CDER Small Business and Industry Assistance: Import and Export of Human Drugs and Biologics
Imports
The Federal Food, Drug, and Cosmetic Act (Act) prohibits the interstate shipment (which includes importation and exportation) of unapproved new drugs. Thus, the importation of new drugs that lack FDA approval, whether for personal use or otherwise, violates the Act. Unapproved new drugs include any drugs--including foreign-made versions of U.S. approved drugs--that have not been manufactured in accordance with FDA approval.
Imported products regulated by the FDA are subject to inspection at the time of entry by the U.S. Bureau of Customs & Border Protection (Customs). Shipments not found to comply with the law are subject to detention. They must be brought into compliance, destroyed, or re-exported. Under the Act, FDA may refuse admission to any drug that "appears" to be unapproved, misbranded, or adulterated, placing the burden on the importer to prove that specific drugs sought to be imported are not in violation of the Act. For example, without evidence that specific drugs sought to be imported have been manufactured pursuant to an approved new drug application or abbreviated new drug application, in the manufacturing facility permitted under the application, the drugs might appear to be unapproved new drugs.
The importation and exportation of controlled substances requires compliance with provisions enforced by the U.S. Drug Enforcement Administration (DEA). Information can be obtained at the DEA Office of Diversion Control website. Also, the United States Department of Agriculture (USDA) has certain requirements for the importation and exportation of animal-derived products, such as biological drugs. Information can be obtained at the USDA Veterinary Services Import and Export website.
Information about how drugs are approved in the U.S. can be found on the CDER Small Business and Industry Assistance (CDER SBIA) website. A draft guidance, Unapproved Drugs - Compliance Policy Guide (PDF - 66KB), on current agency policy regarding drugs marketed in the u.s. that lack required fda approval is available. the following information on imports/exports contains references to the act and regulations set forth at title 21, code of federal regulations (cfr) (regulations of the food and drug administration). you can download the referenced sections of the act or the regulations by using this link to the act: Federal Food, Drug, and Cosmetic Act and this link to the regulations: Code of Federal Regulations.
Registration of Foreign Manufacturers
Effective May 24, 2002, all foreign drug establishments whose products are imported or offered for import into the United States are required to register with FDA: Federal Register Notice (PDF - 136KB). Foreign firms must also identify a United States agent and submit a list of every drug in commercial distribution. For additional information, see:
-
Drug Registration and Listing website
-
Drug Listing Requirements for Foreign Drug Establishments (Code of Federal Regulations)
FDA's Import Program / General Procedures
Entry of Product into the United States
To ensure that FDA is notified of all regulated products imported into the United States, the importer, or his/her representative, must file an entry notice and an entry bond with Customs pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs. FDA is notified by Customs of the product’s entry and makes a decision as to its admissibility. If FDA does not wish to examine the entry, the product is allowed to proceed into United States commerce. Generally, if FDA decides to examine an entry, an agency representative will collect a sample from the shipment for laboratory evaluation. If the analysis indicates that the product complies with the Act and related regulations, the shipment may be released into United States commerce. If there is a violation, the product will be detained. If not brought into compliance, the product will be refused admission. When a sample of an article offered for import has been requested by FDA, the owner or consignee must hold the shipment and not distribute it until further notice is received regarding the results of the examination of the sample. If it appears that the article is violative, FDA issues a Notice of Detention and Hearing to the owner or consignee of the article, specifying a place and a time period whereby the individual may introduce testimony concerning the acceptability of the product.
For specific information on Customs procedures, requirements, forms, and other mattters, contact your local Customs office. Information is also available at the U.S. Customs website.
Refusal of Admission
Section 801 of the Act directs FDA to refuse admission to any article that appears to be in violation of the Act. If admission of the product is refused, the importer must either re-export or destroy the product under Customs or other approved supervision. If the product is not destroyed or re-exported, Customs issues a notice for redelivery to the importer of record. Failure to redeliver the refused product may result in Customs assessing liquidated damages against the importer's bond.
Application to Recondition
If admission is refused, the importer may submit an application to recondition the product to bring it into compliance with the Act. The owner or consignee also may submit an application to FDA to relabel or perform other actions to bring the article into compliance. An application for authorization to relabel or perform other actions to bring the article into compliance must contain a detailed proposal of the steps to be taken and specify the place where the operations will be carried out and the approximate time for completion. All applications to recondition a product are subject to FDA review and approval. See the Regulatory Procedures Manual (Chapter 9) for details on reconditioning.
