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Everything You Need to Know About USP 800


January 22, 2019

USP 800 is the standard governing hazardous drugs and their handling during receipt, storage, compounding, dispensing, administration, and disposal of both sterile and nonsterile preparation. USP 800 is in place to protect personnel and environments from hazardous drugs compounds, such as those in chemotherapy drugs or radiopharmaceuticals. USP 800 focuses on the safe handling of hazardous drugs (HDs) to minimize the risk of exposure to healthcare personnel, patients, and the environment. A drug is considered hazardous if

it exhibits 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.

USP 800 details numerous requirements for HDs, including the responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating, and cleaning; spill control; and documentation.

The USP 800 standard applies to all healthcare personnel who receive, prepare, administer, transport, or come in contact with HDs and any environments where HDs are handled. Any facility that handles HDs must incorporate a number of policies into an occupational safety plan. The bare minimum of these policies to include are: a list of HDs, facility and engineering controls, competent personnel, safe work practices, proper use of PPE, and policies for HD waste segregation and disposal.

List of HDs

The documentation for HDs in a facility must include any items on the NIOSH list and must be reviewed at least every 12 months. Any new agents and dosages must be reviewed against the facility’s existing documentation. An assessment of risk should be performed.

The assessment of risk for an HD includes:

  • The type of HD
  • Dosage form
  • Risk of exposure
  • Packaging
  • Manipulation

Facility and Engineering Controls

USP 800 dictates where must be designated areas for receipt, unpacking, and storage of HDs. In addition, a facility needs designated areas for Nonsterile HD compounding and Sterile HD compounding if such actions are performed within. Depending on the HD, certain areas require negative room pressure to contain the HD.

PPE

PPE must be worn when handling or coming in contact with HDs at any point, including receipt, storage, transport, compounding – both sterile and nonsterile, administration, spill control, and waste disposal. PPE items can include gloves; gowns; covers for head, hair, sleeves, and shoes; eye and face protection, and respiratory protection.

Personnel must be trained and demonstrate handling competencies before handling any HDs. The compounding supervisor must be trained in every aspect of the HD handling process. HD waste disposal must comply with all applicable federal, state, and local regulations, including unused HDs and trace-contaminated PPE and other materials.

 

Click to learn more about USP 797 and best practices for USP compliance.