Preparing for Future Products of Biotechnology (2017) / Chapter Skim
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Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates
Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates
Pages 209-212
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From page 209... ...
. to be safe under the conditions of its intended use; except that such term does not include [pesticide chemicals and residues, color additives, new animal drugs, or dietary supplements]
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originally created this category administratively by interpreting powers elsewhere provided in its statutes (Hutt et al., 2014) , but the Orphan Drug Act Amendments of 1988 later defined it as "a food that is formulated to be consumed or administered enterically under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on scientific principles, are established by medical evaluation."
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From page 211... ...
The composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof 2. 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 Provided that any drug intended for minor use or use in a minor species that is not the subject of a final regulation published by the Secretary through notice and comment rulemaking finding that the criteria of paragraphs 1 and 2 have not been met (or that the exception to the criterion in paragraph 1 has been met)
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From page 212... ...
Articles recognized in the official United States Pharmacopoeia, on other product official Homoeopathic Pharmacopoeia of the United States, or definitions) official National Formulary, or any supplement to any of them; and 2.
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