SUBCHAPTER 26E ‑ MANUFACTURERS: DISTRIBUTORS:
DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES
SECTION .0100 ‑ REGISTRATION OF MANUFACTURERS:
DISTRIBUTORS: AND DISPENSERS OF CONTROLLED SUBSTANCES
10A NCAC 26E .0101 SCOPE
Procedures governing the registration of manufacturers,
distributors and dispensers of controlled substances pursuant to General
Statutes 90‑101 to 90‑103 are set forth generally by those sections
and specifically by the rules of this Section.
History Note: Authority G.S. 90‑100; 143B‑210(9);
Eff. June 30, 1978.
10A NCAC 26E .0102 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 "Commission" means the same as defined
in G.S 90-87
(3) 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 and ethers whenever the
existence of such 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) ethylmorphine;
(iv) hydrocodone;
(v) hydromorphone;
(vi) metopon;
(vii) morphine;
(viii) oxycodone;
(ix) oxymorphone;
(x) thebaine;
(xi) mixed alkaloids
of opium listed in Schedule I of the North Carolina Controlled Substances Act;
(xii) cocaine; and
(xiii) 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, ethers and salts is possible within the
specific chemical designation listed in Schedule II of the North Carolina
Controlled Substances Act; and
(f)
methamphetamine including its salts, isomers and salts of isomers when
contained in any injectable liquid.
(4) The term
“commercial detection service” means the same as defined in G.S. 90-102.1.
(5) The term "DEA" means the Federal Drug
Enforcement Administration.
(6) The term "Director" means the Director of
the Division of Mental Health, Developmental Disabilities and Substance Abuse
Services, Department of Health and Human Services.
(7) The term “dog handler” means the same as defined in
G.S. 90-102.1. For purposes of this definition person means an individual.
(8) The term “drug detection dog” means the same as
defined in G.S. 90-102.1.
(9) The term "hearing" means any hearing held
pursuant to this part of the granting, denial, revocation or suspension of a
registration pursuant to G.S. 90‑102 and 90‑103.
(10) The term "individual practitioner" means
same as defined in G.S. 90-87
(11) The term "person" means the same as
defined in G.S. 90-87.
(12) The terms "register" and
"registration" refer only to registration required and permitted by
G.S. 90‑102.
(13) The term
"registrant" means any person who is registered pursuant to G.S. 90‑102.
(14) The term "office-based opioid
treatment" means any controlled substance listed in Schedules III-V
dispensed for the maintenance or detoxification treatment of opioid addiction
or for the detoxification treatment of opioid dependence.
(15) Any term not defined in this Section shall have the
definition set forth in G.S. 90‑87.
History Note: Authority G.S. 90‑100; 90-102.1;
143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. February 1, 2005; July 1, 2004; May 1, 1990;
May 15, 1979; September 30, 1978.
10A NCAC 26E .0103 ADDITIONAL INFORMATION
Information regarding procedures under these rules and
instructions supplementing these rules will be furnished upon request by
writing to the director.
History Note: Authority G.S. 90‑100; 143B‑210(9);
Eff. June 30, 1978;
Amended Eff. May 15, 1979.
10A NCAC 26E .0104 PERSONS REQUIRED TO REGISTER
(a) Any person who manufactures, distributes
or dispenses any controlled substance or uses any controlled substance for the
purpose of the initial and maintenance training of drug detection dogs or who
proposes to engage in the manufacture, distribution or dispensing of any
controlled substance or use of any controlled substance for the purpose of the
initial and maintenance training of drug detection dogs in this state shall
obtain annually a registration unless exempted by law or pursuant to Rules
.0109-.0111 of this Section.
(b) Only persons actually engaged in such activities are
required to obtain a registration; related or affiliated persons who are not
engaged in such activities are not required to be registered. (For example, a
stockholder or parent corporation of a corporation manufacturing controlled
substances is not required to obtain a registration.)
(c) Any person applying for registration or re-registration
shall file, annually, an application for registration with the Department of
Health and Human Services and submit the required nonrefundable fee with the
application. Categories of applicants and the annual fee for each category are
as follows:
CATEGORY FEE
(1) Clinic
125.00
(2) Hospital
300.00
(3) Nursing
Home
100.00
(4) Teaching
Institution
100.00
(5) Researcher
125.00
(6) Analytical
Laboratory
100.00
(7) Distributor
500.00
(8)
Manufacturer
600.00
(9)
Office-Based Opioid Treatment
0.00
(10)
Dog Handler
125.00
(d) For any person applying for registration at least six
months or less prior to the end of the fiscal year, the required annual fee
submitted with the application shall be reduced by one-half of the above listed
fee for each category.
History Note: Authority G.S. 90‑100; 90‑101;
90-102.1; 143B‑210(9);
Eff. June 30, 1978;
Amended Eff. February 23, 2005; January 1, 1994.
10A NCAC 26E .0105 SEPARATE REGISTRATION FOR INDEPENDENT
ACTIVITIES
(a) The following groups of activities are deemed to be
independent of each other:
(1) manufacturing controlled substances;
(2) distributing controlled substances;
(3) dispensing controlled substances listed in
Schedules II through V;
(4) conducting research [other than research
described in Subparagraph (6) of this Paragraph] with controlled substances
listed in Schedules II through V;
(5) conducting instructional activities with controlled
substances listed in Schedule II through V;
(6) conducting research with narcotic drugs
listed in Schedules II through V for the purpose of continuing the dependence
on such drugs of a narcotic drug dependent person in the course of conducting an
authorized clinical investigation in the development of a narcotic addict
rehabilitation program pursuant to a notice of claims investigational exemption
for a new drug approved by the Food and Drug Administration;
(7) conducting research and instructional
activities with controlled substances listed in Schedules I and VI;
(8) conducting chemical analysis with
controlled substances listed in any schedule;
(9) dispensing
of controlled substances in Schedules III-V for opioid treatment; and
(10) possessing or training with controlled
substances for the purpose of providing a commercial detection service.
(b) Every person who engages in more than one group of
independent activities shall obtain a separate registration for each group of
activities except as provided in this Paragraph. Any person when registered to
engage in the group activities described in each Subparagraph of this Paragraph
shall be authorized to engage in the coincident activities described in that
Subparagraph without obtaining a registration to engage in such coincident
activities provided that unless specifically exempted, the person complies with
all requirements and duties prescribed by law for persons registered to engage
in such coincident activities as follows:
(1) A person registered to manufacture any
controlled substance or basic class of controlled substance shall be authorized
to distribute that substance or class but no other substance or class which the
person is not registered to manufacture.
(2) A person registered to manufacture any
controlled substance listed in Schedules II through V shall be authorized to
conduct chemical analysis and preclinical research (including quality control
analysis) with narcotic and nonnarcotic controlled substances listed in those
Schedules the person authorized to manufacture.
(3) A person registered or authorized to
conduct research with a basic class of controlled substances listed in
Schedules I and VI shall be authorized to manufacture such class if and to the
extent that such manufacture is set forth in the research protocol filed with
the Drug Enforcement Administration and to distribute such class to other
persons registered or authorized to conduct research with such class or
registered or authorized to conduct chemical analysis with controlled
substances.
(4) A person registered or authorized to
conduct chemical analysis with controlled substances shall be authorized to
manufacture such substances for analytical or instructional purposes, to
distribute such substances to other persons registered or authorized to conduct
chemical analysis or instructional activities or research with such substances
and to persons exempted from registration pursuant to Rule .0111 of this
Section and to conduct instructional activities with controlled substances.
(5) A person registered or authorized to
conduct research [other than research described in Paragraph (a)(6) of this
Rule] with controlled substances listed in Schedules II through V shall be
authorized to conduct chemical analysis with controlled substances listed in
those schedules in which the person is authorized to conduct research, to
manufacture such substances if and to the extent that such manufacture is set
forth in a statement filed with the application for registration and to
distribute such substances to other persons registered or authorized to conduct
chemical analysis, instructional activities or research with such substances
and to persons exempted from registration pursuant to Rule .0111 of this
Section and to conduct instructional activities with controlled substances.
