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
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
- Regulator / programme
- FDA (drug GMP) our reading
- 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
- Retention period
- at least 1 year after the expiration date of the batch verified
- When the clock starts
- the expiration date of the batch verified
- 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
Values marked our reading are our classification of what the source says — the source does not print them in those words. The quote below is the evidence for each one; judge it yourself.
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.
— ecfr.gov, retrieved 2026-08-11
Source
- ecfr.govhttps://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-J/section-211.180