reglab/statecodes huggingface dataset:
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 61-06-01-05 - Drug distribution and control

Current through Supplement No. 393, July, 2024
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 pharmaceutical products purchased and dispensed by a
						pharmacy providing home health care pharmacy services must meet national
						standards of quality (USP-NF standards) and must be clearly and accurately
						labeled by the manufacturer or distributor as to contents.
3.
Procedure manual.
A policy
						and procedure manual must be prepared in accordance with section
						61-02-01-18 home health care
						pharmacy services.
4.
Prescription.
The pharmacist or pharmacy intern acting under the
						immediate supervision of a pharmacist must receive a written or verbal
						prescription from a physician before dispensing any compounded, sterile
						parenteral product. Prescriptions must be filed as required by law or rules of
						the board.
5.
Profile.
A pharmacy generated profile must be maintained for each patient as
						required by North Dakota Century Code section 43-15-31.1, and must also
						include:
a. Age.
b. Weight.
c. Sex.
d. Patient directions.
e. Other drugs patient is
						receiving.
f. Drug sensitivities
						and allergies to drugs and foods.
g. Primary diagnosis.
h. Documentation of patient training and
						continued competency.
i.
						Documentation of patient visits.
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 61-06-01-06 - Cytotoxic agents

Current through Supplement No. 393, July, 2024
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:
1. All chemotherapy agents should be
						compounded in a vertical flow, class II, biological safety cabinet. If
						possible, other products should not be compounded in this cabinet.
2. Protective apparel must be worn by
						personnel compounding chemotherapy drugs. This includes disposable masks,
						gloves, and gowns with tight cuffs.
3. Proper aseptic and safety techniques must
						be used by personnel compounding chemotherapy agents.
4. Appropriate disposal procedures for
						cytotoxic waste must be developed that comply with applicable state and federal
						regulations.
5. Written procedures
						for handling both major and minor spills of cytotoxic agents must be developed.
6. Prepared doses of chemotherapy
						must be dispensed and shipped in a manner to minimize the risk of accidental
						rupture of the primary container.
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 61-06-01-07 - Patient care guidelines

Current through Supplement No. 393, July, 2024
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 monitoring of the patient, and the
						reimbursement for services. This must be documented in the patient's profile.
2.
Patient training.
The patient, the patient's physician, or the patient's pharmacist shall
						demonstrate or document the patient's training and competency in managing this
						type of therapy in the home environment prior to any drugs, supplies, or
						equipment being dispensed. A pharmacist must be involved in the patient
						training process in any area that relates to drug compounding, labeling,
						storage, stability, or incompatibility. The pharmacist shall reassess and
						document on the profile the patient's competency in the necessary areas at
						least every six months.
3.
Pharmacist-patient relationship.
It is imperative that a
						pharmacist-patient relationship be established and maintained throughout the
						patient's course of therapy. The patient should be visited by the pharmacist at
						least monthly; telephone contact will not suffice. This must be documented in
						the patient's profile.
4.
Patient monitoring.
The pharmacist should have access to clinical
						and laboratory data concerning each patient and should monitor each patient's
						response to the patient's drug therapy. Any unexpected or untoward response
						should be reported to the prescribing physician.
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 61-06-01-08 - Quality control

Current through Supplement No. 393, July, 2024
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.
1.
Hood certification.
All
						laminar flow hoods must be certified by federal standard 209B for operational
						efficiency at least every twelve months. Appropriate records must be
						maintained.
2.
Prefilters.
Prefilters for the clean air source must be replaced on a regular basis
						and these activities documented.
3.
Bulk compounding.
If bulk
						compounding of parenteral solutions is performed utilizing nonsterile
						chemicals, extensive end product testing must be documented prior to the
						release of the product from quarantine. This process must include testing for
						sterility and pyrogens.
4.
Expiration dates.
If the product is assigned a lengthy expiration
						date (anything exceeding ten days), there must be in-house data or data in the
						literature to assure the sterility and stability of the product at the time it
						is used by the patient.
5.
Quality control audits.
There must be documentation of quality
						assurance audits at regular, planned intervals.
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 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-01 - Definitions

Current through Supplement No. 393, July, 2024
For purposes of this chapter, the following definitions
							apply:
1. The terms "hospital" and "medical center" are
							synonymous.
2. "Hospital pharmacy" is defined as those portions of a
							hospital where drugs, medications, devices, and other materials used in the
							diagnosis and treatment of injury, illness, and disease (hereinafter referred
							to as "drugs") are manufactured, produced, sold, or
							distributed.
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 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-02 - Applicability

