What does it mean to be USP 797 compliant?
USP <797>, from the United States Pharmacopeia, is a set of enforceable sterile compounding standards. It applies to compounding pharmacies and facilities involved in the preparation of compounded sterile preparations (CSPs).
What is the difference between USP 797 and USP 800?
USP 797 provides standards for compounding of sterile preparations while USP 800 provides standards for the safe handling of HDs to minimize exposure risks. USP 797 promotes the protection of the sterility of the drug, while USP 800 is focused on the safety of personnel who come in contact with the HDs.
Why is USP 800?
Considering the potential impact on health and safety, the purpose of USP <800> is to define standards for handling hazardous drugs (HDs) and to help promote patient, worker and environmental protection.
When did USP 797 go into effect?
On January 1, 2004, the first version of USP Chapter <797>, Pharmaceutical Compound- ing: Sterile Preparations became official,1 which details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all prac- tice settings in which sterile preparations are …
What is the current version of USP 797?
The currently official <797>, last revised in 2008, remains official. On June 1, 2019, USP published revisions to General Chapter <795> for nonsterile compounding and General Chapter <797> for sterile compounding, as well as a new General Chapter <825> for radiopharmaceuticals.
What are the USP 797 guidelines?
– Replacement Filters. Filters are what keep the air in a cleanroom clean. – Gowning Materials. – Cleanroom Cleaners.
What are the differences between USP 795, 797, and 800?
Falck K,Gröhn P,Sorsa M,Vainio H,Heinonen E,Holsti LR.
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 is the purpose of USP 797?
Remove outer garments and jewelry,makeup,including earbuds and headsets