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 Code of Federal Regulations (Last Updated: May 6, 2024)
 Title 21 - Food and Drugs
 Chapter I - Food and Drug Administration, Department of Health and Human Services
 SubChapter C - Drugs: General
 Part 207 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code
 Subpart C - National Drug Code

  § 207.37 - What restrictions pertain to the use of the NDC?  

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  • § 207.37 What restrictions pertain to the use of the NDC?

    (a) A product may be deemed to be misbranded if an NDC is used:

    (1) To represent a different drug than the drug for which the NDC has been assigned, as described in § 207.33;

    (2) To denote or imply FDA approval of a drug; or

    (3) On products that are not subject to parts 207, 607 of this chapter, or 1271 of this chapter, such as dietary supplements and medical devices.

    (b) If marketing is resumed for a discontinued drug, and no changes have been made to the drug that would require a new NDC under § 207.35, the drug must have the same NDC that was assigned to it as described in § 207.33, before marketing was discontinued.