US Pharmacopeia Seeks Public Comment on General Chapter <823>

January 10, 2011

US Pharmacopeia Seeks Public Comment on General Chapter <823>

The US Pharmacopeia – a scientific, nonprofit organization responsible for establishing quality standards for radiopharmaceutical products marketed in the United States – is seeking public comment on revisions to General Chapter <823>, Radiopharmaceuticals for Positron Emission Tomography – Compounding, until March 31, 2011.  The proposed revisions are to reflect changes in the production of PET drugs since the standard’s original publication in 1998.

Once the revised General Chapter <823> is published, US Pharmacopeia will petition the US Food and Drug Administration (FDA) to update its reference in the regulations to cite the revised version.  Until FDA makes this change, PET drug manufacturers will have to comply with the 1998 version of <823> or the 21 CFR <212> to meet CGMP requirements.

On Thursday, January 20, 2011, as part of the SNM 2011 Mid Winter Meeting in Palm Springs, CA, Sally Schwarz, MS, RPh, BCNP and Ravi Ravichandran, PhD will lead an educational session to detail the proposed changes to Chapter <823> and offer the rationale behind the changes. 

For additional information and to view the proposed changes please visit www.usp.org/goto/usp823.