USP General Chapter <825> Postponed Until Further Notice

October 4, 2019 Update

The United States Pharmacopeial Convention (USP) is postponing the official dates of several recently revised chapters until further notice.

USP’s Bylaws provide that the date by which conformance with a standard is required shall be postponed while an appeal is pending. They further provide that if a standard is upheld, the date by which conformance is required shall be reestablished so that the period allowed for implementation is not less than that provided for upon original publication of the standard.

In practice, the above provisions mean the following with respect to the compounding chapters currently under appeal:

  • Chapters <795>, <797>, and <825> will be postponed until further notice.
  • None of these chapters will become official on the originally anticipated date of December 1, 2019.
  • Regardless of the outcome of the appeals process, USP would not reestablish an official date for chapters <795>, <797>, or <825> without granting another six-month implementation period, at a minimum.
  • USP cannot predict or project a future official date for any of these chapters at this time, as the appeals process remains actively in progress. 

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 addressed by the USP by inclusion of some standards for compounded sterile radiopharmaceuticals in the subsequent revisions of <797>, but many felt that this was still inadequate. In 2016 SNMMI developed a White Paper entitled “USP Public Standards for Compounded Sterile Radiopharmaceuticals: Recommendations from SNMMI” which recommended that USP create a separate General Chapter for Radiopharmaceutical Preparation, Compounding, and Dispensing. Subsequently USP held a stakeholders workshop on radiopharmaceutical compounding and thereafter agreed to create this new General Chapter <825> dedicated to radiopharmaceuticals.

The chapter will become official on December 1, 2019, and 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 agencies including boards of pharmacy, and accreditation organizations. USP has no role in enforcement.

USP has updated their website with many resources and a FAQ page which can be accessed below. 

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.