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USP 800: The Complete Guide to Hazardous Drug Handling

What USP <800> requires — who it applies to, the facility, PPE, storage, compounding, and disposal standards for hazardous drugs, and how it connects to your chemo and RCRA waste program.

In this guide

  1. What USP 800 is
  2. Who it applies to
  3. The core requirements
  4. USP 800 & waste disposal
  5. USP 800 vs. RCRA

What USP 800 is

USP General Chapter <800> is the U.S. Pharmacopeia standard for safely handling hazardous drugs across their whole life in a healthcare setting — receiving, storage, compounding, administration, and disposal — to protect workers, patients, and the environment from exposure. It’s the framework behind containment hoods, PPE, and hazardous-drug segregation.

Who USP 800 applies to

Any entity that handles drugs on the NIOSH hazardous drug list — pharmacies, hospitals, clinics, oncology and infusion centers, and veterinary practices. If your staff receive, store, compound, administer, or dispose of hazardous drugs, USP <800> applies. The list isn’t just chemo — it includes many everyday drugs.

The core requirements

  • Designated person — someone accountable for the hazardous-drug program.
  • Assessment of risk — documented, for drugs handled in limited ways.
  • Facility & engineering controls — containment, ventilation, and dedicated storage.
  • PPE — appropriate to the task and exposure.
  • Receiving & storage — hazardous drugs separated and handled safely.
  • Deactivation, decontamination & cleaning, plus spill control.
  • Disposal — hazardous-drug waste contained and destroyed compliantly, all documented.

USP 800 & waste disposal

The disposal half of a USP <800> program is where it meets your waste streams. Trace hazardous-drug and chemo waste goes to yellow-container trace chemo for incineration; bulk and P-listed hazardous drugs go to RCRA-hazardous disposal. Segregating that waste correctly — and documenting its destruction with a manifest or Certificate of Destruction — is what closes the USP <800> loop. See the chemo disposal guide for the split.

USP 800 vs. RCRA — how they fit together

They’re different standards that overlap: USP <800> protects people by governing handling; RCRA protects the environment by governing hazardous-waste disposal. Many drugs are covered by both — you handle them under USP <800> and dispose of them under RCRA / Subpart P. A complete program does both, and one disposal partner can cover the waste side of each.

Frequently asked questions

What is USP 800?

USP General Chapter <800> is the U.S. Pharmacopeia standard for safely handling hazardous drugs in healthcare settings — from receiving and storage through compounding, administration, and disposal — to protect workers, patients, and the environment. It applies to any facility that handles drugs on the NIOSH hazardous drug list.

Who does USP 800 apply to?

Any healthcare entity that handles hazardous drugs — pharmacies, hospitals, clinics, infusion and oncology centers, and even veterinary practices. If your staff receive, store, compound, administer, or dispose of drugs on the NIOSH hazardous drug list, USP <800> applies to you.

What are the main USP 800 requirements?

The core areas are: a designated person overseeing the program, an assessment of risk, engineering and facility controls (containment, ventilation, storage), personal protective equipment, safe receiving and storage, compounding controls, deactivation/decontamination and cleaning, spill control, and compliant hazardous-drug waste disposal — all documented.

Is USP 800 the same as RCRA?

No, but they overlap. USP <800> is a handling and safety standard (protecting people); RCRA is the EPA's hazardous-waste disposal law (protecting the environment). Many hazardous drugs are covered by both — you handle them under USP <800> and dispose of them under RCRA. A compliant program satisfies both.

How does USP 800 relate to waste disposal?

USP <800> requires that hazardous-drug waste be contained and disposed of properly, which links directly to your trace-chemo (yellow) and RCRA-hazardous (black) waste streams. Segregating and documenting that waste — with a permitted-facility destruction path — is the disposal half of a USP <800> program.

Keep reading

Educational reference only, not legal advice, a formal waste determination, or training certification. Verify current federal and state requirements and the product’s safety data sheet. Waste acceptance remains subject to review by a licensed disposal partner.