United States Pharmacopeia <800>: Hazardous Drugs – Handling in Healthcare Settings 

Section 4: Responsibilities of Personnel Handling Hazardous Drugs

Sections 1 through 3 of United States Pharmacopeia (USP) Chapter 800: Hazardous Drugs—Handling in Healthcare Settings defines the broad scope of the risks associated with practice sites, drugs and points within the medication management process critical to preventing occupational exposures. Section 4 assigns accountability to assure a hazardous drug safety program is put into place and is continually monitored. Ultimately the responsibility lies with the pharmacist in charge to assure that compliance with state and federal regulations are met. In the standard, an assigned person must be in place to formally address the complexities of such a program.

USP does not state that the responsible individual is a pharmacist or that the position solely focuses on hazardous drugs. However, given the short time line for compliance sites will need to assess who within their program is best suited to understand the greater than 180 compliance ‘musts’ and if their time can be devoted to other tasks. The assigned responsible person must be able to interpret laws, regulations, and standards and transition them into practice. Nationally, USP 800 must be formally addressed and in practice by July 1, 2018, however, states may require compliance prior to this date, i.e., Washington, California. So, who is the most qualified professional to take on the task of overseeing a hazardous drug safety program? Taking a high-level view, let’s review some of the basic job requirements:

  • Continuous education of self on current regulations, standards and best practice documents from professional societies including pharmacy and nursing practices.
  • Education of administrative leadership of the comprehensive rationale for risk-mitigation procedures and risks of noncompliance is a continuous and engaging requirement of the responsible person.
  • An investigative understanding of highly specialized environmental controls of facilities for storage and compounding areas possibly requiring potential facility upgrades.
  • Complexities of changing practice to meet the standards across pharmacy and nursing practices, documenting required tasks and ensure competency of personnel add to onerous task for compliance.
  • For established programs, the responsible person is responsible for the oversight of monitoring personnel, facility engineering controls and maintaining reports of testing/sampling performed in facilities.
  • Any excursions or deviations from standards or standard operating procedures require acting on the results, continually assessing and reporting potential risks to the administrative teams for support and guidance.
  • Continuous education of healthcare team of program successes, excursion and planning for future needs.

A successful hazardous drug safety program relies on the responsibility of each individual who is fortunate to work within one of these programs. Each person assigned tasks throughout the spectrum of handling hazardous drugs plays an integral part of assuring the next person in the chain is safe: from receiving drugs at the facility to compounding doses to verifying dosages to delivery to patient care units, to administration of the dose to handling wastes and contaminated linen. Each person along the chain should take the time to read and comprehend established regulations and standard operation procedures to better understand the important role they play in the hazardous drug safety program.

Administrative support is a key attribute to organizations and their teams for a continually successful and dynamic hazardous drug safety program.

Has your site assigned someone to be the USP 800 expert?

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.

Don’t know where to start with a hazardous drug safety program, Visante, Inc. offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards


[1] 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 May 10, 2017

[2] NIOSH [2004]. NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed May 10, 2017.


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