Entering the U.S. pharmaceutical market involves more than simply manufacturing and packaging a product. For over-the-counter (OTC) drug manufacturers and distributors, regulatory compliance is a legal requirement and a gateway to credibility. Two critical components in this compliance framework are FDA OTC Drug Registration and FDA NDC Registration. Understanding and fulfilling these obligations ensures that your products are legally marketed and trusted by both regulators and consumers.
What is FDA OTC Drug Registration?
FDA OTC Drug Registration is the process by which manufacturers, repackers, relabelers, and distributors of OTC drugs must register their facilities with the U.S. Food and Drug Administration (FDA). In addition to registering the facility, companies are also required to list each drug product they intend to market in the United States.
This registration is governed by Section 510 of the Federal Food, Drug, and Cosmetic Act and must be renewed annually between October 1 and December 31. Failing to register or update your drug listing can result in your product being considered misbranded, leading to enforcement actions, import alerts, or product seizures.
The Role of FDA NDC Registration
Once a company has completed its establishment registration, it must also complete FDA NDC Registration, which involves assigning a National Drug Code (NDC) to each OTC product. The NDC is a unique, 10- or 11-digit identifier that tracks the drug throughout the supply chain. It is structured into three segments:
- Labeler Code – Assigned by the FDA and identifies the manufacturer or distributor.
- Product Code – Identifies the specific drug, including its strength, dosage form, and formulation.
- Package Code – Indicates package size and type.
FDA NDC Registration ensures traceability and transparency in drug identification and is often required by healthcare providers, wholesalers, pharmacies, and insurance systems. Without a valid NDC, your product cannot be properly tracked, which may prevent it from being stocked or sold in major marketplaces.
Why Both Registrations Matter
Both FDA OTC Drug Registration and FDA NDC Registration are legally required for selling OTC drugs in the United States. Together, they form the foundation of drug compliance, safety monitoring, and traceability. Completing only one step without the other can result in regulatory violations and may limit your product's distribution and availability.
Additionally, these registrations increase your product’s legitimacy in the eyes of retailers and consumers. They assure stakeholders that your product complies with U.S. quality and safety standards, which can be essential for building brand reputation and trust.
Conclusion
For any company entering or operating in the U.S. OTC drug market, completing both FDA OTC Drug Registration and FDA NDC Registration is essential. These steps not only ensure legal compliance but also enhance your product’s marketability and credibility. While the process may seem complex, getting it right from the beginning can save time, avoid penalties, and build consumer confidence. Partnering with regulatory experts can help streamline the process and ensure you meet all FDA requirements efficiently.
