records for all components, drug product containers, closures, and labeling
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
- Regulator / programme
- FDA (drug GMP) our reading
- Record type
- records for all components, drug product containers, closures, and labeling verified
- Retention period
- at least 1 year after the expiration date verified
- When the clock starts
- the expiration date 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 last lot of drug product incorporating the component or using the container, closure, or labeling 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
( 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.
— 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