Code of Federal Regulations (Last Updated: April 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter K - Tobacco Products |
Part 1107 - Exemption Requests and Substantial Equivalence Reports |
Subpart E - Miscellaneous |
§ 1107.58 - Record retention.
Latest version.
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§ 1107.58 Record retention.
Each applicant that receives an order under § 1107.46 authorizing the marketing of a new tobacco product must maintain all records required by this subpart and that support the SE Report for a substantial equivalence order. These records must be legible, in the English language, and available for inspection and copying by officers or employees duly designated by the Secretary. All records must be retained for a period of not less than 4 years from the date of the order even if such product is discontinued.