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.