Preparing your Pharmacy for USP <800>

More than 8 million U.S. health care personnel are potentially exposed to hazardous drugs (HDs) every year. Both acute and chronic health issues could impact you, your staff, your patients, and your pharmacy as a whole. Considering the potential risks, USP created General Chapter <800> to define new standards for handling HDs and help promote patient, worker and environmental protection. 

The compliance deadline for USP <800> is December 1, 2019. This aligns with the revision of USP <797>. Initially, USP <797> offered the main guidance related to HDs. But the chapter was primarily focused on providing proper guidelines for sterile compounding of both hazardous and nonhazardous drugs and preventing contamination. It did not include standards for the handling of HDs. USP <800>, on the other hand, details the entire handling process from receipt to disposal.

This article will give you a glimpse into some of these new standards to help you get an understanding of what is involved to keep your pharmacy compliant.   
 

Two of the more unique, and potentially challenging, requirements include designating a compounding supervisor and HD-specific areas for receipt, storage, and compounding. While the chapter did not specify any particular certification or qualification, it stresses the importance of the compounding supervisor understanding the need for risk-prevention policies and the consequences of noncompliance. USP <800> goes on to describe the necessary equipment and requirements for each area where an HD may be handled, including the need for negative pressure from surrounding areas. 
 

One key responsibility of the compounding supervisor is the bi-annual environmental wipe sampling for HD surface residue. USP <800> also specifies the proper protocol for when contamination is found.
 

USP <800> offers specific standards and protocols for gloves, gowns, shoe and hair covers, face protection, and respiration protection.  For gloves, the new guidelines state they must meet American Society for Testing and Materials standard D6978.  Gowns must be disposable and resist permeability by HDs. It also mentions that a fit-tested NIOSH-certified N9S or higher respirator provides sufficient defense against particles.
 

The new mandates include the use of specific engineering controls in all stages of the compounding stages to prevent contamination. A designated room needs to be established for segregated compounding with proper airflow and pressure. Within that room, a ventilated device designed to minimize HD exposure needs to run continuously if it supplies some or all of the negative pressure from surrounding rooms.
 

USP <800> dedicated two sections on how to communicate and monitor staff who may be exposed to HDs. It’s imperative that a hazard communication plan includes a written plan about how safety protocols will be implemented, standards for proper and accurate labeling, tagging, and/or marking, and Safety Data Sheets for each hazardous chemical. Also, note that any staff members who may become a parent must confirm in writing that they understand the risks.

All personnel who may handle or come in contact with HDs should be part of the medical surveillance program and must complete their training and education before an initial work assignment. According to UP <800>, the medical surveillance program should be seen as part of a larger exposure control program that works hand-in-hand with the engineering controls, operating procedures, and protective equipment. It is also a proactive tool that can help detect early health issues. 

The risks that come with handling HDs are severe. USP <800> is looking to mitigate those risks with comprehensive and robust regulations and guidelines. By ensuring your pharmacy is compliant, and all personnel are properly educated and trained, you can feel confident in providing a safe atmosphere for you, your staff, and your patients. 

To learn more, see the full USP General Chapter <800>.
 

Founded in 1996, Pharma Logistics is the trusted, proven industry leader in reverse pharmaceutical distribution services, including rapid credit, box and ship, onsite and drug take back programs. Pharma Logistics’ clients include hospital pharmacies, the DOD and VA Health System, independent pharmacies, pharmacy chains and physicians’ offices.