subchapter 26F – controlled substances
SECTION .0100 ‑ SCHEDULES OF CONTROLLED SUBSTANCES
10A NCAC 26F .0101 DEFINITIONS
As used in this Section, the following terms shall have the
meanings specified:
(1) The term "act" means the North Carolina Controlled
Substances Act (G.S. Chapter 90, Article 5).
(2) The term "basic class" means, as to
controlled substances listed in Schedules I, II and VI:
(a) Each of the opiates, including its isomers,
esters, ethers, salts and salts of isomers, esters, ethers and salts is
possible within the specific chemical designation listed in Schedule I of the
North Carolina Controlled Substances Act;
(b) Each of the opium derivatives, 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 listed in Schedule I of the North Carolina Controlled Substances
Act;
(c) Each of the hallucinogenic 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 listed in Schedule I of the North Carolina Controlled
Substances Act;
(d) Each of the following substances, whether
produced directly or indirectly by extraction from substances of vegetable
origin, or independently by means of chemical synthesis or by a combination of
extraction and chemical synthesis:
(i) opium, including raw opium, opium extracts,
opium fluid extracts, powdered opium, granulated opium, deodorized opium and
tincture of opium;
(ii) apomorphine;
(iii) codeine;
(iv) etorphine hydrochloride;
(v) ethylmorphine;
(vi) hydrocodone;
(vii) hydromorphine;
(viii) metopon;
(ix) morphine;
(x) oxycodone;
(xi) oxymorphone;
(xii) thebaine;
(xiii) mixed alkaloids of opium listed in Schedule
I of the North Carolina Controlled Substances Act;
(xiv) cocaine; and
(xv) ecgonine;
(e) Each of the opiates, including its isomers,
esters, ethers, salts and salts of isomers, esters and ethers whenever the existence
of such isomers, esters and ethers, and salts is possible within the specific
chemical designation, listed in Schedule II of the North Carolina Controlled
Substances Act;
(f) Methamphetamine, its salts, isomers and
salts of its isomers;
(g) Amphetamine, its salts, optical isomers and
salts of its optical isomers;
(h) Phenmetrazine and its salts;
(i) Methylphenidate;
(j) Each of the substances having a depressant
effect on the central nervous system, 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 listed in Rule .0205 of this
Section.
(3) The term "hearing" means any hearing held
pursuant to this part for the addition, deletion or rescheduling of any
substances within Schedules I through VI of the North Carolina Controlled
Substances Act.
(4) The term "isomer" means, except as used
in Paragraph .0202(d) of this Section, the optical isomer. As used in
Paragraph .0202(d) of this Section, the term "isomer" means the
optical, position or geometric isomer.
(5) The term "interested person" means any
person affected by any decision issuable pursuant to General Statute 90‑88.
(6) The term "proceeding" means all actions
taken for the addition, deletion, or rescheduling of any substance within
Schedules I through VI of the North Carolina Controlled Substances Act, issued
pursuant to General Statute 90‑88, commencing with the publication by the
Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services of the proposed addition, deletion or rescheduling.
(7) The term anabolic steroid means any drug or
hormonal substance, chemically and pharmacologically related to testosterone
(other than estrogens, progestins, and corticosteroids) that promotes muscle
growth, and includes:
(a) Boldenone;
(b) Chlorotestosterone (4‑chlortestosterone);
(c) Clostebol;
(d) Dehydrochlormethyltestosterone;
(e) Dihydrotestosterone (4‑dihydrotestosterone);
(f) Drostanolone;
(g) Ethylestrenol;
(h) Fluoxymesterone;
(i) Formebulone (formebolone);
(j) Mesterolone;
(k) Methandienone;
(l) Methandranone;
(m) Methandriol;
(n) Methandrostenolone;
(o) Methenolone;
(p) Methyltestosterone;
(q) Mibolerone;
(r) Nandrolone;
(s) Norethandrolone;
(t) Oxandrolone;
(u) Oxymesterone;
(v) Oxymetnolone;
(w) Stanolone;
(x) Stanozolol;
(y) Testolactone;
(z) Testosterone;
(aa) Trenbolone; and
(bb) Any salt, ester, or isomer of a drug or
substance described or listed in this Paragraph, if that salt, ester, or isomer
promotes muscle growth. Except such term does not include an anabolic steroid
which is expressly intended for administration through implants to cattle or
other nonhuman species and which has been approved by the Secretary of Health
and Human Services for such administration. If any person prescribes,
dispenses, or distributes such steroid for human use, such person shall be
considered to have prescribed, dispensed, or distributed an anabolic steroid
within the meaning of this Paragraph.
