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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,... "
Code of Federal Regulations: Containing a Codification of Documents of ... - 39. lappuse
1997
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Competitive problems in the drug industry: hearings before Subcommittee on ...

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly and Anticompetitive Activities, United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1975 - 1360 lapas
...prescribes, recommends, or suggests a dosage for use of the drug will also contain substantially the same information for its use, including indications, effects,...methods, and frequency and duration of administration, any relevant hazards, contraindications, side effects, and precautions, as that contained in the labeling...
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Competitive Problems in the Drug Industry: Hearings Before Subcommittee on ...

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1975 - 888 lapas
...prescribes, recommends, or suggests a dosage for use of the drug will also contain substantially the same information for its use, including indications, effects,...methods, and frequency and duration of administration, any relevant hazards, cuntra indication side effects, and precautions, as that contained in tbe labeling...
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Competitive problems in the drug industry: hearings before Subcommittee on ...

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1967 - 410 lapas
...into use and the same information concerning the ingredients of the drug as appears on the label and labeling on or within the package from which the drug is to be dispensed. f. By revising paragraph (c) (3), (4), and (5) to be similar in effect to' paragraph (b) (3), (4),...
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Hearings, 2. sējums

United States. Congress. Senate. Select Committee on Nutrition and Human Needs - 1973 - 1344 lapas
...label bears the legend "Caution : Federal law prohibits dispensing without a prescription," and the labeling on or within the package from which the drug...to be dispensed bears adequate information for its safe and effective use by practitioners, in accord with § 1.106 (b)(3) of this chapter. (2) The Food...
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New Drugs Used for Nonapproved Purposes (Methotrexate for Psoriasis ...

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - 1971 - 152 lapas
...states very clearly, and I will be happy to read it from the regulations, which require that the dnig's "labeling on or within the package from which the...dispensed bears adequate information for its use. * * *" Then it includes all of those aspects, hazards, contraindications, and side effects under which...
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New Drugs Used for Nanapproved Purposes (methotrexate for Psoriasis ...

United States. Congress. House. Government Operations - 1971 - 142 lapas
...states very clearly, and I will be happy to read it from the regulations, which require that the drug's "labeling on or within the package from which the...dispensed bears adequate information for its use. * * *" Then it includes all of those aspects, hazards, contraindications, and side effects under which...
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Hearings

United States. Congress. Senate. Committee on Labor and Public Welfare - 1971 - 1812 lapas
...paragraphs <a> or (b) of this section, the statements may be Included on the carton label and other labeling on or within the package from which the drug Is to be dispensed. (3> The person or firm shipping the new drug shall uv due dlllcence to assure that the drug will actually...
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FDA Papers, 1. sējums

1967 - 618 lapas
...or within prescription drug packages. Known as the "Full Disclosure" regulation, it required that: "Labeling on or within the package from which the...contraindications, side effects, and precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for...
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FDA Consumer, 15. sējums

1981 - 526 lapas
...of 21 CFR § 201.100. including labeling which contains: '(d)(l) . . . adequate information for such use. including indications, effects, dosages, routes,...contraindications, side effects, and precautions, under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for...
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Nutrition and Human Needs--1972: Hearings, Ninety-second Congress, Second ...

United States. Congress. Senate. Select Committee on Nutrition and Human Needs - 1973 - 976 lapas
...the legend "Caution: Federal law prohibits dispensing without a prescription," and the labeling tin or within the package from which the drug is to be dispensed bears adequate information for its safe and effective use by practitioners, in accord with § 1 106 (b)(3) of this chapter. (2) The Food...
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