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USP Publishes General Chapter <825> Effective December 1, 2019

June 5, 2019

THE STORY

On June 1, the U.S. Pharmacopeia (USP) published General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. This General Chapter provides uniform minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and non-sterile radiopharmaceuticals for humans and animals that occur as part of state-licensed activities.

Immediately following the inception of <797>, there was widespread recognition within the Nuclear Medicine and Nuclear Pharmacy communities that radiopharmaceuticals were underserved by the founding chapter and specific standards based on the unique characteristics of radiopharmaceuticals were needed. This concern was immediately addressed by the USP with the recognition and inclusion of standards for compounded sterile radiopharmaceuticals in subsequent revisions <797> and ultimately to this new General Chapter <825>. SNMMI commends USP in this effort to provide a reasonable and rational basis for the protection of patients from unsafe practices when preparing, compounding, dispensing, and repackaging radiopharmaceuticals.

The chapter will become official on December 1, 2019, and as of that date, affected users are expected to meet its requirements. Ensuring compliance with the requirements is the responsibility of regulators such as the U.S. Food and Drug Administration, states, and other government authorities. USP has no role in enforcement.

WHY IT’S IMPORTANT

USP 825 is important for members as it incorporates the specific needs of nuclear pharmacies and nuclear medicine departments in hospitals and clinics and provides the patient safety protection intended by USP.

The new guidance devotes whole sections to the importance of keeping an appropriate environment during the preparation of radiopharmaceuticals, including clean room regimes, hygiene, cleaning equipment, labeling, and air particulate matter monitoring.

Additionally, the chapter describes:

  • Facilities and engineering controls, personnel training and qualifications, and procedural standards for processing radiopharmaceuticals in nuclear pharmacies, nuclear medicine areas in hospitals and clinics, and other healthcare settings that utilize radiopharmaceuticals.
  • For sterile radiopharmaceuticals, these standards balance aseptic handling practices with radiation protection practices to describe appropriate strategies to maintain patient safety while also ensuring the safety of individuals performing these activities.

It is essential members review and compare the practices and procedures in place in their facility against what is included in the new USP chapter. Items like facility design, competency of staff, and infection control practices are critical areas that might need attention and review.

WHAT SNMMI IS DOING

SNMMI is carefully reviewing the General Chapter. As previously reported, SNMMI submitted comments on the draft chapter in November 2018. Many of SNMMI’s recommendations are included in the newly published chapter. You can read SNMMI’s cover letter here. You can read the detailed line by line submission here.

WHAT’S NEXT

USP has updated their website with many resources and a FAQ page which can be accessed below. USP will be presenting at SNMMI’s Annual meeting and all members are encouraged to attend.