§207.37. What restrictions pertain to the use of the NDC?
21 C.F.R. § 207.37
A product may be deemed to be misbranded if an NDC is used:
To represent a different drug than the drug for which the NDC has been assigned, as described in § 207.33;
To denote or imply FDA approval of a drug; or
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.
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.
Source
Source: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.