§ 201.17 Drugs; location of expiration date.
When an expiration date of a drug is required, e.g., expiration dating of drug products required by § 211.137 of this chapter, it shall appear on the immediate container and also the outer package, if any, unless it is easily legible through such outer package. However, when single-dose containers are packed in individual cartons, the expiration date may properly appear on the individual carton instead of the immediate product container.
[43 FR 45076, Sept. 29, 1978]
How BatchGlow handles this
For a kit, the product bill of materials lists the label elements each component must carry on the outer box; for an OTC drug component they include the expiry date.
What it asks for, in plain words
- 21 CFR 201.17
- When a drug must carry an expiration date, the date appears on the immediate container and also on the outer package, if any, unless it is easily legible through that package; single-dose containers packed in individual cartons may carry it on the carton instead.
These summaries are BatchGlow's reading of the text on this page, checked against it on 5 Oct 2026. The text governs.