Current through Supplement No. 393, July, 2024
This chapter is applicable to all hospital pharmacies as
							defined by section
							61-07-01-01.
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 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-03 - Registration

Current through Supplement No. 393, July, 2024
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.
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 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-04 - Personnel

Current through Supplement No. 393, July, 2024
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 functions of
						hospital pharmacies. The director of pharmacy is responsible for all activities
						of the hospital pharmacy, and for meeting the requirements of the North Dakota
						pharmacy practice act and this chapter. Contractual providers of pharmacy
						services shall meet the same requirements as director of pharmacy
						services.
2.
Supportive
						personnel.
The director of a hospital pharmacy must be assisted by a
						sufficient number of additional pharmacists and ancillary personnel as may be
						required to operate such pharmacy competently, safely, and adequately to meet
						the needs of the patients of the hospital.
a.
						Pharmacy technicians may be employed provided they have been approved by the
						director. The director shall develop and implement written policies and
						procedures to specify the duties to be performed by such technical personnel.
						These policies and procedures shall, at a minimum, specify that ancillary
						technical personnel are properly or adequately supervised by a registered
						pharmacist and that ancillary technical personnel are not assigned duties which
						may be performed only by pharmacists.
b. Secretarial support should be provided as
						required to assist with recordkeeping, report submission, and other
						administrative duties.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-05 - Absence of pharmacist

Current through Supplement No. 393, July, 2024
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 both, and in emergency circumstances, by access to the
						pharmacy. A pharmacist must be available for consultation during all absences;
						this protocol can be accomplished by telephone.
2.
Night cabinets.
If night
						cabinets are used, the following should prevail: absence of a pharmacist, must
						be by locked cabinets or other enclosures constructed and located outside of
						the pharmacy area, to which only specifically authorized personnel may obtain
						access by key or combination, and which is sufficiently secure to deny access
						to unauthorized persons by force or otherwise. The director shall, in
						conjunction with the appropriate committee of the hospital, develop inventory
						listings of those drugs to be included in such cabinets and shall ensure that:
a. Such drugs are available therein, properly
						labeled.
b. Only prepackaged drugs
						are available therein, in amounts sufficient for immediate therapeutic
						requirements.
c.Whenever access to
						such cabinets shall have been gained, written physician's orders and proofs of
						use, if applicable, are provided.
d.
						Written policies and procedures are established to implement the requirements
						of this subsection.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-06 - Physical requirements

Current through Supplement No. 393, July, 2024
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.
Each
						hospital pharmacy shall have sufficient equipment and physical facilities for
						proper compounding, dispensing, and storage of drugs, including parenteral
						preparations, and, as a minimum, access to the references for the following
						subjects:
a. Drug interactions.
b. Drug compatibility.
c. Poison and antidote information.
d. Chemistry:
(1) Organic;
(2) Pharmaceutical; and
(3) Biological.
e. Toxicology.
f. Pharmacology.
g. Bacteriology.
h. Sterilization and disinfection.
i. Pharmacy technology,
j. Patient counseling,
k. Rational therapy.
I. Pathology.
m. Current United States Pharmacopeia and
						National Formulary dispensing information.
n. Current state and federal regulations
						applicable to controlled substances.
The technical equipment required by section
							61-02-01-03 may be either at the
							hospital pharmacy or the community pharmacy servicing the hospital
							pharmacy.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-07 - Drug distribution and control

Current through Supplement No. 393, July, 2024
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 safe and efficient distribution of, control of, and
						accountability for drugs. The other professional staff of the hospital shall
						cooperate with the director in meeting this responsibility and in ordering,
						administering, and accounting for pharmaceutical materials so as to achieve
						this purpose. Accordingly, the director is responsible for, at a minimum, the
						following:
a. Preparation and sterilization of
						parenteral medications manufactured within the hospital.
b. Admixture of parenteral products,
						including education and training of nursing personnel concerning
						incompatibility and provision of proper incompatibility information when the
						admixture of parenteral products is not accomplished within the hospital
						pharmacy.
c. Manufacture of drugs,
						if applicable.
d. Establishment of
						specifications for procurement of all materials, including drugs, chemicals,
						and biologicals, subject to approval of the appropriate committee of the
						hospital.
e. Participation in
						development of a formulary for the hospital.
f. Filling and labeling all containers from
						which drugs are to be administered.
g. Maintaining and making available a
						sufficient inventory of antidotes and other emergency drugs, both in the
						pharmacy and inpatient care areas, as well as current antidote information,
						telephone numbers of regional poison control centers, and other emergency
						assistance organizations, and such other materials and information as may be
						deemed necessary by the appropriate committee of the hospital, if
						any.
h. Records of all transactions
						of the hospital pharmacy as may be required by applicable law, state and
						federal, and as may be necessary to maintain accurate control over and
						accountability for all pharmaceutical materials.
i. Participation in drug usage evaluation
						activities.
j. Fullest cooperation
						with teaching or research programs, or both, in the hospital, if any.
k. Implementation of the policies and
						decisions of the appropriate committees of the hospital.
I. Effective and efficient messenger and
						delivery service to connect the pharmacy with appropriate parts of the hospital
						on a regular basis throughout the normal workday of the hospital.
m. Meeting all compliance and other
						requirements of the North Dakota board of pharmacy rules and laws and this
						chapter.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-08 - Nondistributive roles of the pharmacist

Current through Supplement No. 393, July, 2024
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
							medication histories; monitoring of drug therapy; patient education; detection
							and reporting of adverse drug reactions; drug therapy selection; participation
							in drug usage evaluation; and other quality assurance
							programs.
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 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-09 - Administration of drugs

Current through Supplement No. 393, July, 2024
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 procedures specified by the appropriate committee of the
						facility, under applicable law and rules, and by usual and customary standards
						of good medical practice.
2.
Self-administration.
Self-administration of drugs by patients may
						be permitted only when specifically authorized by the treating or ordering
						physician; provided, however, the patient has been educated and trained in the
						proper manner of self-administration and there is no risk of harm to the
						patient or others. The label should contain patient's name, room number, date
						directions, and name and strength of medication, at a minimum.
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 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-10 - Drugs from outside sources

Current through Supplement No. 393, July, 2024
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 of the patients and to properly serve the needs
						of the hospital. Such arrangements must be made in writing and must, at a
						minimum, specify that:
a. The outside
						pharmacist shall act in the capacity of the director (subsection 1 of section
						61-07-01-04) and, therefore, is
						subject to this chapter.
b. Such
						arrangement is contingent upon approval of the board of pharmacy.
c. The pharmacist must be available for
						consultation during all absences, or provide a protocol to contact another
						pharmacist.
d. Adequate storage
						facilities for drugs will be provided.
e. All drugs supplied must be labeled so as
						to ensure that recalls can be effected and that proper control and supervision
						of such drugs may be exercised.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-11 - Quality assurance

Current through Supplement No. 393, July, 2024
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
							written plan should clearly establish responsibility and the need for
							documentation of an effective program.
The director of pharmacy services is responsible for
							developing procedures for quality assurance in centralized intravenous
							admixture services. Such procedures must encompass selection, education, and
							training of personnel, inprocess controls, end-product testing, and sampling
							guidelines. Cautionary measures for the safe admixture of parenteral products
							must be developed.
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 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-12 - Investigational drugs

Current through Supplement No. 393, July, 2024
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 may
							administer such drugs only after they have been educated and trained concerning
							relevant pharmacologic information about such drugs by the clinician or the
							pharmacist. A central unit must be maintained wherein essential information
							regarding such drugs may be obtained. Patients' or representatives' informed
							consent must be obtained prior to investigational drug therapy. Investigational
							drugs must be stored under the same regulations as Schedule II controlled
							substances.
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 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-13 - Inspection

Current through Supplement No. 393, July, 2024
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 verify, at a minimum,
						that:
a. Drugs are dispensed only by
						pharmacists.
b. Ancillary pharmacy
						personnel are properly directed and supervised.
c. Disinfectants and drugs for external use
						are stored separately and apart from drugs for internal use or
						injection.
d. Drugs requiring
						special storage conditions to ensure their stability are properly
						stored.
e. Outdated drugs or
						otherwise unusable drugs have been identified and their distribution and
						administration prevented. An area must be designated for authorized storage of
						such drugs prior to their proper disposition.
f. Distribution and administration of
						controlled substances are properly and adequately documented and reported by
						both pharmacy and medical personnel.
g. Emergency drugs designated pursuant to
						subsection 4 of section
						61-07-01-05 are adequate and in
						proper supply both within the pharmacy and at outside storage
						locations.
h. All necessary and
						required security and storage standards are met.
i. Metric-apothercaries' weight and measure
						conversion tables and charts are reasonably available to all medical
						personnel.
j. All policies and
						procedures of the director and of appropriate committees of the hospital
						relevant to pharmacy are followed.
k. The telephone number of the regional
						poison control information center should be posted by all telephones in the
						nursing stations where drugs are stored.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-07 - Hospital Pharmacy › Chapter 61-07-01 - Hospital Pharmacy › Section 61-07-01-14 - Pharmacist first dose review

