CFR section

21 CFR 361.1(f)(11): 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(f)(11)
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) (11) If the drug is intended for parenteral use, a statement as to whether the contents are sterile;

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