For pharmaceutical companies planning to sell drugs in the United States, compliance with the US FDA Drug Registration and Listing Database is not optional—it is a legal requirement. This database serves as the official record of drug establishments and products that are manufactured, processed, packed, or distributed for the US market.
Every domestic and foreign drug establishment must complete US FDA registration annually. Alongside registration, all commercial drug products must be listed with accurate and up-to-date details. The US FDA uses this information to oversee regulatory compliance, plan inspections, and control product entry into the United States.
How the US FDA Drug Registration and Listing Database Works
The database contains structured information about drug manufacturing facilities, including company ownership, physical location, manufacturing operations, and contact details. Drug listing data includes product names, dosage forms, routes of administration, labeling responsibility, and National Drug Code information when applicable.
Foreign manufacturers must also appoint a US FDA Agent as part of the registration process. The US FDA Agent acts as the official communication link between the FDA and the overseas facility, especially during inspections, compliance inquiries, or emergency situations.
Importance of Timely and Accurate Submissions
Accuracy within the US FDA Drug Registration and Listing Database is essential. Incomplete or incorrect submissions can result in registration rejection, delays in drug approvals, or refusal of product entry at US ports. Regulatory issues linked to database errors may also trigger warning letters or import alerts.
Another critical aspect is annual renewal. US FDA drug establishment registration must be renewed every year between October 1 and December 31. Failure to renew within this period leads to automatic registration cancellation, which can immediately disrupt business operations and shipments.
Why Expert Support Makes a Difference
The technical nature of US FDA electronic systems and evolving regulatory expectations can make registration and listing challenging for many companies. This is especially true for organizations managing multiple products or contract manufacturing arrangements.
XPRO America operates as a dedicated US FDA Consultancy, assisting pharmaceutical companies with drug establishment registration, product listing submissions, US FDA Agent services, and ongoing compliance management. Their regulatory team ensures data accuracy and timely renewals, helping companies avoid costly compliance risks. Businesses seeking tailored regulatory support may connect with their experts via support@xproamerica.com for reliable guidance.
Building a Strong Compliance Foundation
The US FDA Drug Registration and Listing Database is a cornerstone of pharmaceutical compliance in the United States. When managed correctly, it supports uninterrupted market access, smoother inspections, and long-term regulatory stability. With structured processes and experienced guidance, companies can confidently meet US FDA requirements while focusing on growth and product expansion.
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