USP General Chapter <800>

What is USP <800>?

The USP <800> requirements standardizing the safe handling of hazardous drugs will go into effect on November 1, 2023

The updated USP <800> requirements include:

• Responsibilities of personnel handling hazardous drugs
• Facility and engineering protocols
• Procedures for deactivating, decontaminating and cleaning
• Spill control
• Documentation^​

The National Institute for Occupational Safety and Health (NIOSH) defines hazardous drugs as those exhibiting “one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs”¹

USP <800> was developed by USP Compounding Expert Committee, USP Compounding with Hazardous Drugs Expert Panel, US Food and Drug Admin (FDA) and US Center for Disease Control and Prevention (CDC) including NIOSH²

Who does USP <800> affect?

All healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs (HD), and all entities that store, prepare, transport or administer hazardous drugs, including, but not limited to: pharmacies, hospitals, health systems and other healthcare institution personnel, patient treatment clinics and physicians’ practices or veterinarians’ offices.

Why did this happen?

The USP Compounding Expert Committee developed General Chapter <800> to standardize the safe handling of hazardous drugs throughout healthcare environments, in order to help protect both patients and healthcare workers. 

Key USP <800> requirement changes

• Entities must maintain lists of all hazardous drugs (HDs) used in their facilities
  • Identify any new HDs when they enter the market that will be used
  • HD list must be reviewed annually
  • Complete risk assessment including HD type, dosage form, exposure risk, packaging and manipulation        
• Identifying types of exposure
  • Listing all potential exposure based on staff responsibilities and activity
  • Potential routes of exposure include receipt, dispensing, manipulation compounding/mixing, administration, patient care activities, spills, transport and waste     
• Personnel responsibilities and training
  • Each entity is required to designate a trained individual to develop, implement procedures and standards, oversee compliance, training and monitoring of personnel handling HDs
  • All personnel who handles hazardous drugs must be trained based on their job function, before the employee independently handles any hazardous drugs; this includes, but is not limited to, the receiving, labeling, packaging, transport, disposal, administration, deactivation, decontamination, cleaning and disinfection of hazardous drugs and handling areas
  • All personnel who handles hazardous drugs must adhere to the standards for wearing personal protective equipment while mixing or administering the hazardous drugs   
• Facilities and engineering controls
  • Entities must handle HDs in designated areas that include: receipt and unpacking, HD storage facilities, sterile and non-sterile compounding areas (if performed by entity)
• Personal protective equipment (PPE)
  • Healthcare entities must develop standard operating procedures for PPE based on the risk of exposure and the activities performed
  • Gloves – two pairs of chemotherapy gloves are required for administering antineoplastic hazardous drugs
  • Gowns – when gowns are required, they must be disposable and shown to resist permeability by hazardous drugs; gowns must close in the back, be long-sleeved, and have closed elastic or knit cuffs
  • Head, hair, shoe and sleeve covers – provide protection against contact to HD residue
  • Eye and face protection – must be worn when there is risk of spills or splashes or waste materials. Goggles must be used for eye protection
  • Respiratory protection – full-face-piece respirator (fit tested), chemical cartridge-type or powered respirator (PAPR) should be worn during respiratory exposure to HDs to help reduce the risk of spills or splashes of hazardous drugs or hazardous drug waste materials
  • Disposable PPE cannot be reused; reusable PPE must be decontaminated and cleaned after use
• Receiving hazardous drugs
  • Healthcare entities must establish standard operating procedures for receiving hazardous drugs
  • HD should be received from the supplier in impervious plastic and delivered to the HD storage area immediately after unpacking
  • Healthcare personnel must wear PPE, including chemotherapy gloves, while unpacking all HD
• Labeling, packaging, transport & disposal
  • Healthcare entities must establish standard operating procedures for the labeling, packaging, transport and disposal of all hazardous drugs, addressing the prevention of accidental exposures/spills, exposure response training, and the use of a spill kit
• Administering hazardous drugs
  • Healthcare personnel must administer HD safely using compliant protective medical devices and techniques, while wearing appropriate PPE
• Deactivating, decontaminating, cleaning & disinfecting
  • Healthcare entities must establish written procedures for the decontamination, deactivation and cleaning of all areas where hazardous drugs are handled, as well as all reusable equipment and devices which come in contact with hazardous drugs
  • Healthcare personnel performing these activities must wear appropriate PPE resistant to the cleaning agents used, including two pairs of chemotherapy gloves and impermeable disposable gowns
  • Recommended cleaning steps:
    • Deactivation – renders compound inactive – EPA oxidizers (peroxide or bleach)
    • Decontamination – residue removal – validated to be effective for HD decontamination – alcohol, water, peroxide, or bleach
    • Cleaning – removes organic and inorganic material – germicidal detergents
    • Disinfection – destroys microorganisms – EPA-registered disinfectant and/or sterile alcohol 
• Spill control
  • Qualified personnel wearing appropriate PPE must contain and clean hazardous drug spills immediately
  • Personnel qualified for the cleaning of HD spills must be available at all times while HD are being handled
  • Spill kits containing all necessary materials for the cleaning of HD spills must be readily available in all areas where HD are routinely handled
• Medical surveillance
  • Surveillance is a necessary component of the exposure control program, engineering controls and safe work processes to minimize adverse health effects in personnel exposed to HD
  • Medical records of surveillance should be maintained per OSHA regulation concerning access to exposure and medical records