The Code of Federal Regulations of the United States of America

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U.S. Government Printing Office, 1963
The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.

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Страница 49 - That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
Страница 19 - 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 fre-quency and duration of administration, and any relevant hazards, 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 which it is intended, including all purposes for which it is advertised or represented...
Страница 496 - He shall also specify in his order the time within which objection to the authenticity of such documents must be made to comply with paragraph (d) of this section. (c) Documentary evidence not submitted in advance in accordance with the requirements of paragraphs (a) and (b) of this section shall not be received in evidence in the absence of a clear showing that the offering party had good cause for his failure to produce the evidence sooner. (d) The authenticity of all documents submitted in advance...
Страница 25 - The labeling of a food which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such food in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling.
Страница 515 - Caution — If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately.
Страница 6 - The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal which may render the labeling misleading, if there Is a material weight of opinion contrary to such representation.
Страница 24 - An exemption of a shipment or other delivery of a drug or device under paragraph (a) (2) of this section shall become void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by such subparagraph.
Страница 492 - It is understood that when this application is approved, the labeling and advertising for the drug will prescribe, recommend, or suggest its use only under the conditions stated in the labeling which Is part of this application; and if the article Is a prescription drug, it is understood that any labeling which furnishes or purports to furnish information for use or which prescribes, recommends, or suggests a dosage for use of the drug will...
Страница 322 - The date used for computing the 90-day limit for the purposes of section 409(c) (2) of the act shall be moved forward 1 day for each day after the mailing date of the request taken by the petitioner to submit the sample. If the information or sample Is requested a reasonable time in advance of the 180 days, but Is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice. (k...
Страница 320 - English name and complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation Is used as a component, the proprietary name should be followed by a complete quantitative statement of composition. Reasonable alternatives for any listed substance may be specified. If the petitioner does not himself perform...

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