reglab/statecodes huggingface dataset:
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-07 - Pharmacy Patient's Bill of Rights › Section 61-04-07-01 - Pharmacy patient's bill of rights

Current through Supplement No. 393, July, 2024
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, consistent with professional standards, regardless of manner of
						payment, race, sex, age, nationality, religion, disability, or other
						discriminatory factors.
3. To
						pharmaceutical care decisions made in the patient's best interest in
						cooperation with the patient's physician.
4. To have the pharmacist serve as one of the
						patient's advocates for appropriate drug therapy and to make reasonable efforts
						to recommend alternative choices in cooperation with the patient's physician.
5. To have the patient's
						pharmaceutical records maintained in an accurate and confidential manner and
						used routinely to maximize the patient's pharmaceutical care.
6. To receive health care information and to
						review the patient's records upon request.
7. To receive patient counseling, using the
						methods appropriate to the patient's physical, psychosocial, and intellectual
						status.
8. To have the patient's
						prescriptions dispensed and pharmacy services provided at a pharmacy of the
						patient's choice in an atmosphere that allows for confidential communication.
9. To have the patient's drug
						therapy monitored for safety and efficacy and to make reasonable efforts to
						detect and prevent drug allergies, adverse reactions, or contraindications.
10. To monitor the patient's
						compliance and proper drug use and to institute remedial interventions when
						necessary.
11. To have the
						pharmacy patient's bill of rights posted in a prominent place within the
						pharmacy readily visible to the patient.
General Authority: NDCC 28-32-02, 43-15-10(12)(14)(18)
Law Implemented: NDCC
								28-32-03
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-08 - Limited Prescriptive Practices › Section 61-04-08-01

Current through Supplement No. 393, July, 2024
General Authority: NDCC 28-32-02, 43-15-10(9)(12)(14),
								43-15-31.4
Law Implemented: NDCC 28-32-02, 43-15-10(9)(12)(14),
								43-15-31.4
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-08 - Limited Prescriptive Practices › Section 61-04-08-02

Current through Supplement No. 393, July, 2024
General Authority:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
Law Implemented:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-08 - Limited Prescriptive Practices › Section 61-04-08-03

Current through Supplement No. 393, July, 2024
General Authority:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
Law Implemented:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-08 - Limited Prescriptive Practices › Section 61-04-08-04

Current through Supplement No. 393, July, 2024
General Authority:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
Law Implemented:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-08 - Limited Prescriptive Practices › Section 61-04-08-05

Current through Supplement No. 393, July, 2024
General Authority:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
Law Implemented:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-08 - Limited Prescriptive Practices › Section 61-04-08-06

Current through Supplement No. 393, July, 2024
General Authority:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
Law Implemented:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-08 - Limited Prescriptive Practices › Section 61-04-08-07

Current through Supplement No. 393, July, 2024
General Authority:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
Law Implemented:
NDCC
								28-32-02,
								43-15-10(9)(12)(14),
								43-15-31.4
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-08 - Limited Prescriptive Practices › Appendix - COLLABORATIVE AGREEMENT FORM

Current through Supplement No. 393, July, 2024
The pharmacists and practitioners listed below are parties to
							this collaborative agreement, through which the pharmacist receives limited
							prescriptive authority under the supervision of the practitioner in accordance
							with North Dakota Century Code section
							43-15-31.4 and administrative
							rules.
Click
							here to view image
.
[Please review the administrative rules governing
							collaborative agreements which accompany this form before proceeding.]
1. Describe the scope and authority to be exercised by the
							pharmacist. (If requesting authority to initiate drug therapy, pharmacist must
							include credential verification.)
2. Indicate any restrictions placed on the use of certain
							types or classes of drugs or drug therapies under this agreement. (Note:
							Schedule II drugs are excluded by these rules.)
3. If appropriate, indicate any diagnoses which are
							specifically included or excluded under this agreement.
4. Attach any protocols or guidelines to be used in
							decisionmaking or other activities contemplated under this agreement. This must
							include a protocol for treating acute allergic or other adverse reactions
							related to drug therapy.
5. Describe approved situations, if any, in which the
							notification time limit may be extended beyond twenty-four hours (not to exceed
							seventy-two hours). Attach additional sheets if necessary.
Click
							here to view image
.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-09 - Warning Notice › Section 61-04-09-01 - Purpose

