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" Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications,... "
Drug Industry Antitrust Act, 87-1&2 - Page 886
by United States. Congress. Senate. Judiciary - 1961
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The Code of Federal Regulations of the United States of America

1963 - 1124 pages
...required by subdivision (vi) of this subparagraph may be on the crimp of the dispensing tube. (3)(i) Labeling on or within the package from which the drug...indications, effects, dosages, routes, methods, and frequency §1.106 §1.106 and duration of administration, and any relevant hazards, contraindications, side effects,...
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The Code of Federal Regulations of the United States of America

1969 - 668 pages
...purports to furnish information for use of the drug will contain substantially the same information for use, Including indications, effects, dosages, routes,...contraindications, side effects, and precautions, which is contained in the labeling that is part of the application, in accordance with § 1.106 (b)...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1981 - 1252 pages
...purports to furnish information for use of the drug will contain substantially the same information for use, including indications, effects, dosages, routes,...contraindications, side effects, and precautions, which is contained in the labeling that is part of the application, in accordance with II 201.100 or...
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The Code of Federal Regulations of the United States of America

1989 - 240 pages
...caution statement quoted in section 503(b) (4) of the Federal Food, Drug, and Cosmetic Act; and (2) The labeling on or within the package from which the drug...be dispensed bears adequate information for its use by practitioners in accord with the "full disclosure" labeling requirements of 8 201.100 of this chapter,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

2000 - 736 pages
...information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration...contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1965 - 1520 pages
...required by subdivision (vi) of this subparagrapb may be on the crimp of the dispensing tube. (3)(i) Labeling on or within the package from which the drug is to be dispensed bears adequate Information foi its use, including indications, effects dosages, routes, methods, and frequencj and duration of...
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The Code of Federal Regulations of the United States of America

1988 - 772 pages
...professional use of such drug will contain, in the same language and emphasis, the information for use including indications, effects, dosages, routes,...frequency and duration of administration and any relevant warnings, hazards, contraindications, side effects, and precautions, which is contained in the labeling...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1997 - 580 pages
...professional use of such drug will contain, in the §514.106 same language and emphasis, the information for use including indications, effects, dosages, routes,...frequency and duration of administration and any relevant warnings, hazards, contraindications, side effects, and precautions, which is contained in the labeling...
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The Code of Federal Regulations of the United States of America

1993 - 192 pages
...the label tears the legend "Caution: Federal kw prohibits dispensing without a Prescription," and the labeling on or within the package from which the drug is to be dispensed bears adequate ^formation for its safe and effective use by practitioners, in accord with § 201.100(c) of this chapter....
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The Code of Federal Regulations of the United States of America

1981 - 730 pages
...drug will also contain, in the same language and emphasis, informaTitle 21 — Food and Drugs tion for its use including indications, effects, dosages,...methods, and frequency and duration of administration, any relevant hazards, contraindications, side effects, and precautions contained in the labeling which...
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