North Carolina Administrative Code

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) …

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. Ma…

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 manu…

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 S…

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 …

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 …

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 p…

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…

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 …

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…

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 i…

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 Disabilit…

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 …

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 generall…

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 acc…

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 dat…

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 …

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-…

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 aft…

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…

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 exis…

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 o…

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; 90-10…

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, registrati…

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 regis…

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 …

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 employm…

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) T…

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 present…

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: A…

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 unde…

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 G…

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…

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. 9…

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 servic…

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 pa…

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; Pursuant t…

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 encapsulate…

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 hav…

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 oblig…

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, pr…

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: Author…

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 requirement…

10A NCAC 26E .0406 DISPOSAL OF UNUSED CONTROLLED SUBSTANCES FROM NURSING HOME A pharmacy that has dispensed controlled substances for inpatient administration to individuals residing in a licensed nursing home shall be responsible for either returning unused controlled substances…

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 …

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 …

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 patie…