Who assigns the labeler code in the NDC?

The Food and Drug Administration (FDA) assigns the labeler code in the National Drug Code (NDC) system. The labeler code is a unique identifier that is assigned to a specific manufacturer or distributor of a drug. This code is crucial as it helps to identify the entity that is responsible for the drug’s production and marketing. The NDC is a three-segment number that includes the labeler code, product code, and package code, thus facilitating accurate tracking and regulation of pharmaceuticals in the United States.

In contrast, the other agencies mentioned do not handle the assignment of labeler codes. The Federal Trade Commission focuses on consumer protection and the promotion of competition, the Drug Enforcement Administration oversees the regulation of controlled substances, and the Centers for Disease Control primarily deals with public health and disease prevention efforts. Thus, the FDA is the only entity responsible for the management of the NDC system and the assignment of the labeler code, underscoring its critical role in the regulation of drugs.