USP General Chapter <825> Update

September 1, 2021 Update

USP published revisions to Compounding General Chapters <795> Pharmaceutical Compounding  Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations for an extended 150-day public comment period—until January 31, 2022. SNMMI is working to submit comment.

In addition, the USP Compounding Expert Committee (CMP EC) is hosting four Open Forum sessions in September 2021 and January 2022 to discuss questions from interested stakeholders. The CMP EC has also published several informational documents intended to supplement the proposed Chapters and explain the CMP EC’s rationale behind the revisions.

The registration to the open forum sessions can be done by clicking on the links below:

  • <795> Series registration
    • September 8, 2021 | 1:00 – 3:00 p.m. EDT
    • January 12, 2022 | 10:00 a.m. – 12:00 p.m. EDT
  • <797> Series registration
    • September 15, 2021 | 2:00 – 4:00 p.m. EDT  
    • January 19, 2022 | 10:00 a.m. – 12:00 p.m. EDT   

Revisions to chapters <795> and <797> reflect public health considerations, scientifically robust approaches, and numerous stakeholder engagement activities. The CMP EC engaged healthcare practitioners, regulators, academicians, and other key stakeholders in various sessions including semi-structured interviews with stakeholders, a small roundtable discussion with invited participants, and a broader open forum discussion. These engagements helped the CMP EC consider a wider range of perspectives to inform the revisions while maintaining scientific rigor and accounting for today’s public health and practice needs.


SNMMI continues to work closely with the USP to disseminate information. Come back to this webpage for the latest updates from the USP or visit

June 1, 2020 Update

The United States Pharmacopeial Convention (USP) has issued the following update:

In accordance with the Rules and Procedures of the 2015–2020 Council of Experts, the Chemical Medicines Monographs 4 (CHM4) Expert Committee is reinstating the official date of General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging, following the resolution of an appeal related to the chapter. The new official date for General Chapter <825> is December 1, 2020. It may be downloaded here.


The Society of Nuclear Medicine and Molecular Imaging continues to work closely with the USP to disseminate information. Come back to this webpage for the latest updates from the USP.


March 12, 2020 Update

The United States Pharmacopeial Convention (USP) has issued the following update:

After thoughtful deliberation and evaluation, the USP Appeals Panel has issued final decisions on the appeals to revisions to General Chapters <795> Pharmaceutical Compounding – Nonsterile Preparation, <797> Pharmaceutical Compounding – Sterile Preparations, and new chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging, which were published on June 1, 2019.

The final decisions are as follows:

  • The Appeals Panel has granted the appeals to General Chapters <795> and <797> and is remanding the chapters to the Compounding Expert Committee (CMP EC) with the recommendation for further engagement on the issues raised in the appeals.
  • The Appeals Panel has denied the appeal to General Chapter <825> and is encouraging the appellant to submit the narrower request presented at the hearing before the Panel to the Chemical Medicines Monographs 4 Expert Committee (CHM4 EC) as a request for revision.

The impact of these decisions on the appealed chapters is as follows:

  • The currently official versions of <795> (last revised in 2014) and <797> (last revised in 2008) remain official as a result of the remand. Recognizing the public health impact of these standards, USP is committed to further stakeholder engagement through forums, roundtables, and other avenues to gather more input on the issues raised in the appeals. USP and the CMP EC are committed to moving forward in an open, transparent, and balanced manner as soon as practicable to enable the chapters to be finalized and implemented in a timely manner.
  • Due to the denial of the appeal to <825>, the CHM4 EC may reinstate the official date of this new chapter. Based on USP’s Bylaws, the Expert Committee must provide at least another six-month implementation period for this chapter. The CHM4 EC will announce an official date once it is determined. General Chapter <825> will be informational unless otherwise required by a regulatory body.

For more information, please visit the USP Compounding Appeals webpage.

USP shared the final appeals decisions with the appellants earlier today. We encourage you to share the information in this email with your constituents and any other relevant stakeholders. We appreciate your continued engagement and support. If you would like to discuss further, please do not hesitate to reach out to Ravi Ravichandran at to schedule a meeting. If you have further questions, please email  


We remain committed to supporting the quality of and access to compounded preparations.


The Society of Nuclear Medicine and Molecular Imaging continues to work closely with the USP to disseminate information. Come back to this webpage for the latest updates from the USP.


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, 2020, 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.