**OFFICE OF REGULATORY AFFAIRS**

**DIVISION OF IMPORT OPERATIONS AND POLICY**

**GUIDANCE**

**REGULATORY PROCEDURES MANUAL**

**CHAPTER 9**

**SUBCHAPTER IMPORT FOR EXPORT**

Comments and suggestions regarding this document should be submitted to
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be
identified with the docket number listed in the notice of availability
that publishes in the *Federal Register*.

For questions regarding this document contact Joseph McCallion at
301-443-6553.

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Office of Regulatory Affairs**

# September 2002 

**RPM Chapter 9, Subchapter Import for Export**

**SUBCHAPTER**

**IMPORT FOR EXPORT**

**This guidance represents the Food and Drug Administration\'s (FDA\'s)
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.**

**PURPOSE**

This subchapter is to provide guidance to FDA field offices regarding
the handling of certain products that are offered for import under
section 801 of the Federal Food, Drug, and Cosmetic Act (Act). Those
products are those that are offered as "imports for export." The
provision of the Act that permits such imports, section 801(d)(3), is
referred to as the \"import for export\" provision. This guidance is
intended to provide uniform procedures for handling such importations by
all FDA offices. This chapter represents the Agency\'s current thinking
on the application of the import for export provisions of the Act.

**BACKGROUND**

The FDA Export Reform and Enhancement Act of 1996 (Export Reform Act),
Public Law 104-134) amended section 801(d)(3) of the Act to allow the
importation of certain articles that are unapproved or otherwise do not
comply with the Act, provided that those imported articles are further
processed or incorporated into products that will be exported from the
United States, by their initial owner or consignee in accordance with
section 801(e) or section 802 of the Act or section 351(h) of the Public
Health Service Act (PHSA). On June 12, 2002, the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism
Act), Public Law 107-188, was signed into law. Section 322 of PL 107-188
amended section 801(d)(3) of the Act. The amended provision is effective
September 9, 2002.

Under the amended provision of the Act, importers wishing to import
certain violative articles that are intended for further processing or
incorporation into another product and subsequent export must provide
FDA with certain information at the time of initial importation. The
articles include drugs (or components), devices (or components or
accessory of a device or other article of a device requiring further
processing, which is ready or suitable for use for health-related
purposes), food additives, color additives and dietary supplements. The
information includes a statement that confirms the intent to further
process such article or incorporate such article into a product to be
exported and identifies entities in the chain of possession of the
imported article. Importers also must provide certificates of analysis
as necessary to identify the article unless the article is a device or
an article described in section 801(d)(4). Section 801(d)(3)(A)(i)(III).

Under section 803(d)(3)(ii), at the time of initial importation and
before delivery to the importer, initial owner, or consignee, a bond
must be executed providing for liquidated damages in the event of
default, in accordance with United States Customs Service (U.S. Customs)
requirements.

The initial owner or consignee of the article must maintain records of
the use and/or destruction of such imports and must submit the records
or a report to FDA upon request. Section 801(d)(3)(A)(iv) and (v). The
initial owner or consignee must destroy any article or portion not used
in an exported product. Section 801(d)(3)(A)(iii).

The amended section 801(d)(3)(B) provides that FDA may refuse admission
of an article that could otherwise be imported under section
801(d)(3)(A) if there is credible evidence or information indicating
that such article is not intended to be further processed by the initial
owner or consignee or incorporated into a drug, biological product,
device, food, food additive or dietary supplement that will be exported
in accordance with section 801(e) or section 802 of the Act or section
351(h) of the PHSA.

The \"import for export\" requirements for blood, blood components,
plasma, and source leukocytes differ from those for drugs and other
biological products. The Act allows for the importation of these blood
products and components provided they comply with section 351(a) of the
PHSA or FDA permits such imports \"under appropriate circumstances and
conditions\" as determined by the Center for Biologics Evaluation and
Research (CBER) (section 801(d)(4) of the Act). Tissue products may be
imported only if the importation complies with regulations promulgated
under section 361 of the PHSA. The Bioterrorism Act did not amend
section 801(d)(4). However, if CBER approves a particular request for
import under section 801(d)(4), the import must comply with all
applicable requirements of the amended section 801(d)(3) of the Act.
Section 801(d)(4). The import also must comply with all applicable
export requirements when the product is exported. Section
801(d)(3)(A)(i)(I) and (iii).