Current through Supplement No. 393, July, 2024
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.
General Authority: NDCC 28-32-02, 43-15-10
Law Implemented: NDCC 28-32-02,
								43-15-10
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-09 - Warning Notice › Section 61-04-09-02 - Recipient

Current through Supplement No. 393, July, 2024
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.
General Authority: NDCC 28-32-02, 43-15-10
Law Implemented: NDCC 28-32-02,
								43-15-10
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-09 - Warning Notice › Section 61-04-09-03 - Issuance

Current through Supplement No. 393, July, 2024
An agent of the North Dakota state board of pharmacy may
							issue a warning notice at the time a violation is found.
General Authority: NDCC 28-32-02, 43-15-10
Law Implemented: NDCC 28-32-02,
								43-15-10
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-09 - Warning Notice › Section 61-04-09-04 - Filing

Current through Supplement No. 393, July, 2024
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.
General Authority: NDCC 28-32-02, 43-15-10
Law Implemented: NDCC 28-32-02,
								43-15-10
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-09 - Warning Notice › Section 61-04-09-05 - Failure to respond

Current through Supplement No. 393, July, 2024
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.
General Authority: NDCC 28-32-02, 43-15-10
Law Implemented: NDCC 28-32-02,
								43-15-10
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-09 - Warning Notice › Section 61-04-09-06 - Board review of two notices

Current through Supplement No. 393, July, 2024
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.
General Authority: NDCC 28-32-02, 43-15-10
Law Implemented: NDCC 28-32-02,
								43-15-10
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-10 - CLIA Waived Laboratory Tests › Section 61-04-10-01 - Definitions

Current through Supplement No. 393, July, 2024
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.
General Authority:
NDCC 43-15-10
Law Implemented:
NDCC 43-15-10(12)(14),
					 43-15-25.3
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-10 - CLIA Waived Laboratory Tests › Section 61-04-10-02 - Education requirements for pharmacists or pharmacy technicians to perform CLIA waived laboratory tests

Current through Supplement No. 393, July, 2024
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 61-04-10-06:
1.
				Successfully complete training and education that incorporates, at a minimum:
a. Infection control;
b. OSHA requirements;
c. Proper technique to collect laboratory
				specimens;
d. Recognized screening
				and monitoring values;
e. Quality
				control; and
f. The manufacturers'
				instructions for the waived tests being performed.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-10 - CLIA Waived Laboratory Tests › Section 61-04-10-03 - Minimum quality standards required

Current through Supplement No. 393, July, 2024
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;
c. Hazardous waste disposal;
d. Recordkeeping; and
e. Test result reporting.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-10 - CLIA Waived Laboratory Tests › Section 61-04-10-04 - Proper CLIA registration

Current through Supplement No. 393, July, 2024
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.
General Authority:
NDCC 43-15-10
Law Implemented:
NDCC 43-15-10(12)(14),
					 43-15-25.3
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-10 - CLIA Waived Laboratory Tests › Section 61-04-10-05

Current through Supplement No. 393, July, 2024
General Authority:
NDCC
								28-32-02,
								43-15-10
Law Implemented:
NDCC
								43-15-25.3
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-10 - CLIA Waived Laboratory Tests › Section 61-04-10-06 - Exempt tests and methods

Current through Supplement No. 393, July, 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, and triglycerides test by any accepted
				method.
2. Any of the following
				tests by nonautomated or automated urinalysis by dipstick:
a. Bilirubin.
b. Blood.
c. Glucose.
d. Ketone.
e. Leukocyte.
f. Nitrate.
g. Potential of hydrogen (pH).
h. Protein.
i. Specific gravity.
j. Urobilinogen.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-10 - CLIA Waived Laboratory Tests › Section 61-04-10-07 - Delegation to registered pharmacy technicians

Current through Supplement No. 393, July, 2024
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 pharmacist may
				  not delegate the interpretation of the result of a CLIA waived test or clinical
				  education of the patient to the registered pharmacy technician.
General Authority:
NDCC 43-15-10
Law Implemented:
NDCC 43-15-10(12)(14)(19),
					 43-15-25.3
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-11 - Administration of Medications and Immunizations › Section 61-04-11-01 - Definitions

