What people are saying - Write a review
We haven't found any reviews in the usual places.
abbreviated drug application action active ingredient adulterated advisory committee amended animal drug animal feed application submitted application under subsection approved application approved new animal bioequivalence certification class III classified clause color additive cosmetic counterfeit drug court debarment deemed drug or device drug referred drug sample effective date electronic product radiation enactment established exemption expiration export Federal fees filed food additive hearing holder infant formula intended interstate commerce investigations issued label or labeling listed drug manufacturer manufacturing practice margarine misbranded notice nutrient officer or employee oleomargarine panel paragraph patent period person pesticide chemical petition promulgated proposed protocol public health purposes pursuant to subsection reasonable recommendation request respect retary route of administration safety and effectiveness Secretary determines Secretary finds section 505 standard of identity subchapter subparagraph subsection b)(1 testing thereof tion United States Code United States Pharmacopeia violation withdrawal
Page 211 - That all charges for storage, cartage, and labor on goods which are refused admission or delivery shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against any future importation made by such owner or consignee. SEC. 12. That the term "Territory" as used in this Act shall include the insular possessions of the United States. The word "person...
Page 5 - ... any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, and including any source of radiation intended for any such use...
Page 160 - Secretary's order. (i) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.
Page 84 - ... that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.
Page 160 - Secretary, but not exceeding $100 per day, including traveltime; and while so serving away from their homes or regular places of business, they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 of the United States Code for persons in the Government service employed intermittently.
Page 68 - If any word, statement or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Page 49 - Sciences shall designate a member of the advisory committee to appear and testify at any such hearing with respect to the report and recommendations of such committee upon request of the Secretary, the petitioner, or the officer conducting the hearing : Provided, That this shall not preclude any other member of the advisory committee from appearing and testifying at such hearing.
Page 115 - 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...
Page 192 - A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.
Page 190 - The judgment of the court affirming or setting aside, in whole or in part, any action of the Commissioner shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28, United States Code.