(6) A person registered to dispense controlled
substances listed in Schedules II through V shall be authorized to conduct
research [other than research described in Paragraph (a)(6) of this Rule] and
to conduct instructional activities with those substances.
(c) A single registration to engage in any group of
independent activities may include one or more controlled substances listed in the
Schedules authorized in that group of independent activities. A person registered
to conduct research with controlled substances listed in Schedules I and VI may
conduct research with any substance listed in Schedules I and VI for which the
person has filed and approved a research protocol from the Drug Enforcement
Administration.
History Note: Authority G.S. 90‑100; 90-101;
90-102.1; 143B‑210(9);
Eff. June 30, 1978;
Amended Eff. February 1, 2005; July 1, 2004.
10A NCAC 26E .0106 TRAINING AND QUALIFICATION REQUIREMENTS
FOR DOG HANDLERS
(a) An individual applying for registration as a dog handler
shall demonstrate competence in the field of drug detection dog training and
handling. The applicant shall demonstrate competence by achieving
certification as a drug detection dog handler from an approved canine
certification association pursuant to G.S. 90-102.1 and as set forth in Rule
.0107 of this Section.
(b) The applicant shall submit proof to the Department of Health
and Human Services (DHHS) of a Drug Enforcement Administration registration or
pending application.
(c) The applicant shall submit documentation to DHHS verifying
current certification as a drug detection dog handler from an approved canine
certification association as set forth in Rule .0107 of this Section
(d) The applicant shall submit to DHHS five letters of reference
showing the applicant is of good moral character and temperate habits in
accordance with G.S. 90-102.1.
(e) Pursuant to G.S. 90-102.1, the Department of Justice may
provide a criminal record check to the DHHS for an individual who applies for a
new or renewal registration. The applicant shall comply with the criminal
record check including the use of his or her fingerprints and shall incur any
costs associated with the criminal record check.
History Note: Authority G.S. 90-102.1; S.L. 2003-398;
Eff. February 1, 2005.
10A NCAC 26E .0107 APPROVAL OF CANINE CERTIFICATION
ASSOCIATIONS BY THE DEPARTMENT of health and human services
(a) The Department of Health and Human Services shall
approve a canine certification association that requests approval and meets the
requirements as set forth in this Rule.
(b) Each canine certification association shall utilize
certification standards that require the dog handler to demonstrate competence
in the following areas:
(1)
basic canine obedience;
(2)
canine safety;
(3)
drug detection; and
(4)
legal aspects of searches and controlled substances identification.
(c) The canine certification association shall make
available to DHHS the certification procedures and standards it plans to
employ.
(d) The certification procedures and standards shall
certify the dog handler and drug detection dog as a team.
(e) The canine certification association shall submit
documentation to DHHS showing the following:
(1)
the certification procedures and standards it utilizes are accepted as
valid by a court of law; and
(2) the dog handler/drug detection dog teams
that have obtained certifications from that association are accepted as valid
by a court of law.
(f) The DHHS shall review the certification procedures and
standards to verify the association's compliance with the requirements as set
forth in this Rule.
(g) The approval of a canine certification association by
the DHHS shall be valid for three years. Canine certification associations
that want to maintain approval shall request renewal from DHHS prior to the end
of the three year period.
(h) The DHHS shall maintain a list of approved canine
certification associations.
History Note: Authority
G.S. 90-102.1; S.L. 2003-398;
Eff. February 1, 2005.
10A NCAC 26E .0108 SEPARATE REGISTRATION FOR SEPARATE
LOCATIONS
(a) A separate registration is required for each principal
place of business or professional practice at any one general physical location
where controlled substances are manufactured, distributed or dispensed by a
person.
(b) The following location shall be deemed not to be a
place where controlled substances are manufactured, distributed or dispensed by
a person: an office used by agents of a registrant where sales of controlled
substances are solicited, made or supervised but which neither contains such
substances (other than substances for display purposes or lawful distribution
as samples only) nor serves as a distribution point for filling sales orders.
History Note: Authority G.S. 90‑100; 90‑101;
143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990;
Recodified from 10A NCAC 26E .0106 Eff. February 1, 2005.
10A NCAC 26E .0109 EXEMPTION OF AGENTS AND EMPLOYEES:
AGENTS OF MANUFACTURERS
The requirement of registration is waived for any agent or
employee of a person who is registered to engage in any group of independent
activities if such agent or employee is acting in the usual course of his
business or employment.
History Note: Authority G.S. 90‑100; 90‑101;
143B‑210(9);
Eff. June 30, 1978;
Amended Eff. September 30, 1978;
Recodified from 10A NCAC 26E .0107 Eff. February 1, 2005.
10A NCAC 26E .0110 EXEMPTION OF INDIVIDUAL PRACTITIONERS
(a) The requirement of registration is waived for all
physicians, dentists, podiatrists, pharmacists, optometrists and veterinarians
practicing as individual practitioners and licensed in North Carolina by their
respective boards to the extent authorized by their boards; except as noted in
G.S. 90-101(a1).
(b) An individual practitioner (other than an intern,
resident or foreign trained physician on the staff of a Veterans Administration
facility or physician who is an agent or employee of the Health Bureau of the
Canal Zone Government) who is an agent or employee of another practitioner
registered to dispense controlled substances may, when acting in the usual
course of employment, administer and dispense (other than by issuance of
prescription) controlled substances if and to the extent that such individual
practitioner is authorized or permitted to do so by the jurisdiction in which
the individual practices under the registration of the employer or principal
practitioner in lieu of being registered.
(c) An individual practitioner who is an intern, resident
or foreign‑trained physician or physician on the staff of a Veterans
Administration facility or physician who is an agent or employee of the Health
Bureau of the Canal Zone Government may dispense, administer and prescribe
controlled substances under the registration of the hospital or other
registered institution in which the individual is employed in lieu of being
registered, provided that:
(1) such dispensing, administering or
prescribing is done in the usual course of professional practice;
(2) such individual practitioner is authorized
or permitted to do so by the jurisdiction in which the individual is
practicing;
(3) the hospital or other institution by whom
the individual is employed has verified that the individual practitioner is so
permitted to dispense, administer or prescribe drugs within the jurisdiction;
(4) such individual practitioner is acting only
within the scope of employment in the hospital or institution;
(5) the hospital or other institution
authorizes the intern, resident or foreign-trained physician to dispense or
prescribe under the hospital registration and designates a specific internal
code number for each intern, resident or foreign physician so authorized. The
code number shall consist of numbers, letters or a combination thereof and
shall be a suffix to the institution's Drug Enforcement Administration
registration number preceded by a hyphen (e.g., AP0123456‑10 or AP0123456‑A12);
and
(6) current list of internal codes and the
corresponding individual practitioner is kept by the hospital or other
institution and is made available at all times to other registrants and law
enforcement agencies upon request for the purpose of verifying the authority of
the prescribing individual practitioner.
(d) An individual on the staff of a teaching or research
institution may handle controlled substances under the registration of the
institution in which the individual is employed in lieu of being registered,
provided that:
(1) the institution authorizes the staff member
to handle under the institution registration and designates a specific internal
code number for each staff member so authorized. The code number shall consist
of numbers, letters or a combination thereof and shall be a suffix to the
institution's Drug Enforcement Administration registration number preceded by a
hyphen (e.g., AP0123456‑10 or AP0123456‑A12); and
(2) a current list of internal codes and the
corresponding staff members are kept by the institution and is made available
at all times to other registrants and law enforcement agencies upon request for
the purpose of verifying the authority of the individual staff member.
History Note: Authority G.S. 90‑100; 90‑101;
143B‑210(9);
Eff. June 30, 1978;
Amended Eff. July 1, 2004; September 30, 1978;
Recodified from 10A NCAC 26E .0108 Eff. February 1, 2005.
