It is well known that USP Chapter 797 is still under review with no identified approval date. But, a less well-known section on radiopharmaceuticals, USP chapter 825, will become official on December 1, 2020. Although most of our clients do not compound or dispense radiopharmaceuticals, they do administer them. So take these steps to remain compliant.
USP Chapter 825
First, make sure your nuclear medicine department obtains and reviews USP Chapter 825. At present, you can download it for free from the USP website. But once the chapter becomes official, it is likely to convert to a “for sale” publication. If you don’t have a copy, get it this month.
As we stated, this new chapter does not cover administration of radiopharmaceuticals. Nor does it cover the preparation or compounding of PET drugs that are not manufactured as approved drugs.
Focus On These Sections
Pay particular attention to the following sections:
- Section 1 is particularly important. It identifies who is subject to USP Chapter 825 and who is not.
- Section 3 is one your nuclear medicine department should carefully review. It discusses immediate use preparation of sterile radiopharmaceuticals.
In addition, section 3 exempts the requirement for the SEC and PEC you are familiar with in your pharmacy. In fact, providing the work in process meets the immediate use definitions. Further, this section discusses the preparation of radiolabeled red blood cells for immediate use and the simple manipulation of a unit dose by the addition of lidocaine.
Offsite Compounding Requirements
As we discussed, most hospitals don’t compound or dispense. But if you get radiopharmaceuticals from an offsite compounding radiopharmacy, they are subject to this new chapter. As a result, hospital purchases of these patient specific doses is subject to the Joint Commission’s clinical contracting standards under LD.04.03.09. At a minimum, verify that your vendor is compliant with the new USP Chapter 825. Further, have your nuclear medicine department and pharmacy staff collaborate to evaluate vendor compliance with this chapter.
The American Society of Health System Pharmacists developed an evaluation tool for offsite pharmacy compounders. But, it is not nuclear medicine specific. Plus, The American Pharmaceutical Associations Academy of Pharmacy Practice and Management prepared a nuclear pharmacy evaluation tool. But, it is still expressed in terms of USP Chapter 797 rather than the newer USP Chapter 825.
But, combining these templates with your own staff’s expertise will form a useful tool to help evaluate the offsite radioactive isotope vendor. Whenever possible, we recommend evaluating any offsite compounder to include a site visit. Because many hospitals learned the value of verifying offsite quality data after their experience with the New England Compounding Center.
Another USP Chapter 825 Resource
Cardinal, a large national supplier of medications to hospitals and a dispenser of radiopharmaceuticals, posted a document explaining some of the implications of Chapter 825. You may access this information here.
Patton Healthcare Consulting
Patton Healthcare Consulting can help you navigate the new normal. Our new remote consultation “Comprehensive Hybrid Readiness Review” is a hybrid remote/onsite support program. It is designed to assist with assessment and education to meet your needs going forward after this national emergency.
In addition, we understand the need for assistance without disrupting your organization or extensive costs. That’s the specific purpose of this program. Contact us at (888) PHC-INC1 for more information or email us at ExpertAdvice@PattonHC.com.