21 CFR 111.605 - What requirements apply to the records that you make and keep?

Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

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§ 111.605 - What requirements apply to the records that you make and keep?

§ 111.610 - What records must be made available to FDA?

§ 111.605 - What requirements apply to the records that you make and keep?

(a) You must keep written records required by this part for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.

(b) Records must be kept as original records, as true copies (such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records), or as electronic records.

§ 111.610 - What records must be made available to FDA?

(a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested.

(b) If you use reduction techniques, such as microfilming, you must make suitable reader and photocopying equipment readily available to FDA.

authority: 21 U.S.C. 321,342,343,371,374,381,393; 42 U.S.C. 264.

source: 72 FR 34942, June 25, 2007, unless otherwise noted.

cite as: 21 CFR 111.605