Posted on September 30, 2015
In the eight years since the publication of the last revision of USP Chapter 797, the regulatory environment surrounding compounding sterile products (CSPs) has changed dramatically. All but two states now require compliance with USP 797 or with similar regulations and many regulatory organizations have actively undertaken inspection of pharmacies for compliance.
More change is on the horizon. An update to the chapter could make some significant modifications in the sterile compounding process and facility requirements and compounding pharmacists will want to stay aware of the pending changes and perhaps influence them during the revision process.
On October 16, pharmacists and others involved in CSPs can learn more about the proposed changes in a webinar led by Eric Kastango, MBA, BSPharm, FASHP, a compounding pharmacist who has served on the USP Sterile Compounding Committee and USP Council of Experts; and Tony Cundell, PhD, a microbiologist and member of the 2015-2020 USP Microbiology Committee of Experts. They will provide a cross-walk of the current chapter to the proposed revisions and discuss the implications of the changes for all those involved in compounding and compliance.
The revision process for USP 797 began in 2010 with the formation of the 2010-2015 Council of Experts, on which Mr. Kastango served. The council included a wide range of individuals involved in the CSP process from compounding pharmacists to educators, infection control specialists, microbiologists, environmental engineers and others. Together, they have provided expertise to help guide revisions that reflect current science, respond to stakeholder input, and increase the clarity of the chapter.