Knowing the level of risk corresponding to each compounded preparation is important because different rules apply to the compounding process depending on the level of risk.
Here’s a quick guide to the types of situations that fall under each level of risk--low, medium or high--according to USP 797.
Prior to its publication, there was little monetary or official support for pharmacies looking to improve their compounding processes, despite thousands of cases of septicemia from exposure to compounded intravenous (IV) from the 1970s on.
into state legislation and adoption of a policy of enforcement by the Joint Commission encouraged swift action and compliance on the part of hospitals and pharmacies across the country.
The intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs.
The quality control and testing for CSPs in this chapter are appropriate and necessary.
It also covers manually mixing and measuring up to three manufactured products to create a CSP or nutritional solution.
Medium-risk conditions—If you compound or pool multiple doses of sterile products for administration to multiple patients or to a single patient on multiple occasions and the compounding process involves more than single volume transfer or takes a long time (such as complete dissolution or homogenous mixing), the process will usually be considered medium-risk.
The revised chapter describes all the applicable standards for Category 1 and 2 CSPs.
Without performing a sterility test, CSPs should not be stored longer than 48 hours at a controlled room temperature, 14 days in refrigerated settings or 45 days if frozen solid at -20 degrees Fahrenheit or colder.
Low-risk compounding includes using sterile needles and syringes to transfer sterile liquids from manufacturer-sealed ampules or vials to sterile devices or other sterile packages.
Greater care is required for aqueous injections that are compounded sterile preparations (CSPs)the most common CSPs used in therapy.
Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are issues of nonsterility and large errors in ingredients.