CFR section
21 CFR 310.305(g)(3): Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications
PART 310-NEW DRUGS · Subpart D-Records and Reports
Key facts
| Citation | 21 CFR 310.305(g)(3) |
|---|---|
| Section | Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications |
| Part | PART 310-NEW DRUGS |
| Subpart | Subpart D-Records and Reports |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs |
| Regulation text (excerpt) | (3) Manufacturers, packers, and distributors must permit any authorized FDA employee, at all reasonable times, to have access to and copy and verify the records established and maintained under this section. |
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.