Contents

6.7 - GLOSSARY OF IMPORT TERMS

Refer to the Regulatory Procedures Manual Chapter 11 "Glossary" for a more complete listing of import terms. Below is some common import language:

6.7.1 - American Goods Returned

Goods produced in the U.S. which are exported, and then returned to the U.S. They are considered imports. (See Sec. 801(d)(1)of the FD&C Act.[21 U.S.C. 381])

6.7.2 - BONDED WAREHOUSE

One of several classes of Customs Warehouses authorized to receive merchandise that has not been entered into the commerce of the US.  Merchandise is entered into a Customs Bonded Warehouse (CBW) by a “formal entry” or “warehouse entry” requiring complete documentation for the entry, and payment of a fee, but not payment of duty and taxes.  Merchandise in the warehouse can be held for up to 5 years.  After 5 years the merchandise must be entered, exported, or destroyed.  Merchandise in a CWB can be manipulated, but except in certain smelting operations, cannot be manufactured into something else.  If the CBW is located in the US, the merchandise is in interstate commerce and subject to the FD&C Act.

6.7.3 - BREAK-BULK CARGO

Cargo transported in individual units, such as bags or cartons, which are not containerized.

6.7.4 - CONSUMPTION ENTRY (CE)

”Entered for Consumption” means an entry summary for consumption has been filed with CBP in proper form, with estimated duties attached.  The duty can be submitted electronically at the same time as the entry is transmitted or on a 15 day schedule when approved by CBP.

6.7.5 - CONTAINER FREIGHT STATION (CFS)

Another location authorized to receive merchandise under Customs Bond for the purpose of breaking bulk and redelivery of cargo.  Containerized cargo can be moved from the place of unlading to a designated container station, or may be received directly at the container station from a bonded carrier after transportation in-bond, before the filing of an entry of merchandise.

6.7.6 - DATE COLLECTED

The date an import sample is collected.

6.7.7 - DATE OF ARRIVAL

The date a carrier transporting imported cargo arrives in the U.S.

6.7.8 - DATE OF AVAILABILITY

The date imported cargo is available/accessible for sampling by FDA. Goods may not be available for sampling as soon as they arrive in the U.S., due to the way the items were shipped/stored.

6.7.9 - DETENTION

A temporary administrative action taken by FDA against articles offered for entry which are not or appears not to be in-compliance with the laws FDA administers. Detained articles can be released if brought into compliance, refused entry, or seized if not brought into compliance.

6.7.10 - DETENTION WITHOUT PHYSICAL EXAMINATION (DWPE)

An action directed against specific products manufactured or shipped by specific foreign firms. "Import Alerts" list products which may be detained without physical examination due to their violative history or potential.

6.7.11 - DOMESTIC IMPORT (DI) SAMPLE

A sample of an imported article collected after it has been released from import status. See IOM 4.1.4.8.

6.7.12 - ENTRY

“Entry” means documentation required by CBP to be filed with the appropriate Customs Officer to secure the release of imported merchandise from CBP custody, or the act of filing the documentation.

6.7.13 - ENTRY DOCUMENTS (ENTRY PACKAGE)

Information submitted to CBP to determine the merchandise quantity, its contents, and the parties of interest.  Actual documentation for an individual entry can vary greatly, but it generally, consists of a CBP Form CF-3461, and an invoice.  Entry documents can be submitted by paper, or through an electronic transmission in CBP’s Automated Commercial System ( ACS), or a combination of both.

6.7.14 - FILER

A CBP term used to identify the individual or firm responsible for filing an entry.

6.7.15 - FORMAL ENTRY

The entry type required for shipments valued over $2000 or for shipments containing specific commodities designated by CBP.  Formal entry is usually a three-step process, “Entry” – which gains the release of the merchandise from CBP control, “Entry Summary” – which includes determination of the classification and collection of the duty/taxes owed, and “Liquidation” – which is the finalization of the entry process and the completion of an CBP changes to classification and monies owed.

