21 CFR 610.60 - Container label

Cite as21 CFR 610.60
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22 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
    ...the appropriate NDC number in human-readable form, in accordance with the provisions in proposed Sec. 201.2. Current Sec. 610.60(a) (21 CFR 610.60(a)) specifies which items must appear on the label affixed to each container of a biological product capable of bearing a full label and current......
  • Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2016
    • United States
    • Federal Register December 23, 2016
    • December 23, 2016
    ...U.S.C. 264 CFR Citation: 21 CFR 208; 21 CFR 310.501 and 310.515; 21 CFR 201.57(a)(18); 21 CFR 201.80(f)(2); 21 CFR 314.70(b)(2)(v)(B); 21 CFR 610.60(a)(7); 21 CFR 201.100; . . Legal Deadline: None. Abstract: The proposed rule would amend FDA medication guide regulations to require a new for......
  • Part II
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...the appropriate NDC number in human-readable form, in accordance with the provisions in proposed Sec. 201.2. Current Sec. 610.60(a) (21 CFR 610.60(a)) specifies which items must appear on the label affixed to each container of a biological product capable of bearing a full label and current......
  • Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2017
    • United States
    • Federal Register January 12, 2018
    • January 12, 2018
    ...310.501 and 310.515 (removal); 21 CFR 201.57 (a)(18) (revision); 21 CFR 201.809(f)(2) (revision); 21 CFR 314.70(b)(2)(v)(B) (revision); 21 CFR 610.60(a)(7) (removal); . . Legal Deadline: None. Abstract: The proposed rule would amend FDA medication guide regulations to require a new form of ......
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3 cases
  • Graham v. Wyeth Laboratories, No. 85-1481-K.
    • United States
    • United States District Courts. 10th Circuit. United States District Courts. 10th Circuit. District of Kansas
    • July 22, 1987
    ...is indicated and contraindicated; and (4) the product's potential adverse reactions which have been associated with the product's use. 21 C.F.R. §§ 610.60-610.65. The language used is subject to FDA approval, 21 C.F.R. §§ 1, 201; 50 Fed.Reg. 51108 (1985), and, once approved, the language ca......
  • Mazur v. Merck & Co., Inc., Civ. A. No. 85-6494.
    • United States
    • United States District Courts. 3th Circuit. United States District Court (Eastern District of Pennsylvania)
    • June 29, 1990
    ...expiration date, the storage directions, the indications and contraindications of vaccine usage, and the potential adverse reactions. 21 C.F.R. §§ 610.60-610.65. The language of the label and package circular is subject to FDA scrutiny and cannot be changed without FDA authorization. 21 C.F......
  • Jones By Jones v. Lederle Laboratories, No. 85 CV 949.
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • August 1, 1988
    ...and toxicity are prescribed. See id. §§ 620.4, .5. Finally, the general labeling requirements for biological drugs are set forth at 21 C.F.R. §§ 610.60-.65. As of June 1979, the Lederle DTP vaccine Tri-Immunol satisfied all of the relevant requirements, and was licensed by the FDA. The vacc......

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