Under country-of-origin rules, which agency uses the country of origin where the active ingredient was made?

• A. FDA
• B. CBP
• C. NIH
• D. FTC

Answer: (B)

When thinking about country-of-origin rules in import processes, the key role is border enforcement and tariff classification. The agency that uses the country of origin where the active ingredient was made is Customs and Border Protection. CBP relies on the country of origin to determine tariff treatment, eligibility for any trade programs or measures (like quotas or anti-dumping rules), and to ensure the product can be legally admitted into the country.

FDA focuses on safety, labeling, and manufacturing compliance of drugs, not on applying country-of-origin data for import duties. NIH is a research agency, not involved in import controls. FTC handles advertising and consumer protection, not COO determinations for customs. So the border agency that leverages the active ingredient’s country of origin in the import process is CBP.