What restrictions pertain to the use of the NDC?

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs: General
  6. 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
  7. National Drug Code
  8. 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.


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