§ 43-15.3-04 — Requirements to distribute prescription drugs, medical gases, or medical equipment

North Dakota § 43-15.3-04

• Jurisdiction: North Dakota
• Title 43: Occupations and Professions
• Ch. 43-15.3: Wholesale Drug Pedigree

Text

equipment.
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.
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.