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Tips for complying with USP 797


The new guidelines for USP General Chapter <797> are already in place as of the beginning of the year.

To address those issues, you need to update your internal workflows – from receiving medications, compounding, and dispensing.

How do you maintain patient safety and stay on the path of improving clinical outcomes for reimbursements, with all staff needing to learn new standard operating procedures (SOP)? 

Tips on what you need to do internally for USP <797>:

  1.  Read through the USP <797> guidelines and see how they fit in your current SOPs. For a small practice, this is an immense undertaking. Downloading the guidelines has a cost and using the hours of one of your nursing staff to do that research will either impact patient care or your bottom line, or both.
  2. Update your SOPs that make sense for your practice and train your staff. This can be an involved process – there’s rules for compounding and oversight, testing and oversight, even donning the required PPE and oversight. Maybe it’s time to consider outside help to modify your own SOPs, and stay on top of changing requirements.
  3. Understand that training could take months.

As for enforcement of the guidelines, each state is different. Some will involve the state board of pharmacy, others the board of medicine, and others both boards in their oversight. They could also look at your compliance to USP <800> as those guidelines were considered “informational” until <797> became official and enforceable on Nov. 1, 2023. But those boards that do enforce could impose harsh penalties on your practice – more than the cost of doing the early work. Now is the time to begin reviewing and if needed, implementing the needed revisions to make sure your practice is compliant.

John Dodd, a member of our business consulting team, helped many practices with updating their USP <800> guidelines and physical plant needs.  He is available to our community practices to answer questions on the new <797> guidelines, as well as address your concerns with <800>.  John can be reached at

NOTE:  The USP Compounding Compendium made updates to the Compounding Standards (General Chapters <797> and <800> )which are discussed above.  You can read more at: