Registration & Listing

All foreign drug establishments whose products are offered for import into the United States are required to register with FDA. Foreign firms must also identify a United States Agent and submit, in the English language, a list of every drug they have in commercial distribution. The U.S. Agent listed cannot be a mailbox or answering service; it must be an individual with a physical U.S. business address acting as the foreign establishment's agent before the FDA.

The only exception to the registration requirement is for drugs and devices that enter a foreign trade zone (a.k.a. free trade zone) and are re-exported from the United States without ever entering domestic commerce.

Although registration presumably makes it easier for FDA to track down the source of imported products that FDA finds impure, counterfeit, or unsafe, much of the data in the FDA's registration system is never verified or validated. This makes it much more important for legitimate companies to ensure their registrations are correct and their U.S. Agents are performing their services in a manner that satisfies the agency that the foreign manufacturer is fully compliant with FDA requirements.

The fact that a foreign country may have its own registration requirements or that FDA may enter cooperative arrangements with foreign countries does not suffice. Any foreign firm that would export products to the U.S. must register with FDA.

Consultants and attorneys at FDAImports.com can register your drug establishment, list your drug products, and can act as the U.S. Agent for foreign drug manufacturer. Additionally, the firm can provide counsel regarding drug manufacturing and labeling compliance, which is the key to successfully importing legal drugs into the U.S.