Pharm Laws PTCB
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each of the black spaces below before clicking
on it to display the answer.
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| 1994 | 1994 Dietary Supplement Health and Education Act (DSHEA) | -defines dietary supplements
-health-related benefits
-labels can't mislead, write nutritional values
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| 1990 | 1990 Nutrition Labeling and Education Act (NLEA) | -food items and labelling
-vitamins, minerals and nutrients on label
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| 1990 | 1990 Humanitarian Device Exemption-Safe Medical Devices Act (SMDA) | -encourages discovery and use of devices to help diseases that affect less than 4000 people
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| 1972 | 1972 Drug Listing Act (DLA) | -FDA-accurate list of all drugs
-prevents unfair/deceptive labelling
-update Food Drug and Cosmetic Act
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| 1967 | 1967 Fair Packaging and Labeling Act (FPLA) | -net content; name and place of manufacturing; net quantity
-measurements in metric and US units
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| 1970 | 1970 Poison Prevention Packaging Act | -medication with childproof caps
-OTC and legend drugs defined
-exceptions to act
-80% of kids under 5 can't open and 90% of adults can open
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| 1906 | 1906 Federal Food and Drug Act | -stop sale of inaccurately labeled drugs
-truthful info on label
-changes made, rewritten to 1970 FDA act
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| 1914 | 1914 Harrison Narcotic Act | -need a prescription for opium
-huge number of opium addicts in US
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| 1912 | 1912 International Opium Convention | *need to fill this in*
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| 1938 | 1938 Food, Drug, and Cosmetic Act | -1906 act didn't include cosmetics
-misbranding: false claims
-warning on controlled substances
-legal status of FDA
-adulteration: preparation and/or storage of medication
-package inserts and directions
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| 1951 | 1951 Durham-Humphrey Amendment | -caution: prohibit dispensing w/o prescription
-distinction between legend and OTC drugs
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| 1962 | 1962 Kefauver-Harris Amendments (thalidomide disaster) | -safety and effectiveness of new drugs on market
-preventing thalidomide (sleep aid but harms pregnant women)
-more testing required
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| 1970 | 1970 Comprehensive Drug Abuse and Prevention and Control Act | -DEA formed to enforce laws for controlled substances
-stair step schedule (lower number, more severe the rules)
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| 1983 | 1983 Orphan Drug Act | -bypass testing of drug used for rare diseases
-waived for disease of less than 200,000 people in the US
-gave more incentive
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| 1987 | 1987 Prescription Drug Marketing Act | -vets must write presciption before people can buy drugs for animals
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| 1990 | 1990 Omnibus Budget Reconciliation Act (OBRA '90) | -medicaid/medicare reimbursements regulations
-pharmacits offer counsel to patients
-look for interactions, allergic reactions, etc.
-name, when and how long to take, side effects and interactions
-otherwise fines issued
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| 1996 | 1996 Health Insurance Portability and Accountability Act (HIPAA) | -continue health insurance when changing employees
-privacy, rights of patients
-consent forms before info released
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| 2005 | 2005 Combat Meth Act | -OTC status of pseudoephedrine changed since used to make meth
-9g within 30 days allowed
-ID and sign logbook
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| 1990 | 1990 Anabolic Steroids Control Act | -stiffen regulations on abuse problems because of misuse by athletes
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| 1997 | 1997 Food and Drug Administration Modernization Act (FDAMA) | -new drugs reviewed and released faster
-millions have wider and more timely access to new medication
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