1.    A person may not engage in wholesale distributions of prescription drugs without obtaining and maintaining accreditation or certification from the national association of boards of pharmacy’s verified accredited wholesale distributor or an accreditation body approved by the board under subsection 4, obtaining and maintaining a license issued by the board, and paying any reasonable fee required by the board.

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Terms Used In North Dakota Code 43-15.3-04

  • Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
  • Person: means an individual, organization, government, political subdivision, or government agency or instrumentality. See North Dakota Code 1-01-49
  • State: when applied to the different parts of the United States, includes the District of Columbia and the territories. See North Dakota Code 1-01-49
  • United States: includes the District of Columbia and the territories. See North Dakota Code 1-01-49
  • Verified: means sworn to before an officer authorized to administer oaths. See North Dakota Code 1-01-42

2.    The board may not issue or renew the license of a wholesale distributor that does not comply with this chapter. The board shall require a separate license for each facility or    location where wholesale distribution operations are conducted. An agent or employee of any licensed wholesale distributor does not need a license and may lawfully possess pharmaceutical drugs, medical gases, or medical equipment when acting in the usual course of business or employment. The issuance of a license under this chapter does not affect tax liability imposed by the tax department on any wholesale distributor.

3.    An out-of-state wholesale distributor or pharmacy distributor or a principal or agent of the distributor may not conduct business in this state unless the distributor has obtained the necessary license from the board, paid the fee required by the board, and registered with the secretary of state. Application for a license must be made on a form furnished by the board and when submitted by the applicant to the board must include a copy of the certificate of authority from the secretary of state. The issuance of a license under this section does not affect tax liability imposed by the tax department on any out-of-state wholesale distributor or pharmacy distributor. The board may adopt rules that permit out-of-state wholesale distributors to obtain a license on the basis of reciprocity if an out-of-state wholesale distributor possesses a valid license granted by another state and the legal standards for licensure in the other state are comparable to the standards under this chapter and the other state extends reciprocity to wholesale drug distributors licensed in this state. However, if the requirements for licensure under this chapter are more restrictive than the standards of the other state, the out-of-state wholesale distributor shall comply with the additional requirements of this chapter to obtain a license under this chapter.

4.    The board may adopt rules to approve an accreditation body to evaluate a wholesale distributor’s operations to determine compliance with professional standards, this chapter, and any other applicable law, and perform inspections of each facility and location where wholesale distribution operations are conducted by the wholesale distributor.

5.    The board or a designee of the board may conduct inspections during normal business hours upon all open premises purporting or appearing to be used by a wholesale distributor or pharmacy distributor in this state. A distributor that provides adequate documentation of the most recent satisfactory inspection less than three years old by the United States food and drug administration is exempt from further inspection for a period of time determined by the board. This exemption does not bar the board from initiating an investigation pursuant to a complaint regarding a wholesale distributor or pharmacy distributor. A wholesale distributor or pharmacy distributor may keep records at a central location apart from the principal office of the wholesale distributor or pharmacy distributor or the location at which the drugs are stored and from which they were shipped, provided that the records are made available for inspection within three business days of a request by the board. The records may be kept in any form permissible under federal law applicable to prescription recordkeeping.