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SNMMI Comments on USP General Chapter 797 Pharmaceutical Compounding

February 24, 2016

On Wednesday, February 24, 2016, SNMMI submitted comments to the U.S. Pharmacopeial Convention on General Chapter 797 Pharmaceutical Compounding – Sterile Preparations. Chapter 797 has been under review since 2010 and has been significantly revised to clarify requirements, and reflect stakeholder feedback and learnings since the last revision became official in 2008.

USP's major revisions of the General Chapter include:

  1. Reorganization of existing sections and placement of procedural information in boxes
  2. Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2) distinguished primarily by the conditions under which they are made and the time within which they are used.
  3. Removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings
  4. Introduction of the terminology “in-use time” to refer to the time before which a conventionally manufactured product used to make a CSP must be used after it has been opened or punctured, or a CSP must be used after it has been opened or punctured.

SNMMI commented on several revisions of the Chapter. For the preparation of sterile radiopharmaceuticals from non-sterile or non-FDA approved components, SNMMI fully acknowledges and supports categorization as compounded radiopharmaceuticals. The SNMMI also believes that changes and adjustments in radioactive aspects during radiopharmaceutical preparation should not be included within the scope of compounding as these activities do not constitute any changes to approved drug product identity or chemical purity. 

Additionally, SNMMI recommends that the USP establish an expert panel with expertise in nuclear pharmacy and nuclear medicine to assist the Compounding Expert Committee (CEC). The goal of the expert panel would be to make recommendations for sterile radiopharmaceutical preparations to the CEC. SNMMI also  recommends that the USP recognize radiopharmaceuticals as a unique class of products and develop a new general chapter entitled “Radiopharmaceutical Compounding – Sterile Preparations.” The SNMMI recognizes that these recommendations are labor intensive, but strongly believes this approach will effectively serve the short- and long-terms needs of patients, pharmacists, and physicians involved in the preparation and handling of sterile radiopharmaceuticals.

Read SNMMI's full comment letter »