Usp 797 medium risk beyond use dating
Upgrade Your Browser We no longer support this version of your browser.We recommend that you upgrade to the latest version of Internet Explorer, Firefox, Chrome or Safari to improve your security and experience using this website.The risk levels and requirements for each are summarized in Online Table 1.Table 1: USP BUD = beyond use date; ISO = International Organization for Standardization; TPN = total parenteral nutrition.Despite the lack of direct oversight of areas that carry out immediate use compounding, pharmacy departments can increase their contribution to ensure that best practices are met by addressing a variety of requirements.In 2007, the Centers for Disease Control and Prevention published a guideline for preventing transmission of infectious agents in the health care setting.
A study evaluating the incidence of microbial contamination of CSPs evaluated 3 testing environments: an ISO class 5 horizontal laminar-airflow hood in an ISO class 6 cleanroom, an ISO class 7 drug preparation area in an operating room, and an uncontrolled decentralized pharmacy on a ward.
While the safety of compounded sterile preparations (CSPs) has been an important topic in the practice of pharmacy for decades, the recent tragic deaths related to fungal contamination of preservative-free methylprednisolone injection have once again put the topic on the national stage.
In light of this call to ensure patient safety, hospital pharmacies have been evaluating their use of outsourcing and their own compliance with United States Pharmacopeial Convention (USP) chapter Microbial contamination of CSPs can occur in any practice setting and puts patients at risk of significant morbidity and mortality.
It is important to note that some CSPs are prepared and administered in clinics, at the bedside, in procedural areas, and in operating rooms with little direct pharmacy oversight.
While quality and safety programs exist within other health care professions, pharmacy knowledge and involvement in these activities ensures compliance with best practices and also provides an opportunity for pharmacy to take ownership of the complete medication use process.