The Bioterrorism Act also amends section 301 of the Act. The amended
section 301(w) prohibits the making of a knowingly false statement in
any statement, certificate of analysis, record or report required under
section 801(d)(3); the failure to submit a certificate of analysis; the
failure to submit or maintain records; the release into interstate
commerce of any article or portion imported into the United States under
section 801(d)(3) or any finished product made from such article or
portion, except for export in accordance with section 801(e) or section
802 of the Act, or section 351(h) of the PHSA; and, the failure to
export or destroy any articles or portions not incorporated into a
finished product. Section 801(d)(3) requires that the imported article
or portions must be further processed or incorporated into a drug,
biological product, device, food, food additive, color additive or
dietary supplement that will be exported.

**GUIDANCE**

**INFORMATION SUBMISSION, ENTRY REVIEW, AND DOMESTIC**

**FOLLOW-UP**

When a drug or device component, food additive, color additive, or
dietary supplement is imported under section 801(d)(3), the importer is
required to submit a statement to FDA at the time of each importation
with the following information:

> 1\. that such article (the components, parts, accessories, or
> articles) is intended to be further processed by the initial owner or
> consignee or incorporated by the initial owner or consignee into a
> drug, biological product, device, food, food additive, color additive,
> or dietary supplement that will be exported from the United States by
> the initial owner or consignee in accordance with section 801(e) or
> section 802 of the Act or section 351(h) of the PHSA; and
>
> 2\. identification of the manufacturer of such article and each
> processor, packer, distributor or other entity that had possession of
> the article in the chain of possession from the manufacturer to such
> importer of the article.

The statement must be accompanied by such certificates of analysis as
are necessary to identify such article unless the article is a device or
is an article described in section 801(d)(4). Section
801(d)(3)(A)(i)(III).

In order for FDA to efficiently process such importations, the statement
required to be provided to FDA pursuant to section 801(d)(3)(A)(i) must
include, pursuant to that section, a declaration that the article is
intended to be imported for further processing by the initial owner or
consignee into a drug, biological product, device, food, food additive,
color additive, or dietary supplement that will be exported in
accordance with section 801(e) or section 802 of the Act or section
351(h) of the PHSA. The statement should include information identifying
the article and the initial owner or consignee.

Identification of all entities that had possession of the article in the
chain of possession should include information sufficient to accurately
identify the entity such as the name of each entity (including business
and trade names), complete physical address, transaction dates, and any
other information to aid in identification such as telephone and fax
number, and e-mail address. The statement should include information
sufficient to identify the chain of possession of the article through
each entity, which could include information such as product coding,
lot, batch, or other identification numbers. For medical devices, device
history records required of domestic and foreign manufacturers, pursuant
to 21 C.F.R. 820.184, may provide information to assist in meeting this
requirement. For imported articles subject to section 801(d)(4), the
manufacturer in the chain of possession can be considered to be the
initial collection agency, e.g., a blood collection center for purposes
of information required under section 801(d)(3).

Certificates of analysis, as are necessary to identify the imported
article, must accompany the statement filed pursuant to 801(d)(3)(A)(i).
Section 801(d)(3)(A)(i)(III). The submission of such certificates is not
required if the imported article is a device or is an article described
in 801(d)(4). Certificates of analysis, or equivalent documentation
should provide the article\'s formulation, ingredients, components, or
assay, as appropriate to the type of article.

Certificates of analysis could include documents to assure the identity
of the substance and its components in the chemical and drug industries.
A batch certificate could be a certificate of analysis. A document that
establishes a drug ingredient is certified to meet USP requirements
could be a certificate of analysis. Documents that provide sufficient
information to determine the level, potency, identity, strength, quality
and purity of the drug component and whether prohibited material has
been used in the imported article could be considered certificates of
analysis.

For other products, documents that convey assurance as to the identity
of the article and its components or substances could be a certificate
of analysis. Sufficient information should be provided to determine if
prohibited material has been used in the imported article. For an
article of food additive or color additive, a document indicating
specification of purity or documents establishing the article is a
"certified" color or of "food grade" or "Codex Alimentarius" grade food
additive could meet the requirement of a certificate of analysis.

When the initial owner or consignee of the imported article is not the
importer, the importer should provide FDA with information identifying
the initial owner or consignee with the entry. In cases where the
importer is not the initial owner or consignee and the article is
intended for multiple owners or consignees, each of whom will serve as
the initial owner or consignee for a portion of the article, the
importer should submit a separate statement identifying each owner or
consignee and indicating the amount of the entry each is to receive.
Failure to provide this information at the time of importation may be
viewed by the district as evidence that the product does not meet the
conditions of section 801(d)(3).

