21 NCAC 46 .2803. REQ/PHARMACIES DISPENSING STERILE PHARMACEUTICALS

All locations holding a pharmacy permit where sterile pharmaceuticals are routinely compounded for dispensing must meet the following requirements:

(1)           The location shall have a designated area with entry restricted to designated personnel for preparing compounded sterile products. This area shall be structurally isolated from other areas, with restricted entry or access, and must be designed to avoid unnecessary traffic and airflow disturbances from activity within the controlled facility. It shall be used only for the preparation of these specialty products. It shall 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)           The permit-holder preparing sterile products shall have the following equipment in addition to that required by Board Rule .1601 of this Chapter:

(a)           Environmental control devices capable of maintaining at least Class 100 conditions in the work place where critical objects are exposed and critical activities are performed;

(b)           Sink with hot and cold running water that is convenient to the compounding area for the purpose of hand scrubs prior to compounding;

(c)           Disposal containers for used needles, syringes, etc., and if applicable cytotoxic waste from the preparation of chemotherapy agents and infectious wastes from patients' homes;

(d)           When cytotoxic drug products are prepared, environmental control devices also include biohazard cabinetry;

(e)           Refrigerator-freezer with a thermometer;

(f)            Temperature controlled delivery containers; and

(g)           Infusion devices, if appropriate.

(3)           The permit-holder dispensing sterile pharmaceuticals shall maintain inventories of the following supplies: Disposable needles, syringes, and other supplies needed for aseptic admixture; disinfectant cleaning solution; handwashing agents with bactericidal action; disposable, lint-free towels or wipes; appropriate filters and filtration equipment; oncology drug spill kit; and disposable masks, caps, gowns, and gloves.

(4)           In addition to the requirements of Rule .1601(a)(3) of this Chapter, a permit-holder dispensing sterile pharmaceuticals shall have in its reference library the following reference materials: Handbook on Injectable Drugs (ASHP); King's Guide to Parenteral Admixtures; American Hospital Formulary Service; and Procedure for Handling Cytotoxic Drugs (ASHP).

 

History Note:        Authority G.S. 90‑85.6;

Eff. October 1, 1990;

Amended Eff. April 1, 2003; September 1, 1995.