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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 112
Subpart O - Subpart O—Records
§ 112.161 - What general requirements apply to records required under this part?
§ 112.162 - Where must I store records?
§ 112.163 - May I use existing records to satisfy the requirements of this part?
§ 112.164 - How long must I keep records?
§ 112.165 - What formats are acceptable for the records I keep?
§ 112.166 - What requirements apply for making records available and accessible to FDA?
§ 112.167 - Can records that I provide to FDA be disclosed to persons outside of FDA?
authority:
21 U.S.C. 321
,
331
,
342
,
350h
,
371
;
42 U.S.C. 243
,
264
,
271
source:
80 FR 74547, Nov. 27, 2015, unless otherwise noted.
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