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 1
... DRUGS THURSDAY , JUNE 8 , 2000 HOUSE OF REPRESENTATIVES , COMMITTEE ON ... drugs . There is an increase in concern that drug ingredients made overseas that are ... prescription drug supply and harming patients . ( 1 ) To substantiate our ...
... DRUGS THURSDAY , JUNE 8 , 2000 HOUSE OF REPRESENTATIVES , COMMITTEE ON ... drugs . There is an increase in concern that drug ingredients made overseas that are ... prescription drug supply and harming patients . ( 1 ) To substantiate our ...
Page 2
... drugs from abroad . As some FDA officials have noted , the prevailing high prices and potential protits from prescription drugs provide a strong incentive for counterfeiters to enter the U.S. market . Counterfeit bulk drugs are ...
... drugs from abroad . As some FDA officials have noted , the prevailing high prices and potential protits from prescription drugs provide a strong incentive for counterfeiters to enter the U.S. market . Counterfeit bulk drugs are ...
Page 3
... drugs were counterfeited , including gentamicin sulfate , and sold for use in the manufacture of human prescription generic drugs . ( Notwithstanding the guilty pleas and the admissions to federal investigators , FDA failed to de - bar ...
... drugs were counterfeited , including gentamicin sulfate , and sold for use in the manufacture of human prescription generic drugs . ( Notwithstanding the guilty pleas and the admissions to federal investigators , FDA failed to de - bar ...
Page 4
... prescription drugs made from the counterfeit bulk drugs supplied by Flavine International . " The memorandum summarized the history of counterfeit bulk drug investigations since June 1991 ; described the threat to the human drug ...
... prescription drugs made from the counterfeit bulk drugs supplied by Flavine International . " The memorandum summarized the history of counterfeit bulk drug investigations since June 1991 ; described the threat to the human drug ...
Page 13
... prescription drugs manufactured from imported bulk drugs are not the major source of adverse events . The great majority of adverse event reports in the United States ( U.S. ) are the result of known side effects of drugs . It is ...
... prescription drugs manufactured from imported bulk drugs are not the major source of adverse events . The great majority of adverse event reports in the United States ( U.S. ) are the result of known side effects of drugs . It is ...
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Common terms and phrases
adverse events Agency Agency's agents APIs approved authentic BAKER Bliley bulk pharmaceutical BURR CDER certificates of analysis Chairman chemical China FEI Committee companies compliance counterfeit APIs counterfeit bulk drugs counterfeit drugs counterfeit pharmaceuticals Criminal Investigations Cytotec database developed DINGELL documents domestic Drug Administration drug imports drug listing drug products enforcement entry evaluation FDA's finished drug Flavine Flavine International Food and Drug foreign drug manufacturers foreign inspections foreign manufacturers Forensic Chemistry Forensic Chemistry Center Fred Upton gentamicin sulfate HENNEY human drug identified import alert import inspectors imported counterfeit issue Italy FEI labeling Long March manufacturing practices medicines mifepristone misoprostol OASIS Office of Criminal oxytetracycline Pharmaceutical Factory pharmaceutical products pharmacies potential prescription drugs problem prosecution regulations regulatory reimportation reports requirements safety samples shipments shipped specific STRICKLAND STUPAK substandard testing U.S. agent U.S. Customs Service United
Popular passages
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,...