Knowledge Hub

Learning Objectives:

By completing this course, participants will gain a comprehensive understanding of how CBP and FDA processes operate during drug imports. They will learn to identify the preliminary requirements importers must fulfill to ensure that imported goods meet FDA standards and protect consumer safety. The course provides detailed insight into the five major FDA phases preparing to import, entry submission, entry review, examination and sampling, and compliance review—along with the FDA release and refusal procedures. Participants will understand FDA registration requirements, including FEI registration and drug listing, and will be able to conduct admissibility checks, apply intended use and product codes correctly, and interpret FDA product codes. The course also covers FDA labeling requirements, the use of affirmations of compliance, responding to import alerts, and understanding Detention Without Physical Examination (DWPE). Learners will gain practical knowledge on correcting classification and labeling issues, the roles and responsibilities of CBP and FDA in drug imports, steps and required data for FDA-regulated drug importation, and strategies to reduce compliance risks, avoid delays, and prevent refusals.

Key highlights include:

• Understanding FDA import phases and release/refusal processes

• FDA registration, product codes, labeling, and compliance checks

• Handling import alerts, DWPE, and classification issues

• Reducing compliance risks and ensuring smooth importation