Import/Export - Animal Health Products
Importing Animal DrugsThe importation of animal drugs into the United States requires mandatory compliance with strict laws and regulations. Foreign manufacturers offering animal drugs for import must be registered with the Food and Drug Administration (FDA) and have a designated U.S. Agent as a point of contact. In addition, the Bioterrorism Act of 2002 requires that foreign manufacturers provide the name of each person importing the manufacturers’ drug into the U.S., as well as the name and contact information for the U.S. Agent. All drug production must be compliant with current Good Manufacturing Practices (cGMP) in order to be allowed into the United States.
During the process of importation, Customs and Border Patrol must inform the FDA district office of all formal and informal entries under FDA jurisdiction. Based on the information that is provided, the FDA decides whether or not to release the shipment for entry, hold the shipment for sampling, or deny entry.
In the case that a product is imported into the U.S. to be used in the manufacture of a product for export, it may be allowed entry if the importer provides specific information such as proof that the product is to be further processed and a certificate of analysis of the imported product. Importing requirements for investigational uses depend on whether the testing is pre-clinical or clinical, however FDA authorization is required in certain cases.
TSG’s regulatory experts provide full support for the importation of animal drugs into the United States. We assist clients by acting as a U.S. Agent under the Bioterrorism Act, help with product approvals and overall regulatory support for issues that arise during the importation process.
Exporting Animal DrugsWhen exporting animal drugs from the United States into a foreign country, it is important to be aware of regulations and requirements abroad. While animal drugs that are approved in the U.S. may be exported, entry of the product into the foreign country is subject to regulations of the receiving jurisdiction. Animal drugs that are not approved for use in the U.S. may be exported if they comply with foreign purchaser specifications, laws in the destination country, or if they are labeled for export and are not offered for sale in the United States.
Products exported from the U.S. must also comply with foreign labeling requirements. These requirements apply to labels as well as written or printed materials on any containers or wrappers accompanying the product. In addition, labels must identify all uses of the product that are not approved for use in the United States.
When exporting a product from the U.S., it is critical to maintain detailed records demonstrating compliance with the laws of the destination country, and documents showing that the product has not been offered for sale in the United States. In addition, certain circumstances require an export certification that is issued by the appropriate center compliance director.
TSG’s consultants help with various export issues pertaining to animal drugs. This includes providing the regulatory scope of exporting a product to a foreign country, label compliance issues, record keeping and other general regulatory assistance needed to export an animal health product.