Revisions Finalized to USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations

On November 1, 2022, the United States Pharmacopeia (USP) announced revisions to General Chapter <797> Pharmaceutical Compounding—Sterile Preparations (USP 797).  These revisions have an official effective date of November 1, 2023, and affect all locations where healthcare medications are compounded, including anesthetizing locations. CRNAs/nurse anesthesiologists who engage in medication-compounding practices that fall within USP 797 should be aware of these standards.  While USP does not have enforcement authority, these standards may be adopted by individual facilities and health systems, state and government regulators, and accreditors.  It is possible that these entities may implement the changes found in this revision earlier than the official effective date.  It is important to know if and how your practices are subject to USP 797.  You may hear about these revisions from your facility’s pharmacy director or others in your facility.

According to USP, these revisions are based on updated and current scientific evidence, stakeholder feedback,  and scientific opinion from various experts. AANA extensively commented on the three drafts of revisions released for stakeholder input and advocated for loosening restrictions on medication preparation in anesthetizing locations that are not based on scientific evidence.  The announced finalized revisions are generally an improvement over the previous version in place since 2008, reflecting the value of AANA advocacy and comments.  The 2008 version included restrictions that disrupt anesthesia workflows, delaying perioperative care, potentially jeopardizing patient safety, and wasting medications in the process.

CRNAs/nurse anesthesiologists may be aware of USP 797’s “immediate use” rule, which in the previous 2008 version allowed preparation of a single-dose medication to be exempt from the rigorous additional USP 797 requirements if the preparation met certain conditions.  One of these conditions was the “1-hour rule,“ which required that many medications, defined as “compounded sterile preparations” (CSPs), begin administration within 1 hour of the start of preparation.  The new USP 797 revisions extend this time period to 4 hours, a more practical and reasonable time period.  Highlights of the revised USP 797 include:

• “Sterile compounding” is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile preparation
• USP 797 does not apply to administration of medications; administration is out of scope of the chapter.
• For “immediate use CSPs”:
  • Training and competency assessments are determined by the specific tasks performed and the facility’s standard operating procedures (SOPs), which must include aseptic processes to minimize the potential for contact with nonsterile surface surfaces, introduction of particulate matter or biological fluids, and mix-ups with other conventionally manufactured products or CSPs.
  • The preparation involves not more than 3 different sterile products. Any unused starting component from a single-dose container must be discarded after preparation is complete.
  • Single-dose containers must not be used for more than 1 patient.
  • Administration must begin within 4 hours following the start of preparation. If administration has not begun within 4 hours, the medication must be promptly, appropriately, and safely discarded.
  • Unless directly administered by the person who prepared it or administration is witnessed by the preparer, the CSP must be labeled with the names and amounts of all active ingredients, the name or initials of the person who prepared the preparation, and the 4-hour time period within which administration must begin.
• Preparing a conventionally manufactured sterile product in accordance with the directions in the manufacturer’s approved labeling or manufacturer’s supplementary materials is out of scope of this chapter if:
  • The product is prepared as a single dose for an individual patient; and
  • The approved labeling includes information for the diluent, the resultant strength, the container closure system, and storage time.
• Withdrawing a dose from a container or spiking an IV bag of a conventionally manufactured sterile product without any further manipulation is considered administration rather than compounding and is out of the scope of USP 797.

For additional information on USP 797 and the revisions, including FAQs and a fact sheet, see Updates to USP General Chapters <795> and <797>.

AANA worked continuously over the multi-year revision period to advocate for safe and reasonable medication practices in the anesthesia environment, including the removal of the restrictive 1-hour rule. In addition to submitting extensive and numerous comments, AANA closely monitored the development process   AANA will continue to advocate for safe and reasonable medication practices for CRNAs/nurse anesthesiologists and serve as a resource to the profession and external entities as these standards are adopted and enforced by third parties.  If you have questions, please reach out to AANA Professional Practice at practice@aana.com.