USP General Chapter <800>
USP General Chapter <800> Hazardous Drugs — Handling in Healthcare Settings · USP General Chapter 800 · hazardous drug · NIOSH HD List · C-PEC · C-SEC · Assessment of Risk
Term — USP General Chapter <800> on hazardous drug handling: uSP <800> hazardous-drug framework — effective December 2019, CMS-enforceable November 2023, applies to all entities handling NIOSH-Listed HDs (antineoplastic Table 1, non-antineoplastic Table 2, reproductive-effect Table 3), Assessment of Risk pathway for non-antineoplastic and non-manipulated antineoplastic dosage forms, Containment Primary Engineering Control in negative-pressure Containment Secondary Engineering Control with 30 ACH minimum for sterile compounding, chemo-rated ASTM D6978 gloves double-gloved with ASTM-rated gown, environmental wipe sampling every 6 months, intersection with USP <795>, USP <797>, OSHA HazCom and state Boards of Pharmacy.
USP General Chapter <800> establishes standards for handling hazardous drugs in healthcare settings. NIOSH List of Antineoplastic and Other Hazardous Drugs — Table 1 antineoplastic (cytotoxic and non-cytotoxic anticancer), Table 2 non-antineoplastic meeting one or more NIOSH HD criteria (carcinogenicity, teratogenicity, reproductive/developmental toxicity, organ toxicity at low doses, genotoxicity, structure/toxicity profile similar to existing HDs), Table 3 reproductive-effects-only. Assessment of Risk pathway — for Table 2/3 substances and antineoplastic dosage forms not requiring manipulation beyond counting/repackaging, entity may document AoR defining alternative containment strategies (drug type, dosage form, packaging, manipulation, exposure routes, mitigation); 12-month review minimum. Sterile HD compounding — Containment Primary Engineering Control (Class II Type B2 BSC or CACI) externally vented in ISO Class 7 Containment Secondary Engineering Control buffer room with negative pressure 0.01-0.03 inches water column, 30 air changes per hour, externally vented, with anteroom. Non-sterile HD compounding — Containment Ventilated Enclosure or Class I BSC in non-classified C-SEC with negative pressure and 12 ACH. Storage — dedicated negative-pressure area 12 ACH. PPE — chemo-rated ASTM D6978 gloves double-gloved when compounding, ASTM-rated single-use back-closure fluid-resistant gown, head/hair/shoe covers, eye/face protection, NIOSH-approved respirator for spills. Deactivation/decontamination/cleaning three-step process (sodium hypochlorite then thiosulfate then germicidal detergent typical). Environmental wipe sampling every 6 months with trending; commonly-referenced cyclophosphamide benchmark 1 ng/cm². Personnel competency training initial and 12-month reassessment; medical surveillance program recommended. Spill kits, eye-wash, post-exposure protocol documented. Intersects USP <795> and <797> 2023 revisions, OSHA HazCom (29 CFR 1910.1200), state Boards of Pharmacy and CMS Conditions of Participation from November 2023. Joint Commission and DNV accreditation surveys assess <800> compliance.
- USP General Chapter <800>
- USP General Chapter <795>
- USP General Chapter <797>
- 29 CFR 1910.1200
- NIOSH List of Antineoplastic and Other Hazardous Drugs
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