Current through Supplement No. 393, July, 2024
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 will be sufficient to
						comply with the requirement.
3.
						This provision does not apply to the following situations:
a. When the physician controls the ordering,
						dispensing, and administration of the drug, such as in the operating room,
						endoscopy suite, or emergency room.
b. When time does not permit the pharmacist's
						review, such as with "stat" orders or when the clinical status of the patient
						would be significantly compromised by the delay resulting from the pharmacist's
						review of the order.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-01 - Permit

Current through Supplement No. 393, July, 2024
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 dispensing the
							prescription for a North Dakota resident shall abide by state law and rules of
							the board.
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
Law Implemented: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14),
								43-15-34, 43-15-35, 43-15-36,
								43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-02 - Permit application - Renewal

Current through Supplement No. 393, July, 2024
Pharmacy permit application forms must be available from the
							board and submitted for approval. Pharmacy permits must be renewed annually by
							July first.
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
Law Implemented: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14),
								43-15-34, 43-15-35, 43-15-36,
								43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-03 - Fees

Current through Supplement No. 393, July, 2024
The out-of-state pharmacy annual permit fee must be set by
							the board not to exceed three hundred dollars.
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
Law Implemented: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14),
								43-15-34, 43-15-35, 43-15-36,
								43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-04 - Pharmacy permit - Home jurisdiction

Current through Supplement No. 393, July, 2024
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.
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
Law Implemented: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14),
								43-15-34, 43-15-35, 43-15-36,
								43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-05 - Applicable law and rules

Current through Supplement No. 393, July, 2024
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.
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
Law Implemented: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14),
								43-15-34, 43-15-35, 43-15-36,
								43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-06 - Compliance

Current through Supplement No. 393, July, 2024
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 pharmacy operation
							pertaining to the provisions of receiving, dispensing, and delivering
							prescription drugs to North Dakota.
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
Law Implemented: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14),
								43-15-34, 43-15-35, 43-15-36,
								43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-07 - Reporting

Current through Supplement No. 393, July, 2024
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 applicable
							standards of care when dispensing prescription orders for delivery to North
							Dakota consumers. The out-of-state pharmacy shall also disclose the pharmacist
							in charge and location, names, and titles of all principal corporate officers
							and all pharmacists who are dispensing prescription drugs to residents of this
							state. This disclosure must be on an annual basis.
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
Law Implemented: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14),
								43-15-34, 43-15-35, 43-15-36,
								43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-08 - Administrative inspection

Current through Supplement No. 393, July, 2024
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 regulatory
				  authorities to conduct and perfect periodic routine inspections.
1. To obtain a license as a nonresident
				pharmacy, an applicant shall:
a. Have
				submitted an application form prescribed by the board as required under section
				61-08-01-02; and
b. Have paid the
				fees specified by the board for the issuance of the license as specified in
				article 61-11.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-09 - Records

Current through Supplement No. 393, July, 2024
Prescription records documenting prescriptions dispensed and
				  distributed to North Dakota consumers must be readily retrievable and available
				  for board review upon request.
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
Law Implemented:
NDCC 28-32-02,
					 43-15-10(7)(8)(9)(12)(14), 43-15-34, 43-15-35, 43-15-36, 43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-10 - Counseling services

Current through Supplement No. 393, July, 2024
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 pharmacies'
							telephone number will be prominently identified and affixed on the prescription
							container label. Guidelines for counseling services must be consistent with
							professional practice counseling guidelines set in chapter 61-04-13.
General Authority:
NDCC 28-32-02,
								43-15-10(7)(8)(9)(12)(14), 43-15-34, 43-15-31.2, 43-15-35, 43-15-36, 43-15-38
Law Implemented:
NDCC 28-32-02,
								43-15-10(7)(8)(9)(12)(14), 43-15-34, 43-15-31.2, 43-15-35, 43-15-36, 43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-11 - Patient profile record system and prescription drug information required

