21 CFR 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

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

Subpart C - National Drug Code Official text on eCFR Amendment history

(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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FDA guidance that cites § 207.37

Amendment history

Federal Register documents that created or amended this section.