FDA Drug Establishment Registration and FDA Drug Listing

According to the United States’ Food and Drug Administration, U.S. FDA Drug Regulations, all drug establishments that formulate, develop, manufacture, process or pack drugs that are marketed in the U.S. must register with FDA. Furthermore, all drug establishments that formulate, develop, manufacture, process or pack drugs that are marketed in the U.S. must list all of their marketed products through Electronic Drug Registration and Listing System (eDRLS).

FDA National Drug Code NDC Labeler Code

The United States’ Drug Listing Act of 1972 requires registered drug establishments to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution. Drug products are identified and reported using a unique 10 digit , three-segment number, called the National Drug Code (NDC Labeler code), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC directory to public.

FDA OTC Drug Establishment Registration and OTC Drug Listing

Over-the-counter (OTC) drug products play an increasingly important role in America’s health care system. OTC drugs are defined as drugs that are safe and effective for use by individuals without requiring a prescription. Currently, there are over 300,000 marketed OTC drugs in the U.S. The FDA reviews the active ingredients and labeling of over 80 therapeutic categories of OTC drugs instead of individual drug products.

FDA Drug Labeling and Ingredient Requirement

Regardless of the manufacturing origin, all of the drugs that are in the U.S. market must comply with the Federal Food Drug and Cosmetic Act (FDCA). ‘Intended use’ of a drug article is the primary factor in defining which FDA regulations will be applicable for specific drug label.

FDA Drug Color Additives Requirement

All drug color additives must be FDA approved for their specific intended use and formulation. Drug colors additives must be either FDA certified colors (on a batch basis), or exempted from FDA color certification. Batch Certification is a process by which FDA evaluates the composition of all colors used in drug formulation. To obtain the color additive batch certification, drug manufacturers must submit a sample of the color additive for each batch used in the product formulation along with the batch-specific documents. After proper examinations U.S. FDA will certify the color additive if the analysis of the batch sample meets the FDA requirements.