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Pharm Laws PTCB
| Question | Answer | Answer 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
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