(8) Any term not defined in this Rule shall have the
definition set forth in General Statute 90‑87.
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. September 1, 1998; August 1, 1991; May 1,
1990.
10A NCAC 26F .0102 SCHEDULE I
(a) Schedule I shall consist of the drugs and other
substances, by whatever official name, common or usual name, chemical name or
brand name designated and as specified in G.S. 90-89. Each drug or substance
has been assigned the Drug Enforcement Administration controlled substances
code number set forth in the Code of Federal Regulations, Title 21, Section
1308.11.
(b) The Commission for MH/DD/SAS may add, delete or
reschedule substances within Schedules I-VI as specified in G.S. 90-88.
(c) As specified in G.S. 90-88, the Commission for
MH/DD/SAS adds the following substance within Schedule I for Stimulants:
(1) 2, 5 - Dimethoxy-4-(n)-
propylthiophenethylamine; and
(2) N-Benzylpiperazine.
(d) As specified in G.S. 90-88, the Commission for
MH/DD/SAS adds the following substance within Schedule I for Hallucinogens:
(1) Alpha-Methyltryptamine
(2) 5-Methoxy-n-diisopropyltryptamine.
History Note: Authority G.S. 90‑88; 90‑89;
143B‑147;
Eff. June 30, 1978;
Amended Eff. November 1, 2005; July 1, 1995; November 1,
1994; April 1, 1994; January 1, 1994.
10A NCAC 26F .0103 SCHEDULE II
(a) Schedule II shall consist of the drugs and other
substances by whatever official name, common or usual name, chemical name or
brand name designated and as specified in G.S. 90-90. Each drug or substance
has been assigned the Drug Enforcement Administration controlled substances
code number set forth in the Code of Federal Regulations, Title 21, Section
1308.12.
(b) As specified in G.S. 90-88, the Commission for
MH/DD/SAS adds Lisdexamfetamine, its salts, isomers, and salts of its isomers
to Schedule II for Stimulants.
(c) As specified in G.S. 90-88, the Commission for
MH/DD/SAS adds Tapendatol, its esters, ethers, salts, isomers and salts of its
isomers, esters and ethers to Schedule II for Opiates.
History Note: Authority G.S. 90‑88; 90‑90;
143B‑147;
Eff. June 30, 1978;
Amended Eff. January 1, 1994; April 1, 1993; August 1,
1991; August 1, 1989;
Temporary Amendment Eff. May 13, 1997;
Amended Eff. February 1, 2010; June 1, 2009; August 1,
2002; July 1, 1998.
10A ncac 26F .0104 SCHEDULE III
(a) Schedule III shall consist of the drugs and other
substances, by whatever official name, common or usual name, chemical name, or
brand name designated and as specified in G.S. 90-91. Each drug or substitute
has been assigned the Drug Enforcement Administration controlled substances
code number set forth in the Code of Federal Regulations, Title 21, Section
1308.13.
(b) As specified in G.S. 90-88, the Commission for
MH/DD/SAS adds Embutramide to Schedule III for Depressants.
(c) As specified in G.S. 90-88, the Commission for
MH/DD/SAS adds Buprenorphine to Schedule III for Narcotic Drugs.
(d) As specified in G.S. 90-88, the Commission for MH/DD/SAS
adds for anabolic steroids, including their salts, esters and ethers:
(1) Boldione (androsta-1,4-diene-3,17-dione);
(2) Desoxymethyltestosterone
(17[alpha]-methyl-5[alpha]-androst- 2-en-17[beta]-ol) (a.k.a., madol); and
(3) 19-nor-4,9(10)- androstadienedione (estra-4,9(10)-diene-
3,17-dione).
