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What is a "Compounded Sterile Preparation" According to USP Chapter 797?

USP Chapter 797 deals with policies and practices for compounding sterile preparations safely and without contamination. A compounded sterile preparation (CSP) is a dosage unit that:

• Is prepared according to the manufacturer's labeled instructions
• Contains non-sterile ingredients or uses non-sterile components or devices that need to be sterilized before use
• Is a biologic, diagnostic, drug, nutrient, or pharmaceutical that matches either of these characteristics

Examples include baths and soaks for live organs and tissues, implants, inhalations, injections, powder for injection, irrigations, metered sprays, and ophthalmic and otic preparations.

USP 797 includes specific information about preparing, storing, and administering CSPs. Sections include -

• Microbial risk levels
• Expiration dating
• Packaging, chemical stability, and product integrity
• Validations and media fills
• Compounding accuracy

Microbial Risk Levels

USP 797 assigns each CSP to one of three potential contamination risk levels: low, medium, or high. The risk level a CSP is assigned to depends on its compounding environment; its potential for microbial, chemical, and physical contamination; and the nature of production of the CSP (for example, using automated filling equipment or reservoirs of injection and infusion devices).

Below are examples of the three risk levels for CSPs:

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

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

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

Expiration Dating

Expiration dating refers to how long a CSP can be stored and at what temperature.

Packaging, Chemical Stability, and Product Integrity

This section of USP 797 requires that the packaging selected for CSPs is appropriate to preserve its sterility and strength until the beyond-use date.

Validations and Media Fills

USP 797 outlines different media-fill procedures that compounding professionals can perform at their facilities, depending on the risk category of the CSP.

Compounding Accuracy

USP 797 also sets requirements for compounding accuracies. Automated-filling machines must be carefully calibrated and fill volumes verified.