Pharmacy Law Practice Exam 2025 - Free Pharmacy Law Practice Questions and Study Guide

The expiration date of a pharmaceutical product is established by the manufacturer based on stability studies conducted for the product under specified storage conditions outlined in the package insert. These stability studies assess how the drug's quality, potency, and safety are maintained over time when stored as directed. The results of these studies provide the necessary data to support the product's shelf life, which is then indicated on the packaging.

This process ensures that patients receive medications that are effective and safe to use up until the marked expiration date. Such rigorous testing is crucial, as it ensures adherence to safety and efficacy standards, which cannot be determined solely through customer feedback or a pharmacist's subjective judgment. While local regulatory authorities do oversee compliance with these guidelines, they are not responsible for determining expiration dates directly; that responsibility lies with the manufacturer.