What are standards for an immediate use CSP?
IMMEDIATE USE— CSPs must meet ALL of the following conditions. Unless required for preparation, the prep procedure occurs continuously AND does not exceed 1 hour. exposed to contact contamination. Administration begins NO MORE than one hour following the START of preparation of the CSP.
How long must an acceptable hand washing take place to comply with USP 797?
30 seconds
Wash hands and forearms up to the elbows with soap and water for at least 30 seconds.
Is USP 797 enforceable?
This updated guidance supersedes previous statements released by The Joint Commission related to medication compounding. On March 12, 2020, USP published that the 2019 revision of USP 797 was remanded as a result of a final appeal hearing. Therefore, the 2019 revision of USP 797 is no longer enforceable.
Is USP 797 required?
To achieve the safety goals of USP <797>, it is necessary for hospitals and other facilities to perform a gap analysis by reviewing the procurement, storage, handling, compounding, and administration of drugs, as well as the design of the cleanroom where compounding takes place, the equipment used, operational …
How long should hands be washed with antimicrobial soap with antiseptic activity and water?
20 seconds
Scientific studies show that you need to scrub for 20 seconds to remove harmful germs and chemicals from your hands. If you wash for a shorter time, you will not remove as many germs. Make sure to scrub all areas of your hands, including your palms, backs of your hands, between your fingers, and under your fingernails.
What does USP 797 cover?
USP 797 is the standard in place governing the sterile preparation of compounded pharmaceuticals. USP 797 covers the compounding of both hazardous and nonhazardous drugs with a focus on the protection of sterile compounds and environments from contamination.
Does USP 800 replace USP 797?
The updated USP 797 and new USP 800 standards may require both design and process changes. USP 797 provides standards for compounding of sterile preparations while USP 800 provides standards for the safe handling of HDs to minimize exposure risks.
Who does USP 797 apply to?
USP <797> explicitly states that the standards do apply to all places where CSPs are prepared, including physicians’ practice facilities. Enforcement most likely falls under state agencies, such as state boards of pharmacy, state boards of medicine, and state departments of health.
What is the purpose of USP 797?
Remove outer garments and jewelry,makeup,including earbuds and headsets
What effect does USP 797 have on pharmacies?
USP chapter 797 has also had a significant effect on high-risk compounding procedures. The standards for compounding high-risk preparations are much more stringent than those for low- and medium-risk preparations.
What are the differences between USP 795, 797, and 800?
Falck K,Gröhn P,Sorsa M,Vainio H,Heinonen E,Holsti LR.
What are the USP 797 guidelines?
– Replacement Filters. Filters are what keep the air in a cleanroom clean. – Gowning Materials. – Cleanroom Cleaners.