CGMP for PET drugs: important steps to take now.

The U.S. Food and Drug Administration (FDA), taking into consideration the unique nature of PET drugs and PET drug production, published the final rule 21 CFR Part 212, “Current Good Manufacturing Practice (CGMP) for Positron Emission Tomography Drug Products,” on December 10, 2009 (Fed Reg. 2009;74:65409). This regulation contains binding requirements for CGMP for PET drugs and is enforceable in court. The guidance “PET Drugs. . .CGMP,” published at the same time as Part 212, describes FDA’s current thinking on specific approaches to comply with Part 212 requirements (Fed Reg. 2009;74:65538).