When evaluating foreign sourcing for a drug, which factor must be considered?

• A. Whether the source is registered with the FDA, whether the drug manufactured in another country is FDA-approved for use in the United States, and whether it is eligible to be imported for resale
• B. The price and supplier rating only
• C. Whether the drug is manufactured domestically
• D. Whether the supplier has a US distribution license

Answer: (A)

Regulatory compliance for importing drugs from abroad is the key idea. When you source internationally, you must verify that the foreign manufacturing source is registered with the FDA. This registration shows the facility is recognized by the FDA and subject to inspections and standards. In addition, the drug itself must be approved by the FDA for use in the United States, or at least meet the FDA’s criteria for importation and resale. This ensures the product has been reviewed for safety, efficacy, and proper labeling, and that it can legally be brought into the U.S. market.

Simply looking at price and supplier rating ignores these critical regulatory safeguards. Whether a drug is manufactured domestically doesn’t address eligibility for US import, and a supplier having a US distribution license doesn’t automatically guarantee that the specific foreign product is FDA-approved and importable.