Does the final rule apply to PET dugs used in clinical investigations and non-clinical research?
The final rule at 21 CFR part 212 establishes CGMP regulations for PET drugs produced for routine clinical use (i.e., use in humans not a part of a clinical trial for an unapproved PET drug). PET drugs intended for clinical investigations only or for research only may be produced in accordance with either the CGMP regulations at 21 CFR part 212 or with the current United States Pharmacopeia (USP) general chapter 823 titled “Radiopharmaceuticals for Positron Emission Tomography–Compounding.” This is explained in the Federal Register announcement for the CGMP regulation and in the Guidance. 3. How will FDA inspect PET drug production? The CGMP regulations announced today will become effective in 2 years. During the next 2 years, producers of PET drugs can expect FDA will continue to perform inspections of selected PET producers using the current standard, USP chapter 823. FDA will also continue to inspect new PET producers, including those producers who apply to make a type of PET drug t
