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Has USP made any updates to the chapter since it was published?

Yes. USP sub-committee Chairwoman Patricia Kienle, RPh, MPA, FASHP, recently spoke at the ACA, IACP, ACVP Educational Conference in February 2016. She publicly stated that she believes there is an error in section 5.3 of the chapter, which pertains to the ventilation of the C-SEC.

Ms. Kienle believes that it was not the committee’s intention to require the C-SEC to be vented through HEPA filtration before being vented to the outside. Thus, the first bullet in section 5.3 would simply read, “Be externally vented.”

The announcement of the change to USP <800> can be found on the USP website here: http://www.usp.org/usp-nf/notices/hazardous-drugs-handling-healthcare-settings.

USP has publicized that under USP General Chapter <800> section 5.3, “Facilities and Engineering Controls,” the C-SEC will not have to be vented through HEPA filtration for non-sterile or sterile compounding.

API Active pharmaceutical ingredient
CACI Compounding aseptic containment isolator
C-PEC Containment primary engineering control
C-SEC Containment secondary engineering control
HD Hazardous drug
HEPA High-efficiency particulate air
NIOSH National Institute for Occupational Safety and Health
SOP Standard operating procedure
  1. US Pharmacopeial Convention. (2016). Frequently Asked Questions: <800> Hazardous Drugs—Handling in Healthcare Settings. Retrieved from http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings