| 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... | |
| 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... | |
| 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... | |
| 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... | |
| 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... | |
| 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... | |
| 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... | |
| 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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