North Dakota Administrative Code

Controlled drugs and noncontrolled drugs dispensed pursuant to a prescription must bear a label, permanently affixed to the immediate container in which the drug is dispensed or delivered and which is received by the purchaser or patient, which must include the following: 1. The …

The patient hard copy prescription form for noncontrolled drugs must contain the following: 1. The name and address of the patient; 2. The date of issuance; 3. The name of the drug; 4. The quantity; 5. The strength; 6. Adequate directions for use; 7. The prescriber's name, either…

The patient hard copy prescription form for controlled drugs must contain the following: 1. The name address of the patient; 2. The date of issuance; 3. The name of the drug; 4. The quantity; 5. The strength; 6. Adequate directions for use; 7. The prescriber's name, either printe…

North Dakota pharmacies and pharmacists shall provide pharmaceutical care so that the patient has the following rights: 1. To professional care provided in a competent and timely manner in accordance with accepted standards of pharmacy practice. 2. To be treated with dignity, con…

A warning notice to the pharmacist, pharmacy permittee, licensee, or registrant protects public health by allowing them to expeditiously correct violations of laws and rules and report these corrections to the board of pharmacy in writing. History: Effective October 1, 1999. Gene…

A warning notice may be issued to any permittee, licensee, or registrant found to be violating the provisions of this title, North Dakota Century Code chapter 43-15 or 43-19, or any federal, state, or local laws and rules. History: Effective October 1, 1999. General Authority: ND…

An agent of the North Dakota state board of pharmacy may issue a warning notice at the time a violation is found. History: Effective October 1, 1999. General Authority: NDCC 28-32-02, 43-15-10 Law Implemented: NDCC 28-32-02, 43-15-10

The warning notice may become an integral part of a file and be maintained in the file sixty months and discarded if no further action is pending. History: Effective October 1, 1999. General Authority: NDCC 28-32-02, 43-15-10 Law Implemented: NDCC 28-32-02, 43-15-10

Permittees, licensees, or registrants who fail to satisfactorily respond to a warning notice may be referred to the board for review or complaint and hearing by the executive director of the board. History: Effective October 1, 1999. General Authority: NDCC 28-32-02, 43-15-10 Law…

Any permittee, licensee, or registrant receiving two or more warning notices within a twenty-four month period may be referred to the board for review or complaint and hearing. History: Effective October 1, 1999. General Authority: NDCC 28-32-02, 43-15-10 Law Implemented: NDCC 28…

For purposes of this chapter: 1. "CLIA" means the federal Clinical Laboratory Improvement Act of 1988, as amended. 2. "OSHA" means the federal occupational safety and health administration. History: Effective December 1, 1999; amended effective April 1, 2016; January 1, 2024. Gen…

CLIA waived laboratory tests. A pharmacist and each pharmacy technician delegated must meet the following requirements in order to perform CLIA waived laboratory tests authorized by North Dakota Century Code section 43-15-25.3 or added to the list as allowed by section 61-04-10-0…

Pharmacists performing CLIA waived laboratory tests must meet the following standards: 1. Develop and maintain a policy and procedure manual that includes the following areas: a. Quality control; b. Infection control; 1 c. Hazardous waste disposal; d. Recordkeeping; and e. Test r…

The pharmacist-in-charge of a licensed pharmacy performing tests or any pharmacist operating in a facility not licensed by the board is responsible for ensuring that the location has a current CLIA waived certificate. History: Effective December 1, 1999; amended effective April 1…

Repealed effective January 1, 2024.

An individual licensed or registered by the board, performing the following food and drug administration-waived tests and using the following methods, is exempt from the provisions of North Dakota Century Code chapter 43-48: 1. Total cholesterol, HDL cholesterol, LDL cholesterol,…

Under the responsibility of the pharmacist-in-charge or pharmacist, a registered pharmacy technician may assist in performing CLIA waived laboratory tests. The registered pharmacy technician must have met the education requirements in section 61-04-10-02. The responsible pharmaci…

For purposes of this chapter: 1. "Authorized pharmacist" means a pharmacist who has successfully completed an appropriate study or training pertaining to the administration of drugs and maintains continuing competency according to the standard of care. 2. "Authority" means design…

A pharmacist must attest to possessing the following qualifications in order to obtain authority from the board: 1. Obtain and maintain a license to practice pharmacy issued by the North Dakota state board of pharmacy; 2. Successfully complete the educational requirements set for…

Repealed effective April 1, 2020.

The order must be written, received electronically or if received orally be reduced to writing, and must contain at a minimum the: 1. Identity of the practitioner issuing the order; 2. Identity of the patient to receive the injection; 3. Identity of the medication or vaccine, and…

A practitioner may prepare a written protocol governing the administration of medications with an authorized pharmacist for a specific period of time or purpose. The written protocol may be valid for a time period not to exceed two years, subject to earlier withdrawal by the prac…

A pharmacist administering shall meet the following recordkeeping and notification requirements: 2 1. Notification of administration must be made to the ordering physician or nurse practitioner and other authorities as required by law and rule. Notification may be through inclusi…

Pharmacists may administer medications at any location within North Dakota or may be limited to those specifically identified in a written protocol. The location must: 1. Ensure privacy; 2. Be maintained to promote an aseptic environment; 3. Have adequate telecommunications devic…

