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21CFR207.37

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

Regulation Text

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

Authority

21 U.S.C. 321,331,351,352,355,360,360b,371,374,381,393;42 U.S.C. 262,264,271.

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Related Guidelines (1)

21CFR207.37 — § 207.37 What restrictions pertain to the use of the NDC? | CFR Explorer | BioRegHub