History Note: Authority G.S. 90-88; 90-91; 143B-147;
Eff. June 30, 1978;
Amended Eff. July 1, 2011; June 1, 2009; August 1, 2002;
August 1, 1991; December 1, 1987; August 1, 1987; July 1, 1982.
10A NCAC 26F .0105 SCHEDULE IV
(a) Schedule IV shall consist of the drugs and other
substances by whatever official name, common or usual name, chemical name or
brand name designated and listed in either G.S. 90-92 or this Rule. Each drug
or substance has been assigned the Drug Enforcement Administration (DEA) controlled
substances code number set forth in the Code of Federal Regulations, Title 21,
Section 1308.l4.
(b) As specified in G.S. 90-88, the Commission for
MH/DD/SAS adds the following substances within Schedule IV for Depressants:
(1) Dichloralphenazone - DEA controlled
substances code number 2467;
(2) Zopiclone - DEA controlled substances code
number 2784;
(3) Fosporopol - DEA controlled substances code
number 2138; and
(4) Carisoprodol - DEA controlled substances
code number 8192.
History Note: Authority G.S. 90-88; 90-92; 143B-147;
Eff. June 30, 1978;
Amended Eff. July 1, 1993; January 1, 1989; December 1,
1987; August 1, 1987;
Temporary Amendment Eff. May 28, 1998;
Temporary Amendment Expired March 12, 1999;
Amended Eff. August 1, 2000;
Temporary Amendment Eff. January 1, 2002; February 15,
2001;
Amended Eff. July 1, 2012; July 1, 2011; November 1,
2005; April 1, 2003; August 1, 2002.
10A NCAC 26F .0106 SCHEDULE V
(a) Schedule V shall consist of the drugs and other
substances by whatever official name, common or usual name, chemical name or
brand name designated and listed in either G.S. 90-93 or this Rule. Each drug
or substance is set forth below with its corresponding Drug Enforcement
Administration (DEA) controlled substances code number set forth in the Code of
Federal Regulations, Title 21, Section 1308.l5.
(b) Narcotic drugs containing non-narcotic 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 limited quantities as set forth below, which shall include one
or more non-narcotic active medicinal ingredients in sufficient proportion to
confer upon the compound, mixture, or preparation valuable medicinal qualities
other than those possessed by narcotic drugs 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
and not less than 25 micrograms atropine sulfate per dosage unit.
(c) Stimulants. Unless specifically exempted or excluded
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 and salts of
isomers: Pyrovalerone - DEA controlled substances code number 1485.
(d) Depressants. Unless specifically exempted or excluded
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, including its salts:
(1) Lacosamide – DEA controlled substances code
number 2746; and
(2) Ezogabine – DEA controlled substances
number 2779.
History Note: Authority G.S. 90-88; 90-93; 143B-147;
Eff. June 30, 1978;
Amended Eff. July 1, 2012; February 1, 2010; April 1,
1992; August 1, 1988; December 1, 1987; April 1, 1983.
10a NCAC 26F .0107 SCHEDULE VI
(a) Schedule VI shall consist of the drugs and other
substances by whatever official name, common or usual name, chemical name or
brand name designated listed in this Rule. Each drug or substance has been
assigned the Drug Enforcement Administration code number set forth opposite it:
Tetrahydrocannabinols 7370
(b) Synthetic equivalents of the substances contained in
the plant or in the resinous extractives of cannabis, and/or synthetic
substances, derivatives and their isomers with similar chemical structure and
pharmacological activity such as the following:
1 cis or trans
tetrahydrocannabinol and their optical isomers.
6 cis or trans
tetrahydrocannabinol and their optical isomers.
3, 4 cis or trans tetrahydrocannabinol
and its optical isomers.
(Since nomenclature of these substances is not
internationally standardized, compounds of these structures, regardless of
numerical designation, designations of atomic position are covered.)
Marijuana 7360
History Note: Authority G.S. 90‑88(a);
Eff. June 30, 1978.
