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USP <800> deadline extended to Dec. 1, 2019



The deadline for compliance with the new United States Pharmacopeia (USP) General Chapter <800> has been extended to Dec. 1, 2019 – more than a year later than the original July 1, 2018, effective date.


USP <800> "Hazardous Drugs: Handling in Healthcare Settings" – published Feb.1, 2016, in the USP-National Formulary (USP-NF) – provides the first enforceable standards to minimize healthcare workers’ risk of exposure to harmful materials in pharmacies. Concurrent with its release will be an updated USP General Chapter <797>, originally implemented to prevent patients from becoming ill due to contaminated drugs.


“The USP-NF delayed the implementation of USP <800> so they can issue an updated <797> and <800> at the same time with all the requirements synchronized” said IMEG Client Executive Mike Lawless. “This way there aren’t any conflicts or differences between the two standards.”


Lawless has provided engineering design for many healthcare facilities and their pharmacies, and recently presented on USP <800> for the Missouri Society for Healthcare Engineering. His presentation covered how the new USP <800> affects hospital pharmacy:


  • Airflow
  • Floorplans
  • Pressurization/monitoring
  • Hazardous drug storage
  • Room temperature
  • System infrastructure
  • HVAC
  • Exhaust location
  • Room construction
  • Door interlocks
  • Low voltage systems


While many healthcare facilities have begun the evaluation and planning process to ensure their pharmacy department is compliant, many others have yet to begin. Prior to making any design decisions, however, Lawless said it is important to understand the specific requirements of USP <800> and their impact on facility management, operating procedures, personal protective equipment, proper decontamination and cleaning, and other related topics within the pharmacy department. He added that engaging pharmacists in the design discussion is key since they will be the ones who will operate the upgraded facility.


“The design team and owner need to make sure they’re engaged with the pharmacists and facility staff to make sure they receive a solution they can maintain.”


For more information on compliance with the new standards, watch this presentation or contact these IMEG healthcare design experts: