Do the Retest Date and Expiration Date Mean the Same Thing?

Expiration date: The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf-life specifications if stored under defined conditions and after which it should not be used.

Retest date: The date when a material should be reexamined to ensure that it is still suitable for use.

Retest period: The period of time during which the drug substance is expected to remain within its specification and, therefore, can be used in the manufacture of a given drug product, provided that the drug substance has been stored under the defined conditions. After this period, a batch of drug substance destined for use in the manufacture of a drug product should be retested for compliance with the specification and then used immediately.

A batch of drug substance can be retested multiple times and a different portion of the batch used after each retest, as long as it continues to comply with the specification.

An API expiry or retest date should be based on an evaluation of data derived from stability studies.
If the API material has an assigned expiration date: User of the API material cannot extend the manufacturer’s expiration date by means of re-testing.

If the API is labeled with a retest date: The API material can be re-tested, and if retest results are in compliance with the material specification for critical attributes, such as content and purity (chemical & microbiological), the batch may be used immediately. Use immediately is not defined by the FDA.

Common practice in the industry is to use within 30 days of the retest date. Under current rule, a new date for retesting beyond 30 days of immediate use should be based on current retest results and supporting stability data. Successive retest periods may not be longer than the original retest period assigned by the manufacturer of the API.

Can expiration dates be extended?

FDA’s guidance for industry, “Changes to an Approved NDA or ANDA” explains that the manufacturer of an approved drug product may extend the expiration date for the drug product based on their own testing and acceptable data in accordance with a protocol approved in the new drug application (NDA) or abbreviated new drug application (ANDA) (see 21 CFR 314.70). To help alleviate drug shortages, FDA has also approved extensions of expiration dates when data supporting the extension are available(Shelf-Life Extension Program-SLEP).

Read also:

• Expiry Period for Reagents Used in the Laboratories | EDQM
• Expiry Period for Reagents Used in the Laboratories | FDA

Reference: (ICH Q7A: Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients, ICH Q1A(R2), 314.70 Supplements and other changes to an approved NDA.