Title 21

PART 112 SUBPART O

Subpart O - Records

• 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.
• 80 FR 74547, Nov. 27, 2015, unless otherwise noted.

21:2.0.1.1.12.14.1.1	SECTION 112.161	112.161 What general requirements apply to records required under this part
21:2.0.1.1.12.14.1.2	SECTION 112.162	112.162 Where must I store records
21:2.0.1.1.12.14.1.3	SECTION 112.163	112.163 May I use existing records to satisfy the requirements of this part
21:2.0.1.1.12.14.1.4	SECTION 112.164	112.164 How long must I keep records
21:2.0.1.1.12.14.1.5	SECTION 112.165	112.165 What formats are acceptable for the records I keep
21:2.0.1.1.12.14.1.6	SECTION 112.166	112.166 What requirements apply for making records available and accessible to FDA
21:2.0.1.1.12.14.1.7	SECTION 112.167	112.167 Can records that I provide to FDA be disclosed to persons outside of FDA

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