Deciphering the Levels of Containment for Non-Sterile Compounds
Does your pharmacy require Level A, B, or C containment?
- The first step to evaluate the required level of containment is to reference the NIOSH Hazardous Drugs List and review the Safety Data Sheets for the Active Pharmaceutical Ingredient(s) (APIs) with which you compound.
- Once you have determined which of your APIs are hazardous (NIOSH and/or WHMIS hazards), a risk assessment must be undertaken to identify the appropriate level of containment to minimize contamination of each compounded product and to provide adequate protection for personnel.
- Please note: Hazardous drugs which are classified by NIOSH as Group 1 require Level C containment and are not eligible for an assessment of risk.
Important: In Alberta, where there is uncertainty as to the level of risk, the higher standard must be adhered to.
- Simple and moderate compounds as defined in USP
||Separate space designated for compounding
- Complex compounds defined in USP 795
- Complex and small quantities of ingredients/preparations which require ventilation
||Separate well-ventilated room
Larger workspace and appropriate equipment
Environment conducive to little or no interruptions
May require a ventilated containment device when certain powders, aromatic products or hazardous products are compounded
- Hazardous drugs which are classified by NIOSH as Group 1
- Hazardous material classified by NIOSH as a health hazard, such as those very irritating to the respiratory tract, the skin, and the mucous membrane
- NIOSH group 2 and 3 drugs where large quantities of APIs are used routinely
Well-ventilated with appropriate air exchange, negative pressure
Appropriate containment device (C-PEC) for materials being compounded
Standards for Pharmacy Compounding of Non-Sterile Preparations
Guidance Document for Pharmacy Compounding of Non-sterile Preparations