Elevating Healthcare: USP <797> Unveils New Standards for Sterility Assurance

USP <797> has been the guiding standard for pharmacies, hospitals, and healthcare facilities across the United States. Its mission? Ensuring that compounded sterile preparations (CSPs) are prepared and maintained to prevent harm to patients due to microbial contamination.

The arrival of new medications, evolving technology, and advanced research have all contributed to the need for a revamped USP <797>. On November 1, 2023, more rigorous standards for testing and maintaining sterility went into play for any facility that provides CSPs. What’s new in this updated revision?

  • Enhanced Sterility Assurance: The revised USP <797> raises the bar on sterility assurance, demanding stricter measures to prevent contamination and ensure safety.
  • Harnessing Cutting-Edge Technology: It’s not just about “what” but “how.” The new USP <797> embraces modern technology, promising more precise, efficient, and reliable methods for microbial control.
  • A Risk-Based Approach: One size doesn’t fit all. The revision introduces a risk-based approach, allowing tailored testing protocols based on different preparations’ unique characteristics and risks.
  • Quality Control Evolution: Quality control becomes more robust and integrated, promising uncompromising standards throughout the compounding process.

The changes are intended, above all else, to improve patient safety. Embrace the changes, and if you ever need guidance, Biolog Lab Services is your partner in navigating the updated requirements for sterility assurance. Reach out to us today and discover how we can assist you in ensuring your CSPs and your lab are meeting the highest quality and safety standards. Find out more about our Lab Services offerings to comply with USP <797>.