reglab/statecodes huggingface dataset:
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0200 - LABELING AND PACKAGING CONTROLLED SUBSTANCES: RECORDS OF REGISTRANTS › Section 26E .0201 - LABELING AND PACKAGING REQUIREMENTS GENERALLY

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-100;
					 90-104;
					 143B-210(9);
Eff. June 30, 1978;
Amended Eff. September 30, 1978;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0200 - LABELING AND PACKAGING CONTROLLED SUBSTANCES: RECORDS OF REGISTRANTS › Section 26E .0202 - RECORD AND INVENTORY REQUIREMENTS GENERALLY

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-104;
Eff. June 30,
					 1978;
Amended Eff. May 1, 1990;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0300 - PRESCRIPTIONS › Section 26E .0301 - PRESCRIPTION REQUIREMENTS GENERALLY

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-100;
					 90-106;
					 143B-147;
Eff. June
					 30, 1978;
Amended Eff. August 1, 1987; July 1, 1982;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0300 - PRESCRIPTIONS › Section 26E .0302 - NONPRESCRIPTION REQUIREMENTS GENERALLY

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-106;
Eff. June 30,
					 1978;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0300 - PRESCRIPTIONS › Section 26E .0303 - USE OF CONTROLLED SUBSTANCES IN SCHEDULE VI

Current through Register Vol. 39, No. 2, July 15, 2024
(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.
Authority
					 G.S.
					 90-113.3;
Eff. June 30,
					 1978;
Amended Eff. September 15, 1980;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0300 - PRESCRIPTIONS › Section 26E .0304 - HOSPITALS HAVING 24 HOUR PHARMACY SERVICE

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-100;
					 143B-147(a)(5);
Eff. June 30, 1978;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0300 - PRESCRIPTIONS › Section 26E .0306 - SUPPLYING OF METHADONE IN TREATMENT PROGRAMS BY RN

Current through Register Vol. 39, No. 2, July 15, 2024
(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.
Authority
					 G.S.
					 90-100;
					 143B-147(a)(5);
Eff. June 30, 1978;
Amended Eff. May 1, 1990;
Amended
					 Eff. August 1, 2002;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0300 - PRESCRIPTIONS › Section 26E .0307 - PREPRINTED PRESCRIPTION BLANKS PROHIBITED

Current through Register Vol. 39, No. 2, July 15, 2024
The preprinting of or use of preprinted prescription blanks
					 with the name of Schedule II through V Controlled Substances shall be
					 prohibited.
Authority
					 G.S.
					 90-100;
					 143B-147;
Eff. April
					 1, 1983;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0300 - PRESCRIPTIONS › Section 26E .0308 - USE OF SYNTHETIC CANNABINOIDS IN SCHEDULE II

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-90;
					 90-100;
					 90-101(h);
					 143B-147;
Eff.
					 December 1, 1986;
Amended Eff. December 1, 1987;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0400 - MISCELLANEOUS › Section 26E .0401 - DEFINITIONS

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-100;
					 143B-147;
Eff. June
					 30, 1978;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0400 - MISCELLANEOUS › Section 26E .0402 - APPLICATION OF OTHER STATE LAW AND FEDERAL LAW

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-100;
					 143B-147;
Eff. June
					 30, 1978;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0400 - MISCELLANEOUS › Section 26E .0403 - DISTRIBUTION TO SUPPLIER

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-100;
					 143B-147;
Eff. June
					 30, 1978;
Amended Eff. September 30, 1978;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0400 - MISCELLANEOUS › Section 26E .0404 - DISCONTINUANCE OR TRANSFER OF BUSINESS

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-100;
					 143B-210(9);
Eff. June 30, 1978;
Amended Eff. May 15, 1979;
Pursuant
					 to G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0400 - MISCELLANEOUS › Section 26E .0405 - PROCEDURE FOR DISPOSING OF CONTROLLED SUBSTANCES

Current through Register Vol. 39, No. 2, July 15, 2024
(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).
Authority
					 G.S.
					 90-100;
					 143B-147;
Eff. June
					 30, 1978;
Amended Eff. July 1, 1994;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0400 - MISCELLANEOUS › Section 26E .0406 - DISPOSAL OF UNUSED CONTROLLED SUBSTANCES FROM NURSING HOME

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-100;
					 143B-210(9);
Eff. June 30, 1978;
Amended Eff. September 15, 1980; May 15,
					 1979;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0400 - MISCELLANEOUS › Section 26E .0407 - DISPOSAL BY REGISTRANTS AND PRACTITIONERS: SCHEDULES II V

Current through Register Vol. 39, No. 2, July 15, 2024
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.
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;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0400 - MISCELLANEOUS › Section 26E .0409 - DISPOSAL OF UNUSED PORTIONS OF INJECTABLE: SCHEDULES II V

