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Updated Guidance on Compounding Effective November 1, 2023

  • The US Pharmacopeia (USP) has recently released updated guidance for safe medication handling and compounding (General Chapter <797>). USP <797> is a comprehensive set of standards designed to improve patient safety by reducing the number of transmitted infections due to improperly compounded pharmaceuticals.
  • USP <797> defines sterile compounding as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile However, administration and preparation per the manufacturer’s approved labeling are out of the scope of the chapter.

  • USP <797> standards apply to all persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared for human and animal patients. This includes, but is not limited to, pharmacists, technicians, nurses, physicians, veterinarians, dentists, naturopaths, and chiropractors in all places including, but not limited to, hospitals and other healthcare institutions, medical and surgical patient treatment sites, infusion facilities, pharmacies, and physicians’ or veterinarian practice sites. Any person entering a sterile compounding area, whether preparing compounded sterile products or not, must meet the requirements of personal hygiene and garbing.
  • The key changes most likely to affect surgical and procedural facilities are outlined below. Facilities should consider updating their policies and procedures to reflect the changes. This is not all-inclusive of the updated changes published. Each facility is responsible for reviewing the updated information and identifying the changes that impact their facility and patient population.
  • Drawn-up medications are now good for four hours after preparation (instead of one hour) and must be stored according to manufacturers' guidelines until administered and administration must begin before the beyond use date (BUD).
  • There may be no more than three different sterile products combined.
  • Any personnel compounding medications must be trained and demonstrate competency in aseptic processes as they relate to the assigned task and the facility’s policies and procedures, along with personal hygiene and garbing. This should take place at least every 12 months and documentation of competency must be included in the personnel file.

In addition to your search, here are some resources / links with more information on the USP 797 changes:

<797> FAQs

USP 797 Key Changes (ashp.org)

Images of USP 797 Revision 2023 Chart

Since 1980, QUAD A (a non-profit, physician-founded and led global accreditation organization) has worked with thousands of healthcare facilities to standardize and improve the quality of healthcare they provide – believing that patient safety should always come first.