For pharmaceutical companies planning to sell drugs in the United States, US FDA drug registration and listing search is a core regulatory requirement. Before any drug product enters the US supply chain, both the manufacturing establishment and the drug itself must be properly registered and listed with the U.S. Food and Drug Administration. These steps ensure transparency, traceability, and regulatory oversight across the pharmaceutical market.
US FDA Drug Establishment Registration Explained
Drug establishment registration is mandatory for all facilities involved in manufacturing, processing, packaging, labeling, repackaging, relabeling, or testing drug products intended for the US market. Registration must be completed annually and updated whenever facility details change. Once registered, the FDA issues a Facility Establishment Identifier (FEI), which is used for inspections, compliance tracking, and import verification.
Foreign manufacturers must also designate a US FDA U.S. Agent, who serves as the official communication link between the FDA and the overseas facility. Without valid establishment registration, drug shipments may be detained or refused entry into the United States.
FDA Drug Listing and Product Identification
FDA drug listing focuses on individual products rather than facilities. After establishment registration, companies must submit detailed drug listing information, including proprietary name, active ingredients, dosage form, strength, route of administration, and National Drug Code (NDC). The NDC is a unique identifier used for drug tracking, billing, and regulatory monitoring.
Drug listings must remain active and accurate. Any formulation change, labeling update, or discontinuation requires timely updates in the FDA system. Annual renewal of listings is also required to maintain compliance.
FDA Drug Registration and Listing Search
The FDA provides online databases that allow users to perform FDA registration and listing searches. These tools help importers, distributors, hospitals, and regulatory professionals confirm whether a drug manufacturer is registered and whether a drug product is properly listed. Conducting these searches is a common due diligence step before partnerships, audits, or US shipments.
It is important to understand that FDA registration and listing do not indicate product approval or clinical evaluation. They simply confirm that regulatory information has been submitted and maintained.
Professional Support for FDA Compliance
Managing FDA registration and listing can be complex, especially for global companies unfamiliar with US regulatory expectations. XPRO America, a US FDA Consultancy, supports pharmaceutical manufacturers with drug establishment registration, FDA drug listing, U.S. Agent services, and ongoing compliance management.
If your organization needs assistance verifying FDA registration status or maintaining accurate listings, the XPRO America regulatory team can be reached via support@xproamerica.com to help ensure uninterrupted access to the US pharmaceutical market.
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