// October 15, 2014

Debate on Proposed Guidelines for Handling Hazardous Drugs to Re-Open

hazardous drugs, health and safety

Recently,  Fred M. Eckel, RPh, MS, ScD, Editor-in-Chief of Pharmacy Times wrote an editorial inspired by the debate generated by a proposed new United States Pharmacopeia (USP) General Chapter <800>: “Hazardous Drugs: Handling in Healthcare Settings.” The purpose of the proposed general chapter is to provide standards to protect personnel and the environment when handling hazardous drugs (HDs).

The debate over this critical issue prompted Eckel to consider the important, though often behind-the-scenes role that USP plays in pharmacy practice.

Speaking with USP expert volunteers and delegates, Eckel concluded that in addition to its important work establishing compounding monographs, general chapters and providing reference material; USP demonstrates value to pharmacy practice in many ways – including: medication error prevention, drug information, and pharmacy practice standards. USP also provides a unique forum where medicine and pharmacy can interact and affect change. The debate over General Chapter <800> only highlights the role USP plays in protecting healthcare practitioners as well as patients.

You will soon have an opportunity to experience this unique forum and exchange of ideas for yourself. Based on the nature and significance of the comments received on the proposal in Pharmacopeial Forum 40(3) [May–Jun. 2014], the Compounding Expert Committee is revising and republishing General Chapter <800>. The revised general chapter proposal will reflect new and revised guidance documents, respond to stakeholder input, and improve the clarity of the general chapter. The revised proposal is tentatively projected to be published in Pharmacopeial Forum 41(2) [Mar.–Apr. 2015].

The new proposed General Chapter and the decision to publish a revised proposal are just the latest examples of the inclusive, informed, and transparent debate provided by USP on topics of critical importance to pharmacy and healthcare practice.

More information about USP General Chapter <800>  is available on the USP website. Follow USP's Quality Matters blog for information on this and other issues.

Editors Note: The Compounding Expert Committee has confirmed that it will republish General Chapter <800> in PF 41(2) [Mar.–Apr. 2015].  The revision clarifies wording and reflects new and revised guidance documents and stakeholder input. To allow additional time for public review and comment, the committee has presented General Chapter <800> in advance of its publication in PF 41(2) and it is available for download and review on the usp.org website here: http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings