PET biomarker manufacturing

Consistency. Quality assurance. Patient safety.

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FDA enforcement statement

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What is the impact of 21 C.F.R. Part 212?

Due to the uniqueness of positron emission tomography (PET) biomarkers, Food and Drug Administration Modernization Act of 1997 initially allowed the production and sale of PET biomarkers in accordance with U.S. Pharmacopeia (USP) standards governed by USP <823> compounding requirements.  However, effective June 12, 2012 this will change.

As of that date, all PET biomarkers will be manufactured based on current Good Manufacturing Practices (cGMP) found at 21 C.F.R. Part 212.   cGMP helps ensure PET biomarkers have the high levels of consistency, quality and purity required by the FDA and gives you confidence in the safety and efficacy of the drugs you administer to your patients.

21 C.F.R. Part 212 Cardinal Health Statement of Compliance