What is an active ingredient as defined by the FDA?

An active ingredient is the substance or substances in a drug product that is responsible for the intended therapeutic effect. It is the component of a drug that causes the desired pharmacological action.

In the context of the FDA (Food and Drug Administration), active ingredient refers to the chemical substance(s) in a drug product that is responsible for the intended therapeutic effect, as well as ingredients that are added to the product to improve its stability, appearance, or other characteristics, such as fillers, binders, and preservatives.

FDA regulates active ingredients in drugs and other medical products, and they require certain information to be submitted to them when a new drug is developed. This information includes information about the identity, purity, quality, strength and composition of the active ingredient(s) in the drug product.