North Dakota Administrative Code

This chapter is applicable to all hospital pharmacies as defined by section 61-07-01-01. History: Effective April 1, 1988. General Authority: NDCC 28-32-02 Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)

All hospital pharmacies shall register annually with the board of pharmacy; certificates of registration may be issued only to those hospital pharmacies which satisfy the provisions of all rules of the board and laws of North Dakota. History: Effective April 1, 1988. General Auth…

1. Director. Each hospital pharmacy must be directed by a pharmacist-in-charge, hereinafter referred to as the director of pharmacy, who is licensed to engage in the practice of pharmacy in this state, and who is knowledgeable in and thoroughly familiar with the specialized funct…

1. General. During such times as a hospital pharmacy may be unattended by a pharmacist, arrangements must be made in advance by the director for the provision of drugs to the medical staff and other authorized personnel of the hospital, by use of night cabinets or floor stock, or…

1. Area. A hospital pharmacy shall have within the hospital it services, sufficient floor space allocated to it to ensure that drugs are prepared in sanitary, well-lighted, and enclosed places, and which meet the other requirements of this section. 2. Equipment and materials. Eac…

1. General. The director of pharmacy services shall establish written procedures for the safe and efficient distribution of pharmaceutical products. An annual updated copy of such procedures must be on hand for inspections. 2. Responsibility. The director is responsible for the s…

These functions include, but are not limited to, chart review; audits; clinical tasks; committee participation; drug information; inservice training of the pharmacists, the pharmacy staff, and other health professionals; poison control; nursing unit inspections; preparation of me…

1. General. Drugs may be administered at a hospital only upon the orders of those members of the medical staff who have been granted clinical privileges or who are authorized members of the house staff and, by authorized licensed hospital personnel in accordance with policies and…

1. Outside pharmacies. Whenever drugs or pharmaceutical services are obtained from outside of a hospital, arrangements must be made to ensure that such outside pharmacist provides services with sufficient professionalism, quality, and availability to adequately protect the safety…

The director of pharmacy services is responsible for developing procedures for an ongoing quality assurance program of pharmaceutical services that includes a mechanism for reviewing and evaluating drug-related patient care, as well as an appropriate response to findings. This wr…

Investigational drugs must be properly labeled and may be administered only under the personal and direct supervision of the principal physician-investigator or physician-investigator's authorized clinician with prior approval of the appropriate committees of the hospital. Nurses…

1. Monthly. The director of pharmacy shall inspect, no less than once a month, personally or by qualified designee, all matters within the director's jurisdiction and responsibility and make appropriate written records and notations of such inspections. Such inspections shall ver…

1. A hospital pharmacy must have a pharmacist review all medication order prior to the first dose being administered to the patient. Policies and procedures must be put into place to ensure compliance. 2. Either a pharmacist onsite or the use of hospital telepharmacy services wil…

Any pharmacy operating outside the state which ships, mails, or delivers in any manner a dispensed prescription drug or legend drug into North Dakota shall obtain and hold a pharmacy permit issued by the North Dakota state board of pharmacy and that part of the pharmacy operation…

Pharmacy permit application forms must be available from the board and submitted for approval. Pharmacy permits must be renewed annually by July first. History: Effective April 1, 1988. General Authority: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14), 43-15-34, 43-15-35, 43-15-36, 43-…

The out-of-state pharmacy annual permit fee must be set by the board not to exceed three hundred dollars. History: Effective April 1, 1988. General Authority: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14), 43-15-34, 43-15-35, 43-15-36, 43-15-38 1 Law Implemented: NDCC 28-32-02, 43-15-…

An out-of-state pharmacy doing business in North Dakota by dispensing and delivering prescription drugs to North Dakota consumers shall maintain a document that it has a pharmacy permit in good standing in its respective home jurisdiction. History: Effective April 1, 1988; amende…

North Dakota pharmacy laws and rules shall be applicable to control interjurisdictional prescription commerce and to govern the practice of pharmacy for that portion of the pharmacy practice or operation. History: Effective April 1, 1988; amended effective January 1, 2005. Genera…

The pharmacist in charge and pharmacy owner, or partners, or corporate officer and owners where applicable, appearing on the permit or the permittee will be responsible for complete compliance with the North Dakota laws or rules insofar as the standards of practice for the pharma…

The pharmacist in charge appearing on the permit shall submit an affidavit with the initial permit application and renewal applications annually which affirm that the pharmacist understands North Dakota pharmacy laws and rules and that the pharmacy is in complete compliance with …

North Dakota pharmacy inspectors may conduct onsite periodic routine inspections during reasonable business hours of out-of-state pharmacies registered to do business in North Dakota. Alternatively, the North Dakota board of pharmacy may contract with the respective out-of-state …

Prescription records documenting prescriptions dispensed and distributed to North Dakota consumers must be readily retrievable and available for board review upon request. History: Effective April 1, 1988; amended effective October 1, 2019. General Authority: NDCC 28-32-02, 43-15…

Out-of-state pharmacies shall provide accessible telephone counseling service for patients' drug inquiries with a licensed pharmacist during regular working hours. Available telephone counseling service must be provided that is consistent with the standard of due care. The pharma…

An out-of-state pharmacy shall comply with the patient profile record system requirements of North Dakota Century Code section 43-15-31.1 and the prescription drug information requirements of North Dakota Century Code section 43-15-31.2 for that part of the pharmacy operation dis…

Out-of-state pharmacies soliciting, receiving, and dispensing prescription orders delivered to North Dakota ultimate residents constitutes doing business in the state. History: Effective April 1, 1988. General Authority: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14), 43-15-34, 43-15-3…

