Pharmacy OneSource Blog

Reviewing the Proposed Changes to USP Chapter 797 and its Impact on Pharmacy

Posted on 10/12/16

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Regulatory entities are continuing to review pharmacy compounding facilities, ensuring that proper practices are followed. In addition to increased scrutiny, existing regulations have been reevaluated to provide a higher level of detail for compounding staff to follow.

As the USP Compounding Expert Committee finalizes revisions to USP Chapter 797, those involved in compounding sterile preparations can expect more focus on quality assurance and control activities to achieve and maintain a proper state of control, according to Eric S. Kastango, MBA, RPh, FASHP.1

Some of the specific changes anticipated:

  • Changes to the placement of primary engineering controls
  • Frequency of environmental sampling including viable air sampling and surface sampling
  • Frequency of staff testing including media fills and gloved fingertip testing
  • Limitation on beyond-use dating to no more than 42 days if refrigerated, 45 days if frozen
  • Switching from three standard risk levels (low, medium and high) to two neutral categories (Category 1 and Category 2)
  • Allows low-risk compounding activity like reconstitution of vials to be done in uncontrolled environments if aseptic technique is followed

What is the impact of these proposed changes? For facilities already in compliance with current Chapter 797 standards, the changes to environmental sampling frequencies may make organizations consider whether to bring compounding back under pharmacy responsibility, according to Kastango. Hospital pharmacies may currently subcontract viable air sampling to certifiers who test during the certification of the primary and secondary engineering controls. But if the frequency of air sampling techniques increases, hospitals may consider purchasing a volumetric air sampler and other appropriate equipment, implement proper training, and conduct this testing on their own. 

Facilities that have not achieved compliance with USP 797 yet can get started with implementing compliant practices that follow the current chapter. Proper employee garbing, robust hand hygiene, and cleaning and disinfecting procedures can be integrated into workflows at a low cost. Patients are at risk when facilities are not following proper techniques, and staff may even be legally accountable for harm resulting from non-compliance. 

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References

  1. Kastango, E. “The Upcoming USP <797> Revision.” Pharmacy Purchasing & Products. April 2016, Vol. 13 (4). http://www.pppmag.com/article/1844

Topics: Sterile Compounding

About the Author

Deb Oroszlan is the Marketing Director for Pharmacy OneSource - Wolters Kluwer.