Subpart O—Records

Sections

• 112.161
  § 112.161 What general requirements apply to records required under this part?
• 112.162
  § 112.162 Where must I store records?
• 112.163
  § 112.163 May I use existing records to satisfy the requirements of this part?
• 112.164
  § 112.164 How long must I keep records?
• 112.165
  § 112.165 What formats are acceptable for the records I keep?
• 112.166
  § 112.166 What requirements apply for making records available and accessible to FDA?
• 112.167
  § 112.167 Can records that I provide to FDA be disclosed to persons outside of FDA?