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-100;
					 143B-147;
Eff. June
					 30, 1978;
Amended Eff. May 15, 1979; September 30,
					 1978;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0400 - MISCELLANEOUS › Section 26E .0410 - RECORD OF ALL CONTROLLED SUBSTANCES DISPENSED

Current through Register Vol. 39, No. 2, July 15, 2024
Practitioners shall maintain a readily retrievable record
					 of all controlled substances dispensed whether or not the practitioner charges
					 the patient for the controlled substance.
Authority
					 G.S.
					 90-100;
					 143B-147;
Eff.
					 September 15, 1980;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0500 - ADMINISTRATIVE FUNCTIONS: PRACTICES AND PROCEDURES › Section 26E .0501 - SCOPE

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-101;
					 90-107;
Eff. June 30,
					 1978;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0500 - ADMINISTRATIVE FUNCTIONS: PRACTICES AND PROCEDURES › Section 26E .0502 - DEFINITIONS

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-100;
					 143B-210(9);
Eff. June 30, 1978;
Amended Eff. August 1, 1990; May 15,
					 1979;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0500 - ADMINISTRATIVE FUNCTIONS: PRACTICES AND PROCEDURES › Section 26E .0503 - AUTHORITY TO MAKE INSPECTIONS

Current through Register Vol. 39, No. 2, July 15, 2024
(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.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0500 - ADMINISTRATIVE FUNCTIONS: PRACTICES AND PROCEDURES › Section 26E .0504 - EXCLUSION FROM INSPECTION

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-101;
					 90-107;
Eff. June 30,
					 1978;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0500 - ADMINISTRATIVE FUNCTIONS: PRACTICES AND PROCEDURES › Section 26E .0505 - ENTRY

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-101;
					 90-107;
Eff. June 30,
					 1978;
Amended Eff. May 15, 1979; September 30, 1978;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0500 - ADMINISTRATIVE FUNCTIONS: PRACTICES AND PROCEDURES › Section 26E .0506 - NOTICE OF INSPECTION

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-101;
Eff. June 30,
					 1978;
Amended Eff. August 1, 1990;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0600 - CONTROLLED SUBSTANCES REPORTING SYSTEM › Section 26E .0601 - SCOPE

Current through Register Vol. 39, No. 2, July 15, 2024
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.
Authority
					 G.S.
					 90-113.70;
					 90-113.76;
Temporary
					 Adoption Eff. January 1, 2007;
Eff. April 1, 2007;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0600 - CONTROLLED SUBSTANCES REPORTING SYSTEM › Section 26E .0602 - DEFINITIONS

Current through Register Vol. 39, No. 2, July 15, 2024
(a) As used in this
				  Section, the following terms shall have the meanings as specified:
(1) "Controlled substance reporting system
				  (CSRS)" means the reporting system as set forth in Article 5E of Chapter
				  90.
(2) "ASAP" means the American
				  Society for Automation in Pharmacy.
(3) "DEA" means the Drug Enforcement
				  Administration responsible for enforcing the controlled substances laws and
				  regulations of the United States.
(4) "Delegate Account Holder" means a person
				  designated to review records of the CSRS with the written approval of the
				  Master Account Holder.
(5) "DHHS"
				  means North Carolina Department of Health and Human Services.
(6) "Dispense" means the same as defined in
				  G.S.
				  90-87.
(7) "Dispenser" means the same as defined in
				  G.S.
				  90-113.72 and
				  90-113.73(f).
(8) "Good faith" means an attempt to report
				  the information required by
				  G.S.
				  90-113.73(b) that was
				  unsuccessful due to a temporary electrical or technological failure impacting
				  the transmission of data to the CSRS.
(9) "Master Account Holder" means a
				  practitioner, as defined in
				  G.S.
				  90-87, who has current DEA registration.
(A) "Zero Reporting" means the following:
				  instances when a dispenser who, except as provided in
				  G.S.
				  90-113.73(c) and (d), fails
				  to comply with the reporting provisions of 90-113.73; or
(B) instances when a dispenser does not
				  dispense any Schedule II - IV controlled substances during the previous
				  business day.
(10)
				  "Pharmacist-patient Relationship" means a consensual relationship in which an
				  individual seeks pharmaceutical care from a pharmacist, and the pharmacist
				  affirmatively acts to provide pharmaceutical care, or agrees to do
				  so.
(11) "Prescriber-patient
				  Relationship" means a consensual relationship in which an individual seeks
				  medical care from a prescriber, and the prescriber affirmatively acts to
				  provide medical care, or agrees to do so.
(12) "Data Errors Notification" means a
				  written notification from DHHS to a dispenser of failure to report data as
				  required by
				  G.S.
				  90-113.73 and of errors related to the
				  submission of that data. Errors occur when information required per Rule
				  10A NCAC
				  26E .0604(a) is omitted,
				  incomplete, or submitted late.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0600 - CONTROLLED SUBSTANCES REPORTING SYSTEM › Section 26E .0603 - REQUIREMENTS FOR TRANSMISSION OF DATA

