CFR section
21 CFR 511.1(b)(7)(ii): New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act
PART 511-NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
Key facts
| Citation | 21 CFR 511.1(b)(7)(ii) |
|---|---|
| Section | New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act |
| Part | PART 511-NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE |
| Subchapter | 21 CFR E Drugs Animal |
| Product types cited | General, Veterinary |
| Regulation text (excerpt) | (ii) Shall maintain complete records of the investigations, including complete records of the receipt and disposition of each shipment or delivery of the new animal drug under investigation. Copies of all records of the investigation shall be retained by the investigator for 2 years after the termination of the investigation or approval of a new animal drug application. |
At a glance
- 10–99 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.