Drugs

Positron Emission Tomography (PET)

Notice of FDA Exercise of Enforcement Discretion for PET Drugs until June 12, 2012 (PDF - 15KB)

Registration and Listing

Requirements for drug establishment registration and drug listing are set forth in section 510 of the Federal Food, Drug and Cosmetic Act (the Act), section 351 of the Public Health and Service Act (the PHS Act), and in FDA’s regulations at 21 CFR Part 207. Fundamental to FDA’s mission to protect the public health is the collection of this information, which is used for important activities such as postmarket surveillance for serious adverse drug reactions, inspection of drug manufacturing and processing facilities, and monitoring of drug products imported into the United States.

The Business Operation Code for PET Drug Production is C91403. (Business Operation)

Positron Emission Tomography (PET) Drug SPL - SPL Training Session

Labeling

Additional Information

CGMP for PET Drugs

Compliance Program Guidance Manual

FDA has posted the Compliance Program Guidance Manual for PET CGMP drug inspections. FDA’s Compliance Programs provide instructions to FDA personnel for inspecting facilities, sampling and analyzing FDA-regulated products, and initiating and implementing regulatory follow up, when appropriate. FDA personnel who will be involved in evaluating PET production facilities are being trained to use the PET Compliance Program, to know the PET CGMP regulations and guidance, and to understand the unique aspects of PET production. FDA will offer webinars to the PET community to explain this program and provide general information about FDA inspection practices beginning in 2012.

Suitability Petitions

Historical Information

 

Page Last Updated: 12/17/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.