Contents

SUBCHAPTER 600 - IMPORTS

601 - AUTHORITY

Section 801 of the FD&C Act [21 U.S.C. 381] authorizes FDA examination of foods, drugs, cosmetics and devices offered for entry into the United States. Section 536 of the FD&C Act [21 U.S.C. 360mm] authorizes refusal of radiation emitting products which fail to comply with the requirements of Section 534 (h) of the FD&C Act [21 U.S.C. 360kk (h)]. 19 CFR 151.4 of the U.S. Customs regulations authorizes employees of FDA to examine or take samples of entry merchandise released under immediate delivery.

The procedures outlined in this chapter cover imported merchandise subject to, but not limited to, the following Acts/Regulations:

• Federal Food, Drug, and Cosmetic Act
• Fair Packaging and Labeling Act
• Nutrition Labeling and Education Act (NLEA)
• Import Milk Act/Filled Milk Act
• Federal Caustic Poison Act
• Radiation Control for Health and Safety Act
• Public Health Service Act, Part F, Subpart 1, Biologic Products
• Title 21 CFR Subpart E - Imports and Exports (1.83), etc.
• Title 19 CFR Customs Duties (authority to sample delegated by Custom Regulations, etc.)

602 - PRODUCTS IMPORTED UNDER THE PROVISIONS OF SECTION 801(d)(3) OF THE FD & C Act

PRODUCTS IMPORTED UNDER THE PROVISIONS OF SECTION 801(d)(3) OF THE FD&C Act [21 U.S.C. 381 (d)(3)]: Import For Export (IFE) Processing & Follow-Up

PURPOSE: To establish procedures facilitating the uniform review of Import for Export (IFE) at the time of entry and domestic follow up to insure articles entered as Import for Export are either exported or destroyed but not distributed domestically.

REFERENCES: Regulatory Procedures Manual Chapter 9, Federal Food, Drug, and Cosmetic Act

BACKGROUND: Section 801(d)(3) of the FD&C Act [21 U.S.C. 381 (d)(3)] allows the importation of certain violative FDA-regulated articles into the U.S. on a conditional basis that they are not for domestic distribution. Those articles include human and veterinary drugs (or their components); device components or accessories, or other devices requiring further processing for health-related purposes; and food additives, color additives and dietary supplements including in bulk form. They must be explicitly intended for further processing or incorporation into other products and subsequent export.

Documentation required at the time of importation under section 801(d)(3) of the Act [21 U.S.C. 381 (d)(3)] includes:

A statement the article is intended to be further processed or incorporated into a drug, biologics product, device, food, food additive, color additive or dietary supplement that will be exported under sections 801(e) or 802 of the FD & C Act [21 U.S.C. 381 (e) or 382] or section 351(h) of the Public Health Service Act (PHSA);

Information to identify the manufacturer of the article and each processor, packer, distributor, or other entity in chain of possession from manufacturer to importer;

Such certificates of analysis as necessary to identify the article, unless it is a device or falls under section 801 (d)(4) of the FD&C Act [21 U.S.C. 381 (d)(4)] - blood and blood components;

In addition, a bond must be executed providing for payment of liquidated damages in accordance with the Bureau of Customs and Border Protection's (CBP) requirements.

PROCEDURE:

Import for Export entry procedures and follow-up.

A. Entry Review

1. If electronic submission is made, it is unlikely all of the information required under section 801(d)(3) FD & C Act [21 U.S.C. 381 (d)(3)] will be provided electronically. Districts should request the supporting documents (if not already received from the broker or importer) by setting an entry option of Documents Requested (DRQ) and/or Entry Incomplete (DEF) on all entries with IFE in the Affirmation of Compliance (AOC) field in OASIS, or those suspected to be IFE, which lack complete supporting documents.

If the entry is indeed an IFE entry and the AOC was not included in the original entry, the entry reviewer should modify the AOC field in OASIS to indicate “IFE”.

2. If the required documentation is not provided after a DRQ, entry reviewers should take the appropriate compliance follow-up, under the basis the required IFE documentation was not provided to FDA at the time of initial importation.

Districts should determine the appropriate time frame for receiving the required IFE documents in particular circumstances. It is anticipated three (3) days from the DRQ or DEF notice will usually be adequate for the required IFE documentation to be submitted. This is because the broker may need to communicate FDA’s requirement for documents to an importer. If all required documentation is provided, the entry should be given a “May Proceed”. NOTE: All documentation supporting the IFE entry should be processed in accordance with step 4 below.

If documentation is not adequate, the district should issue a detention after review of the documentation, in accordance with normal procedures outlined in the RPM Chapter 9.

3. If the entry is marked IFE, but review of the entry information or supporting documents indicates the AOC was entered inappropriately, the entry reviewer should note this in the entry remarks section.

4. Copy and attach all entry documentation and forward to the FDA home district of the initial owner or consignee, identifying the following:

-FOREIGN MANUFACTURER/SHIPPER

-ENTRY NO.

