Section 61-06-01-04 - Physical requirementsThe 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.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. 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. N.D. Admin Code 61-06-01-04
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)