New mandatory rules will soon apply to every site that handles hazardous drugs.
The U.S. Pharmacopeial (USP) released General Chapter 800 within USP-797 in order to ensure that hazardous drugs are handled properly. This general chapter provides protections for health care workers, including pharmacists, against residual exposure in health care facilities.
These new mandatory USP 800 site rules will go into effect by December 2019, and will apply to any site that handles hazardous drugs, as designated by the National Institute for Occupational Safety and Health (NIOSH).
Concerns surrounding the usage of hazardous materials, such as those used in chemotherapy drugs, have been a topic of discussion since as early as the 1970s. Chemotherapy agents were originally mixed on countertops or workbenches, allowing contaminates into the air and to attach to the drywall of the room. These contaminates left health care workers, pharmacists, and patients at risk of exposure.
New Regulations for Compounding Sites
USP 800 encourages the use of personal protective equipment (PPE) and health care and janitorial training for the handling and removal of hazardous waste. Additionally, primary and secondary engineering controls have been defined in order to maintain a safe facility for both Hazardous Drug, Non-Sterile, and Hazardous Drug Sterile compounding.
New site regulations include guidelines and restrictions for the handling and storage of hazardous drugs (HD) and its respective compounding. Researchers have linked exposure to these compounds to harmful side effects, including chromosome alteration and certain cancers.
What does this mean for my facility?
New building safety measures for pharmacies and compounding facilities must be in place by December 2019 if site renovations have been started. These standards will apply to both sterile and non-sterile compounding processes. Site renovations and upfits should be completed by a qualified health care contractor.
If your health care facility in North Carolina needs to be upgraded to meet the new regulations set in place, contact Hayco Construction today.
As an ICRA Certified construction company, our experienced construction crew has the knowledge and expertise required to handle construction around hazardous and infectious materials. We are already working with some of the top medical facilities in North Carolina to ensure their facilities will comply with new standards by December 2019.