USP <800>

USP General Chapter <800> sets the standard for protecting healthcare personnel, patients and the environment from exposure to hazardous drugs — defined as drugs on the current NIOSH hazardous-drug list (antineoplastics, certain non-antineoplastics with hazardous properties, and reproductive-only hazardous drugs). It applies to all healthcare settings and to every person who comes into contact with a hazardous drug at any point in its lifecycle: receipt, storage, transport, compounding (sterile and non-sterile), dispensing, administration, deactivation, decontamination, cleaning, disinfection, spill response and waste disposal.

<800> became official 1 December 2019 and is enforceable through state Boards of Pharmacy (for pharmacy operations) and OSHA's General Duty Clause (for worker safety). It is intentionally co-resident with <795> and <797>: the sterile/non-sterile compounding chapters set the quality standard, <800> overlays the containment standard.

Scope is anchored to the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. NIOSH categorises drugs in Tables 1 (antineoplastic), 2 (non-antineoplastic with hazardous properties) and 3 (reproductive only) — though the most recent NIOSH revision restructured these. Any drug on the active list is in scope by default. A facility may elect to handle certain dosage forms of certain drugs under reduced controls (e.g. final dosage forms that do not require manipulation) by performing and documenting an Assessment of Risk (AoR).

The AoR is a written, reviewed, approved evaluation per dosage form per drug that considers: type of hazard (carcinogen, teratogen, reproductive toxicant, organ toxicant, genotoxin), dosage form (intact tablet vs crushed vs oral liquid vs IV), risk of exposure (route, frequency, quantity), packaging integrity, and manipulation required. The AoR must specify the alternative containment, PPE and handling controls that compensate for any reduced-from-baseline control, and it must be reviewed at least annually and on any change to the drug, dosage form or facility process.

Compounding hazardous drugs requires negative-pressure containment. For sterile hazardous-drug compounding, the room (the C-SEC, containment Secondary Engineering Control) must be ISO 7, negative pressure to surrounding areas (0.01 to 0.03 in. wc negative), with externally vented HEPA exhaust, minimum 12 air changes per hour. The PEC (C-PEC) must be a Class II Type A2 or B2 BSC, or a Compounding Aseptic Containment Isolator (CACI) — not a standard LAFW, which would push hazardous-drug aerosol into the operator's face.

Non-sterile hazardous-drug compounding (crushing tablets, opening capsules, preparing oral suspensions) requires a Containment Ventilated Enclosure (CVE) — a negative-pressure cabinet that captures dust and vapour and exhausts externally. Receipt and storage must be in a dedicated, negative-pressure area for antineoplastic intact drugs (or in a separate negative-pressure room for unpacking); Tables 2/3 may be stored with other inventory if AoR allows.

PPE for hazardous-drug handling is dedicated, double-gloved (chemo-tested ASTM D6978 gloves, outer pair changed every 30 min or on contamination), with chemo gown (impermeable, sleeves to wrist), head and hair cover, shoe covers, eye/face protection where splash risk exists, and respiratory protection (N95 minimum, P100 for spills) per OSHA. PPE is donned in a defined sequence, doffed in a defined sequence, and removed-PPE is treated as contaminated waste.

Closed System Transfer Devices (CSTDs) are required for administration of antineoplastic hazardous drugs and 'should' be used for compounding when the dosage form allows. A CSTD mechanically prohibits transfer of environmental contaminants into the system and escape of hazardous drug or vapour out — vial adapters, syringe adapters and infusion sets all carry CSTD-compatible interfaces. The chapter does not endorse a specific brand; it sets the performance characteristic.

<800> recommends (does not mandate) routine surface wipe sampling for hazardous-drug residue at least every 6 months on representative locations: BSC/CACI work surface, pass-through, exterior of vials/bags after compounding, counter surfaces in administration areas. There is no formal action level — any detectable residue indicates contamination requiring investigation and corrective action. Sites typically set internal action levels per drug (e.g. cyclophosphamide > 1.00 ng/cm²) based on published benchmarks.

Deactivation, decontamination, cleaning and disinfection are four distinct steps with prescribed agents: deactivation typically uses peroxide/bleach to inactivate the drug, decontamination removes drug residue, cleaning removes general soil, disinfection kills microbes. All four steps are required on the C-PEC daily, on the C-SEC monthly, and after every spill. Spill response requires a written plan, a stocked spill kit in every area handling hazardous drugs, and trained spill responders.

Training is required for all personnel who handle hazardous drugs — initial competency and at least annually thereafter, with documentation per the named person. Topics: hazardous-drug list and AoR, PPE selection and use, negative-pressure design, CSTD use, spill response, exposure response. N95/P100 respirator users must be fit-tested per OSHA before first use and annually thereafter.

Medical surveillance is recommended (not mandated by <800> but expected by OSHA): baseline and periodic health assessment for personnel handling hazardous drugs, with surveillance focused on reproductive history, hepatic and renal function, and any acute exposure events. Exposure events must be documented and reported per the facility's OSHA-compliant exposure plan.

1. AoR exists for drugs the facility chose to handle under reduced controls but is generic — not specific to the dosage form, not reviewed annually, not signed by the named DP.
2. Sterile hazardous-drug compounding done in a Class II Type A2 BSC vented internally to the room — not externally exhausted as the chapter requires.
3. Storage room pressure not negative, or pressure-differential gauge not read or logged daily.
4. Chemo gloves single-pair, or outer pair worn beyond 30 min, or gloves not ASTM D6978-tested.
5. CSTD not used for administration of antineoplastic infusions despite the chapter requirement.
6. Wipe sampling never performed, or performed once five years ago, or performed with no action plan for positive results.
7. Spill kit missing items, expired, or not located where spills can plausibly occur (e.g. no spill kit in the administration area).
8. Annual training not documented for all hazardous-drug handlers; respirator fit-test expired.

• Drug master holds NIOSH classification and active AoR per dosage form; if a drug + dosage form has no AoR on file, default containment controls apply automatically.
• AoR records carry a one-year review date with named DP owner — expiry triggers a notification and freezes any reduced-control handling for that drug + dosage form until renewed.
• Negative-pressure telemetry from C-SEC and storage room streams into V5; an excursion outside −0.01 to −0.03 in. wc opens a deviation and freezes hazardous-drug compounding in the affected room.
• Operator competency file tracks hazardous-drug training annual due-date, respirator fit-test due-date and CSTD competency; expiry blocks the operator from initiating hazardous-drug work at the kiosk.
• Wipe-sampling schedule auto-generates pulls at the configured 6-month cadence; positive results above the facility action level open an investigation and prompt the decontamination workflow.
• Spill kit inventory tracked per location with expiry; spill events open an incident record with the trained responders pre-assigned per shift.