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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Importing CBER-Regulated Products into the United States Questions and Answers

What is the process for importing into the United States?

Generally, the process of importing into the United States is governed by Customs laws and regulations which are administered by the U.S. Customs and Border Protection (CBP). CBP has primary responsibility for regulating and facilitating international trade, collecting import duties, and enforcing United States trade laws. All merchandise coming into the United States clears CBP and is subject to duty unless specifically exempted by law. CBP clearance involves a number of steps: entry, inspection, appraisement, classification, and liquidation. Information must be filed with CBP for all goods imported into the United States. This information, presented in an "entry notice," must be filed with CBP by the importer of record. Frequently, a Customs broker files the entry notice on behalf of the importer of record. (The importer of record is the party holding the bond and is responsible for entry. The importer of record may be the broker, consignee, or true owner of the goods.) The person presenting entry information to CBP is known as the "filer." In order that the merchandise may be delivered to the importer or owner while review of the entry is taking place, a monetary bond is obtained. The bond contains a condition for the redelivery of an imported shipment, or any portion of it, upon demand of CBP.

What standards apply to imports that are regulated by the Center for Biologics Evaluation and Research (CBER)?

CBER regulates biological and related products, including blood and blood products (which includes certain kinds of devices), vaccines, allergenics, tissues, and cellular and gene therapies. CBER also regulates the medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products and all HIV test kits used both to screen donor blood, blood components, and cellular products and to diagnose, treat, and monitor persons with HIV and AIDs. In order to import a CBER-regulated product into the United States, the product must meet FDA’s regulatory requirements. Foreign firms which manufacture products regulated by CBER that are directly or indirectly imported into the United States must comply with applicable FDA requirements before, during, and after importing into the United States. FDA does not recognize regulatory approvals from other countries.

What role does FDA play when an FDA-regulated article is offered for import?

If the article being imported falls under FDA's jurisdiction, it is subject to FDA review. Section 801 of the Federal Food, Drug, and Cosmetic Act (21 USC 381) sets out basic standards and procedures for FDA review of imports under its jurisdiction. Section 801(a) provides for examination of imports and also authorizes FDA to refuse admission of imports that appear, from examination or otherwise, to violate FDA requirements. FDA regulations at 21 CFR 1271.420 set out the basic import standards and procedures for human tissues. As explained in more detail below, FDA and CBP have coordinated their efforts and work together to ensure the smooth processing of FDA-regulated imports.

How does the U.S. Customs and Border Protection (CBP) notify FDA of entries of FDA-regulated products?

FDA receives electronic information about most FDA related entries from CBP. FDA currently receives this information through its Operational and Administrative System for Import Support (OASIS).

When submitting an entry notification, a filer will determine the appropriate Harmonized Tariff Schedule (tariff) code for each product being offered for importation. CBP uses the tariff code, in part, to determine if other government agencies also need to make an admissibility determination. However, a tariff code may cover a wide range of products and may include both products that are subject to FDA jurisdiction and products that are not subject to FDA jurisdiction. When this is the case, filers are usually given the option of "disclaiming" FDA jurisdiction. This is accomplished by disclaiming the "line" in the entry that applies to those products. (Each distinct category of product in an entry will have its own “line” in the entry. For example, if a shipment of a vaccine consisted of both multi-dose vials and pre-filled, single dose syringes, the vials would be one line and the syringes another line.)

What information is submitted to CBP and FDA about an FDA-regulated product?

The entry information submitted to CBP and then to FDA includes:

  • the identification of the product by the tariff code;
  • the entry type;
  • the entry number;
  • the arrival date;
  • the port of entry;
  • the port of unlading;
  • the carrier code;
  • the vessel name and voyage, flight or trip number;
  • the importer and ultimate consignee;
  • the quantity;
  • the value;
  • the country of origin;
  • the bill of lading or airway bill number;
  • the manufacturer;
  • the importer of record; and
  • the ultimate consignee.

The tariff codes are flagged to indicate which products will require FDA review. The additional information that is currently transmitted to FDA includes:

  • the FDA manufacturer;
  • the FDA shipper;
  • the FDA Country of Production (country of origin);
  • the complete FDA product code;
  • a description of the article in common business terms;
  • the quantity for each FDA line; and
  • Affirmations of Compliance.