Current through Supplement No. 393, July, 2024
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 designation on an active pharmacist license that a pharmacist
				is providing administrations and has attested the pharmacist is knowledgeable
				about and meet the requirements in North Dakota Century Code section 43-15-31.5
				and this chapter.
3. "Qualified
				pharmacy technician" means a registered pharmacy technician who has
				successfully completed an appropriate study or training pertaining to the
				administration of injections and maintains continuing competency.
4. "Written protocol" means a standing
				medical order between a duly licensed practitioner and an authorized pharmacist
				which contains information required by board rules.
General Authority:
NDCC 43-15-10
Law Implemented:
NDCC 43-15-10,
					 43-15-31.5
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-11 - Administration of Medications and Immunizations › Section 61-04-11-02 - Qualifications established to obtain authority

Current through Supplement No. 393, July, 2024
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 forth in North Dakota Century Code section 43-15-31.5
				according to the administrations that a pharmacist intends to perform. The
				educational requirements may be obtained through the pharmacist's accreditation
				council for pharmacy education accredited doctor of pharmacy program in which
				the pharmacist is or will complete. Educational requirements also may be
				obtained through training received after graduation and should be sufficient to
				ensure any intended administrations can be provided competently to meet the
				standard of care;
3. Obtain and
				maintain current certification in cardiopulmonary resuscitation or basic
				cardiac life support;
4. Complete
				an attestation process adopted by the board and, upon any request, provide
				required documentation; and
5.
				Maintain continuing competency to retain the authority according to the
				pharmacist's standard of care.
General Authority:
NDCC 43-15-10
Law Implemented:
NDCC 43-15-10,
					 43-15-31.5
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-11 - Administration of Medications and Immunizations › Section 61-04-11-03

Current through Supplement No. 393, July, 2024
General Authority: NDCC 43-15-10
Law Implemented: NDCC 43-15-10,
								43-15-31.5
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-11 - Administration of Medications and Immunizations › Section 61-04-11-04 - Requirements of practitioner order for a pharmacist to administer injections

Current through Supplement No. 393, July, 2024
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
				dose, to be administered; and
4.
				Date of the original order and the dates or schedule, if any, of each
				subsequent administration.
General Authority:
NDCC 43-15-10
Law Implemented:
NDCC 43-15-10,
					 43-15-31.5
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-11 - Administration of Medications and Immunizations › Section 61-04-11-05 - Requirements of written protocol

Current through Supplement No. 393, July, 2024
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 practitioner. The
				  protocol must contain the:
1. Identity
				of the participating practitioner and the pharmacist;
2. Identity of the drug which may be
				administered;
3. Identity of the
				patient or groups of patients to receive the authorized drug;
4. Identity of the authorized routes and
				sites of administration allowed;
5.
				Identity of the course of action the pharmacist shall follow in the case of
				reactions following administration;
6. Recordkeeping requirements and procedures
				for notification of administration.
General Authority:
NDCC 43-15-10
Law Implemented:
NDCC 43-15-10,
					 43-15-31.5
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-11 - Administration of Medications and Immunizations › Section 61-04-11-06 - Requirements of records and notifications

Current through Supplement No. 393, July, 2024
A pharmacist administering shall meet the following
				  recordkeeping and notification requirements:
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 inclusion of the record
				in the patient's medical record or by submission to the immunization
				information system.
a. When administration has
				occurred pursuant to an order, the pharmacist shall notify the ordering
				physician or nurse practitioner within forty-eight hours of the identity of the
				patient, identity of the medication or vaccine administered, route of
				administration site of the administration, dose administered, and date of
				administration and the disposition of any adverse events or reactions
				experienced by the patient.
b. When
				administration has occurred pursuant to a written protocol, the pharmacist
				shall notify the participating physician or nurse practitioner within fourteen
				days of the identity of the patient, identity of the medication or vaccine
				administered, site of the administration, dose administered, and date of
				administration and the disposition of any adverse events or reactions
				experienced by the patient.
c. In
				the case of immunizations and vaccinations, the pharmacist shall also provide
				notification to the physician or nurse practitioner of the manufacturer and lot
				number of the product administered.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-11 - Administration of Medications and Immunizations › Section 61-04-11-07 - Location of administration by injection

Current through Supplement No. 393, July, 2024
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 devices to summon aid and communicate
				emergency situations; and
4. Have
				adequate equipment and supplies to respond to adverse events and emergency
				situations.
General Authority:
NDCC 43-15-10
Law Implemented:
NDCC 43-15-10,
					 43-15-31.5
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-11 - Administration of Medications and Immunizations › Section 61-04-11-08 - Policy and procedural manual

