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> and <800>. Some areas have been remodeled while others have simply been scrapped in favor […]
Posted in Pharmacy Practice | Tagged IV ROOM, Pharmacy Practice, Regulation, USP 797, USP 800 | Permalink | Leave a response
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 both sterile and non-sterile products. He was someone that I looked up to during my […]
Posted in Pharmacy Practice | Tagged IV ROOM, Patient Safety, Regulation, USP 800 | Permalink | 1 Response
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 the key is for everyone to at least understand and agree that the BUD of […]
Posted in Pharmacy Practice | Tagged IV ROOM, Pharmacy Practice, Regulation, USP 797 | Permalink | 2 Responses
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 I think adding such recommendations to a USP General Chapter is a good idea. On […]
Posted in Pharmacy Practice | Tagged IV ROOM, Pharmacy Practice, Regulation, USP 797, USP 800 | Permalink | 2 Responses