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:
- 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.
- Garb: Details for personal protective equipment are based on the function being performed
- Cleaning: Deactivation and disinfection with an oxidizer, cleaning with a germicidal detergent, and disinfection with sterile alcohol.
- 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.
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If you need help designing, constructing, or certification of your cleanroom, we recommend contacting Cleanroom Design LLC.
