USP <825> Preparing For Compliance

  • Posted on August 24, 2020

By Robert Rosar, R.Ph. , Quality Assurance and Compliance Specialist

It is now time to prepare your facility for compliance with the standards set forth in the US Pharmacopia or USP <825>.  It will be official December 1, 2020. USP Chapter <825> specifically outlines expectations for those who are compounding, preparing, preparing with minor deviations, and/or

repackaging/dispensing radiopharmaceuticals.

Why this Chapter was developed?

USP Chapter <825> was developed in response to public comments associated with a series of revised and published papers from key opinion leaders, healthcare practitioners and industry experts who felt USP <797> was difficult to comply with due to the nature of the drug products we compound and dispense. USP <825> considers the precautions that we have to take when handling radioactive materials and the shorter shelf life and lower microbial risk factors involved in our preparations. 

So to whom does the Chapter apply?

It applies to all individuals who prepare, compound, dispense, or repackage radiopharmaceuticals.  With that said, not only nuclear pharmacists and nuclear pharmacy technicians working in a commercial nuclear pharmacy setting, but also nuclear medicine technologists (students), and physician residents and trainees. Nuclear medicine departments and nuclear cardiology clinics are also in scope.

What is Jubilant Radiopharma™ doing?

We formed a USP <825> committee consisting of nuclear pharmacists, quality, regulatory, and radiation safety professionals. We completed a comprehensive gap assessment, an impact assessment, and then developed a 3-month implementation plan (involving changes in procedure, process, equipment, etc.). 

The new chapter requires monthly environmental monitoring (EM) testing of classified areas instead of biannual testing. This will require Jubilant Radiopharma to develop an internal EM Program vs leveraging a 3rd party and each radiopharmacy will need to purchase an additional incubator and revise SOPs, and train personnel. We will also have to use a 3rd party microbiology lab for speciation of organisms when colony forming units, or CFUs, are identified during testing. 

For our customers and the nuclear medicine community, we developed a “Changes Affecting Nuclear Medicine Departments” presentation to support immediate needs, are developing a “Continuous Education Training Program” for the Nuclear Medicine Community, and identified a list of ancillary products to meet long-term needs.

What should Nuclear Medicine Professionals do?

We encourage you to create a USP <825> Team consisting of a Joint Commission (TJC) compliance representative, Pharmacy Director (or delegate), Nuclear Medicine Department, Quality Assurance and Risk Management personnel to work on identifying compliance gaps, develop a plan of action to close those gaps, implement the plan and monitor the plan to validate against accreditation requirements. 

This team will help you with your inspection readiness activities and can identify and leverage SOPs already established within your organization. The Pharmacy Department can play a pivotal role in helping your institution maintain compliance.

We also encourage you to attend one of our upcoming presentations on USP <825> and contact your local Jubilant Radiopharmacy to assist you with any questions that you may have.  We also will have an extensive list of ancillary supplies available to help you with compliance to these standards.



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