Usp 797 medium risk beyond use dating

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.

Thus, access to pharmacy services 24 hours a day, 7 days a week is essential to providing safe, high-quality patient care.

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Usp 797 medium risk beyond use dating

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 9-year tenure of USP some of these practices persist as a result of their past success, convenience, and the comfort level of health care personnel.

As owners of the medication use process, pharmacists should continue to work with their colleagues in other professions involved in the preparation and administration of sterile products to ensure that immediate-use practices are not only compliant with the national standard, but also that they are accurate, cost-effective, and safe for the specific patient population in question.

Risk of Microbial Contamination While the benefit of bedside preparation of agents clearly outweighs the risk in certain situations, there appears to be a greater risk of microbial contamination in syringes prepared in patient care areas.

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.

This guideline identified areas of injection practice that posed the greatest risk for infection transmission.

The recommendations are listed in Online Table 2 and focus mainly on preventing the reuse of syringes/cannulas/needles and the primary use of single-dose and single-patient vials.

Only low-risk compounding may occur under these circumstances, and the product must be administered within 1 hour.

A pharmacist is not required to verify the sterility, stability, or accuracy of the final product.

The publication of the USP in 2004 represents the first official enforceable standard for sterile compounding in the United States.

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