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Pharm Laws PTCB

QuestionAnswerAnswer 2
1994 1994 Dietary Supplement Health and Education Act (DSHEA) -defines dietary supplements -health-related benefits -labels can't mislead, write nutritional values
1990 1990 Nutrition Labeling and Education Act (NLEA) -food items and labelling -vitamins, minerals and nutrients on label
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
1972 1972 Drug Listing Act (DLA) -FDA-accurate list of all drugs -prevents unfair/deceptive labelling -update Food Drug and Cosmetic Act
1967 1967 Fair Packaging and Labeling Act (FPLA) -net content; name and place of manufacturing; net quantity -measurements in metric and US units
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
1906 1906 Federal Food and Drug Act -stop sale of inaccurately labeled drugs -truthful info on label -changes made, rewritten to 1970 FDA act
1914 1914 Harrison Narcotic Act -need a prescription for opium -huge number of opium addicts in US
1912 1912 International Opium Convention *need to fill this in*
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
1951 1951 Durham-Humphrey Amendment -caution: prohibit dispensing w/o prescription -distinction between legend and OTC drugs
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
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)
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
1987 1987 Prescription Drug Marketing Act -vets must write presciption before people can buy drugs for animals
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
1996 1996 Health Insurance Portability and Accountability Act (HIPAA) -continue health insurance when changing employees -privacy, rights of patients -consent forms before info released
2005 2005 Combat Meth Act -OTC status of pseudoephedrine changed since used to make meth -9g within 30 days allowed -ID and sign logbook
1990 1990 Anabolic Steroids Control Act -stiffen regulations on abuse problems because of misuse by athletes
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
Created by: wisco