10A NCAC 26E .0111 EXEMPTION OF LAW ENFORCEMENT OFFICIALS
(a) The requirement of registration is waived for the
following persons in the circumstances described in this Rule:
(1) any person employed by the following
agencies who is lawfully engaged in the enforcement of any North Carolina or
federal law relating to controlled substances, drugs or customs and is duly
authorized to possess controlled substances in the course of his official
duties: the Department of Health and Human Services, the North Carolina
Department of Justice, the North Carolina Board of Pharmacy, the Drug
Enforcement Administration, the United States Bureau of Customs and the United
States Food and Administration;
(2) any dog handler who is employed or under
contract to a North Carolina law enforcement agency and any other person
specified in G.S. 90-101(c)(5);
(3) any person employed by any political
subdivision of the State who is engaged in the enforcement of any state or
local law relating to controlled substances and who is duly authorized to
possess controlled substances in the course of his official duties; or
(4) any official of the United States Army,
Navy, Marine Corps, Air Force, Coast Guard or Public Health Service who is
authorized to prescribe, dispense or administer but not to procure or purchase
controlled substances in the course of his official duties. Such officials
shall follow procedures set forth in Section .0400 of this Subchapter regarding
prescriptions but shall state the branch of service or agency (e.g., United
States Army or Public Health Service) and the service identification number of
the issuing official in lieu of the registration number required on
prescription forms. The service identification number of a Public Health
Service officer is his social security number.
(b) Any official exempted by this Rule may, when acting in
the course of his official duties, possess any controlled substance and
distribute any such substance to any other official who is also exempted by
this Section and acting in the course of his official duties.
(c) Any official exempted by this Rule may procure any
controlled substance in the course of an inspection in accordance with
.0503(a)(4) of this Subchapter or in the course of any criminal investigation
involving the person from whom the substance was procured.
History Note: Authority G.S. 90‑100; 90‑101;
90-102.1; 143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. February 1, 2005; May 1, 1990;
Recodified from 10A NCAC 26E .0109 Eff. February 1, 2005.
10A NCAC 26E .0112 TIME FOR APPLICATION FOR REGISTRATION:
EXPIRATION DATE
(a) Any person who is required to be registered and who is
not so registered may apply for registration at any time. No person required
to be registered shall engage in any activity for which registration is
required until the application for registration is granted and certificate of
registration is issued by the director to such persons. However, a person
already registered under federal law shall be allowed to continue to engage in
the activity for which federal registration is allowed during the time his
application is being processed and until such application is denied.
(b) Any person who is registered may apply to be re‑registered
not more than 60 days before the expiration date of the registration.
(c) All registrations shall expire annually on the
anniversary of their date of inception as hereafter set out. For the purposes
of these registrations, the state shall be divided into a Northern, Central,
and Southern Region. The counties which are included in each of these regions
are specified in Paragraph (d) of this Rule. The date of expiration for each
registration shall be determined by the region of the state in which the
registrant is located. The registrations from the Northern Region shall expire
on October 31 of each year. The registrations from the Central Region shall
expire on December 31 of each year. The registrations from the Southern Region
shall expire on July 31 of each year. If the registrant registers within the
three months preceding the expiration date for his region, the registration
which he receives shall not expire until the expiration date of the following
year. However, for the registration year of 1989 all renewal registrations
shall be handled in accordance with Paragraph (e) of this Rule.
(d) The counties of the State of North Carolina are divided
into three regions as follows:
(1) The Northern Region shall include the
following counties: Alamance; Alleghany; Ashe; Bertie; Camden; Caswell; Chowan;
Currituck; Dare; Durham; Edgecombe; Forsyth; Franklin; Gates; Granville;
Guilford; Halifax; Hertford; Martin; Nash; Northampton; Orange; Pasquotank;
Perquimans; Person; Rockingham; Stokes; Surry; Tyrrell; Vance; Warren;
Washington; Watauga; Wilkes; and Yadkin.
(2) The Central Region shall include the
following counties: Alexander; Avery; Beaufort; Buncombe; Burke; Caldwell; Carteret; Catawba; Chatham; Cherokee; Clay; Craven; Davidson; Davie; Graham;
Greene; Haywood; Hyde; Iredell; Jackson; Johnston; Jones; Lenoir; Macon; Madison; McDowell; Mitchell; Pamlico; Pitt; Randolph; Rowan; Swain; Wake; Wayne; Wilson; and Yancey.
(3) The Southern Region shall include the
following counties: Anson; Bladen; Brunswick; Cabarrus; Cleveland; Columbus; Cumberland; Duplin; Gaston; Harnett; Henderson; Hoke; Lee; Lincoln; Mecklenburg;
Montgomery; Moore; New Hanover; Onslow; Pender; Polk; Richmond; Robeson;
Rutherford; Sampson; Scotland; Stanly; Transylvania; and Union.
(e) All renewal registrations applied for on October 31,
1989 shall be granted in accordance with the following specifications:
(1) The renewal registrations received from the
Northern Region shall be granted for the period of October 31, 1989 until
October 31, 1990.
(2) The renewal registrations received from the
Central Region shall be extended until December 31, 1989 at which time they
will be granted for the period of December 31, 1989 until December 31, 1990.
(3) The renewal registrations received from the
Southern Region shall be granted for the period of October 31, 1989 until July
31, 1990.
History Note: Authority G.S. 90‑100;
Eff. June 30, 1978;
Amended Eff. May 1, 1990; July 1, 1989; May 15, 1979;
Recodified from 10A NCAC 26E .0110 Eff. February 1, 2005.
10A NCAC 26E .0113 APPLICATION FORMS: CONTENTS: SIGNATURE
(a) Any person required to be registered and who is not
registered and applying for registration:
(1) to manufacture or distribute controlled
substances, shall apply on Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services Form 225;
(2) to dispense controlled substances listed in
Schedules II through V, shall apply on Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services Form 224;
(3) to conduct instructional activities with
controlled substances listed in Schedules II through V, shall apply on
Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services Form 224;
(4) to conduct research with controlled substances
listed in Schedules II through V other than research described in .0105(a)(6)
of this Subchapter, shall apply on Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services Form 225 with evidence of federal
registration to conduct research with such controlled substances;
(5) to conduct research with narcotic drugs
listed in Schedules II through V, as described in .0105(a)(6) of this
Subchapter, shall apply on Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services Form 225 with evidence of federal
registration to conduct research with narcotic drugs;
(6) to conduct research with controlled
substances listed in Schedules I and VI, shall apply on Commission for Mental
Health, Developmental Disabilities and Substance Abuse Services Form 225 with
evidence of federal registration to conduct research with such controlled
substances;
(7) to conduct instructional activities with
controlled substances listed in Schedules I and VI, shall apply as a researcher
on Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services Form 225 with evidence of federal registration to conduct
instructional activities with controlled substances; to conduct chemical
analysis with controlled substances listed in any schedule, shall apply on
Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services Form 225;
(8) to conduct chemical analysis with
controlled substances listed in any schedule, shall apply on Commission for Mental
Health, Developmental Disabilities and Substance Abuse Services From 25;
(9) to dispense controlled substances in
Schedule III-V for opioid treatment, shall apply on Commission for Mental
Health, Developmental Disabilities and Substance Abuse Services Form 224; and
(10) to provide a commercial detection service,
shall apply on Commission for Mental Health, Developmental Disabilities
and Substance Abuse Services Form 225.
(b) Any person registered and who is applying for
re-registration:
(1) to manufacture or distribute controlled
substances, shall apply on Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services Form 227;
(2) to dispense controlled substances in
Schedules II through V, shall apply on Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services Form 226;
(3) to conduct instructional activities with
controlled substances listed in Schedules II through VI, shall apply on
Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services Form 226;
(4) to conduct research with controlled
substances listed in Schedules II through V other than research described in
Rule .0105(a)(6) of this Subchapter, shall apply on Commission for Mental
Health, Developmental Disabilities and Substance Abuse Services Form 227;
(5) to conduct research with narcotic drugs
listed in Schedules II through V, as described in Rule .0105(a)(6) of this
Subchapter, shall apply on Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services Form 227;
(6) to continue to conduct research with
controlled substances listed in Schedules I and VI under one or more approved
research protocols, shall apply on Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services Form 227;
(7) to continue to conduct instructional
activities with controlled substances listed in Schedules I and VI under one or
more approved federal instructional statements, shall apply as a researcher on
Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services Form 227;
(8) to conduct chemical analysis with
controlled substances listed in any schedule, shall apply on Commission for
Mental Health, Developmental Disabilities and Substance Abuse Services Form
227;
(9) to dispense controlled substances in
Schedule III-V in opioid treatment , shall apply on Commission for Mental
Health, Developmental Disabilities and Substance Abuse Services Form 226; and
(10) to provide a commercial detection service,
shall apply on Commission for Mental Health, Developmental Disabilities and
Substance Abuse Services Form 227.