6.7.16 - FOREIGN TRADE ZONES

Foreign Trade Zones are established under the Foreign Trade Zones Act.  Merchandise properly admitted into an FTZ is considered outside the territory of the US for the purposed of duty and taxes.  Several classes of merchandise are present in an FTZ at any one time.  Some of these classes provide duty advantages when the merchandise is eventually entered into the commerce of the US.  Other classes of merchandise are prohibited by law from entering the commerce and must be exported or destroyed.  There is no time limit on how long merchandise can remain in a FTZ without entry or export.  If the FTZ is located in the US, the merchandise is in interstate commerce and subject to the FD&C Act.

6.7.17 - IMMEDIATE DELIVERY (ID) / CONDITIONAL RELEASE

Entry/Immediate Delivery (CF 3461) must be filed within 15 calendar days of arrival of merchandise in the U.S.  Merchandise may be released for immediate delivery if it is arriving by land from Canada and Mexico.   Products may be released for immediate delivery pending entry process completion.  Even though CBP has allowed the immediate delivery, FDA regulated products are conditionally released until FDA makes an admissibility decision.  The conditional release period ends when FDA May Proceeds the entry or issues a refusal.

6.7.18 - IMPORT ALERTS

Import Alerts are guidance documents concerning significant re-occurring, new or unusual  problems affecting import coverage. They are available on the internet at www.fda.gov/ora/fiars/ora_import_alerts.html.

6.7.19 - IMPORTER OF RECORD

The party in whose name the entry is made.  For example, a Customs House Broker might make an entry and become the “importer of record” by using his importer ID and bond on behalf of his client, the true “importer” of the merchandise.  For FDA purposes, the “importer of record” is the person or company filing the redelivery bond under Sections 802(b) and 536(b) of the FD&C Act [21 U.S.C. 382(b) and 360mm(b)]  .

6.7.20 - IMPORT SECTIONS

Import Sections (536, 801 and 802) are those sections of the Federal Food, Drug, and Cosmetic Act containing the Import/Export Provisions

6.7.21 - IMPORT STATUS

The standing of an article in the import system which is not yet released.

6.7.22 - INFORMAL ENTRY

A simplified import entry procedure accepted at the option of CBP for any shipment not exceeding a specified value.  Informal entries are filed with complete paperwork and any duties and taxes are paid at the time of filing.  The entry liquidates at time of filing.

6.7.23 - IMMEDIATE TRANSPORTATION (IT)

An entry document filed with Customs by the importer. It allows the immediate transport of merchandise without a determination of admissibility, from the port of unlading under Customs bond. In general, the importer must file a consumption entry within 6 months of the date of importation or export the merchandise.  FDA typically examines this merchandise at inland port of entry.

6.7.24 - LINE (LINE ITEM)

Each portion of an entry which is listed as a separate item on an entry document. An importer may identify merchandise in an entry in as many portions as he chooses, except each item in the entry having a different tariff description and rate must be listed separately.

6.7.25 - LOT

An entry, group of entries, or a portion of an entry of merchandise which can clearly be defined as appropriate for FDA sampling and examination purposes.

6.7.26 - MARKS

Words or symbols, usually including the country of origin, marked on cartons, bags, and other containers of imported merchandise for identification purposes. A Customs requirement.

6.7.27 - PORT (POINT) OF ENTRY

The Customs location where the Consumption Entry is made. This may or may not be at the Port of Unloading (the point of physical entry into the U.S.)

6.7.28 - REDELIVERY BOND (AKA ENTRY BOND)

A bond posted by the importer of record with Customs. For FDA regulated products, this is currently in the amount of three times the value of the imported product, to insure redelivery of the product for examination, reconditioning, export, or destruction.

6.7.29 - STRIPPING (OF CONTAINERS)

The removal of articles from a transportation "Container" for examination or sampling.

6.7.30 - SUPERVISORY CHARGE

The charges for FDA supervision of the reconditioning and examination of articles after detention. (See 21 CFR 1.99).

6.7.31 - WAREHOUSE ENTRY (WE)

An entry document filed with Customs by the importer which allows the goods to go immediately into a bonded warehouse.

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