CFR section
21 CFR 312.6(a): Labeling of an investigational new drug
PART 312-INVESTIGATIONAL NEW DRUG APPLICATION · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 312.6(a) |
|---|---|
| Section | Labeling of an investigational new drug |
| Part | PART 312-INVESTIGATIONAL NEW DRUG APPLICATION |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (a) The immediate package of an investigational new drug intended for human use shall bear a label with the statement “Caution: New Drug-Limited by Federal (or United States) law to investigational use.” |
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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.