USP <797> United States Pharmacopeia (USP)

The revised USP <797> guidelines state that: “Occupational exposure to hazardous drugs can result in: (1) acute effects, such as skin rashes; (2) chronic effects, including adverse reproductive events; and (3) possibly cancer.”

With regards to safe handling, USP <797> also states:

• in order to ensure containment, especially in operations preparing large volumes of hazardous drugs, environmental sampling to detect uncontained hazardous drugs should be performed routinely (e.g., initially as a benchmark and at least every six months or more often as needed to verify containment);
• the use of a CSTD [i.e., vial transfer systems that allow no venting or exposure of hazardous substance to the environment] is preferred because of their inherent closed system process;
• in facilities that prepare a low volume of hazardous drugs, the use of two tiers of containment (e.g., CSTD within a biological safety cabinet [BSC] or a compounding aseptic containment isolator [CACI] that is located in the non-negative pressure room) is acceptable.