Is compounding defined as mixing according to the manufacturer's approved labeling?

Compounding is defined as the preparation of a medication by combining, mixing, or altering ingredients to create a medication tailored to the needs of a patient, rather than simply mixing according to the manufacturer's approved labeling. This distinction is crucial because compounding often involves customizing a drug formulation that may not be commercially available or altering a medication’s form (such as changing a tablet into a liquid for easier administration).

While the manufacturer's approved labeling provides specific instructions for how to use their formulations, it does not encompass the process of compounding as defined by pharmacy regulations. Compounding allows pharmacists to meet unique therapeutic needs—such as dosages not supplied by manufacturers, special flavors for pediatric patients, or avoiding certain allergens in drug formulations.

Because compounding is fundamentally aimed at individualized patient care rather than simply adhering to a manufacturer’s instructions, the statement in question is false.