USP 797
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 […]
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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
Cool technology for pharmacy – Formulary Toolkit
Omnicell has been busy developing the IV automation and technology that they acquired from Aeysnt. Honestly, a couple of years ago I was ready to write off Aesynt’s presence in the IV room because of their tiny market share. This is when their current IV room products were still part of Health Robotics. With that […]
Posted in Pharmacy Practice | Tagged IV ROOM, Pharmacy Practice, USP 797 | Permalink | 2 Responses
JerryFahrni.com Podcast | Episode 12: Pharmacy IV room discussion with Ray Vrabel, PharmD
Show Notes: Host: Jerry Fahnri, Pharm.D. Jerry and Ray talk about the pharmacy IV room, specifically where we’ve been, where we’re at, and where we’re headed. Topics include workflow, the impact of USP <797> on pharmacy iv room operations, and thoughts on currently available iv workflow management system technologies. You can learn more about Ray […]
Posted in Podcast | Tagged IV ROOM, Patient Safety, Pharmacy Practice, Pharmacy Technology, USP 797, USP 800 | Permalink | 2 Responses
Recommendations for technology-assisted CSP preparation
Both ISMP and ASHP are working on draft recommendations for technology in the IV room. ISMP’s version is an update to their ‘Guidelines for Safe Preparation of Sterile Compounds’ that was originally published in 2013. The proposed revision is open for public comment until April 10th. ASHP is also working on new recommendations for the […]
Posted in Pharmacy Practice | Tagged IV ROOM, Pharmacy Practice, Pharmacy Technology, USP 797, USP 800 | Permalink | 3 Responses
Novel formulation of ethanol for glove decontamination to prevent Clostridium difficile contamination
Clostridium difficile is a major problem in hospitals across the U.S. According to the CDC, it is estimated that C. difficile caused almost half a million infections in the U.S. in 2011, and approximately 83,000 of the patients who developed C. difficile experienced at least one recurrence and 29,000 died within 30 days of the […]
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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
Major differences between proposed USP Chapter 800 and current USP Chapter 797
USP <800> is still in draft form. The official date of the chapter has not yet been determined and is dependent on several factors, but expect it to become official some time in mid to late 2016. And while USP <797> is in the process of being updated, the current version is still the one […]
Posted in Pharmacy Practice | Tagged IV ROOM, Pharmacy Practice, USP 797, USP 800 | Permalink | 3 Responses
USP soliciting comments for proposed changes to Chapter <797> Pharmaceutical Compounding—Sterile Preparations
The USP Compounding Expert Committee has published a Notice of Intent to Revise for General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. I knew this was coming. I’ve talked to several people this year that indicated that revisions to Chapter <797> were imminent, especially with the introduction of USP <800> Hazardous Drugs—Handling in Healthcare Settings. According the USP […]
Posted in Pharmacy Practice | Tagged Cleanroom, IV ROOM, Pharmacy Practice, USP 797 | Permalink | 2 Responses
What USP <797> has to say about beyond-use dating of stock bags
Nothing. It says nothing, which leaves things open to interpretation. That’s bad. Beyond use dating (BUD) in USP <797> is pretty straightforward, but there’s really no language in there describing stock bags. Here are some things to think about. When performing routine compounding, USP <797> states that in the absence of sterility testing, the assigned BUD […]
Posted in Pharmacy Practice | Tagged IV ROOM, Pharmacy Practice, USP 797 | Permalink | 4 Responses