The US Drug Registry is the regulatory system used by USFDA to monitor drug manufacturing establishments and drug products supplied to the United States market. Any company involved in manufacturing, processing, repacking, relabeling, or exporting drugs to the US must comply with USFDA drug registration and listing requirements.
Registration in the US Drug Registry is not optional. Without it, drug products may be blocked at US ports, delayed in distribution, or subject to regulatory enforcement.
Why the US Drug Registry Exists
The US Drug Registry allows USFDA to maintain centralized oversight of the pharmaceutical supply chain. Through this system, USFDA is able to:
- Identify facilities involved in drug manufacturing and processing
- Track drug products introduced into US commerce
- Assign compliance responsibility to manufacturers and labelers
- Support inspections, recalls, and safety-related actions
The registry ensures traceability and accountability across the drug lifecycle.
Core Components of the US Drug Registry
The US Drug Registry operates through two mandatory USFDA compliance activities:
1. USFDA Drug Establishment Registration
This records the physical facility where drugs are manufactured or processed. Each establishment must be registered separately, even if multiple facilities belong to the same company.
2. USFDA Drug Product Listing
This records detailed information about each drug product marketed in the United States, including formulation, dosage, labeling, and identification data.
Both components must remain active for continued legal access to the US market.
Who Must Register with USFDA?
USFDA registration requirements apply to a wide range of pharmaceutical entities, including:
- Prescription drug manufacturers
- Over-the-counter (OTC) drug manufacturers
- Contract manufacturing organizations (CMOs)
- Repackers and relabelers
- Foreign drug manufacturers exporting to the US
Foreign companies must also appoint a US Agent, who acts as the official communication link between the company and USFDA.
Annual Registration and Compliance Timelines
USFDA drug establishment registration must be renewed every year.
Key Rules to Remember
- Annual renewal window: October 1 to December 31
- Applies to US-based and foreign establishments
- Registration must be active before import or distribution
- Failure to renew results in inactive registry status
Inactive registration often leads to shipment holds or import refusal.
USFDA Drug Listing and National Drug Code (NDC)
After establishment registration, each drug product must be listed with USFDA. Drug listing submissions include:
- Drug name and formulation
- Dosage form and strength
- Route of administration
- Manufacturer and labeler information
- National Drug Code (NDC)
The NDC is a unique identifier used across US supply chains and reimbursement systems. While USFDA does not approve NDC numbers, accurate NDC configuration is essential for compliance.
Common US Drug Registry Compliance Risks
Companies frequently face issues such as:
- Incorrect or incomplete SPL submissions
- Inconsistencies between labeling and listing data
- Missed annual renewals
- Incorrect US Agent details
- Misunderstanding USFDA registration as product approval
These issues can delay launches and disrupt US operations.
Why Professional USFDA Support Matters
US Drug Registry compliance requires regulatory expertise, technical accuracy, and ongoing monitoring. Even small errors can lead to enforcement action or loss of market access.
XPRO America, a US FDA Consultancy, provides end-to-end USFDA drug registry services, including establishment registration, drug listing, SPL preparation, NDC configuration, US Agent services, and annual renewal management.
Organizations seeking structured USFDA compliance assistance can contact the regulatory team at support@xproamerica.com.
Conclusion
The US Drug Registry is the regulatory foundation for legal drug distribution in the United States. Accurate USFDA establishment registration and drug listing are essential for compliance, import clearance, and long-term market access.
By maintaining up-to-date USFDA registry records—and partnering with an experienced US FDA consultancy—companies can reduce regulatory risk and operate confidently in the US pharmaceutical market.
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