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
website:
http://www.deadiversion.usdoj.gov/index.html. 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 website:
http://www.aphis.usda.gov/vs/ncie/.
Information about how drugs are approved in the U.S. can be found
on the Small Business Assistance (SBA) website: (http://www.fda.gov/cder/about/smallbiz/default.htm).
A draft guidance on current agency policy regarding drugs marketed
in the U.S. that lack required FDA approval may be found at:
http://www.fda.gov/cder/guidance/5704dft.pdf.
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:
http://www.fda.gov/opacom/laws/, and this link to the
regulations:
http://www.gpoaccess.gov/cfr/index.html.
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:
http://www.fda.gov/ohrms/dockets/98fr/112701a.htm. Foreign
firms must also identify a United States agent and submit a list of
every drug in commercial distribution. For additional
information, see:
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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 Customs website:
http://www.customs.ustreas.gov/xp/cgov/import/.
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 for details on reconditioning:
http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9recon.html.
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 for details on
Automatic Detention:
http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9auto.html.
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 at:
http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9dirs.html.
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
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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:
http://www.fda.gov/ora/fiars/ora_import_ia6666.html.
For additional information, see:
http://www.fda.gov/OHRMS/DOCKETS/98fr/120400b.htm.
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.
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, Sub Chapter Import for Export:
http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9impex.html.
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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 at the following website:
http://www.fda.gov/opacom/fedregister/frexport.html. 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:
For general information, refer to:
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The import program managers in FDA's District Offices are an
additional point of contact.
Import Program Managers
- Atlanta District: Blake Bevill (404) 253-2218
- Baltimore District: Dean Cook (410) 631-0322 x11
- Chicago District: Stephen D. Eich (630) 860-1307 x15
- Cincinnati District: Stephen J. Rabe (513) 679-2700 x122
- Dallas District: Southwest Import District (SWID) (214)
253-5283
- Denver District: SWID (214) 253-5283
- Detroit District: Vickie L. Kaiser (313) 226-5249
- Florida District: Vacant (305) 526-2800 x964
- Kansas City District: SWID (214) 253-5283
- Los Angeles District: Irene Gomez (310)
831-6123 x102
- Minneapolis District: Constance Richard-Math (612) 758-7178
- New Orleans District: John M. McInnis, MEM-RP (901) 544-0345
x25
- New England District: Frank J. Mazzoni (781) 596-7754
- New York District: Upstate: Kevin Murray (716) 551-4461 x3129
- New York District: Downstate: John Moore (718) 340-7000 x5460
- Philadelphia District: Alfred Puglia (215) 597-4390 x4540
- San Francisco District: Janet Codor (510) 337-6786
- Seattle District: Celeste M. Corcoran (425) 483-4971
- San Juan District: Carlos I. Medina (787)
474-9539
For updates, see the FDA Investigations Operations Manual
telephone directory at:
http://www.fda.gov/ora/inspect_ref/iom/iomoradir_monitors.html.
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Date created: July 23, 2004 |