If a drug is labeled with only a US address, how would the FDA and CBP classify it?

• A. Imported
• B. Exempt from import controls
• C. It would be considered manufactured domestically
• D. It would be considered counterfeit

Answer: (C)

Starting with origin determination: FDA and CBP classify a drug by where its final manufacturing step occurred. A label that shows only a United States address strongly indicates the drug was manufactured in the U.S., so it is considered domestically manufactured.

It wouldn’t be categorized as imported because the information given points to domestic production rather than origin outside the United States. It isn’t automatically exempt from import controls simply due to a US address. And labeling with a US address does not by itself mean the product is counterfeit; counterfeit would require evidence of intentional misrepresentation of identity or origin, which isn’t shown here.