Affirmations of Compliance (“AOC”) are voluntary data elements that a customs broker or self-filer currently may use when transmitting certain information to FDA through the CBP’s electronic interface with OASIS. Each AOC provides a mechanism to indicate (or affirm) compliance with a specific FDA regulatory requirement. For example, for a licensed biological product, the AOC would be the BLN (Biologics License Number) or STN (Submission Tracking Number), while for an investigational biological drug product, it would be IND (Investigational New Drug Application Number).

What are product codes? Where can I find the product codes for CBER-regulated products?

The FDA product code is a seven character set of letters and numbers which helps FDA classify and review imports. An FDA product code has 5 parts. The first part is the “Industry Code.” The Industry Code for all CBER-regulated products is the number “57,” so the product codes for all CBER-regulated products begin with “57”. The second part of the product code is the “Class Code.” For CBER-regulated products, the Class Code is a letter that describes, generally, what the product is, for example, a viral vaccine, blood derivative, or human musculoskeletal product. The third part of the product code is the “Subclass Code”. For CBER-regulated products the Subclass Code is a letter that describes how the product will be used in the United States, for example, for further manufacturing, in final dosage form for patient use, or sample for product testing/assessment or FDA/CBER lot release. The fourth part of the FDA product Code is the “Process Indicator Code.” CBER-regulated products do not have a Process Indicator Code so in a CBER product code, this part is filled in with a hyphen “-“. The fifth part of the FDA product code is the “Specific Product Code.” The Specific Product Code for CBER-regulated products is two numbers that specifically describes the particular product.

Some example of complete product codes are: for bulk influenza virus vaccine (i.e., for further manufacture), the product code is 57CI-02, for pneumococcal vaccine in final dosage form, the product code is 57HH-42, and for Peripheral Blood Stem Cells ready for transfusion, the product code is 57MH-02.

How does FDA review import entry information to make admissibility determinations?

After information is transmitted from CBP, OASIS screens the entry information against FDA admissibility criteria. If the FDA electronic review determines that further evaluation of the information or article is not necessary, the system transmits a message back through the FDA/CBP interface that the article “may proceed without FDA examination.” If further evaluation is necessary, FDA staff will review the entry information and may request additional information necessary to make an admissibility determination. If the FDA electronic review indicates that the product appears ``by examination or otherwise'' to be subject to refusal of admission under section 801(a) of the FD&C Act (e.g., appears to be adulterated or misbranded), the FDA reviewer will evaluate the entry information based on FDA guidance, take appropriate action, and notify the importer as well as the customs broker. FDA’s import regulations, which set out the process for notice and refusal, can be found at 21 CFR Part 1, subpart E.

You can find more information about how FDA handles import review of CBER-regulated products in 2 CBER Compliance Programs: CP 7342.007 - Imported CBER-Regulated Products and CP 7342.007 Addendum - Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps).

Are there any other federal agencies that may have requirements that apply to imports of CBER-regulated products?

Yes. In addition to CBP, the Centers for Disease Control and Prevention (CDC); the US Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS); and the US Customs and Border Protection have regulations that may also apply to CBER-regulated products.

If the material is suspected or known to contain etiologic agents or has not been tested for etiologic agents, a CDC Etiologic Agent Import Permit may be required. CDC can be contacted at:

Centers for Disease Control and Prevention
Office of Health and Safety FO5
Atlanta, Georgia 30333
Phone: (404) 639-3311 or (404) 498-2260

The U. S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS), regulates the import of all animal-origin materials that could represent a disease risk to United States livestock and the import and transport of infectious organisms and vectors of disease agents. This includes not only animal products and by products, but biological materials that contain or have been in contact with certain organisms and animal materials (including cell cultures). USDA/APHIS/VS can be contacted at:

USDA, APHIS, VS
National Center for Import and Export
4700 River Rd. Unit 39
Riverdale, MD 20737
Phone: (301) 734-3277

I want to import biological specimens (e.g., blood, tissue, DNA) for testing in a clinical laboratory or for basic scientific research. Does FDA regulate biological specimens intended only for testing in a clinical laboratory or use for basic scientific research?

No. If the biological specimens you are offering for import are intended for use only for testing in a clinical laboratory or for basic scientific research and are not articles intended for the prevention, treatment, diagnosis, or cure of diseases, injuries, or conditions in human beings, the specimens are not considered to be biological products subject to licensure by FDA in accordance with Section 351(a) [42 USC 262(a)] of the Public Health Service Act (PHS Act), nor would they appear to be a drug or device as defined in sections 201(g) and (h), respectively, of the Federal Food, Drug, and Cosmetic Act [21 USC 321(g) and (h)], nor an HCT/P as defined in 21 CFR 1271.3, which was promulgated under Section 361 of the PHS Act [42 USC 264].

