DRUG ESTABLISHMENT REGISTRATION AND DRUG LISTING

FDA Drug Establishment Registration and Drug Listing

Ensure Compliance and Gain Access to the U.S. Pharmaceutical Market with IFC Global

The U.S. Food and Drug Administration (FDA) requires all domestic and foreign facilities involved in manufacturing, repacking, relabeling, or importing drugs into the U.S. to complete Drug Establishment Registration and Drug Listing. These processes are critical to ensure that drugs meet the FDA’s stringent safety, efficacy, and labeling standards.

Non-compliance with these requirements can result in severe consequences, including the detention of products at U.S. ports, regulatory enforcement actions, and loss of market access. IFC Global provides expert guidance to help you navigate the complexities of FDA regulations, ensuring a smooth path to compliance.

What is Drug Establishment Registration?

Drug Establishment Registration is mandatory for all facilities involved in the manufacturing or processing of drugs intended for sale in the U.S. This registration allows the FDA to monitor drug facilities and ensure they adhere to regulatory requirements.

Who Must Register?

• Manufacturers producing finished drug products or active pharmaceutical ingredients (APIs).
• Repackers and relabelers modifying drug packaging or labeling.
• Importers distributing drugs into the U.S.

Why is Registration Essential?

• Legal Requirement: No drug product can be marketed or imported into the U.S. without the facility being registered with the FDA.
• Supply Chain Accountability: Ensures that each facility in the supply chain complies with FDA standards.
• Market Access: Allows drugs to be legally distributed in the U.S.

What is Drug Listing?

Drug Listing involves submitting detailed information about the drug products manufactured, repacked, or relabeled by a registered establishment. This process helps the FDA maintain a comprehensive database of all drug products marketed in the U.S., enabling efficient monitoring and enforcement.

Who Must List Their Products?

• Drug manufacturers, repackers, and relabelers.
• Foreign facilities exporting drugs to the U.S. (in coordination with U.S. importers).

What Information is Required?

• National Drug Code (NDC): A unique identifier for each drug product.
• Drug Formulation: Detailed ingredient list and strength of active ingredients.
• Labeling Information: All marketing and usage instructions provided on the product’s label.
• Dosage Form and Packaging: Specific details about the product’s form (e.g., tablets, liquids) and packaging sizes.

Why Drug Establishment Registration and Listing Are Critical

1. Regulatory Compliance: Both processes are required under the Federal Food, Drug, and Cosmetic Act.
2. Customs Clearance: Ensures smooth entry of drug products into the U.S. without detention or rejection.
3. Safety Monitoring: Allows the FDA to track drug products and quickly address safety or labeling concerns.
4. Market Trust: Demonstrates your commitment to quality and compliance, building confidence with buyers and consumers.

How IFC Global Supports Your Compliance Needs

At IFC Global, we offer comprehensive services to simplify the FDA Drug Establishment Registration and Drug Listing processes:

• Accurate Registration: Ensure your facility’s registration is complete and complies with all FDA requirements.
• Comprehensive Drug Listing: Assist with submitting detailed product information, including NDC assignment and labeling review.
• Regulatory Expertise: Navigate complex FDA requirements with guidance from our experienced professionals.
• Customs Support: Prevent product detentions and ensure smooth U.S. market entry.

Your Trusted Partner for FDA Compliance

With IFC Global, you gain a reliable partner dedicated to helping you meet FDA requirements efficiently and effectively. From initial registration to ongoing updates, we ensure your drug products are always in compliance, minimizing risk and maximizing market potential.

Contact Us Today to begin your FDA Drug Establishment Registration and Drug Listing process and ensure seamless access to the U.S. pharmaceutical market.