-U.S.IMPORTER OF RECORD

-INITIAL OWNER/CONSIGNEE

-ARTICLE/PRODUCT

B. Domestic Follow-up

The FDA home district of the initial owner or consignee should:

1. Ensure the IFE Entry is copied from the IFE shipments for the last 30 days list which is generated by the Division of Import Operations and Policy (DIOP).

2. Ensure supporting documents are sent to the establishment file of the initial owner or consignee.

3. Ensure follow-up inspections are conducted within 6 - 9 months of the initial notification the firm is receiving an IFE entry. All existing IFE entries for the firm should be investigated during the initial IFE inspection. If the product has not been “further processed” or “incorporated” into product for export, the home district should monitor the firm’s practices to ensure there is no violation of the IFE provisions of the Act.

C. Inspection Guidance

When a firm is scheduled for inspection, you should:

1. Review the IFE entry documentation and/or follow-up inspection information from the establishment file prior to conducting the inspection.

2. Verify during the inspection the IFE article:

a. was used to produce an exported product,

b. was destroyed, or

c. is still under the firm’s control pending disposition. If the article is pending disposition, verify a current and valid Customs bond covering the article exists, and the article is the same article that was offered for entry.

If the article was exported or destroyed, you should request the manufacturer's import, export, and/or destruction records to verify the imported article was further processed or incorporated into another product and was exported in accordance with sections 801(e) or 802 of the FD & C Act [21 U.S.C. 381 (e) or 382] or section 351(h) of the PHSA, or destroyed. Please note, 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.

Include in the Establishment Inspection Report or a memo the status of the IFE product and if further follow-up is required.

D. Following review and determination of the necessity of further follow-up, forward the completed EIR or memo and supporting documents to the District which initiated the IFE follow - up.

E. Upon receipt of the completed IFE Follow-up, ensure the following actions are taken:

1. Verify if further follow-up is needed. If so, schedule a follow-up inspection. If further follow-up is NOT needed, document the completed follow-up.

2. Any inspections identifying a prohibited act under section 301(w) of the FD & C Act [21 U.S.C. 331 (w)] should be forwarded immediately to the district compliance branch for regulatory action. See RPM Chapter 9. In addition, a copy of the violative inspection findings should be forwarded to DIOP immediately.

603 - INSPECTOR/INVESTIGATOR ROLE

When performing import operations, you may be assigned field examinations or sample collections in response to potentially violative conditions found during field examinations. Import Alerts in FIARS, Monthly Refusal Reports, and local intelligence should also be used to support sampling and field examination.

604 - GLOSSARY OF IMPORT TERMS

Refer to the Regulatory Procedures Manual (RPM) glossary for a more complete listing of import terms. Below is some common import language:

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])

Bonded Warehouse - A warehouse in the U.S. where imported merchandise is stored under bond prior to being offered for entry.

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

Consumption Entry (CE) - The entry document submitted to customs by the importer when imported merchandise is offered for use.

Container - A unit used for storage and transportation of cargo.

Date Collected - The date an import sample is collected.

Date of Arrival - The date a carrier transporting imported cargo arrives in the U.S.

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.

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.

Detention Without Physical Examination - 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.

Domestic Import (DI) Sample - A sample of an imported article collected after it has been released from import status. See IOM 405.08.

Entry - A formal offering of specific merchandise into the U.S.

Entry Documents (Entry Package) - A group of documents describing the articles offered for importation, which includes consumption entry form, commercial invoice, manifest, etc. Entry documents include all electronic entries filed through Customs' Automatic Commercial System (ACS) covering FDA regulated products.

Filer - A Customs term used to identify the individual or firm responsible for filing an entry.

Formal Entry - As defined by Customs regulations, entries with a value of $2,000.00 or greater. Formal entries must be covered by an entry bond.

Foreign Trade Zones - Areas set aside in the U.S. by U.S. Customs Service, to hold or otherwise manipulate goods for an unlimited period of time awaiting a favorable market in the U.S. or nearby countries, without being subject to U.S. Customs entry, payment of duty, tax, or bond.

Immediate Delivery (ID) - An entry document filed with Customs by the importer. An ID allows the importer to take immediate possession of the goods and allows him 10 days to file the Consumption Entry (CE).

Import Alerts - Guidance documents concerning unusual or new problems affecting import coverage which direct application of sanctions. They are available on the internet at www.fda.gov/ora/fiars/ora_import_alerts.html.

Importer of Record - Importer or his/her representative responsible for assuring an entry of goods is in compliance with all laws affecting the importation. The redelivery bond issued for the entry will be in the name of the importer of record.

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

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

Informal Entry - As defined by Customs Regulations, an entry with a value less than $2,000.00 and, usually not imported under bond.

Intransit Entry (IT) - An entry document filed with Customs by the importer. It allows the merchandise to move from the port of unloading to its destination, under Customs bond, and allows the importer thirty days to file a CE. The merchandise is usually inspected by FDA at the destination point (port of entry).

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.

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.

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.

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.)

Redelivery Bond (AKA Entry Bond) - A bond posted by the importer of record with Customs, 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.

Stripping (Of Containers) - The removal of articles from a transportation "Container" for examination or sampling.

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

Warehouse Entry (WE) - An entry document filed with Customs by the importer which allows the goods to go immediately into a bonded warehouse.