CFR section
21 CFR 361.1(b)(3)(i): Radioactive drugs for certain research uses
PART 361-PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
Key facts
| Citation | 21 CFR 361.1(b)(3)(i) |
|---|---|
| Section | Radioactive drugs for certain research uses |
| Part | PART 361-PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs |
| Regulation text (excerpt) | (i) Under no circumstances may the radiation dose to an adult research subject from a single study or cumulatively from a number of studies conducted within 1 year be generally recognized as safe if such dose exceeds the following: Whole body, active blood-forming organs, lens of the eye, and gonads: Rems Single dose 3 Annual and total dose commitment 5 Other organs: Single dose 5 Annual and total dose commitment 15 |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.