In this episode of Visante Innovators, Jim Jorgenson talks with Pharmacy Stars CEO Keith Streckenbach. Keith is an innovator in sterile drug compounding and passionate about helping pharmacies reach their compliance goals and meet increasingly complex standards.
With USP Chapters 797 and 800 becoming compendial, and therefore enforceable by boards of pharmacy or other regulatory agencies, quickly reaching compliance with these standards is critical. Keith and Jim discuss how to assess your situation and design a compliance roadmap, and where to go for the most helpful resources.
They also cover some of the more challenging aspects of 797 and 800 compliance, how to handle workforce challenges and staying on top of cybersecurity issues. Listeners will be interested to hear about what Jim and Keith see for the future of compliance in this area, such as more frequent use of Current Good Manufacturing Practice (CGMP) standards.