USP 800

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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Mobile compounding units, a.k.a. sterile compounding trailers

Construction on pharmacy cleanrooms is at an all-time high in California. Every hospital I know is either renovating a sterile compounding area —  cleanroom or SCA — or building a new one. Why? Because of USP General Chapter <800>, of course. Never have I seen so little cost so much. That little 19-page document has […]

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USP Announces Intent to Postpone Official Date of USP Chapter <800>

In a notice posted last Friday, USP announced its intention to postpone the official date of USP Chapter <800> — Hazardous Drugs — Handling in Healthcare Settings. According to the notice: “The intent of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of […]

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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 […]

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NIOSH puts the brakes on the CSTD vapor containment protocol

Pharmacy Practice News: “The National Institute for Occupational Safety and Health (NIOSH) held a meeting today in Cincinnati to discuss a universal closed-system drug-transfer device (CSTD) testing protocol, which is being developed… The new protocol will test both physical barrier systems, which block the intake of environmental contaminants or the unintended release of hazardous drugs […]

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Deactivation, Decontamination, Cleaning, and Disinfection of sterile HD compounding areas

USP <800> has an entire section dedicated to deactivation, decontamination, cleaning, and disinfecting areas that are used for compounding sterile hazardous drugs (HDs). The chapter calls for: Establishing written procedures Training personnel Using appropriate personal protective equipment (PPE) resistant to cleaning agents. This includes the use of two pairs of chemo gloves and impermeable disposable gowns […]

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Surface sampling for equipment used for preparing sterile HDs

USP Chapter <800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS is organized into the following main sections: Introduction and Scope List of Hazardous Drugs Types of Exposure Responsibilities of Personnel Handling Hazardous Drugs Facilities and Engineering Controls Environmental Quality and Control Personal Protective Equipment Hazard Communication Program Personnel Training Receiving Labeling, Packaging, Transport, and Disposal Dispensing Final […]

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USP Chapter <800> Terminology

USP <800> Hazardous Drugs – Handling In Healthcare Settings introduces not only new rules around hazardous drug compounding, but some new terminology/vocabulary as well. Most of the terminology doesn’t address unique items, but rather how items are described when handling hazardous drugs (HDs). USP Chapter <800> refers to “containment” primary and secondary engineering controls (C-PECs […]

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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 thoughts on currently available iv workflow management system technologies. You can learn more about Ray […]

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CPhA releases statement on USP <800> and pending California regulation

CPhA recently sent out an alert notifying members of upcoming California State Board of Pharmacy adoption of USP <800> guidelines. You can read about it here. California isn’t planning to adopt the entirety of USP <800>, but what they have decided to adopt will become enforceable on January 1, 2017. “The proposed California BOP regulations […]

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