Current through Supplement No. 393, July, 2024
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
							dispensing a prescription for a North Dakota resident.
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
Law Implemented: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14),
								43-15-34, 43-15-35, 43-15-36,
								43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-12 - Jurisdiction

Current through Supplement No. 393, July, 2024
Out-of-state pharmacies soliciting, receiving, and dispensing
							prescription orders delivered to North Dakota ultimate residents constitutes
							doing business in the state.
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
Law Implemented: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14),
								43-15-34, 43-15-35, 43-15-36,
								43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-08 - Out-of-State Pharmacies › Chapter 61-08-01 - Requirements for Out-of-State Pharmacies › Section 61-08-01-13 - Agent

Current through Supplement No. 393, July, 2024
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.
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
Law Implemented: NDCC 28-32-02, 43-15-10(7)(8)(9)(12)(14),
								43-15-34, 43-15-35, 43-15-36,
								43-15-38
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-09 - Prescription Drug Inventory of Ambulance Services › Chapter 61-09-01 - Prescription Drug Inventory of Ambulance Services › Section 61-09-01-02 - Requirement of pharmacy supplier of ambulance service drugs

Current through Supplement No. 393, July, 2024
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
							61-09-01-01 requirements are
							contained therein and that the ambulance service is complying with those
							requirements. No prescription drugs may be supplied to an ambulance service if
							the requirements of section
							61-09-01-01 are not contained in
							the written prescription drug safeguard policy or if the ambulance service is
							not in compliance with these requirements.
General Authority:
NDCC 28-32-02,
								43-15-10(12), 43-15-10(14)
Law Implemented:
NDCC 28-32-03, 43-15-10(12),
								43-15-10(14)
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-09 - Prescription Drug Inventory of Ambulance Services › Chapter 61-09-02 - Prescription Drug Inventory of Nursing Supply Kits › Section 61-09-02-01 - Prescription safeguard and control policy

Current through Supplement No. 393, July, 2024
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
							following requirements:
1. All
						prescription drugs must be obtained from a licensed pharmacy or licensed
						pharmacist, which may include a hospital pharmacy. The prescription drugs must
						be the property of the pharmacy or pharmacist and not the property of the
						nurse, nursing agency, or home health care agency.
2. The pharmacy from which the drugs are
						obtained shall maintain ownership and be responsible for the medications and
						supplies in the nursing supply kit.
a. Each
						supply kit must be sealed with a tamperproof seal to ascertain entry.
b. Each kit must be delivered to
						and under the control of a registered nurse. Each kit must have a number which
						must be designated to a registered nurse.
c. Each kit must be labeled on the outside of
						the container with a list of drugs and supplies.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-09 - Prescription Drug Inventory of Ambulance Services › Chapter 61-09-02 - Prescription Drug Inventory of Nursing Supply Kits › Section 61-09-02-02 - Requirements of suppliers of nursing supply kits

Current through Supplement No. 393, July, 2024
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 that all of
							section 61-09-02-01 requirements are
							contained therein and that the nurse or nursing agency is complying with those
							requirements. No prescription drug may be supplied to a nurse or nursing agency
							if the requirements of section
							61-09-02-01 are not contained in
							the written prescription drug safeguard policy and procedures or if the nurse
							or nursing agency is not in compliance with these requirements.
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 61-10 - Wholesale Drug Distributors › Chapter 61-10-01 - Wholesale Drug Distributors › Section 61-10-01-01 - Scope

Current through Supplement No. 393, July, 2024
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.
General Authority: NDCC 43-15.1-07
Law Implemented: NDCC
								43-15.1
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-10 - Wholesale Drug Distributors › Chapter 61-10-01 - Wholesale Drug Distributors › Section 61-10-01-02 - Purpose

Current through Supplement No. 393, July, 2024
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 of
							any prescription drugs.
General Authority: NDCC 43-15.1-07
Law Implemented: NDCC 43-15.1;
								21 USC
								353(e)
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-10 - Wholesale Drug Distributors › Chapter 61-10-01 - Wholesale Drug Distributors › Section 61-10-01-03 - Definitions