If the information needed to efficiently process importations and to
make a "May Proceed" decision is not provided at the time the article is
offered for entry, and if the product is otherwise subject to refusal of
admission pursuant to section 801(a), the district may issue a Notice of
Detention and Hearing in accordance with normal procedures (see RPM
Chapter \"Notice of Detention and Hearing\"). If a response to the
Notice of Detention and Hearing is not received by the district within
the designated time (10 days, excluding Saturday, Sunday, and Holiday,
or date requested by on the notice, or additional time as deemed
necessary by the district), a Notice of Refusal should be issued (see
RPM Chapter \"Notice of Refusal of Admission\" Guidance, \"When Should
the Notice of Refusal of Admission be Issued?\"). Once issued,
cancellation of the Notice of Refusal should be considered only under
unusual circumstances at the discretion of the district (see RPM Chapter
\"Notice of Refusal of Admission\" Guidance, \"Reopening of a Case\").

If the district has evidence or information indicating that the imported
article is not intended to be further processed by the initial owner or
consignee, or incorporated by the initial owner or consignee, into a
product included in section 801(d)(3) that will be exported in
accordance with the Act or the PHSA, the district should contact the
Division of Import Operations and Policy (HFC-170) before any action is
taken on the entry. In certain circumstances, application of section
801(d)(3)(B)'s refusal authority may be appropriate.

**Submissions of Entries**

Entries of articles imported pursuant to section 801(d)(3) that are
accomplished by electronic submission of information through the Customs
Automated Commercial System (ACS) and the FDA Operational and
Administrative System for Import Support (OASIS) will necessitate that
the filer declare that the imported article is intended for further
processing or incorporation into a product that will be exported in
accordance with the Act. Section 801(d)(3)(A)(i). If the filer is not
the \"importer, initial owner or consignee" responsible for further
processing or incorporating the imported article into the product to be
exported, the filer of the entry should provide the name of such firm or
individual in the FDA consignee field using the appropriate FDA
Establishment Indicator (FEI) number. When the article is intended for
multiple owners or consignees, a separate FDA line should be created for
each owner or consignee as provided for in the ACS system. FDA has
established an Affirmation of Compliance (AofC), identified by the code
\"IFE\" (Import for Export), that will indicate that the entry is being
made under the import for export provisions of the Act. Use of the
\"IFE\" affirmation triggers prompts for the submission of Quantity and
Value data. If any of this information is not provided, the notification
will be considered incomplete by the system. Such lines with \"IFE\" (or
any Affirmation) will display the Affirmation in the Entry Line Summary
and line detail screen. If electronic submission is made, in most cases
it is unlikely that all of the information required under section
801(d)(3) will be able to be provided through electronic entry.
Districts should request and review the supporting paper entry documents
for all "IFE" entries.

Once the district has determined that all of the appropriate information
has been submitted, either by the on screen review process or by review
of the entry documents, a \"May Proceed\" should be issued in accordance
with OASIS procedures. The filer may be held responsible for the
accuracy of the information provided through OASIS for such importations
and import for export entries will be included in the FDA's filer
evaluation conducted by the district of the broker.

For manual entry submissions, or when FDA has requested supporting paper
entry documents for an electronic "IFE" entry, all documentation
required by section 801(d)(3) should be included in the filer\'s entry
package, including the statement and a certificate of analysis as
necessary. When the imported article is intended for multiple owners or
consignees, a separate statement and certificate of analysis as
necessary should be submitted for each owner or consignee indicating the
portion of the entry each is to receive. Districts should reconcile the
quantities provided and any product not accounted for should be detained
if otherwise subject to refusal of admission pursuant to section 801(a)
as noted above. If the district determines that all information provided
in the manual or electronic submission is appropriate, then the district
should follow their normal procedures for marking the entry \"May
Proceed\".

**Follow-up**

The district responsible for the entry review should use normal
operating procedures to determine whether additional follow-up is
necessary for entries made under section 801(d)(3). This can consist of
additional contact with the importer or the initial owner/consignee at
the time of entry to obtain records to confirm the intended use of the
article and the final disposition of the article. The home district of
the initial owner or consignee should be provided with a copy of the
entry paperwork by the district performing the entry review (where the
home district is not the importing district). Entries processed by OASIS
will be available to home districts through a Sequel (SQL) report.

The imported article will continue to be subject to the U.S. Customs
Temporary Import Bond or other bond instrument as required by U.S.
Customs, under the new section 801(d)(3)(A)(ii) and remains subject to
section 801(a). Any follow-up regulatory actions regarding the failure
of the initial owner or consignee to meet the requirements of section
801(d)(3) should be referred to the Division of Import Operations and
Policy (HFC-170) for handling.

