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USP 800 is the new standard of protective protocols for the safe handling of hazardous drugs from the United States Pharmacopia. It will exert more stringent safe handling recommendations for the industry, including the use of Closed System Transfer Devices. The revised General Chapter was 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.
The current draft of chapter 800 requires facilities to maintain a separate storage area for antineoplastic hazardous drugs that require manipulation other than the counting of final dosage forms. The storage area must be a negative-pressure room with 12 or more air changes per hour. Refrigerated antineoplastic hazardous drugs must be stored in a dedicated refrigerator inside a negative-pressure room with 12 or more air changes per hour.
Hazardous drugs, under chapter 800, encompass all medications specified in the current National Institute for Occupational Safety and Health (NIOSH) list of antineoplastic and other hazardous drugs. Chapter 800 applies to the handling of hazardous drugs during receipt, storage, compounding, dispensing, administration, and disposal and affects all healthcare workers who perform these activities. USP chapter 800, like chapters 795 and 797, will be an enforceable standard. This means that state boards of pharmacy and other regulatory entities can require regulated facilities to comply with chapter 800.
Literature from the National Institute of Occupational Safety and Health, the American Journal of Health-System Pharmacists, the Cancer Journal for Clinicians, the Journal of Occupational & Environmental Medicine, and OSHA NIOSH & The Joint Commission
How prevalent is the risk of exposure to hazardous drugs?
How has the industry responded to this growing problem?
What is a Closed System Drug Transfer Device (CSTD)?
My pharmacy staff already wears personal protective equipment (PPE), are they still at risk of exposure?
What is USP 800?
What makes Corvida Medical® different?