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RISK LEVEL ASSESSMENT

The first step in complying with USP <797> is to assess the risk level, or likelihood of contamination, of the compounding done at the pharmacy. There are three levels of risk: low, medium, and high. Most pharmacies perform low- and medium-risk level compounding.

While USP <797> includes guidelines for assessing risks, these guidelines have been deliberately left general and flexible. As a pharmacist, you are ultimately responsible for determining risk levels, combining USP <797>'s Risk Level Assessment Checklist with your own knowledge and professional judgment. The only exception to this flexibility is that CSPs prepared from bulk, non-sterile components are always a high-level risk.

Below is a description of the three risk levels, including definitions, specific examples, and quality assurance procedures.

Low-Risk Level

Low-risk level compounding occurs in an ISO Class 5 environment and involves only a few basic, closed-system steps. Specific examples include the following:

• Reconstituting single-dose vials of antibiotics
• Preparing hydration solutions
• Compounding CSPs from sterile commercial drugs using commercial sterile devices

Quality assurance procedures at this level include:

• Routine disinfection and air quality testing to maintain an ISO Class 5 environment
• Adequate safety clothing
• Component review before and after compounding
• Final visual inspection of each sterile preparation

At this level, you also need to complete an annual media-fill test.

Medium-Risk Level

Medium-risk level compounding involves complex procedures that may occur over a prolonged period of time. It also includes using pooled sterile commercial products for multiple patients, or for one patient multiple times.

Specific examples include the following:

• Chemotherapy or pain management administered by an infusion device
• Pooled admixtures
• Batched antibiotics
• Parenteral nutrition solutions using automated compounders
• Batch-compounded preparations that do not contain bacteriostatic components

The same quality assurance procedures apply to the medium-risk level as to the low-risk level. However, you must undergo a more challenging annual media-fill evaluation that simulates the most challenging, stressful conditions.

High-Risk Level

High-risk level compounding occurs when:

• CSPs are prepared from non-sterile ingredients
• CSPs are prepared from sterile ingredients, but the environment is not ISO Class 5
• More than six hours passes between compounding and sterilization
• The purity of compounds is not verified by documentation

Specific examples include the following:

• Preparing CSPs from bulk, non-sterile components, such as morphine (always high-risk)
• Using final containers that are non-sterile and must be terminally sterilized

The same quality assurance procedures apply to the high-risk level as to the low- and medium-risk levels. In addition, at this level, you must undergo a semi-annual media-fill evaluation that simulates the most challenging, stressful conditions and uses dry, non-sterile media verification.