21 C.F.R. §201.15 - Drugs; prominence of required label statements
| Cite as | 21 C.F.R. §201.15 |
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9 cases
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Medinatura, Inc. v. Food & Drug Admin., Civil Action No. 20-2066 (RDM)
...homeopathic products bear Latin names which correspond to listings in the 496 F.Supp.3d 439 HPUS. Since Section 502(c) of the Act and 21 CFR 201.15(c)(1) require that all labeling be in English, the industry is required to translate these names from Latin to their common English names as cu......
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U.S. v. 1500 90-Tablet Bottles
......and . all articles of drugs imported by Local Repack from Genendo ... of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq (the "Act"). Defendant ... registered firms may repack and label drug products in compliance with the Act and ... with the Food and Drug Administration as required by the Food, Drug, and Cosmetic Act. 21 U.S.C. § ......
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United States v. Scully
...also argues that the affidavits improperly suggested that distributing non-English label drugs, a violation of an FDA regulation, 21 C.F.R. § 201.15(c)(1), gives rise to criminal liability.However, as noted later, the Court finds that a violation of this FDA regulation can serve in part as ......
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Ramirez v. Plough, Inc., F015950
...in English and no other statute requires printing in another language. Federal regulations also require warnings be in English. (21 C.F.R. § 201.15 Respondent cites several cases including Guerrero v. Carleson (1973) 9 Cal.3d 808, 109 Cal.Rptr. 201, 512 P.2d 833 and Castro v. State of Calif......
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