The characteristics described below for low-risk, medium-risk, and high-risk CSPs are intended as a guide to the breadth and depth of care necessary in compounding, but they are neither exhaustive nor prescriptive.
The licensed health care professionals who supervise compounding are responsible for determining the procedural and environmental quality practices and attributes that are necessary for the risk level they assign to specific CSPs.
A written quality assurance procedure includes the following in-process checks that are applied, as is appropriate, to specific CSPs: accuracy and precision of measuring and weighing; the requirement for sterility; methods of sterilization and purification; safe limits and ranges for strength of ingredients, bacterial endotoxins, particulate matter, and p H; labeling accuracy and completeness; beyond-use date assignment; and packaging and storage requirements.
The dispenser shall, when appropriate and practicable, obtain and evaluate results of testing for identity, strength, purity, and sterility before a CSP is dispensed.
Compounding supervisors shall ensure through either direct measurement or appropriate information sources that specific CSPs maintain their labeled strength within monograph limits for USP articles, or within 10% if not specified, until their beyond-use dates.
All CSPs are prepared in a manner that maintains sterility and minimizes the introduction of particulate matter.
These risk levels apply to the quality of CSPs immediately after the final aseptic mixing or filling or immediately after the final sterilization, unless precluded by the specific characteristics of the preparation, such as lipid-based emulsions where administration must be completed within 12 hours of preparation.
Sterile adhesive seals are aseptically affixed to the rubber closures on the three filled vials, then the vials are incubated as described in the This, or an equivalent test, is performed under conditions that closely simulate the most challenging or stressful conditions encountered during compounding.
For a summary of the criteria according to risk levels, please see the This, or an equivalent test, is performed at least annually by each person authorized to compound in a low-risk level under conditions that closely simulate the most challenging or stressful conditions encountered during compounding of low-risk level CSPs.
Once begun, this test is completed without interruption.
Sterilization of high-risk level CSPs by filtration is conducted entirely with an ISO Class 5 or superior air quality environment (see Quality assurance procedures for high-risk level CSPs include all those for low-risk level CSPs.
In addition, a media-fill test that represents high-risk level compounding is performed semi-annually by each person authorized to compound high-risk level CSPs.