The pharmacy shall maintain a policy and procedural manual, with a section related to the administration of medications, in compliance with section 61-02-01-18. 3 History: Effective May 1, 2002; amended effective October 1, 2014; April 1, 2020. General Authority: NDCC 43-15-10 La…

An authorized pharmacist may delegate the administration of a subcutaneous or intramuscular injectable medication to a qualified pharmacy technician given the following: 1. The medication administration has been delegated by the authorized pharmacist; 2. The authorized pharmacist…

For purposes of this chapter: 1. "Opioid-related drug overdose" means a condition including extreme physical illness, decreased level of consciousness, respiratory depression, coma, or death resulting from the consumption or use of an opioid or another substance with which an opi…

1. Protocol. a. Pharmacists are authorized to furnish opioid antagonist drug therapy solely in accordance with the written protocol for opioid antagonist drug therapy approved by the board. b. Any pharmacist exercising prescriptive authority for opioid antagonist drug therapy sha…

Each prescription dispensed by a pharmacy serving patients in the state and each out-of-state pharmacy providing prescriptions by mail to patients in the state must provide the following in regard to consultation: 1. Provide consultation by a pharmacist or intern on each new pres…

For purposes of this chapter: 1. "ACIP" means the centers for disease control and prevention's advisory committee on immunization practices. 2. "Authorized pharmacist" means a pharmacist who has successfully completed an appropriate study or training pertaining to the administrat…

1. Authorized immunizations. The immunizations authorized to be ordered and administered pursuant to a statewide protocol to patients ages three or older must include an immunization recommended by ACIP in its approved vaccination schedule, any other emergency immunization in res…

For purposes of this chapter: 1. "Authorized pharmacist" means a pharmacist who has successfully completed an appropriate study or training to meet the requirements in this rule. 2. "Statewide protocol" refers to protocols developed by the board for the purpose of an authorized p…

1. Statewide protocol. a. Prescriptive authority for tobacco cessation therapy must be exercised solely in accordance with the statewide protocol approved by the board. b. An authorized pharmacist exercising prescriptive authority shall maintain and have readily available a curre…

It is unlawful to receive, possess, or transfer radioactive drugs, except in accordance with North Dakota Century Code chapter 43-15, this article, and the North Dakota radiological health rules in article 33.1-10. It is also unlawful for any person to provide radiopharmaceutical…

1. "Authentication of product history" includes identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical. 2. "Internal test assessment" includes conducting those tests of a quality assurance necessary to ensure …

services. 1. A nuclear pharmacy providing radiopharmaceutical services shall only be managed by a qualified nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radioactive drugs shall be under the direct supervision of the nuclear pharmacist.…

providing radiopharmaceutical services. A qualified nuclear pharmacist shall: 1. Meet minimal standards of training for medical uses of radioactive material. 3 2. Hold a current, active license to practice pharmacy in this state. 3. Have completed a minimum of seven hundred conta…

Each nuclear pharmacy providing radiopharmaceutical services shall have current editions or revisions of: 1. United States Pharmacopoeia National Formulary, with supplements. 2. Current issues of the Journal of Nuclear Medicine or online access. 3. State laws and regulations rela…

Each pharmacy providing radiopharmaceutical services shall have the following equipment: 1. Area radiation monitor which is stationary and away from other activity. 2. Dose calibrator and well counter. 3. Portable survey meter, capable of measuring up to two thousand mR/hr for de…

For the purpose of this chapter, the following definitions apply: 1. Pharmacy providing home health care pharmacy services. A pharmacy providing home health care pharmacy services is a licensed pharmacy that routinely prepares and dispenses compounded, sterile parenteral products…

All pharmacies providing home health care pharmacy services shall have a current pharmacy permit as provided by North Dakota law and rules of the board. They shall comply with all pharmacy laws and rules as well as the following special rules. The requirements of this chapter are…

1. Pharmacist-in-charge. In addition to the pharmacist-in-charge requirements of section 61-02-01-10, that section of the pharmacy providing home health care pharmacy services must be managed by a pharmacist licensed to practice pharmacy in the state and who is knowledgeable in t…

The physical requirements are as follows: 1. Space. The pharmacy providing home health care pharmacy services shall have a designated area for preparing compounded, sterile parenteral products. This area must be physically separate from other areas and should be designed to avoid…

1. General. A drug distribution system is the entirety of that mechanism by which a physician's prescription is executed, from the time the drug is ordered and received in the pharmacy, to the time the prescribed drug is dispensed to the patient. 2. Purchasing. All drugs and phar…

The following additional requirements are necessary for those pharmacies providing home health care pharmacy services that routinely prepare chemotherapy agents to ensure the protection of the personnel involved: 4 1. All chemotherapy agents should be compounded in a vertical flo…

1. Primary provider. There must be a designated physician primarily responsible for the patient's medical care. There must be a clear understanding between the physician, the patient, and the pharmacist of the responsibilities of each in the areas of the delivery of care, the mon…

There must a documented, ongoing quality control program that monitors personnel performance, equipment, and facilities. The end product must be examined on a sampling basis as determined by the pharmacist-in-charge to assure that it meets required specifications. 5 1. Hood certi…