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

43-15.3-04. Requirements to distribute prescription drugs, medical gases, or medical

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.