How do I tell FDA that a biological specimen is being imported for testing in a clinical laboratory or for basic scientific research?

When submitting an entry notification, a filer will determine the appropriate tariff code for the product being offered for importation. CBP uses the tariff code, in part, to determine if other government agencies also need to make an admissibility determination. However, a tariff code may cover a wide range of products and may include products that are not subject to FDA jurisdiction. When this is the case, filers are usually given the option of "disclaiming" FDA jurisdiction. This is accomplished by disclaiming the "line" in the entry that applies to those products.

Tariff codes that cover both FDA and non-FDA regulated products have an "Other Government Agency (OGA)" flag which would allow the filer to disclaim FDA jurisdiction. If the tariff code you or your filer are using for your specimens does not have an OGA flag that will allow the filer to "disclaim" the line(s) in the entry, the filer should contact FDA's Division of Import Operations & Policy at 301-443-6553 to determine if the OGA flag for the tariff code can be modified to allow use of the disclaim process.

What are my responsibilities as an importer of such biological specimens?

If your biological specimens are intended for testing in a clinical laboratory or for basic scientific research, the product is not regulated by FDA. Thus, when submitting the entry notification for the specimens, the filer should disclaim that line. Note that if the person to whom the product is shipped (the consignee) is not using the samples for testing, but instead is processing or manufacturing HCT/Ps or biological products, drugs, or devices with these biological specimens, then the products are subject to FDA jurisdiction and must meet FDA's requirements for HCT/Ps, biological products, drugs, and/or devices.

In addition, to avoid possible delays with importation of specimens for testing or research, it is recommended that the labeling of each specimen container include the following information to make clear that the specimens do not fall under FDA regulation:

  • An accurate description of the biological specimens. For example: human blood specimen, human tissue specimen, human DNA specimen.
  • A statement regarding the intended use of the specimen. For example: "Human Blood For Testing in a Clinical Laboratory," or "Human DNA Specimen for Basic Scientific Research."
  • If the biological specimen has been tested for infectious agents such as the hepatitis B surface antigen (HBsAg) and/or the antibody to human immunodeficiency virus (anti-HIV), a statement relative to the test results should be included.

Are there any other federal agencies that may have requirements that apply to biological specimens?

Yes. The Centers for Disease Control and Prevention (CDC); the US Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS); and the US Customs and Border Protection have regulations that may also apply to biological specimens.

If the material is suspected or known to contain etiologic agents or has not been tested for etiologic agents, a CDC Etiologic Agent Import Permit may be required. CDC can be contacted at:

Centers for Disease Control and Prevention
Office of Health and Safety FO5
Atlanta, Georgia 30333
Phone: (404) 639-3311 or (404) 498-2260

The U. S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS), regulates the import of all animal-origin materials that could represent a disease risk to United States livestock and the import and transport of infectious organisms and vectors of disease agents. This includes not only animal products and by products, but biological materials that contain or have been in contact with certain organisms and animal materials (including cell cultures). USDA/APHIS/VS can be contacted at:

USDA, APHIS, VS
National Center for Import and Export
4700 River Rd. Unit 39
Riverdale, MD 20737
Phone: (301) 734-3277

The US Customs and Border Protection (CBP) has primary responsibility for regulating and facilitating international trade, collecting import duties, and enforcing United States trade laws. All goods imported or offered for importation into the United States must first pass through CBP control. CBP can be contacted at:

US Customs and Border Protection
(202) 344-2050
1300 Pennsylvania Avenue, N.W.
Washington, D.C. 20229

I want to import human tissues for educational use or for basic scientific research. Does FDA regulate human tissue intended only for educational use or for basic scientific research?

No. If the human tissues you are offering for import are intended for use only for educational use or for basic scientific research and are not intended for implantation, transplantation, infusion, or transfer into a human recipient, the tissues are not subject to FDA’s human tissue regulations or FDA import review. If your broker needs to “disclaim” FDA jurisdiction, please see (link to “How do I tell FDA that a biological specimen is being imported for testing in a clinical laboratory or for basic scientific research?”

I want to import an unlicensed antivenin? What steps should I take?

The steps to take to import an unlicensed antivenin into the United States are explained at Information on the Use of Antivenoms (See Related Information).

 

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