Preparing for USP 800: 4 Key Elements

The new USP chapter <800> guidelines for hospital and institutional pharmacies may be published in early 2016, but pharmacies will be well served by beginning to plan now.

In a recent article published by Pharmacy Times Patricia C. Kienle, MPA, BSPharm, FASHP, director of accreditation and medication safety for Cardinal Health Pharmacy Solutions and a member of the USP Compounding Expert Committee, noted that the scope of USP <800> is wider than that of USP <795> and <797>, but it will be supplementing those standards, rather than replacing them.

According to Kienle, the key elements of USP <800> are:

  1. Facility design: Hazardous drugs must be stored in negative or normal/neutral pressure, and compounding must be completed in certified biological safety cabinets or compounding aseptic containment isolators in a separate room with negative pressure.
  2. Garb: Details for personal protective equipment are based on the function being performed
  3. Cleaning: Deactivation and disinfection with an oxidizer, cleaning with a germicidal detergent, and disinfection with sterile alcohol.
  4. Administering: Closed-system drug-transfer devices should be used when compounding and shall be used when administering.

Many pharmacies throughout the hospital and homecare markets are already adapting to these new guidelines.

Contact Right Way Medical and learn how we can assist you with all of you cleanroom supplies, or click USP 800 supplies to shop online.

If you need help designing, constructing, or certification of your cleanroom, we recommend contacting Cleanroom Design LLC.

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Prior to founding Right Way Medical, Prati held various roles with Apria Healthcare, B. Braun Medical, and Medical Technology Resources, where his final role was Sr. Vice President of Sales and Operations. During his time serving at Medical Technology Resources he was influential in assisting in its acquisition to Medical Specialties Distributor, a company that has since been acquired by McKesson in 2018.

Prati has been involved in various philanthropic organizations including The Make-A-Wish Foundation, A Kid Again, Orphan’s Promise and has served in various board and volunteer roles at Cypress Wesleyan Church (Alton Darby and Dublin campuses) and the Vineyard Church of Columbus.

Josh Prati resides in Powell, Ohio with his wife Christa and two cats, Remey and Molly. He enjoys working out, developing relationships over a home cooked meal, great wine, and is an avid Ohio State Buckeye and Pittsburgh Steeler fan.