For pharmacy leaders, USP <797> compliance is an ongoing commitment, made more complex by standards that continuously evolve. Staying ahead of these changes is essential for upholding quality and safety, requiring a strategy that integrates new requirements into daily practice. Our guide cuts through the complexity, offering a practical roadmap to the key focus areas and common pitfalls of the latest <797> revisions.
USP <797> compliance focus areas
In this guide, Wolters Kluwer’s pharmacy compliance experts break down five specific focus areas that are essential for applying USP <797> standards effectively and identifying gaps in your current operations:
- Scope: Clarify what qualifies as sterile compounding and determine the categories of Compounded Sterile Preparations (CSPs) your facility prepares.
- Personnel: Ensure staff meet documented competency and training requirements for their specific roles.
- Facility: Learn the design and maintenance standards for cleanrooms and segregated compounding areas to maintain aseptic conditions consistently.
- CSPs: Apply appropriate components, beyond-use dates (BUDs), and verification processes to ensure preparation quality.
- Documentation: Implement documentation for Master Formulation Records (MFR) and Compounding Records (CR) to support release testing and quality assurance.
Avoid common compliance pitfalls
This guide also highlights common missteps in USP <797> compliance and provides clear actions to correct them. You will learn why you shouldn't:
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Rely on <797> standards alone without consulting state laws.
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Generalize training requirements for different staff roles.
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Install or relocate Primary Engineering Controls (PECs) without evaluating airflow dynamics.
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Assign beyond-use dates without considering both stability and sterility factors.
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Underestimate the importance of meticulous documentation for every single process.
