Tag Archives: 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> … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … 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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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 … Continue reading

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