Title 21 CFR reference

What this part covers

• Radioactive drugs are considered safe and effective for human research subjects when administered under specific conditions outlined in the regulation.
• Research must focus on obtaining basic information about drug metabolism, human physiology, pathophysiology, or biochemistry, not immediate therapeutic or diagnostic purposes.
• Approval by a Food and Drug Administration-approved Radioactive Drug Research Committee (RDRC) is mandatory.
• RDRC approval requires determination that pharmacological and radiation doses are within specified limits, radiation exposure is justified, and other research standards are met.
• Strict limits are placed on both pharmacological and radiation doses to human research subjects.
• RDRCs must be composed of at least five individuals with specific expertise, including a nuclear medicine specialist, a radioactive drug formulator, and a radiation safety expert.
• Investigators must meet qualifications, obtain licenses for radioactive materials, and ensure human research subjects provide informed consent.
• Specific labeling requirements are detailed for radioactive drugs intended for research use, including "Rx only" and compliance statements.
• Adverse effects must be reported immediately to the RDRC, which then reports them to the FDA.
• Results from research conducted under this part must be included in submissions required under part 312 (Investigational New Drug Application).

Sections in Part 361