# any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product — How long federal regulations require records to be kept: retention periods, what starts the clock, and who they bind

For any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product, regulation is 21 CFR 211.180; regulator / programme is FDA (drug GMP); retention period is at least 1 year after the expiration date of the batch; when the clock starts is the expiration date of the batch; 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 batch, 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:** any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product _(verified: appears in the quote below)_
- **Retention period:** at least 1 year after the expiration date of the batch _(verified: appears in the quote below)_
- **When the clock starts:** the expiration date of the batch _(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 batch _(verified: appears in the quote below)_

## What the source says

> ( a ) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch 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 batch.

## 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/).