(c) Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services Forms 224 and 225 may be obtained by
writing to the Director. Commission for Mental Health, Developmental
Disabilities and Substance Abuse Services Forms 226 and 227 will be mailed as
applicable to each registered person approximately 60 days before the
expiration date of registration; if any registered person does not receive such
forms within 45 days before the expiration date of registration, the registered
person must give notice of such fact and request such forms by writing to the
Director.
(d) Each application for registration to handle any basic
class of controlled substance listed in Schedules I (except to conduct chemical
analysis with such classes) and VI and each application for registration to
manufacture a basic class of controlled substances listed in Schedule II or to
conduct research with any narcotic controlled substance listed in Schedule II
shall include the Federal Drug Enforcement Administration code number for each
class or substance to be covered by such registration.
(e) Each application shall include all information called
for by these Rules unless the item is not applicable, in which case this fact
shall be indicated.
(f) An applicant may authorize one or more individuals who
would not otherwise be authorized to do so to sign applications for the
applicant by filing with the director a power of attorney for each such
individual. The power of attorney shall be signed by a person who is
authorized to sign applications under this Paragraph and shall contain the
signature of the individual being authorized to sign applications. The power
of attorney shall be valid until revoked by the applicant.
History Note: Authority G.S. 90‑100; 90‑102;
143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. February 1, 2005; May 1, 1990; May 15, 1979;
September 30, 1978;
Recodified from 10A NCAC 26E .0111 Eff. February 1, 2005.
10A NCAC 26E .0114 FILING OF APPLICATION: JOINT FILINGS
(a) All applications for registration shall be submitted
for filing to the Director.
(b) Any person required to obtain more than one
registration may submit all applications in one package. Each application must
be complete and shall not refer to any accompanying application for required
information.
History Note: Authority G.S. 90‑100; 143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990; May 15, 1979;
Recodified from 10A NCAC 26E .0112 Eff. February 1, 2005.
10A NCAC 26E .0115 ACCEPTANCE FOR FILING: DEFECTIVE
APPLICATIONS
(a) Applications submitted for filing are dated upon
receipt. If found to be complete, the application will be accepted for filing.
Applications failing to comply with the requirements of this part will not
generally be accepted for filing. In the case of minor defects as to
completeness, the director may accept the application for filing with a request
to the applicant for additional information. A defective application will be
returned to the applicant within 10 days following its receipt with a statement
of the reason for not accepting the application for filing. A defective
application may be corrected and resubmitted for filing at any time; the
director shall accept for filing any application upon resubmission by the
applicant whether complete or not.
(b) Accepting an application for filing does not preclude
any subsequent request for additional information pursuant to .0114 of this
Subchapter and has no bearing on whether the application will be accepted
except as provided in General Statutes 90‑102(c) and (d).
History Note: Authority G.S. 90‑100; 143B‑210(9);
Eff. June 30, 1978;
Amended Eff. May 15, 1979; September 30, 1978;
Recodified from 10A NCAC 26E .0113 Eff. February 1, 2005.
10A NCAC 26E .0116 ADDITIONAL INFORMATION
The director may require an applicant other than one
registered under federal law to submit such documents or written statements of
facts relevant to the application as he deems necessary to determine whether
the application should be accepted. The failure of the applicant to provide
such documents or statements within 60 days after being requested to do so
shall be deemed to be a waiver by the applicant of an opportunity to present
such documents or statements for consideration by the director granting or
denying the application.
History Note: Authority G.S. 90‑100; 143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990; May 15, 1979; September 30,
1978;
Recodified from 10A NCAC 26E .0114 Eff. February 1, 2005.
10A NCAC 26E .0117 AMENDMENTS TO AND WITHDRAWAL OF
APPLICATIONS
(a) An application may be amended or withdrawn without
permission of the director at any time before the date on which the applicant
receives an order to show cause pursuant to .0119 of this Section or before the
date on which a notice of hearing on the application is published pursuant to
Rule .0117 of this Section, whichever is sooner.
(b) After an application has been accepted for filing, the
failure by the applicant to respond to official correspondence regarding the
application when sent by registered or certified mail, return receipt
requested, shall be deemed to be a withdrawal of the application.
History Note: Authority G.S. 90‑100; 143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 15, 1979; September 30, 1978;
Recodified from 10A NCAC 26E .0115 Eff. February 1, 2005.
10A NCAC 26E .0118 ADMINISTRATION REVIEW GENERALLY
The director may inspect or cause to be inspected the
establishment of an applicant or registrant pursuant to Section .0500 of this
Subchapter. The director shall review the application for registration and any
other information concerning the applicant or registrant in order to determine
whether the applicable standards of G.S. 90-102 have been met by the applicant.
History Note: Authority G.S. 90‑104; 143B‑210(9);
Eff. June 30, 1978;
Amended Eff. May 15, 1979;
Recodified from 10A NCAC 26E .0116 Eff. February 1, 2005.
10 NCAC 26E .0119 CERTIFICATE OF REGISTRATION: DENIAL OF
REGISTRATION
(a) The director shall issue a certificate of registration
(Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services Form 223) to an applicant if the issuance of registration or re‑registration
is required under the applicable provisions of G.S. 90-102. Before denying any
application, the director shall issue an order to show cause pursuant to Rule
.0121 of this Section and shall hold a hearing on the application pursuant to
Rule .0122 of this Section.
(b) The certificate of registration (Commission for Mental
Health, Developmental Disabilities and Substance Abuse Services Form 223) shall
contain the name, address and registration number of the registrant, the
activity authorized by the registration, the schedules or Drug Enforcement
Administration controlled substances code number of the controlled substances
which the registrant is authorized to handle and the expiration date of the
registration.
(c) The registrant shall maintain the certificate of
registration at the registered location in a readily retrievable manner and
shall permit inspection of the certificate by an official, agent or employee of
the Department of Health and Human Services or any federal or state agency
engaged in enforcement of laws relating to controlled substances.
History Note: Authority G.S. 90‑100; 90‑103;
143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990; May 15, 1979; September 30,
1978;
Recodified from 10A NCAC 26E .0117 Eff. February 1, 2005.
10A NCAC 26E .0120 SUSPENSION OR REVOCATION OF REGISTRATION
(a) The Commission may suspend any registration pursuant to
G.S. 90‑103(a) and (d). Where the Commission suspends a registration
under G.S. 90‑103(d), the hearing on such suspension must be held no
later than 60 days after the original date of suspension.
(b) The Commission may revoke any registration pursuant to
G.S. 90‑103(a).
(c) Before revoking or suspending any registration, the
Commission shall issue an order to show cause pursuant to Rule .0121 of this
Section. Notwithstanding the requirements of this Section, however, the
Commission may suspend any registration pending a final order pursuant to Rule
.0119 of this Section.
(d) Upon service of the order of the Commission suspending
or revoking registration, the registrant shall immediately deliver his
certificate of registration and any order forms in his possession to the Raleigh office of the Director. Also upon service of the order of the Commission revoking
registration, the registrant shall, as instructed by the Commission:
(1) deliver all controlled substances in his
possession to the Raleigh office of the Director.
(2) place all controlled substances in his
possession under seal as described in G.S. 90‑103(e).
(e) In the event that revocation or suspension is limited
to a particular controlled substance or substances, the registrant shall be
given a new certificate of registration for all substances not affected by such
revocation or suspension. The registrant shall deliver the old certificate of
registration to the Raleigh office of the Director. Also, the registrant
shall, as instructed by the Commission:
(1) deliver to the Raleigh office of the
Director all of the particular controlled substance or substances affected by
the revocation or suspension which are in his possession, or
(2) place all of such substances under seal as
described in G.S. 90‑103(e).
