ASA Submits Comments on USP <797> Proposed Language on Compounding Sterile Preparations

On November 28, 2018, the American Society of Anesthesiologists (ASA) submitted comments to the United States Pharmacopeial (USP) Convention on its proposed language for USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations. ASA supported changes to the language that would effectively remove the “one-hour rule” from this chapter.

ASA members often encounter USP <797> when developing policies around the “one-hour rule” and in workflows related to preparing compounded sterile preparations (CSPs) for urgent cases.  The one-hour rule currently requires that a “[a]dministration begins not later than 1 hour following the start of preparation of the CSP” and “[i]f administration has not begun within 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safely discarded.” Safe practice and care of patients is paramount; however, the one-hour use stipulation has had the potential to endanger patient safety and care. The one-hour rule is an inefficient use of medication resources, particularly in a time of increased cost for medication and drug shortages.

ASA argued that USP <797> should be clearly written for all stakeholders, such as anesthesiologists, hospital administrators and accrediting organizations, to understand. ASA urged USP to clarify that they have indeed removed the one-hour rule language and also asked USP to simplify its proposed definition of administration. ASA further requested that USP allow local policy to determine appropriate time periods for discarding compounded medications in operating and procedure room settings. 

USP publishes its United States Pharmacopeia and releases voluntary standards that are widely adopted by states and facilities. USP <797> covers requirements for sterile preparations for pharmaceutical compounding including what situations are covered by <797>, training of personnel and storage of preparations.

USP plans to publish a final updated version of <797> on June 1, 2019. The anticipated implementation date for <797> is December 1, 2019. 

For questions about USP <797>, please contact the ASA Department of Quality and Regulatory Affairs at [email protected].