Whose responsibility is it to ensure a drug is correctly labeled?

The responsibility for ensuring that a drug is correctly labeled primarily falls on the manufacturer. This is because manufacturers are legally required to ensure that their products are safe, effective, and accurately labeled in compliance with regulatory standards set forth by agencies such as the Food and Drug Administration (FDA). They must provide precise information regarding the drug's ingredients, uses, side effects, and other critical details that healthcare providers and patients need to make informed decisions about the medication.

While pharmacists play a vital role in ensuring that medications are dispensed correctly and that the labeling aligns with the manufacturer's information, their responsibility does not extend to the initial creation and approval of that labeling. Healthcare providers rely on the accuracy of the labels when prescribing medications, and patients depend on this information for proper usage. However, the ultimate responsibility for labeling accuracy rests firmly with the manufacturer, as they are the ones who compile and submit this information in the drug approval process, ensuring compliance with all relevant regulations and standards.