The FDA's Criteria for Equivalency requires the drugs contain identical amounts of the same inactive ingredients. Is this statement true or false?

The statement that the FDA's Criteria for Equivalency requires drugs to contain identical amounts of the same inactive ingredients is misleading. While the FDA does examine the formulation of drugs when assessing equivalency, the focus is primarily on the active ingredients and their effectiveness in producing the desired therapeutic effect. Inactive ingredients can differ between drugs while still allowing for classification as therapeutically equivalent, as long as they do not significantly affect the drug's performance or safety.

Therapeutic equivalence means that products can be expected to give the same clinical result in patients when administered under the conditions specified in the labeling. This is determined primarily by the active ingredients and their bioavailability rather than by having identical inactive ingredients. Therefore, the statement is false as it suggests a stricter requirement than what the FDA actually mandates for drugs to be considered equivalent.