History Note: Authority G.S. 90‑100; 90‑103;
143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990; May 15, 1979;
Recodified from 10A NCAC 26E .0118 Eff. February 1, 2005.
10A NCAC 26E .0121 SUSPENSION OF REGISTRATION PENDING FINAL
ORDER
(a) The Commission may suspend any registration
simultaneously with or at any time subsequent to the service upon the
registrant of an order to show cause why such registration should not be
revoked or suspended in any case where it finds that there is an imminent
danger to the public health or safety. If the Commission so suspends, it shall
serve with the order to show cause pursuant to Rule .0121 of this Section an
order of immediate suspension which shall contain a statement of its findings
regarding the danger to public health or safety.
(b) Upon service of the order of immediate suspension, the
registrant shall promptly return his certificate of registration and any order
forms in his possession to the Raleigh office of Director. Upon service of the
order of the Director immediately suspending registration, the registrant
shall, as instructed by the Commission:
(1) deliver all affected controlled substances
in his possession to the Raleigh office of the Director, or
(2) place all such substances under seal as
described in G.S. 90‑103(3).
(c) Any suspension shall continue in effect until the
conclusion of all proceedings upon the revocation or suspension including any
judicial review thereof, unless sooner withdrawn by the Commission or dissolved
by a court of competent jurisdiction. Any registrant whose registration is
suspended under this Section may request a hearing on the revocation or
suspension of his registration at a time earlier than specified in the order to
show cause pursuant to Rule .0121 of this Section, which request shall be
granted by the director who shall fix a date for such hearing as early as
reasonably possible.
History Note: Authority G.S. 90‑100; 90‑103;
143B‑147(a)(5); 150B‑3(c);
Eff. June 30, 1978;
Amended Eff. May 1, 1990; May 15, 1979; September 30,
1978;
Recodified from 10A NCAC 26E .0119 Eff. February 1, 2005.
10A NCAC 26E .0122 EXTENSION OF REGISTRATION PENDING FINAL
ORDER
In the event that an applicant for registration (who is
operating under a registration previously granted and not revoked or suspended)
has applied for registration at least 45 days before the date on which the
existing registration is due to expire and the director has issued no order on
the application on the date on which the existing registration is due to
expire, the existing registration of the applicant shall automatically be
extended and continue in effect until the date on which the director so issues
his order. The director may extend any other existing registration under the
circumstances contemplated in this Rule even though the registrant failed to
apply for registration at least 45 days before expiration of the existing
registration, with or without request by the registrant, if the director finds
that such extension is not inconsistent with the public health and safety.
History Note: Authority G.S. 90‑100; 90‑103;
143B‑210(9);
Eff. June 30, 1978;
Amended Eff. May 15, 1979; September 30, 1978;
Recodified from 10A NCAC 26E .0120 Eff. February 1, 2005.
10A NCAC 26E .0123 ORDER TO SHOW CAUSE
(a) If, upon examination of the application for
registration from any applicant and other information gathered by the director
regarding the applicant, the director is unable to make the determinations
required by the applicable provisions of G.S. 90-102 to register the applicant,
the Commission shall serve upon the applicant an order to show cause why the
registration should not be denied.
(b) If, upon information gathered by the Commission
regarding any registrant, the director determines that the registration of such
registrant is subject to suspension or revocation pursuant to G.S. 90-103, the
Commission shall serve upon the registrant an order to show cause why the
registration should not be revoked or suspended.
(c) The order to show cause shall call upon the applicant
or registrant to appear before the director at a time and place stated in the
order which shall not be less than 30 days after the date of receipt of the
order. The order to show cause shall also contain a statement of the legal
basis for such hearing and for the denial, revocation or suspension of
registration and a summary of the matters of fact and law asserted.
(d) When authorized by the Commission, any agent of the
Department of Health and Human Services may serve the order to show cause.
(e) All show cause hearings shall be conducted according to
the Administrative Procedure Act, G.S. 150B, Article 3.
History Note: Authority G.S. 90‑100; 90‑103;
143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990; May 15, 1979;
Recodified from 10A NCAC 26E .0121 Eff. February 1, 2005.
10A NCAC 26E .0124 HEARINGS GENERALLY
In a case where the Commission shall hold a hearing on any
registration or application, the hearing officer shall follow the requirements
of the Administrative Procedure Act, Chapter 150B, Article 3.
History Note: Authority G.S. 90‑100; 90‑102;
90‑103; 143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990; May 15, 1979
Recodified from 10A NCAC 26E .0122 Eff. February 1, 2005.
10A NCAC 26E .0125 MODIFICATION IN REGISTRATION
Any registrant may apply to modify his registration to
authorize the handling of additional controlled substances by submitting a
letter of request to the director. The letter shall contain the registrant's
name, address, registration number and the substances and schedules to be added
to his registration. If the registrant is seeking to handle additional
controlled substances listed in Schedules I and VI for the purpose of research
or instructional activities, he shall attach evidence of federal registration
to conduct research with such controlled substances. The request for
modification shall be handled in the same manner as an application for
registration. If the modification and registration is approved, the director
shall issue a new certificate of registration (Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services Form 223) to the
registrant, who shall maintain it with the old certificate of registration
until expiration.
History Note: Authority G.S. 90‑100; 143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990; May 15, 1979;
Recodified from 10A NCAC 26E .0123 Eff. February 1, 2005.
10A NCAC 26E .0126 TERMINATION OF REGISTRATION
The registration of any person shall terminate if and when
such person dies, ceases legal existence, discontinues business or professional
practice or changes his name or address as shown on the certificate of
registration. Any registrant who ceases legal existence, discontinues business
or professional practice or changes his name or address as shown on the
certificate of registration shall notify the director promptly of such fact.
In the event of a change in name or address, the person may apply for a new
certificate of registration in advance of the effective date of such change by
filing an application. The application shall be handled in the same manner as
an application for registration.
History Note: Authority G.S. 90‑100; 143B‑210(9);
Eff. June 30, 1978;
Amended Eff. May 15, 1979;
Recodified from 10A NCAC 26E .0124 Eff. February 1, 2005.
10A NCAC 26E .0127 TRANSFER OF REGISTRATION
No registration or any authority conferred thereby shall be
assigned or otherwise transferred except upon such conditions as the director
may specifically designate and then only pursuant to his written consent.
History Note: Authority G.S. 90‑100; 143B‑210(9);
Eff. June 30, 1978;
Amended Eff. May 15, 1979;
Recodified from 10A NCAC 26E .0125 Eff. February 1, 2005.
10A NCAC 26E .0128 EXEMPTION FROM REGISTRATION
(a) The requirement of registration is waived for homes for
the aged and infirm and for agents and employees of homes for aged and infirm
so long as such agents or employees are acting in the usual course of their
business or employment.
(b) The requirement of registration is waived for community
based residential programs that have nine or fewer beds for individuals who are
mentally ill, mentally retarded or developmentally disabled and for agents and
employees of community based residential programs that have nine or fewer beds
for individuals who are mentally ill, mentally retarded or developmentally
disabled so long as such agents or employees are acting in the course of their
business or employment.
History Note: Authority G.S. 90‑100; 90‑101(d);
143B‑147;
Eff. June 30, 1978;
Amended Eff. May 1, 1990; August 1, 1985;
Recodified from 10A NCAC 26E .0126 Eff. February 1, 2005.
10A NCAC 26E .0129 SECURITY REQUIREMENTS GENERALLY
(a) Any person who manufactures, distributes, dispenses, or
conducts research with any controlled substance shall comply with Part 1301 of
Title 21 of the Code of Federal Regulations, which sets forth security
requirements.
(b) This compliance shall be deemed in compliance with G.S.
90-100, G.S. 90-101(a) and G.S. 90-102(a), Article 5.
History Note: Authority G.S. 90‑100; 143B‑147;
Eff. July 1, 1994;
Recodified from 10A NCAC 26E .0127 Eff. February 1, 2005.
