As the official implementation date of July 1, 2018, for USP Chapter <800> Hazardous Drugs—Handling in Healthcare Settings compliance is rapidly approaching, the time for review of USP’s newest chapter is now rather than June 30, 2018.
Each practice site that handles hazardous drugs vary in overall compliance due to the lack a US practice standard prior to February 2016. USP <800> provides the baseline for sites to conduct a gap analysis to minimal practice safety practice standards and prepare investment in capital, personnel and process changes. The mandates and recommendations listed within USP <800> vary from simplistic process changes to complex engineering control changes. Budgeting and scheduling for compliance should be in play today for any healthcare site handling these drugs.
The new chapter provides a framework of 18 sections that guide sites to compliance:
|Month||Section Reviewed||Month||Section Reviewed|
|Feb 2017||Introduction & Scope||Nov 2017||Receiving|
|Mar 2017||List of Hazardous Drugs||Dec 2017||Labeling, Packaging, Transport & Disposal|
|Apr 2017||Types of Exposure||Jan 2018||Compounding|
|May 2017||Responsibilities of Handling Hazardous Drugs||Feb 2018||Administering|
|Jun 2017||Facilities and Engineering Control||Mar 2018||Deactivating, Decontamination, Cleaning & Disinfecting|
|Jul 2017||Environmental Quality & Control||Apr 2018||Spill Control|
|Aug 2017||Personal Protective Equipment||May 2018||Documentation and Standard Operating Procedures|
|Sep 2017||Hazard Communication Program||Jun 2018||Medical Surveillance|
|Oct 2017||Personnel Training||Jul 2018||Expected Compliance|
Sections Summarized from the following Source: The United States Pharmacopeial Convention; <800> Hazardous Drugs—Handling in Healthcare Settings / Physical Tests First Supplement to USP 39–NF 34; August 1, 2016
Over the coming months, Visante will briefly take a section of the chapter and provide guidance to compliance on the way to the July 1, 2018 deadline.
To further assist clients on the road to compliance, Visante provides a full line of consulting whether clients are just getting started or taking steps to go beyond minimal practice standards. Contact us today to learn more.
USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings
http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed January 8, 2016.