10A NCAC 26F .0108 APPLICATION FOR EXCLUSION OF
NONNARCOTIC SUBSTANCE
(a) Any person seeking to have any nonnarcotic substance
which may, under the Federal Food, Drug and Cosmetic Act (21 USC 301), as
amended, be lawfully sold over the counter without a prescription, excluded
from any schedule, pursuant to General Statute Chapter 90‑88(e) may apply
to the Commission for Mental Health, Developmental Disabilities and Substance
Abuse Services.
(b) An application for an exclusion under this Section
shall contain the following information:
(1) the name and address of the applicant,
(2) the name and the substance for which
exclusion is sought, and
(3) the complete quantitative composition of
the substance.
(c) The Commission for Mental Health, Developmental Disabilities
and Substance Abuse Services may reject an application for filing, giving the
reason therefor, if any of the requirements prescribed in Paragraph (b) of this
Rule is lacking or is not set forth so as to be readily understood. If the
applicant desires, he may amend the application to meet the requirements of
Paragraph (b) of this Rule. If accepted for filing, the Commission for Mental
Health, Developmental Disabilities and Substance Abuse Services shall publish
general notice in three newspapers of statewide circulation qualified for legal
advertising in accordance with Rule 4 of the North Carolina Rules of Civil
Procedure that it will make a determination on the application at its next
regularly scheduled meeting. The Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services shall permit any interested person to
file written comments or objections to the proposal and shall designate in the
notice the time during which such filings may be made.
(d) After consideration of the application and any comments
on or objections to its proposed decision at its next regularly scheduled
meeting, the Commission for Mental Health, Developmental Disabilities and
Substance Abuse Services shall issue and publish in three newspapers of
statewide circulation qualified for legal advertising in accordance with Rule 4
of the North Carolina Rules of Civil Procedure its final order on the
application. This order shall specify the date on which it shall take effect,
which shall not be less than 30 days from the date of publication unless the
Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services finds that conditions of public health or safety necessitate an
earlier effective date in which event the Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services shall specify in the
order its findings as to such conditions.
(e) In the event a nonnarcotic substance no longer meets
the criteria in G.S. 90‑88(e), the Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services may at any time revoke
any exclusion granted pursuant to G.S. 90‑88(e) by following the
procedures set forth in Paragraphs (c) and (d) of this Rule for handling an
application for an exclusion which has been accepted for filing.
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. May 1, 1990.
10A NCAC 26F .0109 EXCLUDED SUBSTANCES
Those drugs which were excluded by the Drug Enforcement
Administration on April 1, 1973, under Section 201(g)(1) of Federal Controlled
Substances Act [21 USC 811(g)(1)], as amended, have been excluded by the Drug Commission
from all schedules pursuant to General Statute Chapter 90‑88(e).
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. September 30, 1978.
10A NCAC 26F .0110 APPLICATION FOR EXEMPT CHEMICAL
PREPARATIONS
(a) Any person seeking to have any preparation or mixture
containing controlled substances and one or more noncontrolled substances
exempted from the application of all or any part of the act pursuant to General
Statute Chapter 90‑88(g) may apply to the Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services.
(b) An application for an exemption under this Rule shall
contain the following information:
(1) the name, address and registration number,
if any, of the applicant;
(2) the name, address and registration number,
if any, of the manufacturer or importer of the preparation or mixture, if not
the applicant;
(3) the exact trade name or other designation
of the preparation or mixture;
(4) the complete quantitative composition of
all the preparation or mixture (including all active ingredients and
noncontrolled substances);
(5) the form of the immediate container in
which the preparation or mixture will be distributed with sufficient
descriptive detail to identify the preparation or mixture (e.g., bottle,
packet, vial, soft plastic pillow, agar gel plate, etc.);
(6) the dimensions or capacity of the immediate
container of the preparation or mixture;
(7) the label and labeling, as defined in Rule
.0201 of Subchapter 26E of this Chapter and of G.S. 90‑106, the North
Carolina Controlled Substances Act, as amended, of the immediate container and
the commercial containers, if any, of the preparation or mixture;
(8) a brief statement of the facts which the
applicant believes justify the granting of an exemption under this Paragraph
including information on the use to which the preparation or mixture will be
put;
(9) the date of application; and
(10) which of the information submitted on the
application, if any, is deemed by the applicant to be a trade secret or
otherwise confidential and entitled to protection under any law restricting
public disclosure of information.
