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USP 797 guidelines and what you need to consider


Turnover in healthcare is at the highest rate in decades, and community practices like yours are no exception. When a clinical staff member resigns, it can cause huge issues – paying overtime to cover, increasing staff workloads – the change is disrupting. Turnover can also impact your practice more than just financially. Without continuity in your processes, you may start to impact patient and staff health and safety.

It is especially true when you consider the November 2022 significant updates to the United States Pharmacopeia (USP) General Chapter <797> guidelines which address preparing compounded sterile medications and may be enforced beginning in November 2023. Continuity is important.

What are some of the changes you need to address?
As an example, there is a significant change in PPE. The guidelines are stricter.  Think mixing gown, shoe covers, double gloves, headcover, etc. (these are not the specific items), but as an idea of how the guidelines address no skin being exposed.

In addition, you will need to have another staff member trained to inspect that the wearing of PPE is followed accurately and documented testing to the guidelines. 

This one guideline alone will ensure that your practice needs to purchase additional PPE, create a standard operating procedure (SOP) for donning/doffing PPE and begin training for both the individual wearing the PPE, as well as the person responsible for oversight.

You’ll also need to ensure that you have cross-trained other staff in the event of sickness, vacation, and staff turnover.  And that is only one example in the new USP <797>. There are several changes that will have an immediate impact on operational requirements.

Continuity is important. Making sure several of your staff understand the procedures assures that continuity as it impacts patient and staff safety.

John Dodd, one of our business optimization consultants, helped many practices update 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: