21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products
| Cite as | 21 CFR 201.56 |
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187 practice notes
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Part II
...21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201.56; 21 CFR 201.57; 21 CFR 201.80 Legal Deadline: None Abstract: To amend the regulations governing the format and content of labeling for human pr......
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Introduction to Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions, 64075-64305 [05-21048]
...Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR 201.56 and Statement of Need: Under FDA's current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (......
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Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
...to define ``content of labeling'' as the content of the prescription drug labeling, as specified in Sec. Sec. 201.56, 201.57, and 201.80 (21 CFR 201.56, 201.57, and 201.80), including all text, tables, and \5\The use of the language ``that the manufacturer regards as subject to section 505 ......
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The Regulatory Plan, 72725-72938 [06-8765]
...21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201.56; 21 CFR 201.57; 21 CFR 201.80 Legal Deadline: None Abstract: To amend the regulations governing the format and content of labeling for human pr......
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79 cases
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Finn v. G. D. Searle & Co.
...informing the medical profession of that risk. Federal law only regulates the content of labels contained in the drug package. (See 21 C.F.R. §§ 201.56, 201.57.) As the Commissioner of the Food and Drug Administration has explained, "[l]abeling is not intended to be a dispositive treatise o......
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O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
...a prescription drug is both "safe" and "effective" under the conditions of use specified in the proposed prescribing information. 21 C.F.R. §§ 201.56(d), 201.57 (FDA must be satisfied that the drug's labeling accurately describes its indications, dosages, administration, contraindications, ......
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Pennsylvania Employees Ben. Trust v. Zeneca, No. 05-5340.
...either on substantial evidence or on substantial clinical experience," but the standard for labeling is substantial evidence); see 21 C.F.R. § 201.56(a)(3) (disallowing claims or suggestions of drug use on labeling if there is a lack of substantial Congress expressly gave the FDA authority ......
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Knipe v. Smithkline Beecham, Civil Action No. 06-3024.
..."[t]he labeling shall contain a summary of the essential scientific information needed for the safe and effective use of the drug." 21 C.F.R. § 201.56(a).4 Drug labeling must include specific information under prescribed section headings, including, inter alia, contraindications, warnings a......
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14 firm's commentaries
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Holding The Line On The Duty To Warn
...“adulteration” and “misbranding”); 21 U.S.C. §352(a) (imposing “false or misleading in any particular” standard for misbranding); 21 C.F.R. §201.56(b) (“labeling shall be informative and accurate” and not “false or misleading in any particular”); 21 C.F.R. §201.57(f)(2) (specifying contents......
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No Ifs, Ands Or Butts Preemption Gutts, Rebutts, And Shutts Down Utts
..."federal regulations do not require a manufacturer to include information about a competitor's product or progress." Id. at *16 (citing 21 C.F.R. §§201.56, 201.57, State-Law Warning Issues Beyond its preemption and other FDCA-related aspects, Utts II has a load of other helpful holdings, mo......
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No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, and Shutts Down Utts
...“federal regulations do not require a manufacturer to include information about a competitor’s product or progress.” Id. at *16 (citing 21 C.F.R. §§201.56, 201.57, 201.80). State-Law Warning Issues Beyond its preemption and other FDCA-related aspects, Utts II has a load of other helpful hol......
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Failure To Contraindicate Claims and Preemption
...§201.57(a)(9) (emphasis added). Highlights must now be included for any prescription drug approved by the FDA after June 30, 2001. See 21 C.F.R. §201.56(c) (setting out staggered compliance schedule, completed in 2013, for drugs approved between that date and June 30, 2006, when all new dru......
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1 books & journal articles
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REGULATORY METASTASIS: ALTERING THE REGULATORY AND PAYER LANDSCAPE TO CHANGE THE LIVES OF CANCER PATIENTS.
...(describing label requirements). The goal of the PLR content and format requirements as described at 21 CFR 201.56 and 201.57 is to enhance the safe and effective use of prescription drug products by providing health care providers with clear and concise PI that is easier to access, read, a......