Current through Register Vol. 39, No. 2, July 15, 2024
(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.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0600 - CONTROLLED SUBSTANCES REPORTING SYSTEM › Section 26E .0604 - REPORTING REQUIREMENTS

Current through Register Vol. 39, No. 2, July 15, 2024
(a) Each dispenser
				  shall report the following information to the Controlled Substances Reporting
				  System in accordance with the time frames provided in
				  G.S.
				  90-113.73:
(1) the dispenser's DEA number;
(2) the name of the patient for whom the
				  controlled substance is being dispensed as well as the patient's:
(A) full address including apartment number
				  where applicable, city, state, and zip code;
(B) telephone number; and
(C) date of birth;
(3) the date the prescription was
				  written;
(4) the date the
				  prescription was filled;
(5) the
				  prescription number;
(6) whether
				  the prescription is new or a refill;
(7) the metric quantity of the drug
				  dispensed;
(8) the estimated days
				  of supply of the dispensed drug, if provided to the dispenser;
(9) the national drug code of the dispensed
				  drug;
(10) the prescriber's DEA
				  number;
(11) the prescriber's
				  national provider identification number, for any prescriber that has one
				  provided, however, a pharmacy shall not be subject to a civil penalty under
				  G.S.
				  90-113.73(e) for failure to
				  report the prescriber's national provider identification number when it is not
				  received by the pharmacy; and
(12)
				  the method of payment for the prescription.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0600 - CONTROLLED SUBSTANCES REPORTING SYSTEM › Section 26E .0605 - PENALTIES

Current through Register Vol. 39, No. 2, July 15, 2024
(a) DHHS shall
				  consider the following factors in determining the amount of each civil penalty
				  assessed against a person who violates Chapter 90, Article 5E:
(1) whether the violation involved an
				  improper attempt to obtain or release information from the CSRS;
(2) whether the person succeeded in
				  improperly obtaining or releasing information from the CSRS;
(3) whether the person committed the
				  violation intentionally, knowingly, or negligently;
(4) the frequency of the violations the
				  person has committed; and
(5) the
				  number of violations the person has committed.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter F - CONTROLLED SUBSTANCES › Section .0100 - SCHEDULES OF CONTROLLED SUBSTANCES › Section 26F .0101 - DEFINITIONS

Current through Register Vol. 39, No. 2, July 15, 2024
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.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter F - CONTROLLED SUBSTANCES › Section .0100 - SCHEDULES OF CONTROLLED SUBSTANCES › Section 26F .0102 - SCHEDULE I

Current through Register Vol. 39, No. 2, July 15, 2024
(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.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter F - CONTROLLED SUBSTANCES › Section .0100 - SCHEDULES OF CONTROLLED SUBSTANCES › Section 26F .0103 - SCHEDULE II

Current through Register Vol. 39, No. 2, July 15, 2024
(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.
(d) As specified in
				  G.S.
				  90-88, the Commission for MH/DD/SAS adds
				  fentanyl immediate precursor chemical, N-phenyl-N-(piperidin-4-yl) propionamide
				  (norfentanyl), DEA controlled substances code number 8366, its esters, ethers,
				  salts, isomers and salts of its isomers, esters and ethers, to Schedule II for
				  Opiates.
(e) As specified in
				  G.S.
				  90-88, the Commission for MH/DD/SAS adds
				  Oliceridine
				  (N-[(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl})amine),
				  DEA controlled substances code number 9245, its esters, ethers, salts, isomers
				  and salts of its isomers, esters and ethers, to Schedule II for
				  Opiates.
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;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2, 2016;
Amended Eff.
					 December 1, 2021.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter F - CONTROLLED SUBSTANCES › Section .0100 - SCHEDULES OF CONTROLLED SUBSTANCES › Section 26F .0104 - SCHEDULE III

Current through Register Vol. 39, No. 2, July 15, 2024
(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).
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter F - CONTROLLED SUBSTANCES › Section .0100 - SCHEDULES OF CONTROLLED SUBSTANCES › Section 26F .0105 - SCHEDULE IV

Current through Register Vol. 39, No. 2, July 15, 2024
(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;
(4) Carisoprodol
				  - DEA controlled substances code number 8192;
(5) Lemborexant - DEA controlled substances
				  code number 2245; and
(6)
				  Remimazolam - DEA controlled substances code number 2846.
North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter F - CONTROLLED SUBSTANCES › Section .0100 - SCHEDULES OF CONTROLLED SUBSTANCES › Section 26F .0106 - SCHEDULE V

Current through Register Vol. 39, No. 2, July 15, 2024
(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 in this Rule 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 in this
				  Paragraph, 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.