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Title 21 Part 111 → Subpart P

Title 21 → Chapter I → Subchapter B → Part 111 → Subpart P

Electronic Code of Federal Regulations e-CFR

Title 21 Part 111 → Subpart P

e-CFR data is current as of April 2, 2020

Title 21Chapter ISubchapter BPart 111 → Subpart P


Title 21: Food and Drugs
PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS


Subpart P—Records and Recordkeeping


Contents
§111.605   What requirements apply to the records that you make and keep?
§111.610   What records must be made available to FDA?

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§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.

(c) All electronic records must comply with part 11 of this chapter.

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§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.

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