FDA Drug Establishment Registration

Pharmaceuticals and over-the-counter (OTC) medications are the most regulated products. Under the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), drug establishments must register and list information for drugs to be submitted electronically unless they are given a waiver. All drug establishments, both foreign and domestic, are required to register their facilities for commercial distribution, along with a list of all their drug products, when operating in the United States. Establishment owners must register within five days of starting operations, and if they have not previously been in operation, they must register within five days after submitting drug applications, biological license applications, and medicated feed mill license applications. 

Foreign establishments operating in the United States (whose products are imported or offered for import) must identify a United States agent during their registration process. The agent may only be one, and must be physically located in the country, and should serve as the point of contact between the business and the FDA.

Establishments must submit registration on or before December 31 of every year. When registering, they must submit the FDA-required listing information. In both June and December, listing information has to be updated every year, which should include the information for drugs not previously listed or for any changes to existing drugs. 

UReg FDA food registration and FDA device registration offers a variety of drug establishment registration services, including:

• OTC drugs label and ingredient review
• Certificate for drug listing
• Certificate for establishment registration
• OTC/drug delisting and listing
• Facility de-registration and registration both annually and for new business
• Acting as an agent for foreign companies

For more information on our drug establishment registration services, please visit us online.