Which law requires that a drug’s label must include its expiration date?

The Drug Amendments of 1962 is the law that mandates that drug labels must include an expiration date. This requirement ensures that consumers and healthcare providers are aware of the period during which the medication is expected to maintain its safety and efficacy. Providing an expiration date helps to reduce the risk of using medications that may no longer be effective after a certain point, which is crucial for patient safety.

The establishment of labeling requirements, including expiration dates, was part of broader efforts by regulatory agencies to enhance drug safety and promote public health following concerns about the effectiveness and safety of pharmaceutical products available to consumers. This law was pivotal in the history of drug regulation, as it not only highlighted the importance of drug efficacy but also reinforced the necessity for manufacturers to provide clear and comprehensive labeling information.

The other laws listed have different focuses. The Fair Packaging and Labeling Act primarily deals with consumer products and their labeling to ensure that consumers are accurately informed about the contents and quantity of products, but it does not specifically address expiration dates for drugs. The Controlled Substance Act regulates the manufacture and distribution of narcotics and other drugs that have the potential for abuse, while the Food, Drug, and Cosmetic Act lays the groundwork for food safety and medication approval processes, but it doesn't specifically require