The pharmaceutical industry in the United States is governed by strict regulations to protect public health and ensure product quality. For companies that manufacture or distribute over-the-counter (OTC) medications, two critical compliance requirements are FDA OTC Drug Registration and FDA NDC Registration. Understanding these processes is essential for gaining legal market access and building consumer trust.
What is FDA OTC Drug Registration?
FDA OTC Drug Registration is the process by which facilities involved in manufacturing, relabeling, repackaging, or distributing OTC drugs must register with the Food and Drug Administration (FDA). This rule applies to both U.S.-based and foreign companies that plan to sell their OTC drugs in the American market.
The registration ensures that the FDA knows exactly where OTC products are made and who is responsible for them. Through FDA OTC Drug Registration, the agency can:
- Conduct inspections of facilities
- Verify compliance with current Good Manufacturing Practices (cGMP)
- Monitor safety and product quality
Foreign manufacturers are also required to appoint a U.S. agent during the FDA OTC Drug Registration process to facilitate communication with the FDA. Without proper registration, products may be refused entry into the U.S. or subject to recalls and penalties.
What is FDA NDC Registration?
In addition to registering the manufacturing facility, companies must also list each drug product with the FDA through FDA NDC Registration. The National Drug Code (NDC) is a unique 10-digit, three-segment identifier that distinguishes every drug on the U.S. market.
The components of the NDC are:
- Labeler Code – identifies the company or distributor
- Product Code – specifies drug strength, dosage form, and formulation
- Package Code – indicates packaging size and type
FDA NDC Registration ensures that each product is properly listed in the FDA’s database. This process improves product traceability, prevents medication errors, and allows quick identification during recalls. Without NDC listing, a drug product cannot be legally marketed in the United States.
How the Two Registrations Work Together
While FDA OTC Drug Registration validates the facility, FDA NDC Registration validates the product. Both steps are required and interconnected. The facility must be registered first, followed by the product listing.
Together, these processes create a transparent system that strengthens consumer protection, builds confidence in the pharmaceutical supply chain, and ensures compliance with FDA regulations.
Conclusion
Both FDA OTC Drug Registration and FDA NDC Registration are crucial for companies entering the U.S. pharmaceutical market. Facility registration confirms that the manufacturer operates under FDA oversight, while product registration ensures that each drug is uniquely identified and traceable. Compliance with these requirements is not only a legal obligation but also a commitment to safety, quality, and consumer trust. By completing both registrations, companies protect public health while securing a stronger position in the competitive OTC drug industry.