SECTION .0200 ‑ LABELING AND PACKAGING CONTROLLED
SUBSTANCES: RECORDS OF REGISTRANTS
10A NCAC 26E .0201 LABELING AND PACKAGING REQUIREMENTS
GENERALLY
Compliance with the labeling and packaging of controlled
substance requirements of federal law, including the requirements presented in
Part 1302 and Sections 1306.14 and 1306.24 of Title 21 of the Code of Federal
Regulations, shall be deemed compliance under General Statute 90‑106(f)
with the addition that a physician dispensing any controlled substance shall
affix to the package a label showing the date, the physician's name and
address, the name of the patient, the name of the controlled substance and
directions for use and cautionary statements, if any, which the physician feels
necessary or which are required by law.
History Note: Authority G.S. 90‑100; 90‑104;
143B‑210(9);
Eff. June 30, 1978;
Amended Eff. September 30, 1978.
10A NCAC 26E .0202 RECORD AND INVENTORY REQUIREMENTS
GENERALLY
Compliance with the record and inventory requirements of
federal law, including the requirements presented in Part 1304 of the Code of
Federal Regulations, shall be deemed compliance under G.S. 90‑104.
History Note: Authority G.S. 90‑104;
Eff. June 30, 1978;
Amended Eff. May 1, 1990.
SECTION .0300 ‑ PRESCRIPTIONS
10A NCAC 26E .0301 PRESCRIPTION REQUIREMENTS GENERALLY
Compliance with the prescription requirements of the federal
law, including the requirements presented in Part 1306 of Title 21 of the Code
of Federal Regulations, shall be deemed compliance under General Statute
Chapter 90, Article 5.
History Note: Authority G.S. 90‑100; 90‑106;
143B‑147;
Eff. June 30, 1978;
Amended Eff. August 1, 1987; July 1, 1982.
10A NCAC 26E .0302 NONPRESCRIPTION REQUIREMENTS GENERALLY
Compliance with the requirements for dispensing without
prescriptions, of the federal law, including the requirements presented in Part
1306 of Title 21 of the Code of Federal Regulations shall be deemed compliance
under General Statute Chapter 90, Article 5.
History Note: Authority G.S. 90‑106;
Eff. June 30, 1978.
10A NCAC 26E .0303 USE OF CONTROLLED SUBSTANCES IN SCHEDULE
VI
(a) Pursuant to General Statute 90‑113.3 the
Department of Health and Human Services is authorized to engage in research in
the misuse and abuse of Schedule VI controlled substances. The Department of
Health and Human Services is also authorized to enter into contracts with other
public agencies, institutions of higher education and private organizations or
individuals for the purpose of research on the misuse and abuse of Schedule VI
controlled substances. Other than through the authority of the Department of
Health and Human Services or proper evidence of federal registration to conduct
research in accordance with General Statutes 90‑102(c) and (d), no other
person is authorized to use Schedule VI controlled substances.
(b) Practitioners licensed pursuant to Chapter 90, Article
5, may dispense Tetrahydrocannabinol (THC) as an antiemetic agent in cancer
chemotherapy. Compliance with the dispensing requirements of the federal law
including the requirements presented in Part 1306 of Title 21 of the Code of
Federal Regulations relating to Tetrahydrocannabinol (THC) shall be deemed
compliance under General Statute 90, Article 5.
History Note: Authority G.S. 90‑113.3;
Eff. June 30, 1978;
Amended Eff. September 15, 1980.
10A NCAC 26E .0304 HOSPITALS HAVING 24‑HOUR PHARMACY
SERVICE
In those hospitals having 24‑hour outpatient pharmacy
service, all controlled substances dispensed to outpatients including emergency
department patients must be dispensed by a pharmacist.
History Note: Authority G.S. 90‑100; 143B‑147(a)(5);
Eff. June 30, 1978.
10A NCAC 26E .0305 HOSPITALS NOT HAVING 24‑HOUR
PHARMACY SERVICE
In those hospitals not having 24‑hour outpatient
pharmacy services or those hospitals having no outpatient pharmacy services,
controlled substances dispensed to emergency department patients when the
pharmacy service is closed shall follow this procedure:
(1) All controlled substances shall be dispensed to a
bona fide patient, or his agent, of the emergency room pursuant to the written
or verbal order of a licensed practitioner who is registered with the Federal
Drug Enforcement Administration to prescribe or dispense controlled substances.
(2) The pharmacist designated by the hospital shall be
responsible for developing and supervising a system of control and
accountability of all controlled substances administered in or dispensed from
the emergency department.
(3) The hospital's emergency department committee (or
like group or person responsible for policy in that department) in conjunction
with the hospital pharmacy shall develop an emergency department formulary or
controlled substances list of those controlled substances which may be
dispensed from the emergency department for patients receiving care in that
department. This formulary or controlled substances list shall consist of
controlled substances of the nature and type to meet the immediate need of
emergency department patients, and quantities in each container shall be
limited to not more than a 24‑hour supply.
(4) Such controlled substances shall be prepackaged in
suitable safety closure containers and shall be appropriately prelabeled
(including necessary auxiliary labels) by the pharmacy so as to provide for all
label information necessary for use as well as other information required by
law.
(5) At the time of delivery of the controlled
substance, the physician, or physician assistant or a registered nurse under
his direction shall appropriately complete the label and initial it.
(6) A suitable and perpetual record of dispensing of
these controlled substances shall be maintained in the emergency department.
The pharmacist shall verify the correctness of this record at least once a
week.
(7) The dispenser shall sign the record of dispensing
that is maintained in the emergency department to verify the controlled
substance ordered.
(8) When the controlled substances are delivered, the
appropriately labeled, prepackaged container of the controlled substance shall
be checked for correctness and given to the patient by the physician or by a
person authorized to prescribe or dispense controlled substances pursuant to
G.S. 90‑18.1 or by a registered nurse or physician assistant under the
supervision of the ordering physician.
History Note: Authority G.S. 90‑100; 143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990; January 14, 1981; September 15,
1980; September 30, 1978.
10A NCAC 26E .0306 SUPPLYING OF METHADONE IN TREATMENT
PROGRAMS BY RN
(a) Methadone or other medications approved for use in
narcotic addiction treatment by the Food and Drug Administration, and under the
North Carolina Controlled Substances Act, may be supplied to a bona fide
patient of a methadone treatment program.
(b) Methadone may be supplied by either a registered nurse
or a licensed practical nurse employed by that program, provided the methadone
is supplied pursuant to the order of the program's medical director, who is a
licensed physician registered with the Federal Drug Enforcement Administration
to dispense controlled substances in the applicable schedule.
(c) The program's medical director shall countersign or
sign in the medical record of the program all orders for methadone or other
medications approved for use in narcotic addiction treatment by the Food and
Drug Administration and under the North Carolina Controlled Substances Act
within 72 hours of the initiation of the order.
(d) For purposes of this Rule, supplying shall not include
prescribing or compounding.
History Note: Authority G.S. 90‑100; 143B‑147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990;
Amended Eff. August 1, 2002.
10A NCAC 26E .0307 PREPRINTED PRESCRIPTION BLANKS
PROHIBITED
The preprinting of or use of preprinted prescription blanks
with the name of Schedule II through V Controlled Substances shall be
prohibited.
History Note: Authority G.S. 90‑100; 143B‑147;
Eff. April 1, 1983.
10A NCAC 26E .0308 USE OF SYNTHETIC CANNABINOIDS IN
SCHEDULE II
Practitioners licensed pursuant to Chapter 90, Article 5,
may dispense the following synthetic cannabinoids only as an antiemetic agent
in cancer chemotherapy:
(1) Dronabinol (synthetic) in sesame oil and
encapsulated in a soft gelatine capsule in a U.S. Food and Drug Administration
approved drug product; and
(2) Nabilone.
History Note: Authority G.S. 90‑90; 90‑100;
90‑101(h); 143B‑147;
Eff. December 1, 1986;
Amended Eff. December 1, 1987.
