Are you ready to comply with USP Chapters 797 and 800? 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 intimately 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 future 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.
Does USP Chapter 797 impact ambulatory surgery centers or long-term care facilities?
Yes. USP Chapter 797 will apply to anyone who compounds sterile products or any facility where compounded sterile products are prepared.
Does USP Chapter 797 apply to the administration of injectable medications?
Although USP Chapter 797 applies to the preparation of injectable medications, it does not apply to the actual administration. For guidance on administration, facilities should follow the safe injection practices recommended by the Centers for Disease Control and Prevention (CDC).
What changes to USP Chapter 797 will impact ASCs?
There are a few new changes in USP Chapter 797 that will directly impact ASCs. One of the changes will impact beyond-use dating. Beyond-use dates apply to many different aspects of medication management at the facility level. This will directly affect many different items including injections (e.g., single-dose, multi-dose vials, intravenous bags pre-drawn syringes), ophthalmic dosage forms, and irrigations for internal body cavities. Another change will impact the handling of hazardous medications. As you may recall, the 2019 revision of USP Chapter 797 would have made Chapter 800 compendially applicable, or enforceable. However, because the 2019 revision was remanded, Chapter 800 was released for informational purposes only on December 1, 2019. When the new version of Chapter 797 is implemented, Chapter 800 will become enforceable. If you are not fully compliant at this time, you will need to be on the day Chapters 797 and 800 go into effect.
Who is responsible for the changes?
Per the USP guidance, each facility will have to designate someone who is responsible for preparing compounded sterile products. This can be the same person who will oversee the development and implementation of policies and procedures related to handling hazardous medications (USP Chapter 800). If you don’t currently have someone in place for USP 800, now is a good time to select the right person and start taking the appropriate steps. For additional steps you can take to comply with USP 800, read my previous post titled “Five reasons why you should comply with USP 800. A consultant pharmacist update”. 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 centers, senior 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.