Current through Supplement No. 393, July, 2024
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.
General Authority:
NDCC 43-15-10
Law Implemented:
NDCC 43-15-10,
					 43-15-31.5
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-11 - Administration of Medications and Immunizations › Section 61-04-11-09 - Qualified pharmacy technician administration of medications

Current through Supplement No. 393, July, 2024
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 is readily and immediately available to the qualified pharmacy
				technician either in-person or by way of an audio and video link;
3. The qualified technician has completed a
				practical training program that is approved by the board. This training program
				must include hands-on injection technique and the recognition and treatment of
				emergency reactions;
4. The
				qualified technician maintains a continuing competency on injections of
				medications which are expected to be performed;
5. The qualified technician has and maintains
				a current certification in cardiopulmonary resuscitation or basic cardiac life
				support; and
6. The authorized
				pharmacist maintains the responsibility for all administrations that are
				delegated to a qualified pharmacy technician. This involves recordkeeping,
				adverse event reporting, and ensuring the pharmacy technician remains
				qualified.
General Authority:
NDCC 43-15-10
Law Implemented:
NDCC 43-15-10,
					 43-15-31.5
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-12 - Limited Prescriptive Authority for Opioid Antagonists › Section 61-04-12-01 - Definitions

Current through Supplement No. 393, July, 2024
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 opioid was combined. This would
						include an overdose that requires medical assistance or a coroner, clinical
						suspicion for drug overdose (respiratory depression, unconsciousness, altered
						mental status), and either a urine toxicology screen positive for opiates or
						negative urine toxicology screen without other conditions to explain the
						clinical condition.
2. "Patient"
						means both an individual who is at risk of opioid overdose and a person who is
						not at risk of opioid overdose but who may be in a position to assist another
						individual during an overdose who has received patient information.
3. "Patient information" means the
						information provided to the patient on drug overdose prevention and
						recognition, opioid antidote dosage and administration, the importance of
						calling 911, care for the overdose victim after administration of the overdose
						antidote, and other issues as necessary.
General Authority:
NDCC
								28-32-02,
								43-15-10
Law Implemented:
NDCC
								23-01-42,
								43-15-10(23)
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-12 - Limited Prescriptive Authority for Opioid Antagonists › Section 61-04-12-02 - Pharmacists furnishing opioid antagonists

Current through Supplement No. 393, July, 2024
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 shall maintain a current copy of
				the written protocol for opioid antagonist drug therapy approved by the
				board.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-13 - PATIENT CONSULTATION REQUIREMENTS › Section 61-04-13-01 - Patient Consultation Requirements

Current through Supplement No. 393, July, 2024
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 prescription dispensed.
2. Provide consultation by a pharmacist or
						intern on each refill prescription dispensed. Pursuant to section 61-02-07.1-05, screening a patient for consultation on a refilled prescription
						may be completed by a registered technician.
3. Counseling can be provided to the patient
						or their agent.
4. For a refilled
						prescription, when the patient or the patient's agent is not available at the
						time of dispensing, the pharmacy must supply written or electronic materials
						and a toll-free phone number for the patient or the patient's agent to contact
						the pharmacist.
5. For a new
						prescription being dispensed by mail to a patient, an attempt to reach the
						patient or the patient's agent must be made for a consultation on the
						prescription; however, if the patient or the patient's agent is not available
						at the time of dispensing, the pharmacy must supply written or electronic
						materials and a toll-free phone number for the patient or the patient's agent
						to contact the pharmacist.
6. This
						section does not apply to prescriptions for patients exempted in North Dakota
						Century Code section 43-15-31.2.
7.
						Failure to provide proper consultation under this section is considered
						unprofessional conduct by the pharmacy and pharmacist under subsection 9 of
						section 61-04-04-01 and is subject to disciplinary action.
General Authority:
NDCC 28-32-02,
								43-15-10(1)(12), 43-15-31.2, 43-15-34, 43-15-35
Law Implemented:
NDCC 28-32-02,
								43-15-10(1)(12), 43-15-31.2, 43-15-34,
								43-15-35
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-14 - Limited Prescriptive Authority for Immunizations › Section 61-04-14-01 - Definitions

