What defines the expiration date of a controlled substance?

The expiration date of a controlled substance is defined as the date through which the drug is considered safe and effective when stored correctly. This definition is crucial because it ensures that patients receive medications that are both potent and safe for use. The expiration date reflects the period established through stability testing conducted by the manufacturer, which assesses how long the drug retains its quality, safety, and efficacy when stored under recommended conditions.

In the context of pharmaceutical law and patient safety, maintaining the integrity of medications until their expiration date is paramount. This ensures that patients are using drugs that will provide the intended therapeutic effect without risk of harm due to degradation or potency loss.

Details such as the conditions under which the drug should be stored are vital, as improper storage can significantly alter the drug's shelf life. Thus, focusing on the specified expiration date allows pharmacists and healthcare providers to guide patients effectively on when a medication can be expected to work safely and as intended.

This answer captures the essence of expiration dates for controlled substances, emphasizing their importance in patient care and regulatory compliance.