Tag Archives: USP 797

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… Read More »

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… Read More »

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… Read More »

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… Read More »

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… Read More »

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… Read More »

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… Read More »