Idaho Admin. Code r. 24.36.01.702 - HAZARDOUS DRUGS PREPARATION

In addition to all other applicable rules in this chapter, including the rules governing Compounding Drug Preparations and Sterile Preparation, these rules apply to all persons, including any business entity, engaged in the practice of compounding or sterile prepackaging with hazardous drugs. Such persons must:

01. Ventilation. Ensure the storage and compounding areas have sufficient general exhaust ventilation to dilute and remove any airborne contaminants.

02. Ventilated Cabinet. Utilize a ventilated cabinet designed to reduce worker exposures while preparing hazardous drugs.

a. Sterile hazardous drugs must 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;

b. When asepsis is not required, a Class I BSC, powder containment hood or an isolator intended for containment applications may be sufficient.

c. A ventilated cabinet that re-circulates air inside the cabinet or exhausts air back into the room environment is prohibited, unless:

i. The hazardous drugs in use will not volatilize while they are being handled; or

ii. Written documentation from the manufacturer attesting to the safety of such ventilation.

03. Clear Identification. Clearly identify storage areas, compounding areas, containers, and prepared doses of hazardous drugs.

04. Labeling. Label hazardous drugs with proper precautions, and dispense them in a manner to minimize risk of hazardous spills.

05. Protective Equipment and Supplies. Provide and maintain appropriate personal protective equipment and supplies necessary for handling hazardous drugs, spills and disposal.

06. Contamination Prevention. 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 unit-of-use packaging.

07. Compliance With Laws. Comply with applicable local, state, and federal laws including for the disposal of hazardous waste.

08. Training. 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.

09. Policy and Procedures Manual. Maintain a policy and procedures manual to ensure compliance with this rule.

Notes

Idaho Admin. Code r. 24.36.01.702

Effective March 28, 2023