The US FDA Drug Establishment Registration is a mandatory requirement under 21 CFR Part 207 for all facilities engaged in the manufacturing, repacking, relabeling, or distribution of human and veterinary drugs intended for the U.S. market. This regulation applies to both domestic and foreign facilities, ensuring that all establishments involved in the drug supply chain are properly registered with the FDA.

The registration process is crucial because it allows the FDA to monitor drug safety, trace supply chains, and enforce compliance with federal drug laws. Without proper registration, facilities risk import refusals, warning letters, product recalls, and enforcement actions that can disrupt business operations.

Drug Establishment Registration must be completed electronically through the FDA’s Electronic Submissions Gateway (ESG) using Structured Product Labeling (SPL) format. In addition, each registered establishment is assigned an FDA Establishment Identifier (FEI) number, which is used to track regulatory compliance and inspections.

Key requirements under 21 CFR Part 207 include:

• Initial Establishment Registration for facilities manufacturing, repacking, relabeling, or distributing drugs.
• Biennial Renewal of registration, which must be completed between October 1 and December 31 of each even-numbered year.
• Drug Listing Submissions for every drug product intended for U.S. commercial distribution.
• Compliance with cGMP (Current Good Manufacturing Practices) to ensure product safety and quality.

At XPRO America, we simplify the complex FDA registration process for pharmaceutical manufacturers and distributors worldwide. Our services include:

• Assistance with ESG account setup and SPL preparation.
• Complete facility registration and product listing support.
• Guidance on compliance with 21 CFR Part 207 requirements.
• Ongoing monitoring to ensure timely biennial renewals and regulatory updates.

By partnering with XPRO America, companies gain confidence that their FDA Drug Establishment Registration is accurate, compliant, and completed on time ensuring uninterrupted access to the U.S. pharmaceutical market.

XPRO America helps with US FDA Drug Establishment Registration (21 CFR Part 207), ESG submissions, and biennial renewals for pharmaceutical facilities.