(c) The Commission for Mental Health, Developmental Disabilities
and Substance Abuse Services may require the applicant to submit such documents
or written statements of fact relevant to the application as it deems necessary
to determine whether the application should be granted.
(d) Within a reasonable period of time after the receipt of
an application for an exemption under this Rule, the Commission for Mental
Health, Developmental Disabilities and Substance Abuse Services shall notify
the applicant of its acceptance or nonacceptance of his application and, if not
accepted, the reason therefor. The Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services need not accept an application for
filing if any of the requirements prescribed in Paragraph (b) of this Rule or
requested pursuant to Paragraph (c) of this Rule is lacking or is not set forth
as to be readily understood. If the applicant desires, he may amend the
application to meet the requirements of Paragraphs (b) and (c) of this Rule.
If the application is accepted, the Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services shall issue and publish in three
newspapers of statewide circulation qualified for legal advertising in
accordance with Rule 4 of the North Carolina Rules of Civil Procedure its final
order on the application. This order shall specify the date on which it shall
take effect which shall not be less than 30 days from the date of publication
unless the Commission for Mental Health, Developmental Disabilities and
Substance Abuse Services finds that conditions of public health or safety
necessitate an earlier effective date in which event the Commission for Mental
Health, Developmental Disabilities and Substance Abuse Services shall specify
in the order its findings as to such conditions.
(e) In the event a preparation or mixture containing
controlled substance no longer meets the criteria in G.S. 90‑88(e) for
being excluded, the Commission for Mental Health, Developmental Disabilities
and Substance Abuse Services may at any time revoke or modify any exemption
granted pursuant to this Section by following the procedure set forth in
Paragraph (d) of this Rule for handling an application for exemption.
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. May 1, 1990.
10A NCAC 26F .0111 EXEMPT CHEMICAL PREPARATIONS
Those drugs which were exempted by the Drug Enforcement
Administration on April 1, 1973, under Sections 302, 303, 305, 306, 307, 308,
309, 1002, 1003, 1004 of the Federal Controlled Substances Act (21 USC 822‑3,
825‑9, 952‑4) as amended, have been exempted by the Commission for
Mental Health, Developmental Disabilities and Substance Abuse Services to the
same extent described in 21 CFR 308.24(b) through (h) pursuant to G.S. 90‑88(g).
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. May 1, 1990.
10A NCAC 26F .0112 APPLICATION FOR EXCEPTION OF A
STIMULANT OR DEPRESSANT
(a) Any person seeking to have any compound, mixture or
preparation containing any depressant or stimulant substance listed in
Paragraph .0204(b) or (c) or in Rule .0205 or in .0206 of this Section excepted
from the application of all or any part of the act, pursuant to G.S. 90‑91(i)
and 90‑92(b), may apply to the Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services.
(b) An application for an exception under this Rule shall
contain the following information:
(1) the complete quantitative composition of
the dosage form,
(2) description of the unit dosage form
together with complete labeling,
(3) a summary of the pharmacology of the
product including animal investigations and clinical evaluations and studies
with emphasis on the psychic or physiological dependence liability, (This must
be done for each of the active ingredients separately and for the combination
product.)
(4) details of dynergisms and antagonisms among
ingredients,
(5) deterrent effects of the noncontrolled
ingredients,
(6) complete copies of all literature in
support of claims,
(7) reported instances of abuse,
(8) reported and anticipated adverse effects,
(9) number of dosage units produced for the
past two years.
(c) The Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services may reject an application for filing,
giving the reason therefor, if any of the requirements prescribed in Paragraph
(b) of this Rule is lacking or is not set forth so as to be readily
understood. If the applicant desires, he may amend the application to meet the
requirements of Paragraph (b) of this Rule. If accepted for filing, the
Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services shall publish general notice in three newspapers of statewide
circulation qualified for legal advertising in accordance with Rule 4 of the
North Carolina Rules of Civil Procedure that it will make a determination on
the application at its next regularly scheduled meeting. The Commission for
Mental Health, Developmental Disabilities and Substance Abuse Services shall
permit any interested person to file written comments on or objections to the
proposal and shall designate in the notice the time during which such filings
may be made.
