ABSTRACT
For every drug product in the marketplace, the FDA requires that an expiration dating period (which is usually referred to as shelf-life) be indicated on the immediate container label. The shelf-life of a drug product is defined as the time interval in which the characteristic of the drug product (e.g., potency) remains within the approved USP/NF specification after being manufactured. The FDA has the authority to issue recalls for drug products that fail to meet the USP/NF specifications for the identity, strength, quality, purity, stability, and reproducibility prior to the expiration date.
