GUIDELINES FOR IMPORTATION #1120
monoclonal antibodies, cell culture supernatants, ascitic fluid, cell extracts, hybridomas, cell cultures/lines which are not derived from livestock* or avian species.
cell lines of livestock* or avian species origin and their products, microbial cultures and their products.
Materials derived from all animals are potentially subject to U.S.Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) regulations and must becleared by USDA inspectors at the port of arrival before entry into theUnited States is authorized. A USDA, APHIS, VS permit is required formaterial derived from animals that may pose a risk of introducing livestockor avian diseases exotic to the United States.
Cell lines and other products of cell lines, including monoclonal antibodies, which:
May be imported without a USDA permit.
In addition, monoclonal antibodies intended for in vivo human use do not require a permit.
However, (1) cell lines derived from livestock or avian species, (2) cell lines derived from any species which will be used for in vivo use, and (3) cell lines of any species which may have been exposed to exotic livestock or avian disease agents will require a USDA, VS import permit.
A USDA, VS import permit will NOT be required for cell lines other products of cell lines, including monoclonal antibodies if the shipment is accompanied by:
This information must be supplied as statements and made available for review by the USDA Inspector at the port of arrival. Do not put the documents INSIDE the shipping container.
Please instruct your shippers to provide this information.
If the above information is not supplied, the shipment will be subject to delays. If the material cannot meet these criteria, a USDA import permit may be required.
Permit applications may be obtained several ways:
*The term, livestock, includes any bovine, ovine, caprine, porcine, and equine animal.