FDA Publishes Guidance on NDC Codes

December 18, 2019

The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.

On Dec. 18, 2019, FDA published draft guidance that details the procedures for obtaining an additional National Drug Code (NDC) for FDA-approved prescription drugs imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 106 U.S.C. 381). Specifically, the guidance discusses the importation of FDA-approved drugs that were also authorized for sale in a foreign country in which the drugs were originally intended to be marketed.

The guidance addresses labeling of multi-market approved products (MMA products); submissions of new drug application (NDA) and biologic license application (BLA) supplements of an MMA product; registering, listing, and proposing an NDC for an MMA product; importation of an MMA product; and supply chain issues.

Source: FDA