Glossary
Shelf Life
The period during which a product is expected to remain within its approved specification under the labelled storage conditions.
Details
Unlike an expiry date, which names a particular day, shelf life means a length of time together with the stability data supporting it. The corpus repeatedly shows a claimed period with no stability data behind it, and an in-use period stated on the label but never confirmed by stability testing across the whole period. Because 21 CFR 211.166(a)(4) requires testing in the same container closure system as the marketed product, check that the basis for setting or extending the period came from data in the actual pack presentation.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Based on the records and information provided, you did not demonstrate that your drug products remain acceptable throughout their assigned shelf life.
FDA · FDA Warning Letter · 2024-11-26 -
For example, your February 26, 2025, response states that there was no stability data to support the (b)(4) shelf life for (b)(4) shipped…
FDA · FDA Warning Letter · 2025-09-16 -
Your firm does not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products meet established specifications and remain acceptable throughout their labeled shelf life.
FDA · FDA Warning Letter · 2025-10-21
