September 25, 2019
USP Postpones Implementation of Revised USP <797>
On September 23, 2019, the US Pharmacopeial Convention (USP) postponed the implementation of its much-anticipated revised Chapter <797> until further notice. After publication of the revised and new compounding standards, USP received several appeals on certain provisions of the chapter and those appeals must be further reviewed. In the interim, the current official chapter USP <797> (last revised in 2008) including, including the one-hour rule, will remain official. The decisions on the appeals to USP <797> do not foreclose the possibility of future revisions to these chapters.
Earlier this year, ASA supported the actions of USP to remove, from chapter <797>, reference to administering a non-hazardous compounded sterile preparation within one hour. ASA believed the revisions to chapter <797> would decrease compliance-related misinterpretation, ambiguity and regulatory burden that physician anesthesiologists have faced for over a decade. The delay in implementing the chapter is a disappointment for ASA, physician anesthesiologists and other medical professionals who advocated for the removal of the burdensome “one-hour rule”.
Physician anesthesiologists should review their local policies and procedures regarding the preparation and administration of drugs in the operating room setting. ASA plans to release additional materials in the upcoming months to assist physician anesthesiologists in addressing USP <797> locally.
ASA welcomes your feedback and learning about your experience with USP <797>. For questions or comments on USP <797>, please contact the ASA Department of Quality and Regulatory Affairs at email@example.com.