FDA IMPORT REQUIREMENTS AND BEST PRACTICES FOR DRUGS AND ...

FDA IMPORT REQUIREMENTS AND BEST PRACTICES FOR

DRUGS AND MEDICAL DEVICES

September 2015

FDA Import Requirements and Best Practices for Drugs and

Medical Devices

FDA Import Requirements and Best Practices for Drugs and Medical Devices

Table of Contents

1. Introduction and Abbreviation Table ..................................................................................................3 2. Importation Process Diagram ............................................................................................................6 3. PREDICT...........................................................................................................................................6 4. MARCS

a. Data Transmission Requirements .......................................................................................8 b. FDA Establishment Registration........................................................................................12 5. OASIS..............................................................................................................................................12 6. Import Trade Auxiliary Communications System (ITACS) ...............................................................13 7. Drugs a. What is a drug? .................................................................................................................14 b. What is an unapproved drug? ...........................................................................................14 c. Drug Development & Steps Toward Drug Approval ..........................................................14 d. API Importation..................................................................................................................15 e. Drug Listing .......................................................................................................................18 f. Drug Labeling for Importation ............................................................................................21 g. R&D Human Use/Investigational Samples ........................................................................22 h. R&D Non-Human Use (Unapproved) ................................................................................24 i. Non-human Use (Approved and Unapproved) ................................................................. 25 8. Devices............................................................................................................................................26 9. Vaccines and Biologics ? CBER Products.......................................................................................31 10. FDA Review Statuses & Responding to FDA Detention a. FDA Review Statuses........................................................................................................32 b. Responding to FDA Detention...........................................................................................33 11. Import Alerts ....................................................................................................................................35 12. Special Situations a. Import for Export................................................................................................................36 b. PLAIR ................................................................................................................................38 c. Foreign Trade Zone...........................................................................................................40 d. Returned of U.S. Pharma ..................................................................................................41 e. Prior Notice........................................................................................................................42 13. Appendix a. Constructing the Manufacturer Code.................................................................................44 b. FDA Product Code Builder ................................................................................................46 c. FDA's Integration to the Automated Commercial Environment (ACE)/International Trade

Data Systems (ITDS).........................................................................................................49 d. Violation Code Translations...............................................................................................53 e. Website Links ....................................................................................................................54

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FDA Import Requirements and Best Practices for Drugs and Medical Devices

1a. Introduction

A cross-functional team from branded and generic pharmaceutical and medical device companies prepared this manual in order to assist the U.S. importer of FDA regulated merchandise. Compliance to the FDA's import regulations and processes continues to be a core competency for U.S. importers as supply chains expand and become more complex. This manual should be utilized as one of many tools in an importer's tool box for compliance with U.S. Participating Government Agencies with import jurisdiction.

This manual serves as a reference source and not meant to provide any legal or regulatory advice. Please note that the abbreviation FD&C Act refers to the Food, Drug & Cosmetic Act.

1b. Abbreviation table

ABI ACE ACC ACS AofC ANC ANDA API BLA

Automated Broker Interface (with CBP) Automated Commercial Environment Accession Number Automated Commercial System (CBP) Affirmation of Compliance codes (for FDA) Annual Report Accession Number Abbreviated New Drug Application Active Pharmaceutical Ingredient Biologics License Application

CBER CBP CDER CFR CM CMC CPT DEV DII DIOP

Center for Biologics Evaluation and Research Customs & Border Protection Center for Drug Evaluation and Research Code of Federal Regulations Contract Manufacturer Chemical Manufacturing Control Component of Device Foreign Manufacturer Registration Number Initial Importer Registration Number Division of Import Operations and Policy (FDA)

DLS

Drug Listing number

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FDA Import Requirements and Best Practices for Drugs and Medical Devices

DUNS FDA FD&C Act FEI FP FTZ HDE HPUS IDE IFE IND ISO ITACS LST MARCS MID NDA NDC NF OASIS ORA OTC PDP PLAIR PLD PMA PMN

Data Universal Numbering System; Dun and Bradstreet Food and Drug Administration Federal Food, Drug, & Cosmetic Act (FDA) Facility Establishment Identifier number (FDA) Finished Product Foreign Trade Zone (US CBP Regulated) Humanitarian Device Exemption Homeopathic Pharmacopoeia of the United States Investigational Device Exemption Import For Export (FDA) Investigational New Drug International Standards Organization Import Trade Auxiliary Communications System Device Listing Number Mission Accomplishment and Regulatory Compliance Services Manufacturer Identification code New Drug Application National Drug Code National Formulary Operational and Administrative System for Import Support (FDA) Office of Regulatory Affairs (FDA) Over The Counter Product Development Protocol number Pre-Launch Activities Importation Request Private Label Distributor Premarket Approval number Premarket Notification number

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FDA Import Requirements and Best Practices for Drugs and Medical Devices

PN

Prior Notice (FDA)

PREDICT

Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting tool

REG

Drug Facility Registration Number

SPL

Structured Product Labeling

TPM

Third Party Manufacturer

USDA

United States Department of Agriculture

USHTS

United States Harmonized Tariff Schedule

USP

United States Pharmacopoeia

XML

Extensible Markup Language

2. Importation Process Diagram

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