Current through Supplement No. 393, July, 2024
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 administration of drugs and maintains
				continuing competency according to the standard of care.
3. "Immunization" has the same meaning as,
				and may be used interchangeable with, the term "vaccination".
4. "Statewide protocol" refers to protocols
				developed by the board for the purpose of an authorized pharmacist ordering and
				administrating immunizations.
General Authority:
NDCC 28-32-02,
					 43-15-10
Law Implemented:
NDCC 23-01-42,
					 43-15-10(24)
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-14 - Limited Prescriptive Authority for Immunizations › Section 61-04-14-02 - Ordering and administration of immunization

Current through Supplement No. 393, July, 2024
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 response to a public health
				emergency, and an immunization recommended by the centers for disease control
				and prevention for international travel.
2. Authorized pharmacist. An authorized
				pharmacist shall meet the standards in section 61-04-11-02 to obtain and
				maintain authority to administer immunizations.
3. Assessment. An authorized pharmacist shall
				assess a patient for appropriateness for receiving a vaccination before
				ordering and administering a vaccine pursuant to the statewide
				protocol.
4. Verification and
				reporting. Before ordering and administration of an immunization pursuant to a
				statewide protocol, the authorized pharmacist shall consult and review the
				statewide immunization registry. The authorized pharmacist or the authorized
				pharmacist's designee shall report any immunization ordered and administered to
				the state immunization registry. The pharmacist may provide the patient with a
				record of the vaccine administered.
5. Records. The prescribing pharmacist shall
				maintain records of all immunizations ordered and administered through the
				statewide protocol. Informed consent must be documented in accordance with the
				statewide protocol. Records must be maintained at least five years from date of
				administration.
General Authority:
NDCC 28-32-02,
					 43-15-10
Law Implemented:
NDCC 23-01-42,
					 43-15-10(24)
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-15 - Limited Prescriptive Authority for Tobacco Cessation Therapies › Section 61-04-15-01 - Definitions

Current through Supplement No. 393, July, 2024
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 pharmacist ordering tobacco cessation therapies for patients
				utilizing tobacco, electronic nicotine delivery systems, or alternative
				nicotine products.
General Authority:
NDCC 28-32-02,
					 43-15-10
Law Implemented:
NDCC 23-01-42,
					 43-15-10(24)
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-04 - Professional Practice › Chapter 61-04-15 - Limited Prescriptive Authority for Tobacco Cessation Therapies › Section 61-04-15-02 - Ordering of tobacco cessation therapies

Current through Supplement No. 393, July, 2024
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 current copy
				of the statewide protocol approved by the board.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-05 - Radiopharmaceutical Services › Chapter 61-05-01 - Radiopharmaceutical Services › Section 61-05-01-01 - Purpose and scope

Current through Supplement No. 393, July, 2024
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 33-10. It is
							also unlawful for any person to provide radiopharmaceutical services unless
							that person is a pharmacist meeting the qualifications of section
							61-05-01-04, or a person acting
							under the direct supervision of a pharmacist meeting those qualifications and
							acting in accordance with North Dakota Century Code chapter 43-15, state board
							of pharmacy regulations, and the North Dakota radiological health rules in
							33-10, with the exception of a medical practitioner, who is listed as an
							authorized user on a radioactive materials license, for administration to the
							practitioner's patients. No person may receive, acquire, possess, use,
							transfer, or dispose of any radioactive material except in accordance with the
							conditions of a radioactive material license on which the person is an
							authorized user, as required by the state department of health pursuant to
							33-10. The requirements of this chapter are in addition to, and not in
							substitution for, other applicable provisions of regulations of the state board
							of pharmacy and the state department of health.
General Authority:
NDCC 28-32-02, 43-15-10(9),
								43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14), 43-15-36
Law Implemented:
NDCC 43-15-10(9),
								43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14),
								43-15-36
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-05 - Radiopharmaceutical Services › Chapter 61-05-01 - Radiopharmaceutical Services › Section 61-05-01-02 - Definitions

