US FDA
21 CFR 211.137 - Expiration Dating
Plain-language explanation, inspection context and common violation patterns.
What it says
Drug products must bear an expiration date determined by appropriate stability testing, ensuring the product meets applicable standards of identity, strength, quality and purity at the time of use throughout the dating period, with the expiration date related to storage conditions stated on the labeling.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- The expiration date is a direct output of the stability programme, meaning changes to formulation, packaging or manufacturing process that could affect stability require reassessment of whether the existing expiration date remains valid.
- Expiration dating is tied specifically to the labeled storage conditions, meaning a product's dating is only valid if actually stored and distributed under those conditions.
- This provision connects directly to the ongoing stability programme requirement, since expiration dating is not a one-time determination made only at initial registration.
What FDA inspectors look for
- Whether the registered expiration date is fully supported by the actual stability data on file, including ongoing annual stability data for marketed batches.
- Whether any process, formulation or packaging change was assessed for its potential impact on the established expiration date before implementation.
- Whether distribution and storage conditions in practice match the conditions the expiration date assumes.
Most common violation
A process or packaging change implemented without assessing whether it could affect product stability and therefore the validity of the existing expiration date.
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