Refrigerated injectables must be maintained at a temperature of 34 to 38 degrees Fahrenheit, until ready for use. The refrigerator is inside the IV preparation room.
Considering this, how do you do fingertip 797?
Accordingly, how many times must negative gloved fingertip sampling be demonstrated?
Successfully complete gloved fingertip and thumb sampling on both hands, no fewer than 3 separate times. After the initial competency evaluation, compounding personnel must successfully complete gloved fingertip and thumb sampling at least every 12 months.
What are the requirements of USP 797?
Other important elements of personnel training for USP 797 include:
- Antiseptic hand washing.
- Disinfection of nonsterile compounding areas.
- Proper measurement and identification of ingredients.
- Proper aseptic handling of products.
- Sterilization of high risk CSPs.
- Proper labeling and packaging of CSPs.
What are the three steps taken to comply with USP 797?
Step 1 of the new training program included an in-person, interactive training course reviewing pertinent information from USP Chapters 797 and 800, such as the importance of sterility, aseptic technique, quality assurance, and the handling of HDs, as well as hands-on practice.
What is an immediate use CSP?
The immediate-use provision allows for the preparation and dispensing of compounded sterile products (CSPs) without the need to be in compliance with USP <797> requirements such as ISO Class 5 hood or isolator, facility design, environmental controls, personnel cleansing and garbing.
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 difference between USP 795 and 797?
Chapter 795 focuses on applying good compounding practices to the process of preparing nonsterile compounded formulations, while Chapter 797 provides procedures and requirements for compounding sterile preparations.
What is the difference between USP 797 and USP 800?
The purpose of USP 797 is a general protection of sterile compounds and spaces from contamination. USP 800 expands controls for the protection of workers and environments against hazardous drug compounds.
What is the main purpose of USP 797?
The purpose of USP Chapter <797> Pharmaceutical Compounding is to provide standards for the protection and safety of patients and healthcare workers involved in sterile compounding preparations such as pharmacists, nurses, physicians and pharmacy technicians by reducing the potential for microbial contamination caused …
What is the minimum amount of time that a BSC must be turned on prior to compounding?
A BSC must be turned on at least 10 minutes before use.
Why is USP 800?
USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.