Current through Supplement No. 393, July, 2024
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 the integrity of the test.
3. "Radiopharmaceutical quality assurance" includes the
							performance of appropriate chemical, biological, and physical tests on
							potential radiopharmaceuticals and the interpretation of the resulting data to
							determine their suitability for use in humans and animals, including internal
							test assessment, authentication of product history, and the keeping of proper
							records.
4. "Radiopharmaceutical service" includes the compounding,
							dispensing, labeling, and delivery of radiopharmaceuticals; the participation
							in radiopharmaceutical selection and radiopharmaceutical utilization reviews;
							the proper and safe storage and distribution of radiopharmaceuticals; the
							maintenance of radiopharmaceutical quality assurance; the responsibility for
							advising, where necessary or where regulated, of therapeutic values, hazards,
							and use of radiopharmaceuticals; and the offering or performing of those acts,
							services, operations, or transactions necessary in the conduct, operation,
							management, and control of radiopharmaceuticals.
General Authority:
NDCC 28-32-02, 43-15-10(9),
								43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14), 43-15-36
Law Implemented:
NDCC 43-15-10(9),
								43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14),
								43-15-36
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-05 - Radiopharmaceutical Services › Chapter 61-05-01 - Radiopharmaceutical Services › Section 61-05-01-04 - General requirements for nuclear pharmacists to manage a nuclear pharmacy providing radiopharmaceutical services

Current through Supplement No. 393, July, 2024
A qualified nuclear pharmacist shall:
1. Meet minimal standards of training for
						medical uses of radioactive material.
2. Hold a current, active license to practice
						pharmacy in this state.
3. Have
						completed a minimum of seven hundred contact hours in a structured educational
						program consisting of didactic instruction in nuclear pharmacy and clinical
						nuclear pharmacy training under the supervision of a qualified nuclear
						pharmacist in a nuclear pharmacy providing nuclear pharmacy services, or in a
						structured clinical nuclear pharmacy training program with emphasis in the
						following areas:
a. Radiation physics and
						instrumentation,
b. Radiation
						protection.
c. Mathematics
						pertaining to the use and measurement of readioactivity.
d. Chemistry of byproduct material for
						medical use.
e. Radiation
						biology.
f. Shipping, receiving,
						and performing related radiation surveys.
g. Using and performing checks for proper
						operation of instruments used to determine the activity of dosages, survey
						meters, and, if appropriate, instruments used to measure alpha-emitting or
						beta-emitting radionuclides.
h.
						Calculating, assaying, and safely preparing dosages for patients or human
						research subjects.
i. Using
						procedures to prevent or minimize radioactive contamination and using proper
						decontamination procedures.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-05 - Radiopharmaceutical Services › Chapter 61-05-01 - Radiopharmaceutical Services › Section 61-05-01-05 - Library

Current through Supplement No. 393, July, 2024
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 relating to
						pharmacy.
4. State and federal
						regulations governing the use of applicable radioactive materials, including
						North Dakota radiological health rules, article 33-10.
5. Nuclear Medicine: The Requisites - by
						Thrall and Ziessman.
6. Principles
						and Practice of Nuclear Medicine - by Early and Sodee.
7. Nuclear Pharmacy - by Chilton and
						Witcofski.
8. Radiopharmaceuticals
						in Nuclear Pharmacy and Nuclear Medicine - by Kowalski and Phelan.
The state board of pharmacy recognizes that the library
							needed will depend on the type of radiopharmaceutical services offered.
							Variations in the required library maybe granted by the state board of
							pharmacy.
General Authority:
NDCC 28-32-02, 43-15-10(9),
								43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14), 43-15-36
Law Implemented:
NDCC 43-15-10(9),
								43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14),
								43-15-36
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-05 - Radiopharmaceutical Services › Chapter 61-05-01 - Radiopharmaceutical Services › Section 61-05-01-06 - Minimum equipment requirements

