The U.S. pharmaceutical industry is one of the most regulated in the world, ensuring that every drug reaching consumers is safe, effective, and traceable. For businesses involved in over-the-counter (OTC) medications, two critical requirements are FDA OTC Drug Registration and FDA NDC Registration. These processes are essential for both compliance and market entry in the United States.
What is FDA OTC Drug Registration?
FDA OTC Drug Registration is the process through which facilities that manufacture, repack, relabel, or distribute OTC drugs must register with the Food and Drug Administration (FDA). This requirement applies equally to U.S.-based facilities and foreign companies exporting products to the U.S.
The purpose of FDA OTC Drug Registration is to maintain transparency and accountability. By registering, companies provide the FDA with detailed information about their facilities, allowing the agency to:
Monitor compliance with current Good Manufacturing Practices (cGMP)
Conduct inspections and audits
Track manufacturers and distributors in case of recalls or safety concerns
Foreign companies must also designate a U.S. agent as part of their FDA OTC Drug Registration, ensuring clear communication between the FDA and the overseas manufacturer. Non-compliance can lead to import refusals, product seizures, or costly penalties.
What is FDA NDC Registration?
In addition to facility registration, every drug itself must be listed with the FDA through FDA NDC Registration. The National Drug Code (NDC) is a unique 10-digit, three-segment identifier assigned to every drug marketed in the U.S.
The three parts of an NDC provide:
Labeler Code – Identifies the manufacturer or distributor
Product Code – Defines the drug’s strength, dosage form, and formulation
Package Code – Specifies the package size and type
FDA NDC Registration ensures that each OTC product is uniquely identifiable within the FDA’s official database. This system is critical for preventing medication errors, assisting healthcare providers in accurate dispensing, enabling efficient recalls, and supporting insurance reimbursement. Without FDA NDC Registration, OTC drugs cannot be legally marketed in the U.S.
How Do the Two Registrations Work Together?
FDA OTC Drug Registration and FDA NDC Registration serve different but complementary purposes. The first confirms that the manufacturing or distribution facility meets FDA requirements, while the second confirms that each specific drug product is properly listed and traceable.
A company cannot successfully market OTC drugs in the U.S. without completing both steps. Together, these registrations form the backbone of FDA compliance, safeguarding consumer health and ensuring that only approved facilities and properly identified products reach the marketplace.
Conclusion
Compliance with FDA OTC Drug Registration and FDA NDC Registration is more than just a regulatory requirement—it is a business necessity. These processes protect consumers, enhance transparency, and build credibility in the marketplace. By completing both registrations, companies demonstrate a strong commitment to safety, quality, and regulatory responsibility. Ultimately, fulfilling these requirements allows businesses to compete successfully in the U.S. pharmaceutical industry while maintaining the highest standards of public health.
