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.
21 CFR Part 201 · Labeling
§ 201.17 Drugs; location of expiration date
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FDA guidance that cites § 201.17
- Medical Gases — Current Good Manufacturing Practice: Draft Guidance for Industry draft 28 Nov 2025
- CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products 20 Oct 2022
- Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors 18 May 2022
- Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry 29 Jul 2020
- Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: Guidance for Industry 28 Feb 2010
- Labeling OTC Human Drug Products -- Questions and Answers 5 Jan 2009
- CVM GFI #73 (VICH GL3(R)) Stability Testing of New Veterinary Drug Substances and Medicinal Products 21 Nov 2007
- CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle 31 Jul 1993
- CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms 31 Jan 1984
Amendment history
Federal Register documents that created or amended this section.
- 43 FR 45076 29 Sept 1978