Current through Supplement No. 393, July, 2024
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 determining contamination and
						for other physic procedures.
4.
						Sufficient quantity of lead bricks, lead plates, leaded glass of high density,
						and leaded or tungsten syringe shields.
5. Refrigerator with freezer with
						temperature-monitoring capabilities.
6. Class A prescription balance or balance of
						greater sensitivity.
7.
						Single-channel or multichannel scintillation counter.
8. Sink with hot and cold running
						water.
9. Wipe test counter capable
						of detecting 0.005 microcuries of the radionuclides in question.
10. Chromatographic equipment.
11. Annually calibrated fume hood, if
						handling volatile radioactive materials.
12. Chemical exhaust hood, if handling large
						quantities of chemicals.
13.
						Electronic balance or class A prescription balance.
14. Lighted microscope or hemocytometer, or
						both.
15. ISO class 5 laminar
						flow-dispensing hood.
16. Forceps
						or tongs for remote handling of material.
17. Hotplate or heat block, or
						both.
18. Class II biosafety
						cabinet for handling blood samples for labeling.
19. Glassware.
20. Other equipment necessary for
						radiopharmaceutical services provided as required by the state board of
						pharmacy.
The state board of pharmacy recognizes that the equipment
							needed will depend on the type of radiopharmaceutical services offered.
							Variations for required equipment may be granted by the state board of
							pharmacy.
General Authority:
NDCC 28-32-02, 43-15-10(9),
								43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14), 43-15-36
Law Implemented:
NDCC 43-15-10(9),
								43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14),
								43-15-36
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-06 - Home Health Care Pharmacy Services › Chapter 61-06-01 - Home Health Care Pharmacy Services › Section 61-06-01-01 - Definitions

Current through Supplement No. 393, July, 2024
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 to outpatients.
2.
Outpatient.
An outpatient is defined as a
							patient in the home environment or an institutionalized patient that is
							receiving compounded sterile parenteral products from a pharmacy outside the
							institution.
3.
Compounded, sterile parenteral products.
Compounded, sterile parenteral products are defined as those parenteral
							drug products that require manipulation by the pharmacist and which must be
							sterile, stable, and effective when dispensed for patient use.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12),
								43-15-10(14)
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-06 - Home Health Care Pharmacy Services › Chapter 61-06-01 - Home Health Care Pharmacy Services › Section 61-06-01-02 - Registration

Current through Supplement No. 393, July, 2024
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 in addition to,
							and not in substitution for, other applicable laws of North Dakota and rules of
							the board.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12),
								43-15-10(14)
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-06 - Home Health Care Pharmacy Services › Chapter 61-06-01 - Home Health Care Pharmacy Services › Section 61-06-01-03 - Personnel

Current through Supplement No. 393, July, 2024
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 the specialized functions of preparing and dispensing compounded, sterile
						parenteral products, including the principles of aseptic technique and quality
						assurance. This knowledge is usually obtained through residency training
						programs, continuing education programs, or experience in an intravenous
						admixture facility. The pharmacist-in-charge is responsible for the purchasing,
						storage, compounding, repackaging, dispensing, and distribution of all drugs
						and pharmaceuticals and is also responsible for the development and continuing
						review of all policies and procedures, training manuals, and the quality
						assurance programs. The pharmacist-in-charge may be assisted by additional
						pharmacists adequately trained in this area of practice.
2.
Supportive personnel.
The
						pharmacist managing the section of the pharmacy providing home health care
						pharmacy services may be assisted by supportive personnel. These personnel must
						have specialized training in this field, and shall work under the immediate
						supervision of a licensed pharmacist. The training provided to these personnel
						must be described in writing in a training manual. The duties and
						responsibilities of these personnel must be consistent with their training and
						experience.
3.
Secretarial
						support.
Secretarial support must be provided as required to assist with
						recordkeeping and other administrative duties.
4.
Staffing.
A pharmacist must
						be accessible at all times to respond to patients' and other health
						professionals' questions and needs.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12),
								43-15-10(14)
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-06 - Home Health Care Pharmacy Services › Chapter 61-06-01 - Home Health Care Pharmacy Services › Section 61-06-01-04 - Physical requirements

Current through Supplement No. 393, July, 2024
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 unnecessary traffic and
						airflow disturbances. It must be used only for the preparation of these
						specialty products. It must be of sufficient size to accommodate a laminar
						airflow hood and to provide for the proper storage of drugs and supplies under
						appropriate conditions of temperature, light, moisture, sanitation,
						ventilation, and security.
2.
Equipment.
a. Laminar airflow
						hood.
b. Infusion pumps, if
						appropriate.
c. Sink with hot and
						cold running water which is convenient to the compounding area for the purpose
						of hand scrubs prior to compounding.
d. Facility for light/dark field examination.
e. Appropriate disposal containers
						for used needles, syringes, etc., and if applicable, cytotoxic waste from the
						preparation of chemotherapy agents.
f. A class II vertical flow biological safety
						cabinet, if chemotherapy agents are routinely prepared.
g. Refrigerator/freezer.