PKG101_FS08_Pharm_Packaging_-_Outline

PKG101_FS08_Pharm_Packaging_-_Outline - Medical and...

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Medical and Pharmaceutical Packaging
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Federal Food and Drugs Act of  1906 Prohibited the interstate transport of unlawful food and  drugs        - The basis of the law rested on the regulation of  product labeling rather than pre-market approval.  Drugs, defined in accordance with the standards of  strength, quality, and purity in the  United States  Pharmacopoeia  and the  National Formulary,  could not be  sold in any other condition unless the specific variations  from the applicable standards were plainly stated on the  label.  The law prohibited the addition of any ingredients that  would substitute for the food, conceal damage, pose a  health hazard, or constitute a filthy or decomposed  substance. 
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Federal Food and Drugs Act of  1906 The food or drug label could not be false or misleading,  and the presence and amount of eleven dangerous  ingredients, including  alcohol,  heroin, and  cocaine, had to be listed.  Little can be done about false therapeutic claims during  this era
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Drug Laws Defined by the Federal Food Drug and  Cosmetic Act of 1938 Act was driven through congress with the  help of journalists and a disaster o Lash Lure o Banbar (a cure for diabetes) o Radithor (Tonic) o Wilhide Exhaler (Tuberculosis)
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Amendments to the 1938 Federal  Food, Drug and Cosmetic Act Durham Humphrey Amendment-1951 Defined what constituted prescription drugs  and OTC drugs
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Amendments to the 1938 Federal  Food, Drug and Cosmetic Act Kefauver-Harris Amendments-1962 Requires efficacy (as well as safety) Required FDA to assess the efficacy of all drugs  introduced since 1938,  Instituted stricter agency control over drug trials  (including a requirement that patients involved must  give their informed consent),  Transferred from the Federal Trade Commission to  the FDA regulation of prescription drug advertising,  Established good manufacturing practices by the drug  industry, Granted the FDA greater powers to access company  production and control records to verify those  practices. 
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U.S. Government- Basic  Overview Legislativ e Judicial Executive Write laws - House of Rep  and the Senate  Constitution  Courts  Interpretation of the  laws   Enforcement of  laws (Positions, Agencies and  Departments)
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Within the Executive Branch Department of Health and Human  Services The FDA is responsible for protecting  the public health by assuring the  safety,  efficacy, (strength to produce effect)  security  human and veterinary drugs,  biological products,  medical devices,  our nation’s food supply,  cosmetics, and  products that emit radiation. 
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PKG101_FS08_Pharm_Packaging_-_Outline - Medical and...

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