Title 36, PROFESSIONS AND OCCUPATIONS

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 feder…

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 ,…

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 …

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 distrib…

Each wholesale drug distributor license expires on December thirty-first following the date of issuance. The board shall provide an application for license renewal to each licensee before December first of each year. To renew a license, the licensee shall submit the renewal appli…

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; (…

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…

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 …

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…

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.

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 …

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 …

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 provi…

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 manufact…

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 manufa…

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…

For the purposes of §§ 36-11A-20 to 36-11A-46 , inclusive, a wholesale distributor is any person other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider or repackager, engaged in wholesale distribution. Source: SL 2007, ch 215 , § 7; SL 2…

Any wholesale distributor who engages in the wholesale distribution of prescription drugs in this state must be licensed by the board, in accordance with §§ 36-11A-20 to 36-11A-46 , inclusive, before engaging in wholesale distributions of wholesale prescription drugs. The board s…

The board shall require the following minimum information from each wholesale distributor applying to obtain a license under § 36-11A-27 : (1) The name, full business address, and telephone number of the licensee; (2) Any trade or business name used by the licensee; (3) The addre…

The board may not issue a wholesale distributor license to an applicant, unless the board or a nationally recognized accreditation program approved by the board: (1) Conducts a physical inspection of the facility at the address provided by the applicant as required in subdivision…

The board may require the applicant to submit the fingerprints provided by a person with a license application for a statewide criminal record check and for forwarding to the Federal Bureau of Investigation for a national criminal record check of the person. Source: SL 2007, ch 2…

The board shall require every wholesale distributor applying for a license to submit a bond of at least one hundred thousand dollars, or other equivalent means of security acceptable to the board, such as an irrevocable letter of credit or a deposit in a trust account or financia…

In accordance with each licensure renewal, the board shall send to each wholesale distributor licensed under § 36-11A-27 a form setting forth the information that the wholesale distributor provided pursuant to § 36-11A-28 . Within thirty days of receiving such form, the wholesale…

The designated representative identified pursuant to subdivision 36-11A-28(7) shall receive and complete continuing training in applicable federal and state laws governing wholesale distribution of prescription drugs. The information provided under § 36-11A-28 may not be disclose…

A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy or chain pharmacy warehouse pursuant to the terms and conditions of the agreement between the wholesale distributor and the pharmacy or chain pharmacy warehouse. Returns of expired, damag…

A manufacturer or wholesale distributor shall furnish prescription drugs only to a person or entity licensed by the appropriate board. Before furnishing prescription drugs to a person or entity not known to the manufacturer or wholesale distributor, the manufacturer or wholesale …

Prescription drugs furnished by a licensee shall be delivered only to the premises listed on the license. However, the licensee may furnish prescription drugs to an authorized person or agent of that person at the premises of the manufacturer or wholesale distributor if: (1) The …

Prescription drugs may be furnished to a hospital pharmacy receiving area provided that a pharmacist or authorized receiving personnel signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug so received. Any discrepancy between receipt and…

A manufacturer or wholesale distributor may not accept payment for, or allow the use of, a person or entity's credit to establish an account for the purchase of prescription drugs from any person other than the owner of record, the chief executive officer, or the chief financial …

A pharmacy distributor is any pharmacy or hospital pharmacy that is engaged in the delivery or distribution of prescription drugs either to another pharmacy or to another person or entity, including to a wholesale drug distributor that is engaged in the delivery or distribution o…

Each wholesale distributor and outsourcing facility located within or outside of the state that provides services to outlets within the state, shall be licensed annually by the board. Each third-party logistics provider located in this state shall be licensed by the board. Source…

Each trading partner who is engaged in the wholesale distribution of a prescription drug including repackagers, but excluding a third-party logistics provider and the original manufacturer of the finished form of the prescription drug, who is provided transaction information, tra…

Each file shall be: (1) Maintained by the purchaser and the licensee for six years from the date of the transaction; and (2) Available for inspection or use within two business days upon a request of an authorized officer of the law. Source: SL 2007, ch 215 , § 26; SL 2017, ch 17…

The board shall issue an order requiring the appropriate person including any distributor or retailer of the drug to immediately cease distribution of the drug within this state if the board finds that there is a reasonable probability that: (1) A wholesale distributor, other tha…

It is unlawful for a person to perform or cause the performance of or aid and abet any of the following acts in this state: (1) Failure to obtain a license in accordance with §§ 36-11A-20 to 36-11A-46 , inclusive, or operating without a valid license when a license is required by…

No person, other than a consumer or patient, may knowingly purchase or receive a prescription drug from any source other than a drug distributor or pharmacy licensed by the board under this chapter or chapter 36-11 , as applicable. Any person who violates this section is guilty o…

No person may sell, purchase, or trade a prescription drug sample or offer to sell, purchase, or trade a drug sample or a drug coupon. No person may counterfeit such a coupon. No person may distribute drug samples except as provided in § 503(d) of the Federal Food, Drug and Cosme…

No person or distribution outlet may engage in the wholesale distribution of prescription drugs in this state unless that person or outlet is licensed by the board as a drug distributor in accordance with the minimum standards, conditions and terms set forth in this chapter and i…

To apply for a wholesale or other drug distributor license, a person must submit an application on a form provided by the board and pay an annual license fee set by the board, not to exceed five hundred dollars. All financial statements or related information submitted by applica…

The board may require a separate license for each facility directly or indirectly owned or operated by the same business entity within this state or for a parent entity with divisions, subsidiaries, or affiliate companies within this state if operations are conducted at more than…