(d) After consideration of the application and any comments
on or objections to its proposed decision at its next regularly scheduled
meeting, the Director shall issue and publish its final order on the
application in three newspapers of statewide circulation qualified for legal
advertising in accordance with Rule 4 of the North Carolina Rules of Civil
Procedure. This order shall specify the date on which it shall take effect
which shall not be less than 30 days from the date of publication unless the
Director finds that conditions of public health or safety necessitate an
earlier effective date in which event the Director shall specify in the order
its findings as to such conditions.
(e) The Director may at any time revoke any exception
granted pursuant to G.S. 90‑91 or G.S. 90‑92(b) by following the
procedures set forth in Paragraphs (c) and (d) of this Rule for handling an
application for an exception which has been accepted for filing.
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. May 1, 1990; May 15, 1979.
10A NCAC 26F .0113 EXCEPTED COMPOUNDS
Those drugs which were excepted by the Drug Enforcement
Administration April 1, 1973, under Section 202(d) of the Federal Controlled
Substances Act [21 USC 812(d)] as amended have been excepted by the Commission
for Mental Health, Developmental Disabilities and Substance Abuse Services from
application of G.S. 90‑104, 90‑105 and 90‑106. Any deviation
from the quantitative composition of any of the listed drugs shall require a
petition for exception in order for that drug to be excepted.
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. May 1, 1990.
10A NCAC 26F .0114 HEARINGS GENERALLY
In any case where the Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services shall hold a hearing on
the addition, deletion or rescheduling of substances within Schedules I
through VI of the North Carolina Controlled Substances Act pursuant to G.S. 90‑88,
the procedures for such hearings and accompanying proceedings shall be governed
generally by the rulemaking procedures set forth in G.S. 150B and specifically
by G.S. 90‑88 and by these rules and regulations, Departmental rules.
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. May 1, 1990.
10A NCAC 26F .0115 PURPOSE OF HEARING
The Commission for Mental Health, Developmental Disabilities
and Substance Abuse Services shall hold a hearing for the purpose of receiving
factual evidence regarding the issues involved in the addition, deletion or rescheduling
with Schedules I through VI of the North Carolina Controlled Substances Act.
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. May 1, 1990.
10A NCAC 26F .0116 WAIVER OR MODIFICATION OF RULES
The Commission for Mental Health, Developmental Disabilities
and Substance Abuse Services may modify or waive any rule in this part by
notice in advance of the hearing with the consent of the parties to the hearing
if it determines that no party in the hearing will be unduly prejudiced and the
ends of justice will thereby be served. Such notice of modification or waiver
shall be made a part of the record of the hearing.
History Note: Authority G.S. 90‑88; 150B‑25;
Eff. June 30, 1978;
Amended Eff. May 1, 1990.
10A NCAC 26F .0117 ADDITION: DELETION OR RESCHEDULING OF A
SUBSTANCE
(a) Any interested person may submit a petition to initiate
proceedings for the addition, deletion or rescheduling of any substances within
Schedules I through VI of the North Carolina Controlled Substances Act pursuant
to the provisions of G.S. 90‑88.
(b) Petitions shall be submitted in quintuplicate to the
Commission for Mental Health, Mental Retardation and Substance Abuse Services
in the following form:
____________________
Date
(The Commission Address)
Dear Sir: The undersigned ____________________ hereby
petitions the commission to initiate proceedings for the addition (deletion or
rescheduling) of a substance within Schedules I through VI of the North
Carolina Controlled Substances Act pursuant to G.S. 90‑88.
Attached hereto and constituting a part of this petition are
the following:
(1) the proposed substance in the form proposed
by the petitioner; (If the petitioner seeks the deletion or rescheduling of an
existing controlled substance, the existing controlled substance together with
a reference to this Section in the latest commission publication of Schedules I
through VI where it appears should be included.)
(2) a statement of the grounds which the
petitioner relies upon for the addition (deletion or rescheduling) of the
substance. (Such grounds shall include a reasonably concise statement of the
facts relied upon by the petitioner including a summary of any relevant medical
or scientific evidence known to the petitioner.)
