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How FDA says to calculate maximum daily exposure for inactive ingredients
Summary
An FDA presenter demonstrated the formula for maximum daily exposure (MDE) and gave a concrete example (20 mg per dose × 2 doses = 40 mg daily), and explained how those values are shown or replaced in IID records.
An agency official explained how to calculate the maximum daily exposure (MDE) for oral products and how that value is reflected in the IID. The official provided the formula and a worked example to illustrate the calculation used for public IID records.
"It is the maximum daily exposure is equal to the maximum number of dosage units recommended per day based on the product labeling multiplied by the dosage unit level of the inactive ingredient or excipient," the agency official said, then illustrated with: "So let's say you have an excipient level of 20 milligrams per dosage unit...if it's 2 dosage units recommended for that day, then you have a total of 40 milligrams maximum daily exposure."
