Expiration dating and stability testing for human drug products

It is important to note that the manufacturers’ expiration dates apply only to the original packaging of the drug, and that once opened these dates no longer apply.

Each state has different requirements, but all pharmacists must give the consumer some sort of expiration date, sometimes called a “beyond use” date.

This overview presents some current issues with testing the stability of current and next- generation biologics.

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Tests and bioassays related to purity, identity, potency, quality, and safety are conducted depending on the product type and intended use.Testing in Stages All stages of a biologic’s life cycle includes stability testing.Experts have divided these tests into six stages, covering development from early stages to late-stage follow-up testing (1, 2): The information that is obtained during testing depends on the stage of development.It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly.More limitations on accuracy are described at the GPO site.

Expiration dating and stability testing for human drug products