All notices to be sent regarding this petition should be
addressed to:
________________________
Name
________________________
Street Address
________________________
City and State
Respectfully yours,
_________________________
Signature of Petitioner
(c) The commission may reject a petition for filing if any
of the requirements in Paragraph (b) of this Rule is lacking or is not set
forth so as to be readily understood. If petitioner desires, he may amend the
petition to meet the requirements of Paragraph (b) of this Rule.
(d) When the commission holds a hearing pursuant to G.S. 90‑88(a),
it shall publish in newspapers of statewide circulation qualified for legal
advertising in accordance with Rule 4 of the North Carolina Rules of Civil
Procedure general notice of any proposed addition, deletion or rescheduling of
a substance pursuant to G.S. 90‑88. Such published notice shall include
a statement of the time, place and nature of the hearings on the proposal.
Such hearings may not be commenced until after the expiration of at least 10
days from the date the general notice is published in accordance with this
Rule. Such published notice shall include a reference to the legal authority
under which the substance change is proposed, a statement of the proposed change
and in the discretion of the commission a summary of the subjects and issues
involved. In addition, notice of the proposed change and the date and place of
the public hearing shall be sent by the commission to each registrant under the
act.
(e) The commission may permit any interested persons to
file written comments on or objections to the proposal and shall designate in
the notice of proposed change the time during which such filings may be made.
(f) The commission shall before adding, deleting or
rescheduling any substance and after gathering the necessary data make a
scientific and medical evaluation as to whether such drug or other substances
should be so controlled, transferred or removed as a controlled substance.
(g) The commission in making its determination whether to
add, delete or reschedule a substance within Schedules I through VI of the
North Carolina Controlled Substances Act must in accordance with G.S. 90‑88(a)
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 the public health;
(7) the potential of the substance to produce
psychic or physiological dependence liability; and
(8) whether the substance is an immediate
precursor of a substance already controlled under the North Carolina Controlled
Substances Act.
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. April 1, 1982.
10A NCAC 26F .0118 BURDEN OF PROOF
At any hearing the proponent for the addition, deletion or
rescheduling of any substance within Schedules I through VI of the North
Carolina Controlled Substances Act shall have the burden of proof.
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978.
10A NCAC 26f .0119 TIME AND PLACE OF HEARING
The hearing will commence at the place and time designated
in the notice published in accordance with .0117(d) of this Subchapter, but,
thereafter, it may be continued from day to day or recessed to a later day
without notice other than announcement thereof by the presiding officer at the
hearing.
History Note: Authority G.S. 90‑88; 150B‑33;
Eff. June 30, 1978.
10A NCAC 26F .0120 FINAL ORDER
As soon as practicable after the hearing has been concluded,
the Commission for Mental Health, Developmental Disabilities and Substance
Abuse Services shall cause to be published its decision in the form of an
order. This order shall specify the date on which it shall take effect which
shall not be less than 30 days from the date of publication unless the
Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services finds that conditions of public health or safety necessitate an
earlier effective date in which event the Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services shall specify in the
order its findings as to such conditions.
History Note: Authority G.S. 90‑88;
Eff. June 30, 1978;
Amended Eff. May 1, 1990.
10A NCAC 26F .0121 MEETING REQUIRED
Pursuant to G.S. 90‑88(d), any time a substance is
added, deleted or rescheduled as a controlled substance, the Commission for
Mental Health, Developmental Disabilities and Substance Abuse Services shall
meet within 180 days and either agree or object to the change. In either case
the Commission for Mental Health, Developmental Disabilities and Substance
Abuse Services shall adopt an order setting forth its decisions and the reasons
therefor.
History Note: Authority G.S. 90‑88(d);
Eff. June 30, 1978;
Amended Eff. May 1, 1990.
10A NCAC 26F .0122 HEARING PROCEDURE
If the Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services objects thereby precipitating a
hearing under G.S. 90‑88(d), the Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services shall follow generally
the procedures set forth in Rules .0114 through .0120 of this Subchapter.
History Note: Authority G.S. 90‑88(d);
Eff. June 30, 1978;
Amended Eff. May 1, 1990.