Counterfeit Bulk Drugs: Hearings Before the Subcommittee on Oversight and Investigations of the Committee on Commerce, House of Representatives, One Hundred Sixth Congress, Second Session, June 8 and October 3, 2000, Volume 4

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Page 155 - ... punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug.
Page 9 - Please note that, for the purpose of responding to these requests, the terms "records" and "relating" should be interpreted in accordance with the Attachment to this letter.
Page 269 - We appreciate your continued interest in these issues, and I will be happy to answer questions. [The prepared statement of Hon.
Page 327 - There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers. closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
Page 127 - counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer,...
Page 10 - records" is to be construed in the broadest sense and shall mean any written or graphic material, however produced or reproduced, of any kind or description, consisting of the original and any non-identical copy (whether different from the original because of notes made on or attached to such copy or otherwise) and drafts and both sides thereof, whether printed or recorded electronically or magnetically or stored in any type of data bank, including, but not limited to, the following: correspondence,...
Page 306 - MD Commissioner Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 Dear Dr.
Page 359 - It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
Page 10 - relating," "relate," or "regarding" as to any given subject means anything that constitutes, contains, embodies, identifies, deals with, or is in any manner whatsoever pertinent to that subject, including but not limited to records concerning the preparation of other records.
Page 10 - ... statistical statements, drafts, contracts, agreements, purchase orders, invoices, confirmations, telegraphs, telexes, agendas, books, notes, pamphlets, periodicals, reports, studies, evaluations, opinions, logs, diaries, desk calendars, appointment books, tape recordings, video recordings, e-mails, voice mails, computer tapes, or other computer stored matter, magnetic tapes, microfilm, microfiche, punch cards, all other records kept by electronic, photographic, or mechanical means, charts, photographs,...

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