The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service’s (APHIS) Veterinary Services (VS)—in consultation with the Food and Drug Administration (FDA)— issued notice on November 17, 2016, that FDA-approved human and veterinary pharmaceuticals pose a negligible risk for introducing foreign animal disease into the United States. Effective November 18, 2016, these commodities may enter the United States without USDA APHIS VS restrictions. Moreover, an import permit (VS Form 16-6) is no longer required for FDA-approved human and veterinary pharmaceuticals in final use-ready dosage (i.e., bulk or packaged).
To facilitate shipment identification for timely delivery, VS recommends that certain documentation accompany each shipment for review by the Department of Homeland Security, Customs and Border Protection (CBP) at U.S. ports of arrival. Documentation recommended for human and veterinary pharmaceuticals will be written statement, supplied on foreign producer/shipper letterhead, that:
- Confirms that the product being imported is approved by the FDA
- Includes a copy of the FDA-approved commercial drug product label
Alternatively, the CBP may use the information contained in shipping documents (e.g., invoices, manifests or products labels) to verify if the shipment contains FDA-approved pharmaceuticals for human use (Orange Book) or FDA-approved pharmaceuticals for veterinary use (Green Book).
The guidance for vaccines for human use remains the same. Vaccines for veterinary use must meet the import requirements currently in the Animal Product Manual. As a reminder, vaccines for human use require a written statement, supplied on foreign producer/shipper letterhead, which confirms that:
- The product being imported is approved by the FDA
- The human vaccine in final dosage form and packaging and intended for human use only
- The product does not contain live livestock and poultry viral agents
- A copy of the FDA-approved commercial vaccine label must be included as well.
If you have any questions about animal products and their eligibility for importation into the United States or their certification requirements, please contact National Import Export Services (NIES) at (301) 851-3300, option 1 or you can email us at: AskNIES.Products@aphis.usda.gov.
