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The United States Pharmacopeia (USP) published its revised standards for USP General Chapters <795> and <797> on November 1, 2022. At the March 2023 business meeting, the Pharmacy Quality Assurance Commission (commission) decided that it will begin enforcing those standards, as well as USP <800>, on November 1, 2023. The commission also decided that it will allow licensees to implement the revised USP <795> and <797> in addition to USP <800> before that date.
For those licensees choosing to implement USP <800> prior to November 1, 2023, this policy statement related to the regulation of the handling of hazardous drugs may be helpful. Please note that this policy statement details the conflicts between USP <800> and the current USP <797>.
The commission will not find deficiencies or take enforcement action against licensees for failure to comply with USP <800> prior to November 1, 2023. This position is detailed in policy statement 65.4, which became effective on October 1, 2022. Policy statement 65.4 will be rescinded on November 1, 2023.
As a reminder, the commission is currently enforcing USP General Chapter <825>. Compliance requirements for <825> began October 1, 2021, where applicable, per WAC 246-945-100 and RCW 18.64.270(2).
Any decision to modify the commission’s enforcement of USP <795>, <797>, <800>, or <825> as stated above, will be made during an open public meeting and distributed via GovDelivery.
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