What constitutes “labeling” under the FDCA?

Under the Federal Food, Drug, and Cosmetic Act (FDCA), “labeling” specifically includes the written, printed, or graphic matter that is displayed on the product's label or accompanies the product itself. This encompasses not just the label on the immediate container of the drug but also any material that might be distributed alongside the drug, such as pamphlets or brochures that provide information about the drug's use, side effects, and administration.

This definition is crucial because labeling must adhere to specific regulations to ensure that consumers receive accurate and comprehensive information about the medications they use. This helps to facilitate safe and effective use of the drug.

The other options, while related to pharmaceuticals, do not fall under the regulatory definition of “labeling.” For instance, oral instructions provided by a pharmacist may aid in the proper use of a medication but do not constitute labeling as defined by the FDCA. Similarly, the packaging design and advertising serve other purposes and are governed by different regulations, focusing more on aesthetics and promotion rather than detailed information provided to users regarding the drug itself.