The US Pharmacopeia (USP) is currently in the process of revising several general chapters that are important to the nuclear medicine community. The USP sets public standards that serve patients, academia, industry, regulators, healthcare professionals, and other stakeholders. As a long-standing part of the revision process, the USP seeks public comments on revisions before adopting final resolutions. Comments from the public play an important role in the USP standards setting process!
Chapter <821> Radioactivity describes requirements for instrumentation used in radioactivity measurements. The Expert Committee responsible for this chapter has revised <821> to update, clarify, and simplify the chapter. In addition, the Committee has created a new informational chapter <1821> to complement <821>. Once finalized, <821> will serve as an enforceable chapter with requirements for instruments used in radioactivity measurements and <1821> will serve as a source of educational information relevant to radioactivity measurements.
Simultaneously with changes to chapters <821> and <1821>, the USP is also introducing a new informational chapter <1823>, which is a source of educational information relevant to PET drugs. These chapters are available on the USP Key Issues page. In addition to the Key Issues page, the USP Quality Matters blog contains more information about these revisions. See: http://qualitymatters.usp.org/updating-quality-standards-nuclear-medicine-and-radioactive-materials.
Stakeholders are encouraged to participate in the standard setting process by commenting on these revisions. Stakeholders include radiopharmaceutical manufacturers and other entities that make radioactivity measurements according to USP standards. The USP is accepting public comments on these revisions until November 30, 2015.