Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter C - Drugs: General |
Part 212 - Current Good Manufacturing Practice for Positron Emission Tomography Drugs |
Subpart H - Finished Drug Product Controls and Acceptance |
§ 212.70 - What controls and acceptance criteria must I have for my finished PET drug products? |
§ 212.71 - What actions must I take if a batch of PET drug product does not conform to specifications? |