For over a decade, anesthesiologists and other qualified anesthesia professionals have made their voices heard against the “one-hour rule,” a restrictive standard imposed by U.S. Pharmacopeia (USP) stating that all immediate-use sterile products must be administered within one hour after the start of preparation. Over the course of this period, anesthesiologists faced confusion and disruption to their workflows, and ASA was at the forefront of this issue in support of its members, building coalitions and submitting a number of comment letters advocating for the repeal of the one-hour rule. With positive breakthroughs in the latest draft of USP's guidance, ASA is working to finally bring this issue to a clear resolution and ensure the rules around compounded sterile preparations enable qualified anesthesia professionals to provide the highest quality of care for their patients.
The one-hour rule was included in the 2008 revisions of USP Chapter <797>, a standard for sterile...