SECTION .0400 ‑ MISCELLANEOUS
10A NCAC 26E .0401 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. 90, Article 5).
(2) Any term not defined in this Rule shall have the
definition set forth in G.S. 90‑87 and Rule .0102 of this Subchapter.
History Note: Authority G.S. 90‑100; 143B‑147;
Eff. June 30, 1978.
10A NCAC 26E .0402 APPLICATION OF OTHER STATE LAW AND
FEDERAL LAW
Nothing in Sections .0100 through .0500 of this Subchapter
shall be construed as authorizing or permitting any person to do any act which
such person is not authorized or permitted to do under federal laws or
obligations under international treaties, conventions or protocols or under
other law of the state, nor shall compliance with such parts be construed as
compliance with federal or state laws expressly provided in such other laws.
History Note: Authority G.S. 90‑100; 143B‑147;
Eff. June 30, 1978.
10A NCAC 26E .0403 DISTRIBUTION TO SUPPLIER
Any person lawfully in possession of a controlled substance
listed in any schedule may distribute (without being registered to distribute)
that substance to the person from whom he obtained it or to the manufacturer of
the substance, provided that a written record is maintained which indicates the
date of the transaction, the name, form and quantity of the substance, the
name, address and registration number, if known, of the supplier or
manufacturer. In the case of returning a controlled substance listed in
Schedule I, II or VI, a Federal Drug Enforcement Order Form shall be used and
be maintained as the written record of the transaction. Any person not required
to register pursuant to G.S. 90‑101 shall be exempt from maintaining the
records required by this Rule.
History Note: Authority G.S. 90‑100; 143B‑147;
Eff. June 30, 1978;
Amended Eff. September 30, 1978.
10A NCAC 26E .0404 DISCONTINUANCE OR TRANSFER OF BUSINESS
Any registrant desiring to discontinue or transfer business
activities altogether or with respect to controlled substances shall return his
certificate of registration to the director for cancellation.
History Note: Authority G.S. 90‑100; 143B‑210(9);
Eff. June 30, 1978;
Amended Eff. May 15, 1979.
10A NCAC 26e .0405 PROCEDURE FOR DISPOSING OF CONTROLLED
SUBSTANCES
(a) Any person in possession of any controlled substance
and desiring or required to dispose of such substance (e.g., upon
discontinuance or transfer of business) shall be in compliance with the State
requirements as long as the requirements prescribed in Part 1307 of Title 21 of
the Code of Federal Regulations, as amended, are met.
(b) Any pharmacy, as defined in G.S. 90‑87, licensed
by the North Carolina Board of Pharmacy and not subject to registration by the
Department, as defined in G.S. 122C‑3, shall comply with State
requirements set forth in 21 NCAC 46 .3001(c).
History Note: Authority G.S. 90‑100; 143B‑147;
Eff. June 30, 1978;
Amended Eff. July 1, 1994.
10A NCAC 26E .0406 DISPOSAL OF UNUSED CONTROLLED SUBSTANCES
FROM NURSING HOME
Controlled substances dispensed to a licensed nursing home
which for any reason are unused shall be returned to the pharmacy from which
they were received. The pharmacist who receives these controlled substances
shall return them to his stock or destroy them in accordance with the procedure
outlined by the director and shall keep a record of this destruction available
for a minimum of two years. This record of destruction shall be kept on the
form entitled "Controlled Substances Destruction Record Nursing
Homes." Controlled substances returned to stock must be in a hermetically
sealed container or in an otherwise pure uncontaminated condition and be
identifiable.
History Note: Authority G.S. 90‑100; 143B‑210(9);
Eff. June 30, 1978;
Amended Eff. September 15, 1980; May 15, 1979.
10A NCAC 26E .0407 DISPOSAL BY REGISTRANTS AND
PRACTITIONERS: SCHEDULES II‑V
The destruction of a controlled substance in Schedules II,
III, IV and V by a registrant or practitioner or by his authorized agent shall
be witnessed by the director or his designated representative or a state or
federal official authorized to enforce the Federal Controlled Substances Act or
the North Carolina Controlled Substances Act except when a dose/doses of any
controlled substance is accidentally contaminated at a nursing station or
adjacent area, the controlled substance may be destroyed at the pharmacy or
nursing station by a practitioner, a registered nurse or a licensed practical
nurse; provided a record of destruction is made on a controlled substance
disposition record showing the date, time, quantity, manner of destruction, and
type of controlled substance, and the initials or signatures of persons
destroying and witnessing the destruction. The destruction shall be in
accordance with the procedures outlined by the director and a record of this
destruction shall be kept available by the registrant or practitioner for a
minimum of two years.
History Note: Authority G.S. 90‑100; 143B‑147;
Eff. June 30, 1978;
Amended Eff. July 1, 1982; September 14, 1981; May 15,
1979; September 30, 1978.
10A NCAC 26E .0408 SPECIAL CONTROLLED SUBSTANCES EMERGENCY
KIT
(a) A (special) controlled substances emergency kit shall
be permitted in those skilled nursing facilities, intermediate care facilities
and combination facilities which are licensed with the Department of Health and
Human Services:
(b) The controlled substances emergency kit shall contain
not more than seven controlled drug entities (Schedules II‑V) as
determined by the medical staff of the facility with the approval of the
pharmaceutical services committee.
(c) Controlled substances for emergency use shall be
obtained through purchase orders from the licensed pharmacist who regularly
provides medications to the facility and its patients. When Schedule II drugs
are purchased, federal Drug Enforcement Administration order forms must be
used.
(d) Controlled substances for emergency use shall be
provided in a single unit‑dose form.
(e) A facility shall be permitted to possess not more than
five doses of each controlled drug entity for each 50 licensed beds or fraction
thereof. The five doses of each drug entity may be of the same or differing
concentrations.
(f) The controlled emergency drug supply shall be used to
meet the urgent needs of patients, consistent with good medical practice. The
need for such use shall be documented in the patient's medical record
consistent with applicable state and federal statutes and regulations.
(g) The controlled substance emergency kit shall be
securely locked and stored with access limited to authorized personnel.
(h) Only those persons designated by the director of the
facility shall have access to the controlled substances emergency kit.
(i) The pharmacist‑supplier of the controlled drugs
for emergency use shall have primary responsibility for the proper control and
accountability of such drugs in the facility.
(j) No person, individual, practitioner or facility shall
be permitted to perform by virtue of these regulations any act otherwise
prohibited by law.
(k) Nothing in these regulations shall compel any licensed
pharmacist to provide controlled drugs for emergency use to any facility
against his professional judgment.
(l) Requirements contained in North Carolina Board of
Pharmacy rule 21 NCAC 46 .1414(i) relating to emergency kits generally shall
apply.
(m) Exceptions to these regulations shall not be made
unless otherwise provided by law.
(n) Each registrant desiring to maintain a controlled
substance emergency kit must be registered with the Federal Drug Enforcement
Administration or receive an exemption from registration by that agency.
History Note: Authority G.S. 90-100; 143B-147;
Eff. June 30, 1978;
Amended Eff. September 30, 1978;
Temporary Amendment Eff. June 15, 1999;
Temporary Amendment Expired February 28, 2000;
Codifier determined that findings did not meet criteria
for temporary rule on May 22, 2000;
Temporary Amendment Eff. May 30, 2000;
Amended Eff. April 1, 2001.
10A NCAC 26E .0409 DISPOSAL OF UNUSED PORTIONS OF
INJECTABLE: SCHEDULES II‑V
Both the amount of the injectable Schedules II‑V
controlled substance administered to the patient and the amount destroyed shall
be recorded on the controlled substances disposition document or the patient's
medical record with initials of individual administering and destroying the
injectable controlled substance. Other procedures of documenting this
information shall be submitted to the director for approval before implementation.
History Note: Authority G.S. 90‑100; 143B‑147;
Eff. June 30, 1978;
Amended Eff. May 15, 1979; September 30, 1978.
10A NCAC 26E .0410 RECORD OF ALL CONTROLLED SUBSTANCES
DISPENSED
Practitioners shall maintain a readily retrievable record of
all controlled substances dispensed whether or not the practitioner charges the
patient for the controlled substance.
