The new version of USP Chapter 797 goes into effect January 1, 2023

The new version of USP Chapter 797 goes into effect November 1, 2023

The new version of USP Chapter 797 goes into effect November 1, 2023. Additionally, USP Chapter 800 (hazardous drugs) becomes enforceable on the same date. Is your facility fully compliant? What steps do you need to take to avoid patient safety issues and regulatory challenges?

Are you ready to comply with USP Chapters 797 and 800? If you waited until now to prepare for the newest requirements, you need to act immediately. Noncompliance with these changes will endanger patients, your staff and result in poor survey results. When was the last time you had a full assessment done to determine your level of compliance?

With the upcoming implementation of the new USP Chapter 797, there are some big changes. Additionally, USP Chapter 800 will also become enforceable. Do you know what you need to do to keep your patients and staff safe? Are you ready for your next survey?

As the newest version of USP Chapter 797 goes into effect, facilities will have to make some adjustments to stay compliant. Policies and procedures will need to be updated and additional staff education provided. Don’t panic; do a quick self-assessment.

Are you thoroughly familiar with both chapters? Do you have a USP champion on your staff? Someone who is responsible for knowing the guidelines and setting up systems to keep your facility compliant? Are you working with an expert pharmacy consultant?

If you answered “yes” to all these questions, you are in good hands and likely in good shape too. If you answered “no” to one or more questions, you would need to make some adjustments to avoid patient safety issues or survey deficiencies. As always, we advocate working with a pharmacy consultant who is specialized and expert in your area of practice. Working with someone who simply checks off items and rubber stamps a report is detrimental to your organization. This is an ideal time to work with someone who has specific expertise on the USP Chapters and knows the required steps for safe handling of compounded and hazardous medications.

As we have been doing over the last year, in the following quarter we will be providing our facilities with answers to the following questions and more…

  • Does USP Chapter 797 impact ambulatory surgery centers or long-term care facilities?
  • How does USP Chapter 797 apply to the preparation and administration of injectable medications?  
  • What changes to USP Chapter 797 will impact ASCs?
  • Who is responsible for the changes?

The new USP Chapter 797 brings with it some changes that will directly impact what facilities do when handling compounded sterile products and hazardous medications. The best way to be compliant is to put in place policies and procedures specific to the operation of your facility. Don’t go at it alone. Engage someone in your organization to be the USP 797/800 champion and rely on the expertise of your pharmacy consultant. If you don’t currently use a pharmacy consultant, or your pharmacist is not expert in this area, contact us and we will guide you in the right direction.


The Consultant Pharmacists at OctariusRx provide guidance on safe medication management, survey readiness and cost savings to ambulatory healthcare facilities/surgery centerssenior care facilities and pharmacies. We also help individual patients optimize their medications to improve their quality of life and save money. Contact us for assistance.


Any health, medical or drug information on the Web Site is for informational purposes only. This information is not intended to be used, and you should not use it, as a substitute for obtaining professional healthcare advice, diagnosis or treatment. You should always seek the advice of your doctor, a pharmacist or other qualified healthcare provider for professional healthcare advice, diagnosis or treatment for any medical condition.