June 04, 2019
Revisions to USP <797> Released; So-called One-Hour Rule Deleted
On June 1, the US Pharmacopeial Convention (USP) released its well-anticipated revisions to Chapter <797> – the chapter that addresses Pharmaceutical Compounding – Sterile Preparations
. Physician anesthesiologists have encountered USP <797> under the so-called “one-hour rule” that required the administration of all immediate-use compounded sterile products (CSPs) begin within one hour after the start of preparation. The American Society of Anesthesiologists (ASA) applauds the actions of USP to remove, from this chapter, reference to administering a non-hazardous compounded sterile preparation within one hour.
Over several years, ASA
engaged USP and other stakeholders, including accreditation organizations, on the burden that the “one-hour rule” placed on physician anesthesiologists, other medical professionals and health systems. ASA repeatedly pointed out to USP and regulatory agencies that the rule lacked supporting evidence demonstrating that administering any compounded drug exceeding one hour increased the risk of contamination of the syringe or negatively affected patient outcomes in the operating room setting.
The misinterpretation and misapplication of this regulation also led to confusion in the perioperative environment in local facilities. As physician anesthesiologists are well-aware, apprehension that this rule (or receiving a citation from an accreditor) may jeopardize patient safety has been a real possibility in scenarios when physician anesthesiologists need to respond to urgent cases such as emergency cardiac procedures, caesarian sections and trauma cases.
In anticipation of its December 1, 2019 implementation, USP has developed
a list of activities and educational programming for interested physicians, pharmacists and other stakeholders on their website. Such activities include live education courses in June and September, a summary of changes the <797> and a Frequently Asked Questions webpage.
Physician anesthesiologists should review their local policies and procedures regarding the preparation and administration of drugs in the operating room setting. ASA expects to release additional materials in the upcoming months to assist anesthesiologists in addressing USP <797> locally.
ASA welcomes feedback about experience with USP <797>. For questions or comments on USP <797>, please contact the ASA Department of Quality and Regulatory Affairs at [email protected]