History Note: Authority G.S. 90‑100; 143B‑147;
Eff. September 15, 1980.
SECTION .0500 ‑ ADMINISTRATIVE FUNCTIONS: PRACTICES AND
PROCEDURES
10A NCAC 26E .0501 SCOPE
Procedures regarding administrative inspections pursuant to
General Statutes 90‑101(f) and 90‑107 are governed generally by
those sections and specifically by the rules of this Section.
History Note: Authority G.S. 90‑101; 90‑107;
Eff. June 30, 1978.
10A NCAC 26E .0502 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 (General Statute Chapter 90, Article 5);
(2) The term "commission" means the
Commission for Mental Health, Developmental Disabilities and Substance Abuse
Services;
(3) The term "controlled premises" means
places where original or other records or documents required under the act are
kept or required to be kept; and places, including factories, warehouses or
other establishments and conveyances where persons registered under the act or
exempted from registration under the act may lawfully hold, manufacture or
distribute, dispense, administer or otherwise dispose of controlled substances;
(4) The term "director" means the Director of
the Division of Mental Health, Developmental Disabilities and Substance Abuse
Services;
(5) The term "inspector" means an officer or
employee of the Department of Health and Human Services authorized by the
director to make inspections under the act;
(6) The terms "register" and
"registration" refer to registration required; and
(7) Any term not defined in this Rule shall have the
definition set forth in General Statute 90‑87.
History Note: Authority G.S. 90‑100; 143B‑210(9);
Eff. June 30, 1978;
Amended Eff. August 1, 1990; May 15, 1979.
10A NCAC 26E .0503 AUTHORITY TO MAKE INSPECTIONS
(a) In carrying out his functions under the act, the
director through his inspectors, is authorized in accordance with General
Statutes 90‑101(f) and 90‑107 to enter controlled premises and
conduct administrative inspections thereof for the purpose of:
(1) inspecting, copying and verifying the
correctness of records, reports or other documents required to be kept or made
under the act and the regulations promulgated under the act, including but not
limited to inventory and other records required to be kept pursuant to Section
.0200 of this Subchapter, prescription and distribution records required to be
kept pursuant to Section .0300 of this Subchapter, shipping records identifying
the name of each carrier used and the date and quantity of each shipment and
storage records identifying the names of each warehouse used and the date and
quantity of each storage;
(2) inspecting within reasonable limits and in
a reasonable manner all pertinent equipment, finished and unfinished,
controlled substances and other substances or materials, containers and
labeling found at the controlled premises relating to this act;
(3) making a physical inventory of all
controlled substances on hand at the premises;
(4) collecting samples of controlled substances
or precursors; (In the event any samples are collected during an inspection,
the inspector shall issue a receipt for such samples on Commission for Mental
Health, Developmental Disabilities and Substance Abuse Services Form 84 to the
owner, operator or agent in charge of the premises.)
(5) checking of records and information on
distribution of controlled substances by the registrant as they relate to total
distribution of the registrant (i.e., has the distribution in controlled
substances increased markedly within the past year, and if so, why); and
(6) except as provided in Section .0500 of this
Subchapter, all other things therein (including records, files, papers,
processes, controls and facilities) appropriate for verification of the
records, reports, documents referred to above or otherwise bearing on the
provisions of the act and the regulations thereunder.
(b) All inspections shall be conducted during regular
business hours and shall be completed in a reasonable manner.
(c) All inspections shall be conducted in accordance with
applicable provisions of the Constitution of the United States and the State of
North Carolina. In any event, the owner (or operator) of the premises, as the
case may be, shall be given reasonable notice of the time, place, purpose and
identity of the person or persons conducting the inspection.
History Note: Authority G.S. 90‑101; 90‑107;
Eff. June 30, 1978;
Amended Eff. August 1, 1990; May 15, 1979.
10A NCAC 26E .0504 EXCLUSION FROM INSPECTION
Unless the owner, operator or agent in charge of the
controlled premises so consents in writing, no inspection authorized by these
regulations shall extend to:
(1) financial data,
(2) sales data other than shipping date, or
(3) pricing data.
History Note: Authority G.S. 90‑101; 90‑107;
Eff. June 30, 1978.
10A NCAC 26E .0505 ENTRY
An inspection shall be carried out by an inspector. Any
such inspector, upon:
(1) stating his purpose;
(2) presenting to the owner, operator or agent in
charge of the premises to be inspected appropriate credentials; and
(3) receiving informed consent, shall have the right to
enter such premises and conduct inspections at reasonable times and in a
reasonable manner.
If entry to inspect premises is denied an inspector by a
registrant or an applicant for registration, a written notice of inspection as
described in Rule .0506 of this Section shall be obtained and executed.
History Note: Authority G.S. 90‑101; 90‑107;
Eff. June 30, 1978;
Amended Eff. May 15, 1979; September 30, 1978.
10A NCAC 26E .0506 NOTICE OF INSPECTION
The notice of inspection (Commission for Mental Health,
Developmental Disabilities and Substance Abuse Services Form 82) shall contain:
(1) the name and title of the owner, operator or agent
in charge of the controlled premises;
(2) the controlled premises name;
(3) the address of the controlled premises to be
inspected;
(4) the date and time of the inspection;
(5) a statement that a notice of inspection is given;
and
(6) the signature of the inspector.
History Note: Authority G.S. 90‑101;
Eff. June 30, 1978;
Amended Eff. August 1, 1990.
SECTION .0600 - Controlled Substances Reporting System
10A NCAC 26E .0601 SCOPE
The rules of this Section as well as the provisions of
Chapter 90, Article 5E shall govern requirements for the controlled substances
reporting system as set forth in G.S. 90-113.70.
History Note: Authority G.S. 90-113.70; 90-113.76;
Temporary Adoption Eff. January 1, 2007;
Eff. April 1, 2007.
10A NCAC 26E .0602 DEFINITIONS
(a) As used in this Section, the following terms shall have
the meanings as specified:
(1) "Controlled substance reporting
system" means the reporting system as set forth in Article 5E of Chapter
90.
(2) "ASAP" means the American Society
for Automation in Pharmacy.
(b) Any term not defined in this Section shall have the
same definitions as set forth in G.S. 90-87 and 90-113.72.
History Note: Authority G.S. 90-113.70; 90-113.76;
Temporary Adoption Eff. January 1, 2007;
Eff. April 1, 2007.
10A NCAC 26E .0603 REQUIREMENTS FOR TRANSMISSION OF DATA
(a) Each dispenser shall transmit to the Department the
data as set forth in G.S. 90-113.73. The data shall be transmitted in the ASAP
Telecommunication Format for Controlled Substances, published by the American
Society for Automation in Pharmacy that is in use in the majority of states
operating a controlled substance reporting system.
(b) The dispenser shall transmit the data electronically
unless the Department approves a request for submission on paper as set forth
in Paragraphs (e) and (f) of this Rule.
(c) The dispenser's electronic transfer data equipment
including hardware, software and internet connections shall be in compliance
with the Health Insurance Portability and Accountability Act as set forth in 45
CFR, Part 164.
(d) Each electronic transmission shall meet data protection
requirements as follows:
(1) Data shall be at least 128B encryption in
transmission and at rest; or
(2) Data shall be transmitted via secure file
transfer protocol. Once received, data at rest shall be encrypted.
(e) The data may be submitted on paper if the dispenser
submits a written request to the Department and receives prior approval.
(f) The Department shall consider the following in granting
approval of the request:
(1) The dispenser does not have a computerized
record keeping system; or
(2) The dispenser is unable to conform to the
submission format required by the database administrator without incurring expenses
over three thousand dollars ($3,000).
(g) The dispenser shall report the data pursuant to the
requirements of G.S. 90-113.73(a).
History Note: Authority G.S. 90-113.70; 90-113.73;
90-113.76;
Temporary Adoption Eff. January 1, 2007;
Eff. April 1, 2007;
Amended Eff. January 1, 2012.
