CFR section
21 CFR 361.1(d)(6): 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(d)(6) |
|---|---|
| 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) | (6) Quality of radioactive drug. The radioactive drug used in the research study shall meet appropriate chemical, pharmaceutical, radiochemical, and radionuclidic standards of identity, strength, quality, and purity as needed for safety and be of such uniform and reproducible quality as to give significance to the research study conducted. The Radioactive Drug Research Committee shall determine that radioactive materials for parenteral use are prepared in sterile and pyrogen-free form. |
At a glance
- 1–9 Inspections citing this section
- None Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.