This section shall apply to all persons engaged in the practice of compounding or sterile prepackaging with hazardous drugs. Such persons shall:

1. (1) Ensure the storage and compounding areas have sufficient general exhaust ventilation to dilute and remove airborne contaminants;

2. (2) Utilize a ventilated cabinet designed to reduce worker exposures while preparing hazardous drugs. Sterile hazardous drugs shall be prepared in a dedicated class II biological safety cabinet or a barrier isolator of appropriate design to meet the personnel exposure limits described in product material safety data sheets. When asepsis is not required, a class I biological safety cabinet, powder containment hood or an isolator intended for containment applications may be sufficient. A ventilated cabinet that re-circulates air inside the cabinet or exhausts air back into the room environment is prohibited unless:

   1. (a) The hazardous drugs in use will not volatilize while they are being handled; or
   2. (b) Written documentation from the manufacturer is provided attesting to the safety of such ventilation.
3. (3) Clearly identify storage areas, compounding areas, containers, and prepared doses of hazardous drugs;
4. (4) Label hazardous drugs with proper precautions, and dispense them in a manner to minimize risk of hazardous spills;
5. (5) Provide and maintain appropriate personal protective equipment and supplies necessary for handling hazardous drugs, spills, and disposal;
6. (6) Unpack, store, prepackage, and compound hazardous drugs separately from other inventory in a restricted area in a manner to prevent contamination and personnel exposure until hazardous drugs exist in their final unity-of-use packaging; and
7. (7) Ensure that personnel working with hazardous drugs are trained in hygiene, garbing, receipt, storage, handling, transporting, compounding, spill control, clean up, disposal, dispensing, medical surveillance, and environmental quality and control.

[54-1767, added 2025, ch. 93, sec. 45, p. 439.]