USP 800 is a national standard designed to protect healthcare workers, patients, and the environment from exposure to hazardous drugs. Officially titled “Hazardous Drugs — Handling in Healthcare Settings,” it covers every stage of a hazardous drug’s journey through a facility: receiving, storage, compounding, dispensing, administration, and disposal. Before USP 800 existed, safety recommendations for handling these drugs were scattered across multiple guidelines. USP 800 consolidates them into a single, universally recognized reference.
Who USP 800 Applies To
USP 800 isn’t just a pharmacy standard. It applies to every person and setting involved in handling hazardous drugs, which means pharmacists, pharmacy technicians, nurses, physicians, risk management staff, and even drug delivery personnel from contracted suppliers all fall under its scope. Any healthcare facility that receives, stores, compounds, or administers hazardous drugs is expected to comply, including hospitals, outpatient clinics, compounding pharmacies, and veterinary facilities.
One notable requirement is that each facility must designate a Compounding Supervisor who is qualified and trained to oversee all aspects of hazardous drug handling. This person is responsible for developing and implementing procedures, ensuring compliance with regulations, verifying personnel competency, and maintaining environmental controls.
What Counts as a Hazardous Drug
USP 800 relies on the NIOSH List of Hazardous Drugs in Healthcare Settings, maintained by the CDC’s National Institute for Occupational Safety and Health, to identify which drugs require special handling. A drug is considered hazardous if it meets certain criteria related to toxicity, such as the ability to cause cancer, harm reproductive health, damage organs at low doses, or mimic the structure of other known hazardous agents.
The NIOSH list organizes hazardous drugs into tables. Table 1 includes antineoplastic drugs (chemotherapy agents), which carry the highest risk and face the strictest containment requirements under USP 800. Table 2 includes non-antineoplastic hazardous drugs, and Table 3 covers drugs that pose a reproductive risk. The table a drug falls into directly determines how tightly it must be controlled at every handling step.
The Role of Assessment of Risk
Not every hazardous drug requires the same level of containment, and USP 800 builds in flexibility through a process called an Assessment of Risk. This evaluation considers the type of drug, its dosage form, the likelihood of exposure, how it’s packaged, and what kind of manipulation is required. For Table 1 antineoplastic drugs that require compounding or manipulation, the containment requirements are strict and non-negotiable. But for other hazardous drugs, facilities can perform an Assessment of Risk and adopt alternative containment strategies if those alternatives still minimize exposure.
For example, reconstituting, mixing, or diluting Table 2 drugs can be evaluated under an Assessment of Risk. A Table 1 antineoplastic in a final dosage form being prepared for immediate administration can also go through this process. However, certain equipment restrictions remain firm: a standard laminar airflow workbench cannot be used for compounding Table 1 antineoplastic drugs, regardless of any risk assessment.
Protective Equipment and Engineering Controls
USP 800 sets specific standards for personal protective equipment based on the task being performed and the drug category involved. Chemotherapy-rated gloves, protective gowns, eye and face protection, and respiratory protection are all addressed. The chapter specifies that protective gloves used for hazardous drug handling must be tested for permeability against chemotherapy agents, and double gloving is standard practice during compounding.
Beyond what workers wear, USP 800 also addresses the physical environment. Hazardous drug compounding areas require specific engineering controls, including negative-pressure rooms that prevent contaminated air from escaping into surrounding spaces. Sterile compounding of antineoplastic drugs must take place in a containment primary engineering control, such as a biological safety cabinet or a compounding aseptic containment isolator, placed inside a negative-pressure room with appropriate air changes per hour.
Decontamination and Cleaning Standards
Surfaces that come into contact with hazardous drugs require a multi-step cleaning process that goes well beyond a standard wipe-down. USP 800 outlines three steps for non-sterile work areas and adds a fourth for sterile environments.
- Deactivation renders any lingering hazardous drug inactive or chemically inert on the surface.
- Decontamination neutralizes and physically removes the drug residue by transferring it to disposable absorbent material.
- Cleaning removes remaining residue and other contaminants using germicidal detergents, surfactants, and water.
- Disinfection destroys microbial growth and is required only for surfaces used in sterile hazardous drug work.
These steps must be performed in order, and each serves a distinct purpose. Skipping deactivation and jumping straight to cleaning, for instance, could leave chemically active drug residue on a surface where workers will continue to prepare medications.
Medical Surveillance and Training
USP 800 expects facilities to establish a medical surveillance program for employees who handle hazardous drugs. This includes baseline health assessments, ongoing monitoring, and a formal process for employees who raise concerns about reproductive health or other adverse effects from exposure. OSHA guidance recommends that when an employee expresses concern about potential harm, the facility should conduct a site visit to verify that all safety systems are working, review work practices, and engage in an interactive process to identify reasonable accommodations for work location, duration, and responsibilities. Employees in these situations should be reassigned with pay retention.
Training is another cornerstone. Every person who handles hazardous drugs must receive education on the risks involved, the proper use of protective equipment, spill management, and the specific procedures their facility has adopted. This training extends beyond pharmacy staff to include nurses who administer the drugs, physicians who prescribe them, and support personnel involved in transport or waste disposal. Competency must be documented, and the designated supervisor is accountable for ensuring it stays current.
When USP 800 Took Effect
USP 800 became officially effective on December 1, 2019. Its enforcement, however, varies by state. USP itself sets the standard but plays no role in enforcement. State boards of pharmacy and other regulators make their own determinations about whether and how to enforce USP 800 within their jurisdictions. Some states adopted it immediately, others incorporated it into existing regulations over time, and a few have yet to formally mandate compliance. Regardless of enforcement status, USP 800 represents the nationally recognized benchmark for safe hazardous drug handling, and accreditation bodies and insurers increasingly expect facilities to meet its standards.