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.

“ASA looks forward to finally settling this issue with the hope that USP will provide a clear and conclusive stance in favor of a four-hour window for compounding of medications for immediate use in the final 2021 revisions of Chapter <797>.”

The one-hour rule was included in the 2008 revisions of USP Chapter <797>, a standard for sterile pharmaceutical compounding that plays a major role in guiding regulatory bodies and accrediting organizations. At the core of the debate was confusion over the definition of sterile compounding; the standard mixing of medications for administration to patients in the OR was labeled as sterile compounding and was thus subject to the same standards as the procedures at compounding pharmacies. ASA has maintained that the administration of medications in the OR is out of the scope of Chapter <797>.

The rule immediately sparked controversy in 2008 and the intervening years, as qualified anesthesia professionals pointed out that the very brief window of time to administer drugs disrupted anesthesia workflows and caused delays for patients and perioperative teams at facilities without access to a hospital pharmacy or an ISO 5 location. Further, the one-hour window led to serious concerns over upticks in medication wasting. As drug shortages broadly impacted the anesthesiology specialty, only to be exacerbated by COVID-19's supply chain disruptions, qualified anesthesia providers had a clear need for the flexibility of a four-hour window to conserve medications.

Since 2008, ASA has worked tirelessly to address this issue, especially with the advocacy of Tillman Hein, MD. Although USP expressed a willingness to amend USP <797>, the revisions have not come to fruition. The 2019 revisions distinguished the difference between compounding and administration and stated that administration was out of the chapter's scope. This revision was later remanded. In 2019, the ASA Committee on Quality Management & Departmental Administration wanted to further delineate compounding from administration in their passage of the Statement on Administration of Medications (asamonitor.pub/3Mu2tzg). The statement aimed to fill a gap to address medication administration. Some anesthesia groups subsequently used ASA's statement to develop policies locally while working with their pharmacies and compliance officers to better define administration and meet accreditation requirements.

The 2021 draft revisions of Chapter <797> continue with this line of thinking. ASA and the many qualified anesthesia providers in favor of removing the one-hour rule see these revisions as a major step forward in their advocacy, as the draft USP standard allows for the administration of drugs for immediate use within a far more practical window of four hours – a duration considered to be a best practice for the specialty and one that doesn't compromise patient safety. In January 2022, ASA and the Anesthesia Patient Safety Foundation (APSF) submitted a joint comment letter to USP applauding the proposed change while providing feedback for greater clarity and easier clinical application of the standards.

In the letter, ASA and APSF recommended that USP work with relevant regulatory bodies such as the U.S. Food and Drug Administration, accrediting organizations such as the Association for Professionals in Infection Control and Epidemiology, and other stakeholders to mold the key terms and language of Chapter <797> around standardized, agreed-upon definitions. The letter also urged USP to acknowledge that the spiking of I.V. bags is considered “administration” and is not within the scope of USP <797>. ASA and APSF referred to research showing no bacterial growth or risk of contamination within 24 hours of pre-spiking a normal saline I.V. bag. ASA aims for this I.V. spiking issue to be addressed either in the final 2021 revisions or in supplemental materials.

After a long campaign of working with the many stakeholders impacted by the one-hour rule, ASA looks forward to finally settling this issue with the hope that USP will provide a clear and conclusive stance in favor of a four-hour window for compounding of medications for immediate use in the final 2021 revisions of Chapter <797>. This outcome would represent a significant victory for patient safety and for the specialty of anesthesiology.

Matthew Goldan, ASA Regulatory Affairs Operations Associate.

Matthew Goldan, ASA Regulatory Affairs Operations Associate.

Close modal

Elizabeth Rebello, R.Ph, MD, FASA, CPPS, Vice Chair, ASA Committee on Quality Management & Departmental Administration, and Professor of Anesthesiology and Perioperative Medicine, University of Texas MD Anderson Cancer Center, Houston.

Elizabeth Rebello, R.Ph, MD, FASA, CPPS, Vice Chair, ASA Committee on Quality Management & Departmental Administration, and Professor of Anesthesiology and Perioperative Medicine, University of Texas MD Anderson Cancer Center, Houston.

Close modal