FDA Publishes Guidance on NDC Codes

On Dec. 18, 2019, FDA published draft guidance that details the procedures for obtaining an additional National Drug Code (NDC) for FDA-approved prescription drugs imported into the United States in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