1635).
(f) Other substances. Unless specifically excepted or unless listed
in another schedule, any material, compound, mixture, or preparation
which contains any quantity of the following substances including its
salts:
Butorphanol (including its optical isomers) (9720).
Pentazocine (9709).
(g) The board may except by rule any compound, mixture, or
preparation containing any depressant substance listed in subsection
(b), (c), (d), (e), or (f) from the application of any part of this article
if the compound, mixture, or preparation contains one (1) or more
active medicinal ingredients not having a depressant effect on the
central nervous system, and if the admixtures are included therein in
combinations, quantity, proportion, or concentration that vitiate the
potential for abuse of the substances which have a depressant effect
on the central nervous system.
As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1977,
P.L.344, SEC.2; Acts 1979, P.L.303, SEC.6; Acts 1981, P.L.170,
SEC.5; P.L.333-1983, SEC.4; P.L.77-1984, SEC.14; P.L.200-1987,
SEC.12; P.L.288-2001, SEC.17; P.L.8-2004, SEC.3; P.L.22-2008,
SEC.4.
IC 35-48-2-11
Schedule V tests
Sec. 11. (a) The board shall recommend placement of a substance
in schedule V under this chapter if it finds that:
(1) the substance has low potential for abuse relative to the
controlled substances listed in schedule IV under this chapter;
(2) the substance has currently accepted medical use in
treatment in the United States; and
(3) the substance has limited physical dependence or
psychological dependence liability relative to the controlled
substances listed in schedule IV under this chapter.
(b) The board may recommend placement of a substance in
schedule V under this chapter if it finds that the substance is
classified as a controlled substance in schedule V under federal law.
As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.200-1987,
SEC.13.
IC 35-48-2-12
Schedule V
Sec. 12. (a) The controlled substances listed in this section are
included in schedule V.
(b) Narcotic drugs containing nonnarcotic active medicinal
ingredients. Any compound, mixture, or preparation containing any
of the following narcotic drugs, or their salts calculated as the free
anhydrous base or alkaloid, in the following quantities, which shall
include one (1) or more nonnarcotic active medicinal ingredients in
sufficient proportion to confer upon the compound, mixture, or
preparation, valuable medicinal qualities other than those possessed
by the narcotic drug alone:
(1) Not more than 200 milligrams of codeine per 100 milliliters
or per 100 grams.
(2) Not more than 100 milligrams of dihydrocodeine per 100
milliliters or per 100 grams.
(3) Not more than 100 milligrams of ethylmorphine per 100
milliliters or per 100 grams.
(4) Not more than 2.5 milligrams of diphenoxylate and not less
than 25 micrograms of atropine sulfate per dosage unit.
(5) Not more than 100 milligrams of opium per 100 milliliters
or per 100 grams.
(6) Not more than 0.5 milligrams of difenoxin (9168), and not
less than 25 micrograms of atropine sulfate per dosage unit.
(c) Pregabalin (2782).
(d) Pyrovalerone (1485).
As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1979,
P.L.303, SEC.7; Acts 1981, P.L.170, SEC.6; P.L.327-1985, SEC.3;
P.L.22-2008, SEC.5.
IC 35-48-2-13
Repealed
(Repealed by Acts 1979, P.L.303, SEC.13.)
IC 35-48-2-14
Reclassification; rules
Sec. 14. (a) The board may adopt rules under IC 4-22-2 to
reclassify a controlled substance:
(1) from a more restrictive schedule to a less restrictive
schedule; or
(2) as a substance that is not a controlled substance;
if the board finds that the substance qualifies for reclassification
under this chapter and that the same reclassification has been made
in a controlled substance schedule under federal law.
(b) If the board reclassifies a controlled substance under
subsection (a), the board shall recommend the same reclassification
to the general assembly under section 1 of this chapter.
(c) Notwithstanding a provision in this chapter that classifies a
controlled substance in a more restrictive schedule than a rule
adopted under subsection (a), a person who manufactures,
distributes, dispenses, possesses, or uses a controlled substance in
compliance with the requirements applicable to the less restrictive
schedule to which a controlled substance is reclassified under
subsection (a) does not commit an offense under this article.
(d) Notwithstanding a provision in this chapter that classifies a
substance as a controlled substance, a person does not commit an
offense under this article if the board has reclassified the controlled
substance as a substance that is not a controlled substance.
As added by P.L.200-1987, SEC.14.