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)
- Printed Labeling for NDA 22-494 (PDF - 190KB)
- Package Insert for NDA 17-042 (PDF - 177KB)
- FR Notice: Determination that Sodium Fluoride F 18 Injection, 10 - 200 mCi/mL, Was Not Withdrawn for Reasons of Safety and Effectiveness
- Electronic Drug Registration and Listing Instructions
- Step-by-Step Instructions for Creating SPL Files for Electronic Drug Establishment Registration and Listing (PDF - 212KB)
CGMP for PET Drugs
- Small Entity Compliance Guide: PET Drugs - Current Good Manufacturing Practice (CGMP) (PDF - 228KB)
- Federal Register Notice: Final Rule - CGMP for PET Drugs
PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399KB)
Guidance document issued 12/9/2009
The PET drug CGMP regulation found in part 212 currently provides that for investigational PET drugs for human use produced under an investigational new drug application (IND) in accordance with part 312 and PET drugs produced with the approval of a Radioactive Drug Research Committee (RDRC) in accordance with part 361, the requirement under the act to follow CGMP can be met by compliance with part 212 or by producing such drugs in accordance with Chapter 823, “Radiopharmaceuticals for Positron Emission Tomography-Compounding,” May 1, 2009, pp. 365-369, 32d ed. of the United States Pharmacopeia (USP) National Formulary (NF) (USP 32/NF 27) (2009). When we adopted the CGMP regulation, we indicated that it would not be appropriate to permit future changes to USP chapter 823 to be incorporated into part 212 without conducting notice and comment rulemaking. Since that time, we have become aware that USP has revised Chapter 823 (see Chapter 823, “Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses,” May 1, 2012, pp. 398-406, USP 35/NF 30 (2012) (currently available in USP 38/NF 33 (2015))), and we are considering whether to amend the regulations to address those changes.
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 Petition 2012-P-013 - Sodium Fluoride
[Click on the PDF icon from the text 'View Attachment' to view the document]
PET Drug Applications - Content and Format for NDAs and ANDAs_2011(PDF - 429KB) PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011(PDF - 614KB) Sample formats for Form FDA 356h_2011(PDF - 601KB) Positron Emission Tomography (PET) Drug SPL Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography(PDF - 156KB) FDA Oversight of PET Drug Products -- Questions and Answers(PDF - 499KB) Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs(PDF - 369KB) FDA Oversight of PET Drug Products -- Questions and Answers(PDF - 499KB)