106-145.1. Purpose and interpretation of Article. This Article establishes a State licensing program for wholesale distributors to enable wholesale distributors to comply with federal law. This Article shall be construed to do only that required for compliance with 21 U.S.C. 353(e) and 21 C.F.R. Part 205. This Article shall be interpreted to be consistent with […]
106-145.10. Application of other laws. A wholesale drug distributor shall comply with applicable federal, State, and local laws and regulations. A wholesale distributor that deals in controlled substances shall register with the federal Drug Enforcement Administration (DEA) and shall comply with all applicable federal, State, and local laws and regulations. A wholesale drug distributor is […]
106-145.12. Enforcement and implementation of Article. The Commissioner shall enforce this Article by using employees of the Department. The Commissioner may enter into agreements with federal, State, or local agencies to facilitate enforcement of this Article. The Commissioner may adopt rules to implement this Article. (1991, c. 699, s. 2.)
106-145.2. Definitions. The following definitions apply in this Article: (1) Blood. – Whole blood collected from a single donor and processed either for transfusion or further manufacturing. (2) Blood component. – That part of blood separated by physical or mechanical means. (3) Commissioner. – The Commissioner of Agriculture. (4) Common control. – The power to […]
106-145.3. Wholesale distributor must have license. (a) Requirement. – Every wholesale distributor engaged in the wholesale distribution of prescription drugs in interstate commerce in this State shall obtain a license from the Commissioner for each location from which prescription drugs are distributed and shall renew each license annually. A license may cover multiple buildings and […]
106-145.4. Application and fee for license. (a) Application. – An application for a wholesale distributor license or for renewal of a wholesale distributor license shall be on a form prescribed by the Commissioner and shall include the following information: (1) The name, full business address, and telephone number of the applicant. (2) All trade or […]
106-145.5. Review of application and qualifications of applicant. The Commissioner shall determine whether to issue or deny a wholesale distributor license within 90 days after an applicant files an application for a license with the Commissioner. The Commissioner shall have authority to review an application and issue or deny a license, grant reciprocity under G.S. […]
106-145.6. Denial, revocation, and suspension of license; penalties for violations. (a) Adverse Action. – The Commissioner may deny a license to an applicant if the Commissioner determines that granting the applicant a license would not be in the public interest. Public interest considerations shall be limited to factors and qualifications that are directly related to […]
106-145.7. Storage, handling, and records of prescription drugs. (a) Facilities. – All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed for wholesale distribution shall meet the following requirements: (1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations. (2) Have storage areas designed to provide […]
106-145.8. Records of prescription drugs. (a) Records. – A wholesale distributor shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs, including all stored prescription drugs, all incoming and outgoing prescription drugs, and all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs. A wholesale […]
106-145.9. Written procedures concerning prescription drugs and lists of responsible persons. (a) Procedures. – A wholesale distributor shall establish, maintain, and adhere to written procedures for the receipt, security, storage, inventory, and distribution of prescription drugs. These shall include all of the following: (1) A procedure for identifying, recording, and reporting a loss or theft […]
