USP 797 and 800 are here. What’s the difference?
By IPN
In November 2022, the United States Pharmacopeia (USP) put into place the final regulations for General Chapter <797>. The regulations apply to healthcare workers who prepare compounded sterile medications and procedures on how medications are prepared. In your specialty practice, sterile medications could include those administered through injection, intravenous infusion, intraocular (eye), or intrathecal (spine).
How is <797> different from <800>?
USP finalized the guidelines for USP <800> in 2021, and those had to do more with the physical plant – negative pressure rooms for compounding, mixing hood ventilation requirements, negative and positive pressure areas, etc.
USP <797> focuses on one of your top concerns: patient safety. There are several elements to implementing quality health and safety procedures for your practice – and USP <797> provides that guidance. USP <797> helps ensure patient benefit and reduces risks such as contamination, infection, or incorrect dosing.
According to USP, “the authority and responsibility for the quality assurance program should be clearly defined and implemented and should include at least the following nine separate but integrated components:
- Training
- Standard operating procedures (SOP)
- Documentation
- Verification
- Testing
- Cleaning, disinfecting, and safety
- Containers, packaging, repackaging, labeling, and storage
- Outsourcing, if used
- Responsible personnel"
Your state boards of medicine/pharmacy may have additional guidance layered on to the USP guidelines that you need to consider.
These new requirements become effective Nov. 1, 2023, for both USP <797> and <800>.
The investment in time and resources to understanding and implementing the guidance may be overwhelming. But you cannot place your patient’s health and safety at risk.
John Dodd, one of our business optimization consultants, helped many practices update their USP <800> guidelines and physical plant needs. John 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 practiceconsulting@amerisourcebergen.com.
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: https://www.usp.org/compounding.
