# Title 61 — State Board of Pharmacy

## Article 61-06 — Home Health Care Pharmacy Services

## Chapter 61-06-01 — Home Health Care Pharmacy Services

### § 61-06-01-01. Definitions.

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.
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)
### § 61-06-01-02. Registration.

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.
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)
### § 61-06-01-03. Personnel.

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.
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)
### § 61-06-01-04. Physical requirements.

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.
3. Supplies.

a. Disposable needles, syringes, and other supplies needed for aseptic admixture.
b. Disinfectant cleaning solutions.
c. Handwashing agent with bactericidal action.
d. Disposable, lint-free paper towels.
e. Appropriate filters and filtration equipment.
f. Disposable masks and sterile, disposable gloves.
g. Gowns, if chemotherapy agents are routinely prepared.
h. An oncology drug spill kit, if chemotherapy agents are routinely prepared.
4. References. In addition to references required in a retail pharmacy, current edition of an
established reference on intravenous stability and incompatibility, such as, Handbook on
Injectable Drugs, or King's Guide to Parenteral Admixtures.
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)
### § 61-06-01-05. Drug distribution and control.

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.
6. Labeling. Each compounded, sterile parenteral product dispensed to outpatients must be
labeled with a permanent label with the following information:
a. Name, address, and telephone number of the pharmacy providing home health care
pharmacy services.
b. Date and identifying prescription number.
c. Patient's full name.
d. Name of each drug, strength, and amount.
e. Directions for use to the patient, including infusion rate.
f. Physician's full name.
g. Required precautionary information.
h. Date and time of compounding.
i. Expiration date and time.
j. Identity of pharmacist compounding and dispensing.
7. Records and reports. The pharmacist managing the section of the pharmacy providing home
health care pharmacy services shall maintain access to and submit, as appropriate, such
records and reports as are required to ensure patient's health, safety, and welfare. Such
records must be readily available, maintained for five years, and subject to inspections by the
board of pharmacy or its agents. These must include, as a minimum, the following:
a. Policy and procedures manual.
b. Training manuals.
c. Policies and procedures for cytotoxic waste, if applicable.
d. Such other records and reports as may be required by law and rules of the board of
pharmacy.
8. Delivery service. The pharmacist managing the section of the pharmacy providing home
health care pharmacy services is responsible for the environment control of all products
shipped. Therefore, any compounded, sterile parenteral product that is frozen, or requires
refrigeration, must be shipped or delivered to a patient in appropriate coolers and stored
appropriately in the patient's home.
History: Effective April 1, 1988; amended effective October 1, 2014.
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14), 43-15-31, 43-15-31.1
### § 61-06-01-06. Cytotoxic agents.

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.
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)
### § 61-06-01-07. Patient care guidelines.

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.
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)
### § 61-06-01-08. Quality control.

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.
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)
