C14u—Food and Drug Administration Regulated Imports

Subscriber price: $69.00, Non-subscriber price: $90.00
Estimated total study time: 5 hours 11 minutes

This course is for anyone needing a better understanding of the Food and Drug Administration (FDA) import process and information requirements for entry into the United States including information on Prior Notice (PN), Food Facility Registration (FFR), the Foreign Supplier Verification Program (FSVP) and the Voluntary Qualified Importer Program (VQIP).

FDA-Food and Drug Administration Regulatory Authority

This lesson begins with an introduction to the Food and Drug Administration and the products they regulate. We look at the regulatory authority behind the strict import requirements and then begin to examine some of the programs that help keep America's food supply safe.

(Estimated study time: 1 hour 6 minutes)

Introduction
FDA Overview
FDA Regulated Products
FDA Regulatory Authority
FDA Foreign Supplier Verification Program (FSVP)
- FSVP Overview
- Authorization and Responsibilities of the FSVP Importer and Qualified Individual
- FSVP Exemptions and Enforcement Discretion
- FSVP Systems Recognition Arrangements with Foreign Regulatory Agencies
- Unique Firm Identifier for FSVP Food Product Entry Lines
- FSVP Inspections
FDA Voluntary Qualified Importer Program
Marking and Labeling Requirements for Food and Drug-Regulated Products

FDA Prior Notice of Food Products

This lesson focuses on the time limits and pre-arrival import requirements for human and animal food and ingredients. We discuss facility registration and additional data requirements for these shipments.

(Estimated study time: 1 hour 7 minutes)

Introduction
FDA Facility Registration and Advanced Shipment Notice
- FDA Cosmetic Facility Registration
- FDA Food Facility Registration (FFR)
- FDA Bioterrorism Act Prior Notice of Arrival for U.S. Import
FDA Advance Reporting for Human and Animal Food
Food Products and Prior Notice Data Required
Entry Documentation and Information for FDA-regulated Products

Introduction to the FDA Product Code

This lesson provides an overview of the FDA Product Code system, a critical component in ensuring accurate product identification for regulatory compliance. Learners will gain an understanding of how product codes are structured, why they matter, and how to use tools like the FDA Product Code Builder to determine the correct code for various products.

(Estimated study time: 23 minutes)

FDA Product Code Required for Imported Products

This lesson focuses on learning about FDA product codes, their creation, and practicing how to create them.

(Estimated study time: 1 hour 21 minutes)

Introduction
FDA Tutorial Lesson 4 Coding Food, Food-Related, Cosmetic and Vitamin Products
FDA Tutorial Lesson 5 Coding Drugs, Drug Products and Biologics
FDA Tutorial Lesson 6 Coding Animal Use Products
FDA Tutorial Lesson 7 Coding Medical Device, In Vitro Diagnostic and Non-Medical Radiation Emitting Products
FDA Tutorial Lesson 8 Coding Tobacco Products

FDA Import Processing

This lesson explains the import process from beginning to end and the electronic systems FDA uses to review import information. In addition we will touch on the elements that must be transmitted, examination procedures, and steps to rectify FDA Notices of Action.

(Estimated study time: 1 hour 15 minutes)

Introduction
FDA Electronic Systems and Reporting Requirements
Example Data that Triggers PGA Flags in ACE
FDA ACE Tariff Indicators
FDA Entry Review
FDA Import Alerts and Import Reports
FDA Examination or Sampling
FDA Compliance Review and Notice of FDA Action or Refusal