Current through Supplement No. 393, July, 2024
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" means the North Dakota state board of
							pharmacy.
3. "Blood" means whole blood collected from a single donor
							processed either for transfusion or further manufacturing.
4. "Blood component" means that part of blood separated by
							physical or mechanical means.
5. "Drug sample" means a unit of a prescription drug that is
							not intended to be sold and is intended to promote the sale of the drug.
6. "Manufacturer" is defined as provided in subsection 2 of
							North Dakota Century Code section 43-15.1-01.
7. "Prescription drug" is defined as provided in subsection 4
							of North Dakota Century Code section 43-15.1-01.
8. "Wholesale drug distribution" is defined as provided in
							subsection 5 of North Dakota Century Code section 43-15.1-01, provided that:
a. Concerning the exclusion from the definition of "wholesale
							drug distribution" for "intracompany sale" set forth in subdivision a of
							subsection 5 of North Dakota Century Code section 43-15.1-01, such "sale"
							includes any transaction or transfer between any division, subsidiary, parent,
							and/or affiliated or related company under common ownership and control of a
							corporate entity.
b. For purposes of subdivision a of this subsection and
							subdivision d of subsection 5 of North Dakota Century Code section 43-15.1-01,
							"common control" means the power to direct or cause the direction of the
							management and policies of a person or organization, whether by ownership by
							stock, voting rights, by contract, or otherwise.
c. For purposes of subdivision e of subsection 5 of North
							Dakota Century Code section 43-15.1-01, "emergency medical reasons" includes
							transfers of prescription drugs by a retail pharmacy to another retail pharmacy
							to alleviate a temporary shortage, except that the gross dollar value of such
							transfers may not exceed five percent of the total prescription drug sales
							revenue of either the transferor or transferee retail pharmacy during any
							twelve-consecutive-month period.
d. "Wholesale drug distribution" does not include the sale,
							purchase, or trade of blood and blood components intended for transfusion.
9. "Wholesale drug distributor" is defined as provided in
							subsection 6 of North Dakota Century Code section 43-15.1-01.
General Authority: NDCC 43-15.1-07
Law Implemented: NDCC
								43-15.1
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-10 - Wholesale Drug Distributors › Chapter 61-10-01 - Wholesale Drug Distributors › Section 61-10-01-04 - Wholesale drug distributor licensing requirement

Current through Supplement No. 393, July, 2024
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 North
							Dakota Century Code chapter 43-15.1 before engaging in wholesale distribution
							of any prescription drugs in the state of North Dakota.
General Authority: NDCC 43-15.1-07
Law Implemented: NDCC 43-15.1-04,
								43-15.1-05
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-10 - Wholesale Drug Distributors › Chapter 61-10-01 - Wholesale Drug Distributors › Section 61-10-01-05 - Minimum required information for licensure

Current through Supplement No. 393, July, 2024
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:
a.
						The name, full business address, and telephone number of the licensee;
b. All trade or business names
						used by the licensee;
c.
						Addresses, telephone numbers, and the names of contact persons for all
						facilities used by the licensee for the storage, handling, and distribution of
						prescription drugs;
d. The type of
						ownership or operation, i.e., partnership, corporation, or sole proprietorship;
						and
e. The names of the owner or
						operator, or both, of the licensee, including:
(1) If a person, the name of the person;
(2) If a partnership, the name of
						each partner, and the name of the partnership;
(3) If a corporation, the name and title of
						each corporate officer and director, the corporate names, and the name of the
						state of incorporation; and
(4) If
						a sole proprietorship, the full name of the sole proprietor and the name of the
						business entity.
North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-10 - Wholesale Drug Distributors › Chapter 61-10-01 - Wholesale Drug Distributors › Section 61-10-01-06 - Minimum qualifications

Current through Supplement No. 393, July, 2024
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, state, or local laws relating to drug samples, wholesale or retail
						drug distribution, or distribution of controlled substances;
b. Any felony convictions of the applicant
						under federal, state, or local laws;
c. The applicant's past experience in the
						manufacture or distribution of prescription drugs, including controlled
						substances;
d. The furnishing by
						the applicant of false or fraudulent material in any application made in
						connection with drug manufacturing or distribution;
e. Suspension or revocation by federal,
						state, or local government of any license currently or previously held by the
						applicant for the manufacture or distribution of any drugs, including
						controlled substances;
f.
						Compliance with licensing requirements under previously granted licenses, if
						any;
g. Compliance with
						requirements to maintain or make available to the board of pharmacy or to
						federal, state, or local law enforcement officials, or both, those records
						required under this section;
h.
						Any other factors or qualifications the board of pharmacy considers relevant to
						and consistent with the public health and safety; and
i. Other factors or requirements contained in
						subsection 5 of North Dakota Century Code section 43-15.1-04.