Any pharmaceutical company planning to manufacture, export, or distribute drug products in the United States must comply with US FDA drug registration and listing requirements. Understanding how FDA drug registration and listing search works is essential for verifying compliance, avoiding shipment delays, and maintaining long-term access to the US pharmaceutical market.
US FDA Drug Establishment Registration Requirements
Drug establishment registration applies to all facilities involved in manufacturing, processing, packaging, labeling, repackaging, relabeling, or testing drug products for the US market. Registration is mandatory and must be renewed annually. Facilities are also required to update their records whenever there is a change in ownership, address, or operational activity.
After successful registration, the facility is assigned a Facility Establishment Identifier (FEI). This number is used by the U.S. Food and Drug Administration for inspections, compliance monitoring, and import screening. For foreign manufacturers, appointing a US FDA U.S. Agent is compulsory, as the agent acts as the official point of contact for FDA communications.
FDA Drug Listing and Product Identification
FDA drug listing focuses on individual products rather than facilities. Once establishment registration is complete, each drug intended for US distribution must be listed with detailed product information. This includes the drug name, active ingredients, dosage form, strength, route of administration, and National Drug Code (NDC).
The NDC is a unique identifier that helps the FDA track drugs throughout the supply chain. Drug listings must remain accurate and active. Any changes to formulation, labeling, packaging configuration, or product status must be reported promptly, and listings must be reconfirmed each year.
FDA Drug Registration and Listing Search Explained
The FDA provides public databases that support FDA drug registration and listing searches. These tools allow users to verify whether a manufacturing site is properly registered and whether a specific drug product is listed. Importers, distributors, and regulatory professionals rely on these searches as part of due diligence before commercial agreements, audits, or US shipments.
It is important to understand that FDA registration and listing do not mean FDA approval. Approval is a separate regulatory process, while registration and listing confirm that required regulatory information has been submitted.
Professional Support for FDA Compliance
Managing FDA registration, listing renewals, and database accuracy can be complex, particularly for international manufacturers. XPRO America, a US FDA Consultancy, supports pharmaceutical companies with drug establishment registration, FDA drug listing submissions, U.S. Agent services, and ongoing compliance oversight.
Companies seeking dependable guidance for FDA drug registration and listing search or compliance maintenance can connect directly with the XPRO America regulatory specialists at support@xproamerica.com to ensure accurate filings and uninterrupted US market access.
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