The Code of Federal Regulations of the United States of America

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U.S. Government Printing Office, 1980 - Administrative law
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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Page 76 - The composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions...
Page 76 - ... for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug...
Page 130 - Its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) That on the basis of new Information before him, evaluated together with the evidence before him when the application was approved, the labeling of such drug...
Page 65 - Whenever the Secretary finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with micro-organisms during the manufacture, processing, or packing thereof in any locality, be injurious to health...
Page 14 - If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated.
Page 549 - ... may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use) , and...
Page 17 - ... required by or under authority of the act to appear on the label; (5) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device...
Page 126 - Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling...
Page 126 - ... to determine whether such drug is safe for use under such conditions. In making this determination the Commissioner shall consider, among other relevant factors: (i) The probable consumption of such drug and of any substance formed in or on food because of the use of such drug; (ii) The cumulative effect on man or animal of such drug, taking into account any chemically or pharmacologically related substances; (iii) Safety factors which, in the opinion of experts qualified by scientific training...
Page 24 - ... will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until...

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