Hazardous Drug Handling and Related Regulations
Contain, don't just clean
USP <800> applies wherever hazardous drugs (HDs) are handled - receiving, storage, compounding, administration, waste, and spill control - and it is not limited to oncology. The NIOSH list organizes HDs into Table 1 (antineoplastic), Table 2 (non-antineoplastic), and Table 3 (reproductive risk at low doses); the list must be reviewed at least every 12 months and the facility's own HD list maintained. An assessment of risk (AOR) may justify alternative containment for some dosage forms, but it must be documented, reviewed annually, and cannot be used to exempt antineoplastic HDs that require manipulation.
Engineering: HD compounding occurs in a C-PEC (BSC or CACI) that is externally vented, inside a C-SEC maintained at negative pressure of at least 0.01 in. w.c. relative to adjacent areas, with at least 12 air changes per hour. PPE includes two pairs of ASTM-tested chemotherapy gloves, a gown, eye and face protection, and respiratory protection when aerosols may form. Closed system transfer devices reduce but do not replace PPE or engineering controls.
Cleaning follows a fixed sequence: deactivate, decontaminate, then clean, with approved agents for each step; spills use a dedicated kit and waste stream.
Traps: a non-vented hood; skipping deactivation; assuming a CSTD makes gloves optional.
Rule of thumb: negative pressure, external venting, two pairs of gloves - no exceptions for 'just counting' a Table 1 drug that must be manipulated.