# Title 61 — State Board of Pharmacy

## Article 61-07 — Hospital Pharmacy

## Chapter 61-07-01 — Hospital Pharmacy

### § 61-07-01-01. Definitions.

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.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-02. Applicability.

This chapter is applicable to all hospital pharmacies as defined by section 61-07-01-01.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-03. Registration.

All hospital pharmacies shall register annually with the board of pharmacy; certificates of
registration may be issued only to those hospital pharmacies which satisfy the provisions of all rules of
the board and laws of North Dakota.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)

### § 61-07-01-04. Personnel.

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.
3. Supervision. All of the activities and operations of each hospital pharmacy must be personally
and directly supervised by its director or pharmacist's designee. All functions and activities of
ancillary personnel must be personally and directly supervised by a sufficient number of
registered pharmacists to ensure that all such functions and activities are performed
competently, safely, and without risk of harm to patients.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-05. Absence of pharmacist.

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.
3. Access to pharmacy. Whenever any drug is not available from floor supplies or night
cabinets, and such drug is required to treat the immediate needs of a patient whose health
would otherwise be jeopardized, such drug may be obtained from the pharmacy in
accordance with the requirements of this section. One supervisory registered professional
nurse and only one in any given eight-hour shift is responsible for removing drugs therefrom.
The responsible nurse, in times of emergency, may delegate this duty to another nurse. The
responsible nurse must be designated by position, in writing, by the appropriate committee of
the hospital and, prior to being permitted to obtain access to the pharmacy, shall receive
thorough education and training in the proper methods of access, removal of drugs, and
records and procedures required. Such education and training must be given by the director of
pharmacy, who shall require, at a minimum, the following records and procedures:
a. Removal of any drug from the pharmacy by an authorized nurse must be recorded on a
suitable form showing patient name, room number, name of drug, strength, amount, date,
time, and signature of nurse.
b. Such form must be left with the container from which the drug was removed, both placed
conspicuously so that it will be found by a pharmacist and checked properly and
promptly; or, in the case of a unit dose, place an additional dose of the drug, or the box,
on the form.
4. Emergency kits. Emergency drugs, as approved by the medical staff, must be in adequate
and proper supply in the pharmacy and in designated hospital areas. The pharmacist is
responsible both for the contents of emergency medication carts, kits, and for the inspection
procedure to be used.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-06. Physical requirements.

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.
l. 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.
3. Storage. All drugs must be stored in designated areas within the hospital pharmacy which are
sufficient to ensure proper sanitation, temperature, light, ventilation, moisture control,
segregation, and security.
4. Alcohol and flammables. Alcohol and flammables must be stored in areas that shall meet, at
a minimum, basic local building code requirements for the storage of volatiles and such other
laws, ordinances, regulations as may apply.
5. Unattended areas. In the absence of authorized personnel, and whenever any area of a
hospital pharmacy is not under the personal and direct supervision of authorized personnel,
such area must be locked.
6. Security. All areas occupied by a hospital pharmacy must be capable of being locked by key
or combination, so as to prevent access by unauthorized personnel. The director shall
designate, in writing, by title and specific area, those persons who shall have access to
particular areas within the pharmacy.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(11), 43-15-10(12), 43-15-10(14)
### § 61-07-01-07. Drug distribution and control.

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.
l. 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.
3. Labeling.
a. For use inside the hospital. All drugs dispensed by a hospital pharmacy, not on an
individual prescription, intended for use within the hospital, must be dispensed in
appropriate containers and adequately labeled so as to identify, at a minimum, brand
name or generic name, strength, quantity, source, and expiration date.
b. For use outside the pharmacy. All drugs dispensed by a hospital pharmacy to patients
about to be discharged or to whom it is certain will carry the item dispensed outside of
the hospital, in compliance with pharmacy practice act and rules, must be labeled with
the following information:
(1) Name, address, and telephone number of the hospital pharmacy.
(2) Date and identifying serial number.
(3) Full name of patient.

(4) Name of drug strength, and number of units.
(5) Directions for use to the patients.
(6) Name of physician prescribing.
(7) Required precautionary information regarding controlled substances.
(8) Such other and further accessory cautionary information as may be required or
desirable for proper use and safety to the patient.
c. Drugs added to parenteral admixtures. Whenever any drugs are added to parenteral
admixtures, whether within or outside the direct and personal supervision of a
pharmacist, such admixtures must be labeled with a distinctive supplementary label
indicating the name and the amount of the drug added, date and time of addition and
expiration, and name of person so adding.
4. Discontinued drugs. The director shall develop and implement policies and procedures to
ensure that discontinued and outdated drugs and containers with worn, illegible, or missing
labels are returned to the pharmacy for proper disposition or that the director or the director's
designee make proper disposition or dispose of such drugs at the storage site.
5. Physician's orders. Drugs may be dispensed from the hospital pharmacy only upon written
or verbal orders, direct copies or facsimiles thereof, of authorized physicians. Verbal orders for
drugs are accepted only by personnel so designated in accordance with applicable law and
regulations governing such acts and in accordance with the approved medical staff rules and
regulations.
a. Authorization. The appropriate committee of the hospital shall designate, from time to
time as appropriate, those physicians who are authorized to issue orders to the
pharmacy.
b. Abbreviations. Orders employing abbreviations and chemical symbols may be utilized
and filled only if such abbreviations and symbols appear on a published list of accepted
abbreviations developed by the appropriate committee of the hospital.
c. Requirements - Orders for drugs for use by inpatients. Orders for drugs for use by
inpatients shall contain, at a minimum: patient name and room number, drug name,
strength, directions for use, date, and physician's signature or that of the physician's
authorized representative.
d. Requirements - Orders for drugs for use by outpatients. Orders for drugs for use by
outpatients become prescriptions and must meet all requirements of the law.
e. Pharmacist review. The pharmacist shall review the prescriber's order, or a direct copy
thereof, before the initial dose of medication is dispensed (with the exception of
emergency orders when time does not permit). In cases when the medication order is
written when the pharmacy is "closed" or the pharmacist is otherwise unavailable, the
medication order should be reviewed by the pharmacist as soon thereafter as possible,
preferably within twenty-four hours.
f. Signature. A means of identifying the signatures of all practitioners authorized to use the
pharmaceutical services, as well as a listing of their drug enforcement administration
numbers, must be maintained.
6. Controlled drug accountability. The hospital shall establish effective procedures and
maintain adequate records regarding use and accountability of controlled substances and

such other drugs as the appropriate hospital committee may designate which may specify at
least the following:
a. Name of drug.
b. Dose.
c. Physician.
d. Patient.
e. Date and time of administration.
f. Person administering the drug.
7. Recall. The director shall develop and implement a recall procedure that can be readily
activated to assure the medical staff of the hospital that all drugs included on the recall,
whether within or outside the hospital, are returned to the pharmacy for proper disposition.
8. Suspected adverse drug reactions. Any and all suspected adverse drug reactions must be
reported orally immediately to the ordering physician and in writing to the pharmacy, and to the
appropriate committee of the hospital. Appropriate entry on the patient's record must also be
made. The director may, at the director's discretion, make further reports of such suspected
reactions to the hospital reporting program of the United States food and drug administration,
to the manufacturer, and to the United States pharmacopeia.
9. Records and reports. The director shall maintain and submit, as appropriate, such records
and reports as are required to ensure patient health, safety, and welfare, and, at a minimum,
the following:
a. Physician's orders, direct copies, or facsimiles thereof.
b. Controlled drug accountability report.
c. Reports of suspected adverse drug reactions.
d. Inventories of night cabinets and emergency kits.
e. Inventories of the pharmacy.
f. Biennial controlled substances inventories.
g. Alcohol and flammables reports.
h. Such other and further records and reports as may be required by law and this chapter.
10. Distribution systems.
a. Floor or ward stock system. In this system, all but the most unusual drug items are
stocked on the nursing stations. Drug products which require special control (e.g.,
antineoplastic agents) are often omitted from floor stock, and are sent to the nursing unit
upon receipt of a prescription order for the individual patient. All containers used for floor
stock must meet specific labeling requirements as addressed in these rules.
b. Individual prescription order system. In this system, all medications are dispensed by the
pharmacist on individual prescription orders.

c. Combination of floor stock and the individual prescription order system. In this system,
most drugs are dispensed on an individual prescription basis. The remaining drugs are
obtained via limited floor stock.
d. Unit dose. In this system, medications are contained in single unit packages; they are
dispensed in as ready-to-administer form as possible, for most medications. All doses will
be labeled properly to include name, strength, expiration date, or lot number or control
number, or both.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-08. Nondistributive roles of the pharmacist.

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.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-09. Administration of drugs.

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.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-10. Drugs from outside sources.

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.
2. Brought by patients. Whenever patients bring drugs into a hospital, such drugs may not be
administered unless they can be precisely identified; administration must be pursuant to a
physician's order only. The director of pharmacy will specify the policy and procedure for
handling these medications.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-11. Quality assurance.

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.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-12. Investigational drugs.

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.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-13. Inspection.

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.
2. Annual. The board of pharmacy shall inspect, no less than once a year, by one of its
members or by its qualified designee, all aspects of the management and operation of all
hospital pharmacies in the state, to verify compliance with the law, this chapter, and such
other standards as may be appropriate to ensure that the health, safety, and welfare of
patients of the hospital serviced by the pharmacy are protected. Written reports of an
inspection must be filed with the board and the director. Any discrepancies or deficiencies
noted must be corrected within a reasonable time. Written notice of such corrections must be
filed with the board. Board recommendations may be questioned by written notice to the
executive secretary of the board of pharmacy. Consideration must be given by the board's
inspector or designee to giving thirty days' notice of an inspection to the director of the
pharmacy to be visited. Consideration must also be given to any recent survey by the joint
commission on accreditation of health care organizations.
History: Effective April 1, 1988.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)
### § 61-07-01-14. Pharmacist first dose review.

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 practitioner 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.
4. Each hospital pharmacy must be in compliance with this rule by June 30, 2015.
History: Effective October 1, 2012.
General Authority: NDCC 28-32-02, 43-15-10(9), 43-15-10(14)
Law Implemented: NDCC 43-15-10(9), 43-15-10(14)
