Usp 797 medium risk beyond use dating
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Experiences, case studies and news about infection prevention and control. The full list of FAQs is available here. With the current high demand for compounded medication, are there interim guidelines an organization can follow for sterile compounding while remaining compliant with Joint Commission medication management requirements? Organizations may utilize these guidelines and remain in compliance with Joint Commission standards until the state of emergency has been lifted at the regional, state or national level. For low and medium-risk level compounded sterile preparations CSPs prepared in a segregated compounding area, apply BUDs conservatively, not to exceed:.
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Sterile Compounding Considerations During COVID-19
Key Points to Consider From USP
A multi-dose vial is a vial of liquid medication intended for parenteral administration injection or infusion that contains more than one dose of medication. Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices. Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should only be kept and accessed in a dedicated clean medication preparation area e. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters an immediate patient treatment area, it should be dedicated for single-patient use only.
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Update on Medication Compounding Compliance
Considerations include the microbiological risk level, storage temperature, chemical stability, batch size, and whether or not a sterility test will be performed. The United States Pharmacopeia Chapter provides guidance on the maximum beyond-use date allowed solely based on the microbiological risk level associated with the compounding of a sterile preparation. Compounders should select the shortest beyond-use date between the risk-level based beyond-use date and the chemical stability of the compound. When compounding pharmacists intend to provide a compounded sterile preparation with a beyond-use date that exceeds the risk-level based recommendations in United States Pharmacopeia Chapter , they must ensure that their formulations are sterility tested in compliance with United States Pharmacopeia Chapter.
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. 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. Prior to its publication, there was little monetary or official support for pharmacies looking to improve their compounding processes, despite thousands of cases of septicemia from exposure to compounded intravenous IV from the s on.