When a domestic inspection is conducted at a manufacturer\'s facility
where the imported article is being further processed or incorporated
into a product intended for export, the inspection should include
appropriate review of the domestic manufacturer\'s compliance with
section 801(d)(3). For example, the investigator should request the
manufacturer\'s import, export, and/or destruction records during an
inspection. The records/reports should include documentation indicating
that the imported article was further processed or incorporated into
another product and was exported in accordance with section 801(e) or
section 802 of the Act, or section 351(h) of the PHSA, or destroyed. The
records should establish that the entire amount of the product or
article imported is used or exported or destroyed; that the exported
products are labeled in conformance with section 801(e)(1) and meet the
other requirements of section 801(e)(1) or section 802 of the Act or
section 351(h) of the PHSA, as appropriate. Please note, however, that
for drug products, an initial owner or consignee may be allowed to
retain a sample of the imported article in order to comply with good
manufacturing process (GMP) regulations concerning sample retention.

**TIME FRAME FOR HOLDING IMPORTED PRODUCT**

Section 801(d)(3) allows for the importation of otherwise prohibited
products and articles for manufacturing, further processing or
incorporation and export. The amended provision does not impose any
specific limitations on how long a product can be held in the United
States before it must be further processed or incorporated into a
product and exported or destroyed. A time limitation may be imposed,
however, by Customs through its bond requirements.

**IMPORTED FOR FURTHER PROCESSING**

The legislative history of the Export Reform Act indicates that section
801(d)(3) was intended to allow manufacturing and processing activities
not previously permitted under the Act, and the legislative history of
the Bioterrorism Act does not alter that intent. The terms \"further
processed\" and \"incorporated\" can cover a wide range of activities.
These can include packaging or labeling of finished products and
specialized processing (such as sterilization) of a product. FDA
recognizes that in some instances, it may be advantageous to manufacture
a product in a foreign country and then ship it to the United States for
specialized packaging or labeling. Merely storing an article or product
in the United States before export is not considered "further
processing."

**PRODUCTS SUBJECT TO DETENTION WITHOUT PHYSICAL EXAMINATION**

The import for export provision does not preclude the importation of
articles that otherwise would be subject to detention without physical
examination based on an FDA examination of previous shipments or a
foreign inspection that documented significant good manufacturing
practice (GMP) violations, or manufactured by a foreign firm that has
refused to permit an FDA GMP inspection \[21 CFR 820.1(d)\]. Therefore,
if these articles are offered for import in compliance with section
801(d)(3) or (4) such articles generally could be allowed unless other
grounds exist for refusal of admission. Further guidance on criteria for
accepting products for IFE that would otherwise be detained without
physical examination products may be issued by each Center.

**COMPLIANCE WITH RELEVANT EXPORT PROVISIONS**

At the time of importation, FDA ordinarily will not know if the finished
product will be exported under the provisions of section 801(e)(1) or
section 802 of the Act or section 351(h) of the PHSA. Importers, initial
owners, and consignees of articles imported or offered for import
pursuant to section 801(d)(3) or (4) should determine whether the
intended finished product meets the requirements of one or more of the
export provisions (section 801(e)(1) and section 802 of the Act and
section 351(h) of the PHSA). If they do not meet such requirements, they
must destroy any products that may not be legally exported under the Act
or the PHSA, as applicable. Section 801(d)(3)(A)(i)(I) and (iii).

**IMPORTATION OF FINISHED GOODS FOR STORAGE AND EXPORT WITHOUT FURTHER
PROCESSING AND OTHER ARTICLES NOT INCLUDED UNDER SECTION 801(d)(3)**

Products and articles imported under section 801(d)(3) must be furthered
processed or incorporated into a drug, biological product, device, food,
food additive, color additive or dietary supplement that will be
exported from the United States. This provision does not allow the
import of violative products intended [only]{.underline} for storage.

Importers of electronic products subject to performance standards are
required by U.S. Customs regulation, 19 CFR 12.91, to file the form FDA
2877. Block A.7 on form FDA 2877 needs to be checked to indicate that
the device is for medical device processing under import for export.

Since the wording of the amended section 801(d)(3) specifically
identifies only food additives, color additives, and dietary supplements
as the only food articles that can be imported for export, districts
should not accept notification of import for export of other
[foods]{.underline} that do not meet the criteria of a food additive,
color additive, or dietary supplement. Similarly, cosmetics, as defined
by section 201(i) of the Act, do not meet the criteria for import for
export under the provisions of section 801(d)(3) and any offers for
entry for such importations should be refused admission as appropriate.

