The US Drug Registry is the official regulatory system maintained by USFDA to track drug manufacturing establishments and drug products legally marketed in the United States. Any company involved in manufacturing, processing, repacking, relabeling, or distributing drugs for the US market must comply with USFDA drug registration and listing requirements.
Failure to complete USFDA registration can result in shipment delays, import refusal, or regulatory enforcement action.
What Is the US Drug Registry?
The US Drug Registry is part of the regulatory framework enforced by U.S. Food and Drug Administration, commonly referred to as USFDA. It allows USFDA to maintain visibility over:
- Drug manufacturing and processing facilities
- Drug products supplied to the US market
- Companies responsible for regulatory compliance
The registry is maintained through two mandatory compliance activities:
- USFDA Drug Establishment Registration
- USFDA Drug Product Listing
Both activities must be completed and kept current to legally supply drugs in the United States.
Who Must Register in the USFDA Drug Registry?
USFDA drug 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 point of contact between the company and USFDA.
USFDA Drug Establishment Registration
USFDA drug establishment registration records the physical facility where drugs are manufactured or processed. Each facility must be registered separately, regardless of company ownership.
Key Registration Rules
- Registration is mandatory and renewed annually
- Registration period: October 1 to December 31
- Applies to both US and foreign establishments
- Registration must be active before importation or distribution
If establishment registration is inactive or expired, drug shipments may be detained or refused entry into the United States.
USFDA Drug Listing and NDC
After establishment registration, every 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 details
- National Drug Code (NDC)
The NDC is a unique identifier used throughout the US healthcare and supply chain. While USFDA does not “approve” NDC numbers, accurate NDC configuration is essential for compliance, reimbursement, and distribution.
Common US Drug Registry Compliance Issues
Companies frequently encounter USFDA compliance challenges due to:
- Incorrect or incomplete SPL submissions
- Labeling inconsistencies
- Missed annual registration renewals
- Improper US Agent designation
- Confusion between USFDA registration and drug approval
Even minor errors can delay product launches or disrupt supply chains.
Why Professional USFDA Registration Support Is Important
Managing US Drug Registry compliance requires regulatory expertise, technical accuracy, and ongoing monitoring. Errors can result in delays, enforcement actions, or loss of market access.
XPRO America, a US FDA Consultancy, provides complete USFDA drug registration and listing services for pharmaceutical companies worldwide. Their services include establishment registration, drug listing submissions, SPL preparation, NDC configuration, US Agent support, and annual renewal management.
Organizations seeking structured USFDA compliance support can reach the regulatory team at support@xproamerica.com for tailored guidance.
Conclusion
The US Drug Registry is the foundation of legal drug distribution in the United States. Proper USFDA establishment registration and drug listing are essential for compliance, import clearance, and long-term market access.
By maintaining accurate USFDA registration data—and working with an experienced US FDA consultancy—companies can reduce regulatory risk and operate confidently in the US pharmaceutical market.
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