21 CFR 201.15 - Drugs; prominence of required label statements

Cite as21 CFR 201.15
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16 practice notes
  • Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...in the English language. We are also proposing that labeling be submitted in the English language except, as provided under current 21 CFR 201.15(c), when drugs are distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than Engli......
  • Part II
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...in the English language. We are also proposing that labeling be submitted in the English language except, as provided under current 21 CFR 201.15(c), when drugs are distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than Engli......
  • U.S. v. 1500 90-Tablet Bottles, No. 03 C 6495.
    • United States
    • United States District Courts. 7th Circuit. United States District Court (Northern District of Illinois)
    • August 12, 2005
    ...Genendo admits that a drug held for sale in interstate commerce that fails to meet the requirements of 21 U.S.C. § 352(c) and 21 C.F.R. § 201.15(c)(1) is deemed to be misbranded as a matter of law unless exempt by the 8. Genendo admits that the packaging of a drug can be critical to its saf......
  • United States v. Scully, No. 14–CR–208(ADS)(SIL).
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • June 8, 2015
    ...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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8 cases
  • U.S. v. 1500 90-Tablet Bottles, No. 03 C 6495.
    • United States
    • United States District Courts. 7th Circuit. United States District Court (Northern District of Illinois)
    • August 12, 2005
    ...Genendo admits that a drug held for sale in interstate commerce that fails to meet the requirements of 21 U.S.C. § 352(c) and 21 C.F.R. § 201.15(c)(1) is deemed to be misbranded as a matter of law unless exempt by the 8. Genendo admits that the packaging of a drug can be critical to its saf......
  • United States v. Scully, No. 14–CR–208(ADS)(SIL).
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • June 8, 2015
    ...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 ......
  • Medinatura, Inc. v. Food & Drug Admin., Civil Action No. 20-2066 (RDM)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • October 23, 2020
    ...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......
  • Ramirez v. Plough, Inc., No. F015950
    • United States
    • California Court of Appeals
    • October 7, 1992
    ...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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