What is considered low-risk compounding?
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. It also covers manually mixing and measuring up to three manufactured products to create a CSP or nutritional solution.
What is considered medium risk compounding?
Medium Risk Level Compounding: Products are compounded with aseptic manipulations entirely within an ISO Class 5 or better air quality device, usually within an ISO Class 7 environment, using sterile products, components, and devices.
What is a low-risk CSP?
Low-Risk Conditions— The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 (see Table 1) or better air quality using only sterile ingredients, products, components, and devices.
What is the current USP 797?
It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP <797> describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.
What is the medium risk?
More Definitions of Medium risk Medium risk means the risk of non-compliance is above normal.
What is Category 2 CSP?
A Category 2 CSP is defined as: “A CSP that is assigned a BUD of greater than 12 hours at controlled room temperature or greater than 24 hours refrigerated that is compounded in accordance with all applicable requirements for Category 2 CSPs in this chapter.” The vast majority of compounding pharmacies will be …
What is the beyond use date of the low risk level compounded sterile preparations?
Q: What purpose does the beyond-use date of a compounded sterile prepa- ration (CSP) serve? A: A CSP’s beyond-use date identifies the time by which the preparation – once mixed – must be used before it is at risk for chemical degradation, con- tamination, and permeability of the packaging.
What is CSP in compounding?
tients receive compounded sterile preparations (CSPs) that. are stored for extended periods before use. It has long been. recognized that extended storage of CSPs may allow for the.
What is a low risk?
1 : not likely to result in failure, harm, or injury : not having a lot of risk low-risk investments. 2 : less likely than others to get a particular disease, condition, or injury low-risk patients.
What is a low level of risk?
Low Risk: A hazardous condition is unlikely to cause accidents, and even if it does, results in only negligible damage. So Risk is a combination of Probability and Severity.
What is the medium risk level of compounding?
Medium Risk Level Compounding: Products are compounded with aseptic manipulations entirely within an ISO Class 5 or better air quality device, usually within an ISO Class 7 environment, using sterile products, components, and devices.
What makes a compound a high risk compound?
High-risk compounding would include making a solution that will be terminally sterilized from non-sterile bulk drug or nutrient powders or measuring or mixing sterile ingredients in a non-sterile device prior to sterilization. References: <797>ASHP Guidelines on Compounding Sterile Preparations (2014).
What makes a CSP a medium risk use?
MEDIUM-RISK USE — CSPs must meet ALL of the following conditions Compounded in an ISO Class Five environment and prolonged and complex mixing or transfer or more than three sterile products and entries into any container OR pooling ingredients from multiple sterile products to prepare multiple CSPs
How long can you store high risk compounded products?
In the absence of passing a sterility test, high risk compounded sterile products cannot be stored for more than 24 hours at controlled room temperature, more than three days in cold temperatures or for more than 45 days if frozen solid and held at -20 degrees Fahrenheit or less. Special care must be taken in high-risk compounding.