21CFR201.6

§ 201.6 Drugs; misleading statements.

Regulation Text

(a) Among representations in the labeling of a drug which render such drug misbranded is a false or misleading representation with respect to another drug or a device or a food or cosmetic. (b) The labeling of a drug which contains two or more ingredients may be misleading by reason, among other reasons, of the designation of such drug in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling.

Authority

21 U.S.C. 321,331,343,351,352,353,355,358,360,360b,360ccc,360ccc-1,360ddd,360ddd-1,360ee,360gg-360ss,371,374,379e;42 U.S.C. 216,241,262,264.

View in Graph Explorer

Related Guidelines (6)

Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry (Status: Final)
→
PDUFA Pilot Project: Proprietary Name Review - Concept Paper (Status: Final)
→
Contents of a Complete Submission for the Evaluation of Proprietary Names (Status: Final)
→
CVM GFI #240 Proprietary Names for New Animal Drugs (Status: Final)
→
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry: Draft Guidance for Industry (Status: Draft)
→
Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry: Guidance for Industry (Status: Final)
→

21CFR201.6 — § 201.6 Drugs; misleading statements. | CFR Explorer | BioRegHub