USP General Chapter <800>
USP General Chapter <800> provides standards for the safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients, and the environment in the United States. While the official date of General Chapter <800> isn't until December 1, 2019, many healthcare organizations and pharmacies within hospitals are preparing now, and USP strongly encourages early adoption to protect the public health in all healthcare settings. Keep reading to see some quick information about USP General Chapter <800> and what you can do to prepare for the standards.
USP General Chapter <800> Overview
USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. This chapter is a collection of processes that minimize the exposure to hazardous drugs in healthcare settings.
According to USP, Chapter <800> was written to protect all workers, patients, and the general public who may be assessing facilities where hazardous drugs are prepared. This includes, but is not limited to, pharmacists, technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians.
All individuals affected by Chapter <800> must read the chapter in its entirety, as all of the requirements for hazardous drugs handling are defined in the chapter. Each person must be able to develop and implement appropriate procedures, oversee entity compliance with the chapter and other applicable laws, regulations, and standards, ensure competency of personnel, and ensure environmental control of the storage and compounding areas. While there is no set number of training hours required, we recommend additional training for:
- Handling of hazardous drugs
- Spill preparedness
NIOSH Hazardous Drugs
The National Institute for Occupational Safety and Health (NIOSH) defines criteria and identifies hazardous drugs. To minimize the risk of these hazardous drugs to public health, USP develops standards, including Chapter <800>. Those affected by this standard will need to be able to characterize NIOSH hazardous drugs, and be able to clarify which drugs are hazardous, non-hazardous, and NIOSH regulated.
USP General Chapter <800> is expected to become official on December 1, 2019.
Although it may seem early, now is the time to begin preparing for adoption and implementation of USP General Chapter <800>. If you need help with these standards, please click the button below to contact our team of experts. Our EHS Consulting team can provide guidance, training, and assistance with drug classifications to allow your facility to adopt the standards safely and efficiently.