USP 800 published version was officially finalized and published December 3 2014. USP 800 has the purpose of maximizing safety and minimizing risk for workers handling hazardous drugs like chemotherapy, hormones and the other listed HDs that can be found in Section 2 of the chapter.
Updates From Proposed to USP 800 Published Version
The main changes in this final published version of USP 800 is clarified wording in many sections as well as the removal of the statement concerning no acceptable levels of HDs. There has also been a revision on the section of list of HDs that will allow entities to perform an assessment of risk for non-anti neoplastic drugs and final dosage forms to determine alternative containment strategies and work practices. Some other changes noted in this final version of USP 800 is clarification that hazardous drugs may be unpacked in either a neutral/normal or negative pressure area. Also, allowance for either external venting or redundant high-efficiency particulate air HEPA filtration of containment area primary engineering controls (C-PEC) used for non-sterile compounding has been added.
USP 800 Published Version PPE Changes
There has not been much change in the USP 800 personal protective equipment section of gowns, gloves and other pharmacy apparel. Cleanroom Connection is the leading stocking USP 800-trained pharmacy supplier of all required products. Call our pharmacy cleanroom specialists today to review USP 800, pick out the appropriate chemo gowns, ASTM-rated gloves, chemo sleeve protectors, and other cleanroom products as well as request samples. If you are looking for on-site USP 800 training or consulting, Cleanroom Connection offers that as well through the nation’s leading pharmacy consultation and training company. Let
Cleanroom Connection be your partner in USP 800 compliance. Not only do we offer the guaranteed lowest pricing on all the hazardous drug handling apparel and protection products, our personal customer service and relationships with the nation’s leading compounding pharmacists, trainers, and implementation groups make us an invaluable resource for our customers.
