Tag Archives: Regulation
Building a sterile compounding space in California – Regulatory Hurdles
For almost a year, I’ve been working as a ‘Pharmacy Project Manager’ on a large healthcare system project to bring all their pharmacy sterile compounding spaces — a.k.a. Cleanrooms, SCA’s, C-SCA’s, etc. — into compliance with USP General Chapters <797> … Continue reading
Compounding Today: state board of pharmacy concerns with USP <800>
Each Friday the CompoundingToday Newsletter faithfully appears in my inbox. The newsletter features commentary by Lloyd V. Allen, Jr., Ph.D., RPh, Editor-in-Chief of the International Journal of Pharmaceutical Compounding. Dr. Allen is a legend in the pharmacy compounding world for … Continue reading
Three concepts that create a lot of confusion: stability, beyond-use date, expiration
The differences between stability, beyond-use date (BUD), and expiration for compounded sterile preparations (CSPs) causes a lot of confusion. I’m not even certain that I fully understand their roles in day to day pharmacy operations. With that said, I think … Continue reading
Will the revised USP Chapter 797 include recommendations for automation and technology?
Whether or not future editions of USP General Chapter <797> will include recommendations for IV room automation and technology is a great question, and one that I’ve been pondering for quite some time. I’m torn as to whether or not … Continue reading