Compounding of Hazardous Drugs

Subject to modification by the VTH Director without approval.

Policy

This policy intends to provide the procedure for compounding sterile and non-sterile hazardous drugs and chemicals (which may include chemotherapy, antiviral drugs, hormone therapy, some bioengineered drugs, and miscellaneous). This policy applies to healthcare personnel approved for the compounding of hazardous drugs.

Entity and personnel involved in compounding hazardous drugs must be compliant with appropriate USP standards for compounding, including USP 795, USP 797, and USP 800, as well as any applicable draft guidance for industry or compliance policy guides that are released.

Guidelines

1. Compounding must be done within proper engineering controls.
2. Disposable or cleaning equipment for compounding must be dedicated for use with HDs (such as mortars & pestles, counting trays, and spatulas) and be cleaned accordingly.
3. Appropriate PPE must be worn when handling and compounding according to activity.

Procedure (if applicable)

1. When manipulating hazardous drugs, such as cutting or crushing tablets or opening a capsule, appropriate PPE must be donned and protective measures must be used in order to contain and protect from any dust or particles generated.
2. Compounding non-sterile hazardous drugs will be done in the non-sterile compounding room with required PPE (N95 and gloves). Non-sterile compounded hazardous drugs prepared in the Dispensary include the following: Tylosin capsules, Sotalol capsules, Sotalol oral suspension, and Mycophenolate oral suspension. In the VTH Dispensary, we do not compound non-sterile HDs from bulk chemicals or Class 1 HDs.
3. A sink and eyewash station is available for emergency access to water for the removal of hazardous substances from skin and eyes. A shower is also available for spills of larger amounts.
4. When compounding sterile hazardous drug preparations in a C-PEC, a plastic-backed preparation mat should be placed on the work surface of the C-PEC. The mat should be changed immediately if a spill occurs, or every 30 minutes during use, and should be discarded at the end of the activity. For appropriate PPE based on the activity, follow the chart below.

Definitions (if applicable)

• CTSD : Closed System Transfer Device
  • Drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside the system
• PPE : Personal Protective Equipment
• USP : United States Pharmacopeia
• BSC : Biological Safety Cabinet
• C-PEC : Containment Primary Engineering Control
• CACI : Compounding Aseptic Containment Isolator
• HD : Hazardous Drug

Veterinary Teaching Hospital (VTH): The collective clinical services of the Large Animal Clinic, Midwest Equine, the Small Animal Clinic, and the Veterinary Medicine South Clinic.