April 2019 — Question 16

Which answer below identifies all circumstances whereby a U.S. Customs and Border Protection (CBP) conditional release is considered terminated for food, drugs, devices, cosmetics, and tobacco products imported pursuant to section 801(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 381(a)], as amended?

• AThe conditional release has not been extended in accordance with 19 C.F.R. 141.113(c)(2) and: (1) the FDA issues a notice of refusal of admission; or (2) the FDA issues a notice that the merchandise may proceed; or (3) more than 30 days have passed since the date of release.✓ CBP's answer
• BThe importer has presented documentation to the FDA demonstrating that the merchandise is properly licensed and in compliance.
• CThe conditional release has not been extended in accordance with 19 C.F.R. 141.113(c)(2), and: (1) the FDA issues a notice that the merchandise may proceed; or (2) more than 15 days have passed since the date of release.
• DThe FDA has written to the importer acknowledging receipt of documentation demonstrating that the merchandise is properly licensed and in compliance.
• ENone of the above.