Code · CFR · Title 21 — Food and Drugs · 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

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

120 words·~1 min read·/us/cfr/t21/s§ 207.37·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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.