Tag Archives: 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> … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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