The out-of-state pharmacies doing business in North Dakota by dispensing and delivering prescription orders to North Dakota consumers shall designate a resident agent and a registered office in North Dakota for the service of process. History: Effective April 1, 1988. General Aut…

Each ambulance service shall adopt a written prescription drug safeguard policy which, as a condition precedent to obtaining prescription drugs for ambulance service purposes, at a minimum, must include the following requirements: 1. All prescription drugs must be obtained from a…

The pharmacist-in-charge of the licensed pharmacy or the pharmacist supplying prescription drugs to an ambulance service, prior to supplying said drugs, shall review the written prescription drug safeguard policy of the ambulance service to determine that all of section 61-09-01-…

Each home health care agency, hospital, health system, or pharmacy serving at-home patients shall adopt a written prescription drug safeguard policy and procedures which, as a condition precedent to obtaining prescription drugs for nursing supply kits, at a minimum, must include …

The pharmacist-in-charge of the licensed pharmacy or the pharmacist supplying prescription drugs to a nurse or nursing agency, prior to supplying said drugs, shall review the written prescription drug safeguard policy and procedures of the nurse or nursing agency to determine tha…

This article applies to any person, partnership, corporation, or business firm engaging in the wholesale distribution of any prescription drugs in the state of North Dakota. History: Effective June 1, 1992. General Authority: NDCC 43-15.1-07 Law Implemented: NDCC 43-15.1

The purpose of this article is to implement the Prescription Drug Marketing Act of 1987 by providing minimum standards, terms, and conditions for the licensing by the North Dakota state board of pharmacy of persons who engage in wholesale distribution in the state of North Dakota…

As used in this article: 1. "Article" or "this article" means all of the terms and provisions contained in article 61-10, including sections 61-10-01-01 through 61-10-01-09, inclusive, and any amendments or additions to said article or any of said sections. 2. "Board of pharmacy"…

Every wholesale drug distributor whether located in this state or any other state or foreign territory who engages in wholesale drug distribution of any prescription drugs in the state of North Dakota must be licensed by the board of pharmacy in accordance with this article and N…

1. Each wholesale drug distributor shall provide to the board of pharmacy the following minimum information as part of the application for the license described in this article or North Dakota Century Code chapter 43-15.1 and as part of any application for renewal of such license…

1. The board of pharmacy shall consider, at a minimum, the following factors in reviewing the qualifications for licensure of persons who engage in wholesale distribution of prescription drugs within the state of North Dakota: a. Any convictions of the applicant under any federal…

As a condition for receiving and retaining a wholesale drug distributor license, the licensee shall require each person employed in any prescription drug wholesale distribution activity to have education, training, and experience, or any combination thereof, sufficient for that p…

1. The board of pharmacy has the authority to restrict or suspend any licenses granted under this article or pursuant to North Dakota Century Code chapter 43-15.1 upon conviction of any violation of federal, state, or local drug laws or regulations which constitutes a clear and p…

for the establishment and maintenance of prescription drug distribution records. The following constitutes minimum requirements for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records by wholesale dru…

The following fees must be paid to the board of pharmacy: 1. North Dakota examination $100.00 2. Original or duplicate certificate 25.00 3. Reciprocal licensure 150.00 4. a. Internship licensure - North Dakota State University professional student 100.00 ($90 is paid to the North…

For purposes of this chapter: 1. "Board" means the North Dakota board of pharmacy. 2. "Central repository" means a place where electronic data related to the prescribing and dispensing of controlled substances is collected. 3. "Controlled substance" means a drug, substance, or im…

1. Each dispenser licensed by a regulatory agency in the state of North Dakota who dispenses a controlled substance to a patient shall submit to the central repository by electronic means information regarding each prescription dispensed for a controlled substance. The informatio…

1. The board may charge a fee to an individual who requests the individual's own information from the central repository. 2. The board may charge a fee to a person who requests statistical, aggregate, or other de-identified information. 3. The board may allow access to controlled…

1. Each dispenser licensed by a regulatory agency in the state of North Dakota who dispenses a controlled substance to a patient shall, at a minimum, request and review a prescription drug monitoring report covering at least a one-year time period or another state's report, or bo…

The purpose of this chapter is to schedule substances which have an actual or relative potential for abuse and which bear risk to the public health by unknown individuals using them by inhaling the smoke or vapors or by ingesting or injecting the substances. History: Effective Fe…

The definitions under this rule have the meaning as set forth in North Dakota Century Code chapters 19-03.1 and 43-15. History: Effective February 26, 2010. General Authority: NDCC 19-03.1-02, 19-03.1-05 Law Implemented: NDCC 19-03.1-02

Substances on the drug enforcement administration's published exempt prescription product list are not considered controlled substances. Substances may be added to this section upon a rule change process in accordance with North Dakota Century Code section 19-03.1-02. History: Ef…

1. History. The state examining committee for physical therapists was created in 1959 to assist the state board of medical examiners in the examination and registration of physical therapists in North Dakota. While it operated as a separate committee, it was by law an advisory co…

Unless specifically stated otherwise, the following definitions are applicable throughout this title: 1. "A school of physical therapy or a program of physical therapist assistant training" is a nationally accredited program approved by the board. 2. "Board" means the North Dakot…

Computer-based examinations are available by appointment at designated sites in North Dakota. Other testing sites are available in the United States, United States territories, and Canada. History: Effective December 1, 1980; amended effective July 1, 2004; January 1, 2016. Gener…