Subpart O - RECORDS
- Section 112.161 - [Effective 7/5/2024] What general requirements apply to records required under this part?
- Section 112.161 - [Effective until 7/5/2024] What general requirements apply to records required under this part?
- Section 112.162 - Where must I store records?
- Section 112.163 - May I use existing records to satisfy the requirements of this part?
- Section 112.164 - How long must I keep records?
- Section 112.165 - What formats are acceptable for the records I keep?
- Section 112.166 - What requirements apply for making records available and accessible to FDA?
- Section 112.167 - Can records that I provide to FDA be disclosed to persons outside of FDA?