State Regulations Impact USP 797 Compliance

State Regulations Impact USP <797> Compliance

Kate Douglass, Eric S. Kastango, MBA, RPh, Peter Cantor

April 2012 : State of Pharmacy Compounding - Vol. 9 No. 4 - Page #18

The inaugural USP Chapter <797> Compliance Study was published in the October 2011 issue of Pharmacy Purchasing & Products and is available online at www.pppmag.com/ComplianceStudy . The comprehensive results from this survey not only provide data to measure the success of pharmacies’ efforts in complying with sterile compounding requirements, but also offer access to the tools necessary to continually improve sterile compounding practices. Though deciphering
differences in overall compliance scores based on certain variables was not one of the stated purposes of the USP <797> Compliance Study, upon review and analysis it was observed that statistically significant differences existed in compliance scores based upon state regulatory status.

Compliance Study on Sterile Compounding Practices Calls for Participants

From the National Association of Boards of Pharmacy website dated May 16, 2012:

Compliance Study on Sterile Compounding Practices Calls for Participants

May 16, 2012 03:00 PMTopics: Compounding, Patient Safety

Sterile compounding facilities are invited to participate in the 2012 USP 797 Compliance Study, a National Study of Sterile Compounding Practices, co-directed by sterile compounding experts, Eric Kastango, RPh, MBA, FASHP, and Kate Douglass, MS, RN, APN,C, CRNI. The study is now open and will remain open through June 30, 2012. The study, first conducted in 2011, is the largest and most comprehensive study of 797 compliance ever undertaken in the US, as noted in an announcement from CriticalPoint. After this year, the study team plans to repeat the study again one year after the US Pharmacopeial Convention (USP) Expert Committee makes final the newest changes to the chapter, expected in late 2013. It is hoped that the information and insights gained from this study will assist in benchmarking progress and identifying where additional resources and focus are required to continue to improve sterile compounding practice and patient safety. More information and a link to participate in the study are available at www.797study.com (Survey Code B797A). Questions may also be directed to the study team by calling 240/238-4352. The results of the study will be published this fall in Pharmacy Purchasing & Products Magazine.