Detention Without Physical Examination
In some instances, a product may be detained without physical examination as soon as it is offered for entry into the United States. This process is based on history and/or other information indicating that the product may be violative. When a product is subject to detention without physical examination, the shipper or importer must prove that the product meets FDA requirements. Occasionally, when the violative conditions appear to be geographically widespread, FDA identifies products from an entire country or geographic region for detention without physical examination. See the Regulatory Procedures Manual (Chapter 9) for details on Automatic Detention.
Import Alerts
The purpose of an Import Alert is to identify and disseminate import information (such as problems and violative trends) to FDA personnel, thus providing more uniform and effective import coverage. Import Alerts identify problem commodities and/or shippers and provide guidance to FDA personnel regarding the importation of the products and/or firms covered in the alert. They may also concern products or manufacturers that have met the criteria for detention without physical examination. See the Regulatory Procedures Manual (Chapter 9).
For additional information or questions regarding detention without physical examination or import alerts, contact the Division of Import Operations and Policy (DIOP), HFC-170, 5600 Fisher Lane, Rockville, MD 20857.
Computerization
To assure the expeditious handling of imported products, FDA has automated its import operations. By combining FDA's Operational and Administrative System for Import Support (OASIS) and Customs' Automated Commercial System (ACS), an FDA reviewer can more efficiently evaluate and process each import entry. The import filer transmits the required shipment-specific FDA data into the ACS. Within several minutes, the filer receives notification that either their shipment has been released or FDA wishes to further review the entry. This system provides FDA with immediate data on imported products, provides information on potential problems, and maintains national historical data files to develop profiles on specific products, shippers, and manufacturers. Eventually all filers processing entries through Customs' ACS will provide FDA information electronically.
For additional information on the Import Program's general procedures, see
Import of Active Pharmaceutical Ingredients (APIs)
Import Alert #66-66 provides useful guidance on the import of APIs. This guidance includes information on the detention of APIs, when they can be detained without physical examination, and the type of evidence needed to obtain their release.
For additional information, see the Federal Register Notice (PDF -121KB).
Import of Over-the-Counter (OTC) Drug Products
An OTC Drug Product is a product marketed for use by the consumer without the intervention of a health care professional to obtain the product. In addition to marketing under an approved new drug application or abbreviated new drug application, OTC drug products can be marketed in compliance with an OTC monograph regulation. OTC monographs represent regulatory standards for the marketing of non-prescription drug products without an approved new drug application. An OTC drug can be imported into the United States under an approved new drug application, an approved abbreviated new drug application, or in compliance with an OTC monograph.
- The OTC monographs and ingredients covered by the monographs are provided by the following website: Status of OTC Rulemakings
- The Small Business Assistance website provides the requirements for the approval of a new drug application or an abbreviated new drug application
Both websites provide contact information for inquiries.
Currently there are still several categories of OTC drug products that are not subject to final regulations. Proposed monographs at the OTC website cited above provide guidance for the marketing of products not yet subject to a final rule.
Import for Export
Import for Export refers to the provision of the FDA Export Reform and Enhancement Act of 1996 that allows the importation of certain articles that are unapproved or otherwise do not comply with the Act, provided that those articles are further processed or incorporated into products that will be exported from the United States by their initial owner or consignee. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), effective September 9, 2002, added some requirements to the Import for Export provisions. Information on Import for Export can be found in the Regulatory Procedures Manual (Chapter 9).
Exports
Export of Drugs and Biologics Under the FDA Export Reform and Enhancement Act of 1996
A draft guidance document is available that summarizes and explains the basic requirements and procedures for exporting human drugs (also drug components) and biologics that may not be sold or distributed in the United States. This guidance document also summarizes and explains the requirements for exporting drugs that are approved for marketing in the United States, but which are being exported for an unapproved use. The draft guidance document is available online: Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996. It also provides contacts for additional information.
Export Certificates for Drugs/Biologics
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Act. An export certificate is a document prepared by FDA containing information about a product's regulatory or marketing status.
The following websites provides information and contacts on export certificates for drugs and biologics:
- Guidance on FDA Export Certificates
- Export Certificate Information for CDER regulated drugs
- Export Certificate Information for CBER regulated drugs
For general information, refer to:
The import program managers in FDA's District Offices are an additional point of contact.
See ORA Field Program Monitors (Import Program Managers section) for contact information.
Related Links
- FDA Import Program website