COLUMBUS, Ohio, Nov. 25, 2015 /PRNewswire/ -- USP 800 applies to all healthcare personnel who handle hazardous drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians). The chapter also covers all entities which store, prepare, transport, or administer hazardous drugs (e.g., pharmacies, hospitals, other healthcare institutions, patient treatment clinics, physicians' practice facilities, and veterinarian offices).
What is the purpose of USP 800?
The purpose of the chapter is to describe practice and quality standards for handling hazardous drugs in healthcare settings to promote patient safety, worker safety, and environmental protection. The new general chapter defines processes intended to minimize the exposure to hazardous drugs in healthcare settings.
USP 800 timeline and development process
In December 2011, an Expert Panel was formed with medical and industry experts to provide additional expertise in identifying best practices, alternative techniques and engineering controls, and other elements for handling hazardous drugs. The first proposal of General Chapter <800> was published in the Pharmacopeial Forum (PF) 40(3) [May–Jun. 2014]. Due to the nature and significance of the public comments received on this first proposal, the Expert Committee and Expert Panel significantly revised the General Chapter. Major revisions to the General Chapter included clarifying personnel and environmental requirements and providing an allowance for entities to perform an assessment of risk for handling certain types of HDs. The public comment period for the second proposal of <800> was extended to over six months to allow stakeholders more time to consider, review, evaluate and provide input on the General Chapter.
Based on the public comments received on the second proposal of <800>, the Expert Committee and Expert Panel further revised the General Chapter to clarify certain sections and changed some mandatory requirements to recommendations. As part of the USP standard development process, the Expert Committee voted on and approved the revised General Chapter.
The revised General Chapter <800> will be published on February 1, 2016 in the First Supplement to USP 39–NF 34. Additionally, the Expert Committee approved a delayed official implementation date of July 1, 2018 to allow entities more than two years to implement the chapter.
QleanAir Scandinavia Inc. provides solutions for a clean, safe and controlled environment
Adaptable cleanroom facilities for sterile compounding
QleanSpace is a turn-key cleanroom with guaranteed functionality. Our highly adaptable solutions have short installation time, and provide a safe and efficient environment for your pharmacy operation. QleanSpace will help you transform your existing pharmacy into a facility with USP 800 and/or GMP compliance.
Negative pressure HD storage
QleanStore™ is a storage area for Hazardous Drugs, separate from other inventory to prevent contamination and personnel exposure. QleanStore has a negative pressure with at least 12 air changes per hour in line with USP 800 requirements.
"Having previously worked with the closed system drug transfer device PhaSeal* for six years, I welcome the release of USP 800 as it extends the protection of health care personnel from exposure to Hazardous Drugs."
Dan Pitulia, CEO QleanAir Scandinavia
*The PhaSeal trademark is the property of Becton, Dickinson and Company.
Please visit our booth #3330 at ASHP Midyear in New Orleans or contact info@qleanair.com for more information on how to become compliant with USP standards.
CONTACT: David S. Schneider, President, QleanAir Scandinavia Inc., Phone: +1-614-323-1272
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SOURCE QleanAir Scandinavia Inc.
