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10 Cards in this Set
- Front
- Back
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Federal laws |
set minimum standard of practuces |
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State law |
provides clarification of federal laws and tend to be tighter than the federal laws |
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Food, Drug and Cosmetic Act (FDCA 1938) |
gives the FDA authority to enforce its rules/regulations |
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Durham-Humphrey Amendment (DHA 1951) |
1. AKA the Prescription Drug Amendment 2. Legend drugs must have a caution statement 3. provided additional safeguards for legend and OTC drugs |
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Kefauver-Harris Amendment (1962) |
1. AKA Drug Efficacy Amendment 2. Requires that all new drugs are both safe and effective |
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Controlled Substance Act (1970) |
1. Deals with controlled substances 2. Has five classes or schedules ---> Class1 the highest abuse potential ---> Class 5 limited abuse potential |
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Fair Packing and labeling act |
Requires accurate labeling (must contain all 8 items on the label) |
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Omnibus Budget Reconciliation Act (1990) |
1. AKA OBRA90 2. requires each state to have Drug Utilization Review (DUR) 3. Screen prescriptions for potential problems 4. Offer to console patients 5. maintain patients profiles 6. document actions |
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HIPPA |
Health Insurance Portability and Accountability Act (1196) |
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What does HIPPA |
1. Set of national standard for the protection of certain health information |
