Key Changes to USP Requirements: Effective November 1, 2023


Effective November 1, 2023, the USP requirements aim to establish a standardized approach to safely handle hazardous drugs. This comprehensive update encompasses various aspects such as personnel responsibilities, facility protocols, deactivation and decontamination procedures, spill control, and documentation.

According to the National Institute for Occupational Safety and Health (NIOSH), hazardous drugs exhibit characteristics that pose risks to humans or animals, including carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or mimicry of existing hazardous drugs.

Developed by the USP Compounding Expert Committee, alongside involvement from the US Food and Drug Admin (FDA), US Center for Disease Control and Prevention (CDC), and NIOSH, USP holds significance for those who come into contact with hazardous drugs. This includes healthcare personnel involved in receiving, preparing, administering, transporting, or handling hazardous drugs, as well as entities like pharmacies, hospitals, health systems, patient treatment clinics, and medical or veterinary practices.

The motivation behind USP is to safeguard both patients and healthcare workers by establishing a standardized framework for the safe handling of hazardous drugs in healthcare environments. Experience enhanced safety and protect those you care for with USP.

Key Changes to USP Requirements

To ensure the safe handling of hazardous drugs (HDs) in healthcare facilities, several important requirements have been implemented. Here is a clear and concise summary of the key changes:

  • Maintain lists of all HDs used: Entities must keep an updated list of all HDs used in their facilities.
  • Identify new HDs: Any new HDs entering the market that will be used must be identified.
  • Annual HD list review: The HD list must be reviewed annually to ensure accuracy and relevance.
  • Complete risk assessment: A thorough risk assessment must be conducted, considering factors such as HD type, dosage form, exposure risk, packaging, and manipulation.
  • Identify exposure types: Types of exposure must be identified, including receipt, dispensing, manipulation, compounding, administration, patient care activities, spills, transport, and waste handling.
  • Personnel responsibilities and training: Trained individuals must be designated to develop procedures, oversee compliance, and train personnel handling HDs. All personnel must receive job-specific training.
  • Personal protective equipment (PPE): Standards for wearing PPE while handling HDs must be followed. This includes gloves, gowns, head, hair, shoe, and sleeve covers, eye and face protection, and respiratory protection.
  • Facilities and engineering controls: HDs must be handled in designated areas, including storage facilities and compounding areas. Facilities must adhere to specific guidelines.
  • Receiving HDs: Standard operating procedures must be established for receiving HDs, emphasizing the use of PPE and proper handling.
  • Labeling, packaging, transport, and disposal: Standard procedures must be in place for these activities, focusing on prevention, response training, and the use of spill kits.
  • Administering HDs: Healthcare personnel must administer HDs safely, using compliant medical devices and techniques, while wearing appropriate PPE.
  • Deactivating, decontaminating, cleaning, and disinfecting: Written procedures must be established for these activities, with specific PPE requirements and recommended cleaning steps.
  • Spill control: Qualified personnel wearing appropriate PPE must immediately contain and clean HD spills. Spill kits must be readily available in all areas where HDs are handled.
  • Medical surveillance: Surveillance is crucial for minimizing health risks in personnel exposed to HDs. Medical records should be maintained per OSHA regulations.

These key changes aim to ensure the safe handling of HDs, protecting the health and well-being of healthcare personnel and patients.

Follow your specific cleanroom or company procedural manual before this guide.