Is Your Pharmacy Ready for USP <800>?

The United States Pharmacopeia (USP) Chapter <800> standards for hazardous drug handling will become effective and enforceable on November 1, 2023.  This move coincides with the official implementation of the USP <795> and <797> standards for non-sterile and sterile compounding.   USP <800> has been delayed from its original intended implementation date to align with corresponding references to the <795> and <797> chapters. 

Most states require prescription labels and/or supplemental materials to notify patients and their caregivers of any risks associated with handling hazardous drugs.  A recent newsletter from the Iowa Board of Pharmacy highlighted the importance of clear communication between pharmacies and long-term care (LTC) facilities regarding the proper precautions necessary for handling hazardous drugs.  Due to the remote nature of LTC pharmacy practice, multiple caregivers may come into contact with hazardous medications, such as nursing staff, delivery personnel, and family members.  It is imperative that pharmacies label hazardous medications appropriately to mitigate safety risks due to exposure.  

What is UPS Chapter <800>? 

USP Chapter <800> outlines the specific handling requirements for drugs that pose a hazard to human health.  The list of these drugs is maintained by the National Institute for Occupational Safety and Health (NIOSH) and includes antineoplastic (chemotherapy) drugs, as well as many more common medications.  It is important to note that the hazard posed by some of these drugs may be dependent on the dosage form or how the drug is being handled – as not all dosage forms or activities may be hazardous. 

The guidelines in USP <800> specify specific handling and precautionary measures that pharmacies and other personnel must take in order to safely handle and dispense hazardous drugs.  These policies and procedures should be accessible to all personnel who might encounter hazardous drugs in the course of their work.  For chemotherapy drugs, the guidance on handling is non-negotiable.  This may include precautions such as gowns, eye protection, respirators, single or double gloves, and engineering controls such as negative pressure environments. 

For some hazardous drugs, such as those carrying a reproductive risk only, pharmacies may create their own risk assessment to outline the procedures that will be followed for a given activity.  This flexibility allows pharmacies to comply with safety precautions while minimizing the impact on operational workflow. 

Many state boards of pharmacy have added language to their regulations to adopt the USP <800> guidance.  State inspectors may begin to evaluate and enforce hazardous drug handling requirements beginning on or after November 1, 2023.  It is therefore critically important that pharmacies are not only aware of the USP <800> guidance but also that they have policies and procedures in place to effectively document how hazardous drugs should be handled, which may include the pharmacy’s own assessment of risk. 

How FrameworkLTC Can Help

FrameworkLTC users have built-in USP <800> compliance tools to assist in identifying hazardous drugs and complying with NIOSH handling guidance.  The hazardous drug icon, a small yellow biohazard symbol, appears next to the name of hazardous drugs throughout the application.  This icon can be clicked on to display the NIOSH classification and handling information.  Pharmacies can also build their own library of custom risk assessments, customized for the specific type of handling activity if permitted by the NIOSH guidelines.  This tool allows FrameworkLTC uses to maintain robust compliance with USP <800> while minimizing the regulatory impact on pharmacy operations. 

Take Your Next Step in the Compliance Journey

Compliance with USP <800> hazardous drug handling guidance is a critical requirement for pharmacies in order to keep employees safe and to avoid fines and penalties from regulatory authorities.  As a partner in this effort, SoftWriters is continuously innovating to bring integrated compliance solutions to our customers through industry-leading products and services.   

For more information on USP <800>, please visit www.usp.org.

For more information on SoftWriters product solutions to achieve and maintain compliance with USP <800>, contact support@softwriters.com.