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Is Your Facility Prepared for USP 800?

August 2, 2017


Compliance is required by July 1, 2018.

hospital.jpgIn February 2016 the United States Pharmacopeial Convention (USP) published a new standard, General Chapter 800 Hazardous Drugs - Handling in Healthcare Settings (USP<800>). The new chapter was developed to help protect personnel, patients, and the environment by reducing the risk of residual exposure in healthcare settings. Facilities must implement this new standard by July 1, 2018 (July 1, 2017 in California).

The toxic effects and safe handling of hazardous drugs are a major concern of healthcare professionals. The National Institute for Occupational Safety and Health (NIOSH) considers drugs to be hazardous if they exhibit characteristics of carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, or genotoxicity, or drugs with structure and toxicity profiles of new drugs that mimic existing hazardous drugs. Growing evidence suggests occupational exposure to any of over 200 hazardous drugs commonly used in healthcare settings can result in acute and chronic health effects.

USP<800> requirements include, but are not limited to:

  • Responsibilities of personnel handling hazardous drugs
  • Facility and engineering controls and personal protective equipment (PPE) considerations
  • Environmental quality and controls (monitoring)
  • Procedures for deactivating, decontaminating and cleaning
  • Handling and spill control
  • Documentation
  • Medical monitoring

USP<800> “applies to all healthcare personnel who handle hazardous drug preparations and all entities that store, prepare, transport, or administer hazardous drugs.”

ATC’s Healthcare Specialists and national network of Certified Industrial Hygienists, scientists and risk assessors can help you comply with the USP<800> requirements.

Contact Bob Sorvillo at (321) 403-3075 or bob.sorvillo@atcassociates.com to get started.

About this blog

Welcome to our postings on the environment and regulatory impact.  We strive to keep you informed with the latest changes in regulations and with lessons learned from our time in the field


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