The amended section 801(d)(3) also identifies specific products into
which articles imported pursuant to the section can be incorporated for
export. These are drugs, biological products, devices, foods, food
additives, color additives, and dietary supplements. Cosmetics are not
listed as a product that falls within this provision. Therefore,
violative color additives intended for processing into a
[cosmetic]{.underline} product do not fall within the scope of section
801(d)(3), and entries for such importations should be refused
admission, as appropriate.

**IMPORTATION OF VIOLATIVE COMPONENTS FOR FURTHER PROCESSING INTO OTHER
COMPONENTS AND UNFINISHED PRODUCTS**

Many manufacturers assemble their products in various stages. These
manufacturing steps may include sending partially completed products to
firms in the United States for further manufacturing or processing, but
not into a finished product. Neither the statutory language of the
amended section 801(d)(3) nor the legislative history of the Export
Reform Act or the Bioterrorism Act require that violative components
allowed to be imported must be incorporated into "finished products."
Because components, or \"subassemblies,\" are the finished product of
the U.S. manufacturer (although not necessarily a consumer ready
product) and would constitute a drug, biological product, device, food
additive, color additive, or dietary supplement within the Act\'s
meaning, the agency has concluded that articles imported for use in the
manufacture of such products fall within the scope of the import for
export provision. Therefore, such products are subject to the
requirements of section 801(e) or section 802 of the Act or section
351(h) of the PHSA.

**IMPORT FOR EXPORT PROVISIONS FOR PRODUCTS MANUFACTURED IN FOREIGN
TRADE ZONES**

Foreign Trade Zones are federally sanctioned sites that, only for tariff
purposes, are considered outside of the "Customs territory" of the
United States. Nevertheless, products stored or manufactured in a
Foreign Trade Zone are within the territory of the United States for the
purposes of the Act and are expected to meet the same requirements as
other products regulated by FDA \[see Compliance Policy Guides 110.600
\"FDA Authority Over Products of Foreign Origin Located in Foreign Trade
Zones, Bonded Warehouses, or on Bonded Carriers\" (CPG 7150.14), and
110.200 \"Export of FDA Regulated Products from U.S. Foreign Trade
Zones\" (CPG 7150.11)\]. These include the requirements of section
801(d)(3) and section 801(d)(4).

**RECORDS AND INFORMATION TO BE PROVIDED TO FDA UPON REQUEST**

The new section 801(d)(3)(A)(iv) requires that the initial owner or
consignee maintain records on the use or destruction of the imported
articles or portions and to provide records when requested. The initial
owner or consignee is also required to submit a report to FDA, upon
request, that provides an accounting of the export or destruction of
such imported article or portions and the manner in which such owner or
consignee complied with the requirements of section 801(d)(3). The
records should include the statements and any certificates of analysis
required to be submitted at the time of import as described above.
Additional records could include documentation with more specific
identification of the product such as Customs entry number, date,
quantities, manufacturing process and controls and intent of the
importation (i.e., further processing into product intended for
exportation). Records on export or other disposition need to be retained
(section 801(d)(3)(A)(iv)) and should include information such as
quantity, dates, destination, shipping, means of destruction, and any
records required under the export record keeping and notification
regulation. (21 C.F.R. 1.101).

**AGENCY CONTACTS**

Questions regarding importation of specific products should be referred
to the appropriate Center (e.g., biological products, tissues, and
procedures for considering requests to import violative blood products
under section 801(d)(4) should be referred to CBER, Office of Compliance
and Biologics Quality, Division of Case Management, Biological Drug and
Device Compliance Branch (HFM-624); unapproved drugs should be referred
to the Center for Drug Evaluation and Research, Office of Compliance, or
Division of Labeling and Non-Rx Drug Compliance, Import/Export
International Drug Team (HFD-316); food additives and color additives
should be referred to the Center for Food Safety and Applied Nutrition,
Office of Field Programs, Division of Enforcement, Imports Branch
(HFS-606); medical devices and radiation emitting electronic products or
their components should be referred to the Center for Devices and
Radiological Health, Office of Compliance, Division of Program
Operations (HFZ-305); feed additives, veterinary medical devices, and
unapproved animal drugs should be referred to the Center for Veterinary
Medicine, Division of Compliance (HFV-230)).

Information concerning CBER's review of import for export requests under
section 801(d)(4) (blood and blood products) is in CBER's SOPP 8503.2,
available at
[www.fda.gov/cber/regsopp/85032.htm](http://www.fda.gov/cber/regsopp/85032.htm).

Questions regarding the procedures to be followed by districts or
industry relating to interaction with Customs should be addressed to the
Division of Import Operations and Policy (HFC-170) 301-443-6553.