USP Chapter 800, An Update

Steven M. Burghart, DPh, MBA, BCPP
CPNP Immediate Past President

On June 17, 2014, CPNP submitted comments to USP on the first draft of General Chapter 800 Hazardous Drugs – Handling in Healthcare Settings. Our comments included opposition to the use of NIOSH 2012 Hazardous Drugs List as the mandatory minimum list of hazardous medications. The original draft chapter specified that all facilities must treat all medications on the NIOSH list as hazardous. The NIOSH list contains many psychotropics that are commonly used is psychiatry without special handling precautions including, carbamazepine, clonazepam, oxcarbazepine, paroxetine, risperidone, valproate and ziprasidone. Implementation of the draft standards as initially written would have placed an impossible burden on facilities that handle these medications.

USP released a revised draft General Chapter 800 in December 2014. CPNP is pleased to report that the revised draft chapter incorporated improvements that address many of our previous concerns. 

Significant revisions to the chapter included:

• Use of the NIOSH list no longer required. Alternatively, institutions may develop their own list based on an assessment of risk.
• Removed the statement that there was “no acceptable level of exposure” to hazardous drugs
• Non-antineoplastics that do not require manipulation other than counting may be dispensed without restrictions
• Meds that are non-antineoplastics may be stored in regular inventory
• Facilities may determine their own appropriate personal protection equipment requirements for non-antineoplastics
• Requirements for worker training, and handling of hazardous drugs are reasonable including removing the requirement that these drugs be unpacked in a negative pressure room.

CPNP submitted a second letter of comment to USP on May 4, 2015. CPNP requested that USP consider exclusion of non-antineoplastic agents (psychotropics) that are on the NIOSH list from USP Chapter 800. Additionally, CPNP requested that the requirement for maintaining medical surveillance records (quantities of hazardous drugs handled, etc.) be eliminated for non-antineoplastic agents.  USP has been very responsive to input from CPNP leadership. We look forward to working with them on this important issue.

To assist membership with meeting the requirements of USP Chapter 800, CPNP has launched a new task force under the leadership of Ann Richards. This task force began its work in April 2016. The task force is charged with reviewing USP Chapter 800 and:

1. Developing tools and resources to assist members in implementing an assessment of risk program.
2. Recommending other tools and resources of value in implementing USP 800.
3. Disseminate information and resources to the membership.