# records for all components, drug product containers, closures, and labeling — How long federal regulations require records to be kept: retention periods, what starts the clock, and who they bind

For records for all components, drug product containers, closures, and labeling, regulation is 21 CFR 211.180; regulator / programme is FDA (drug GMP); retention period is at least 1 year after the expiration date; when the clock starts is the expiration date; exceptions and notes is in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling, recorded from its source on 2026-08-11.

- **Regulation:** 21 CFR 211.180 _(verified: appears in the quote below)_
- **Regulator / programme:** FDA (drug GMP) _(our reading, not quoted from the source)_
- **Record type:** records for all components, drug product containers, closures, and labeling _(verified: appears in the quote below)_
- **Retention period:** at least 1 year after the expiration date _(verified: appears in the quote below)_
- **When the clock starts:** the expiration date _(verified: appears in the quote below)_
- **Exceptions and notes:** in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling _(verified: appears in the quote below)_

## What the source says

> ( b ) Records shall be maintained for all components, drug product containers, closures, and labeling for at least 1 year after the expiration date or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under <https://www.ecfr.gov/current/title-21/section-211.137> § 211.137 , <https://www.ecfr.gov/current/title-21/section-3> 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling.

## Source

- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-J/section-211.180

Last verified: 2026-08-11. Review by: 2027-08-11.
Part of [How long federal regulations require records to be kept: retention periods, what starts the clock, and who they bind](https://referencesource.org/record-retention-periods-federal/).