36-11A-1. Definitions. Terms used in this chapter mean: (1)Repealed by SL 2017, ch 174, §1; (2)”Board,” the Board of Pharmacy; (3)”Chain pharmacy warehouse,” a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales or transfers of such drugs to a group of chain pharmacies that have the same common […]
36-11A-1.1. Trading partner defined. As used in this chapter, the term, trading partner, means: (1)A manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or (2)A third-party […]
36-11A-1.2. Transaction defined. As used in this chapter, the term, transaction, means the transfer of product between trading partners in which a change of ownership occurs. The term does not include: (1)Intracompany distribution of any product between members of an affiliate or within a manufacturer; (2)The distribution of a product among hospitals or other health […]
36-11A-1.3. Transaction information defined. As used in this chapter, the term, transaction information, means the proprietary or established name or names of the product, the strength and dosage form of the product, the national drug code number of the product, the container size, the number of containers, the lot number of the product, the transaction […]
36-11A-1.4. Transaction statement defined. As used in this chapter, the term, transaction statement, means a statement, in paper or electronic form, that the entity transferring ownership in a transaction: (1)Is authorized under federal law; (2)Received the product from a person who is authorized as required under federal law; (3)Received the transaction information and transaction statement […]
36-11A-10. Temporary licenses. The board may grant temporary licensure when a wholesale drug distributor first applies for a license to operate within this state. Temporary licenses remain valid until the board approves or denies the license or for ninety days, whichever occurs first. Source: SL 1991, ch 307, §10.
36-11A-11. Out-of-state distributor–License–Application–Violation as felony. No out-of-state wholesale drug distributor may conduct business in this state without first obtaining a license from the board and paying the license fee set by the board. Application for an out-of-state wholesale drug distributor license under this section shall be made on a form provided by the board. Each […]
36-11A-12. Approval or denial of application or renewal–Appeal. The board may approve, approve with conditions, or deny the application for licensure or renewal of licensure as a wholesale distributor based on information concerning the qualifications of the applicant provided in the application. No license to engage in wholesale drug distribution may be issued or renewed […]
36-11A-13. Expiration and renewal of license. Each wholesale drug distributor license expires on December thirty-first following the date of issue. The board shall provide an application for license renewal to each licensee before December first of each year. If application for renewal of the license accompanied by the annual license fee is not made before […]
36-11A-14. Promulgation of rules. The board shall promulgate rules, pursuant to chapter 1-26, pertaining to: (1)Application procedures and information required for initial application and for renewal of license; (2)Treatment of confidential materials; (3)Qualification of applicants; (4)Temporary licensure; (5)Licensure by reciprocity; (6)Annual license fee; (7)Requirements for storing and handling prescription drugs; (8)Record keeping; (9)Liability insurance; (10)Security […]
36-11A-16. Inspection–Exemption–Penalty. For the purpose of conducting an inspection, persons authorized by the board and showing identification may enter during normal business hours all premises in this state purporting or appearing to be used by a drug distributor. No person may deny the right of entry as provided in this section to an authorized person. […]
36-11A-17. Records–Availability. A licensee may keep records at a central location apart from the principal office of the wholesale drug distributor or the location at which the drugs were stored and from which the drugs were shipped if the records are made available for inspection within two working days after a request by the board. […]
36-11A-18. Limitations on state board of pharmacy. The board may not require the employment of licensed pharmacists by wholesale distributor licensees unless otherwise required by law, nor may the board regulate prices or the terms and conditions of sale of prescription drugs unless otherwise specified in this chapter. Source: SL 1991, ch 307, §18.
36-11A-19. Complaints–Procedure. Complaints arising from any provision of this chapter shall be handled in compliance with contested case procedure in chapter 1-26, and the board may suspend, revoke, or condition the license of the licensee if the facts warrant. Source: SL 1991, ch 307, §19.
36-11A-2. Distribution defined. As used in this chapter, the term, distribution, means the sale, purchase, trade, delivery, handling, storage, or receipt of a product. The term does not include: (1)Intracompany sales between any division, subsidiary, parent or otherwise affiliated or related company under the common ownership and control of a corporate entity; (2)The purchase or […]
36-11A-20. Authorized distributor of record defined. For the purposes of this chapter, an authorized distributor of record is a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer’s prescription drug. An ongoing relationship is deemed to exist between such wholesale distributor and a manufacturer when the wholesale distributor, including […]
36-11A-21. Drop shipment defined. For the purposes of §§36-11A-20 to 36-11A-46, inclusive, drop shipment is the sale of a prescription drug to a wholesale distributor by the manufacturer of the prescription drug, or that manufacturer’s co-licensed product partner, that manufacturer’s third party logistics provider, or that manufacturer’s exclusive distributor, whereby the wholesale distributor or chain […]
36-11A-22. Manufacturer’s exclusive distributor defined. For the purposes of §§36-11A-20 to 36-11A-46, inclusive, a manufacturer’s exclusive distributor is any person who contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer and who takes title to that manufacturer’s prescription drug, but who does not have general responsibility […]
36-11A-23. Normal distribution channel defined. For the purposes of §§36-11A-20 to 36-11A-46, inclusive, a normal distribution channel is a chain of custody for a prescription drug that goes from a manufacturer of the prescription drug, or from that manufacturer to that manufacturer’s co-licensed partner, or from that manufacturer to that manufacturer’s third-party logistics provider, or […]
36-11A-24. Third party logistics provider defined. For the purposes of §§36-11A-20 to 36-11A-46, inclusive, a third party logistics provider is any person who contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer, but does not take title to the prescription drug or have general […]
