subchapter 26F – controlled substances

Link to law: http://reports.oah.state.nc.us/ncac/title 10a - health and human services/chapter 26 - mental health, general/subchapter f/subchapter f rules.html
Published: 2015

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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.