After Years of ASA Advocacy, USP Chapter <797> Revisions Support Anesthesia Workflows and Patient Safety

This week, United States Pharmacopeia (USP) announced revisions to its General Chapter <797>, a standard for sterile pharmaceutical compounding that plays a major role in guiding regulatory bodies and accrediting organizations.

The revisions included the establishment of a clear distinction between administration and compounding. This decision effectively ends the restrictive “one-hour rule” that previously mandated health care professionals to administer immediate-use sterile products within one hour after the start of preparation.

In conjunction with these revisions, The Joint Commission (TJC) published Frequently Asked Questions with a clarification that pre-spiking IV bags is outside the scope of USP <797>. Hospitals and other health care facilities will now be responsible for developing their own policies on IV spiking, and TJC will follow those policies for facility surveys.                                           

ASA applauds USP for making these clear and decisive changes to Chapter <797> that will enable more efficient workflows for anesthesiologists and other qualified anesthesia professionals, ensure patient safety, and raise the quality of patient care. For over a decade, ASA has been at the forefront of this issue in support of its members, submitting numerous comment letters and building coalitions advocating for the repeal of the one-hour rule.

ASA acknowledges Dr. Elizabeth Rebello and Dr. Tillman Hein for their leadership and advocacy on USP <797> – both members have served as ASA liaison to USP.

For more details, see the full Chapter 797 revisions here.

For more information on these issues, please contact the ASA Department of Quality and Regulatory Affairs (QRA) at [email protected].