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" State or possession, any virus, therapeutic serum, toxin, antitoxin, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of... "
Public Health Service Code: Hearing Before a Subcommittee of the Committee ... - Page 15
by United States. Congress. House. Committee on Interstate and Foreign Commerce - 1944 - 187 pages
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Validation Compliance Annual: 1995

International Validation Forum - Science - 1995 - 1114 pages
...analogous product, or arsphenamine or its derivatives (or any trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man. Additional interpretation of the statutory language is found in 21 CFR 600.3. Veterinary biologicals...
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Searching for Magic Bullets: Orphan Drugs, Consumer Activism, and ...

Lisa A Basara, Michael E Montagne - Science - 1994 - 296 pages
...toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or similar product applicable to the prevention, treatment, or cure of diseases or injuries of humans. Specific biologies include albumin and packed red blood cells-two products that are used for...
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Ricky Ray Hemophilia Relief Fund Act of 1995: Hearing Before the ...

United States. Congress. House. Committee on the Judiciary. Subcommittee on Immigration and Claims - Health & Fitness - 1997 - 440 pages
...antitoxin, vaccine, blood, blood component or derivative, allergenic products, or analogous products applicable to the prevention, treatment, or cure of diseases or injuries of man unless the same has been propagated or manufactured and prepared at an establishment holding an unsuspended...
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Synthetic Biodegradable Polymer Scaffolds

Anthony Atala, David J. Mooney - Science - 1997 - 276 pages
...analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man." Products considered to be "biological products" under the PHS Act are also considered "drugs" or "devices"...
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The Inside Story of Medicines: A Symposium

Gregory Higby, Elaine Condouris Stroud - Chemotherapy - 1997 - 328 pages
...other laws under the PHS 's jurisdiction, a biologic product was, by definition, a serum, toxin, etc. "applicable to the prevention, treatment or cure of diseases or injuries of man;" see 12 Fed. Reg. 6218, 16 September 1947. 24. "Mixed Vaccines," Journal of the American Medical Association...
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Mammalian Cell Biotechnology in Protein Production

Hansjörg Hauser, Roland Wagner - Science - 1997 - 520 pages
..."... "Biological product" means any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man: . . . ". However the regulation affairs between drugs (CFR 21 subchapter C and D) are very similar...
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Surgical Adhesives & Sealants: urrent Technology and Applications

David H. Sierra, Renato Saltz - Technology & Engineering - 1998 - 276 pages
...antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product . . . applicable to the prevention, treatment, or cure of diseases or injuries of man . . ." [2]. Although there are similarities between the definitions of drugs and of biologics, there...
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Red Blood Cell Substitutes: Basic Principles and Clinical Applications ...

Alan Rudolph - Medical - 1997 - 512 pages
...antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product . . . applicable to the prevention, treatment or cure of diseases or injuries of man." While there are similarities between drugs and biologics, there are important differences. Drugs have...
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Importing Into the United States: A Guide for Commercial Importers

Barry Leonard - 1999 - 115 pages
...any other trivalent organic arsenic compound), except materials to be used in research experiments, applicable to the prevention, treatment, or cure of diseases or injuries of man is prohibited unless these products have been propagated or prepared at any establishment holding an...
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Customs Regulations of the United States

U.S. Customs Service - Customs administration - 216 pages
...analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man is prohibited unless such virus, serum, toxin, antitoxin, or other product has been manufactured at...
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