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13 Cards in this Set
- Front
- Back
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Federal Food, Drug & Cosmetic Act |
1906
Designated official drug references |
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Shirley Amendment |
Prohibited fraudulent claims by manufacturers
1938 Required labeling requirements - contents, manufacturer, directions for use, brand name and generic name
Coolent mixed with sulfa drugs |
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Harrison Narcotic Act |
1914
Established word narcotic
Regulated import, manufacture, sale of habit forming drugs |
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Durham-Humphrey Amendment |
1945 Provided for direct supervision and inspection of drugs during production
1952 - distiguished b/t OTC and Rx specifying procedures for distribution of prescription drugs
Put MDs in charge of prescriptions |
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Kefauver-Harris Amendment |
1962
Tightened saftey control of drug testing and statements about adverse reaction and contraindications |
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Controlled Substances Act |
1970
Categorized controlled substances based on abuse potential
Established governmental programs to prevent and treat drug abuse
Schedule 1 - No currently accepted use Schedule 2 - High abuse potential, accepted use, severe dependence potential Schedule 3 - Abuse potential, accepted use Schedule 4 - Low abuse potential, antianxiety meds Schedule 5 - Lowest abuse potential |
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Drug Regulation Reform Act |
1978
Reduced timeline to develop drugs in US from 12 to 7 years on average |
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Orphan Drug Act |
1983
Offered manufacturers incentive to develop drugs for conditions with low incidence |
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Drug Price Competition and Patent Term Restoration |
Generic company can market generic versions of bioequivalent therapies |
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Pregnancy Categories |
A - Adequate studies in pregnant women B - Animal studies no risk to fetus, or animal studies show risk but adequate studies in humans show no risk C - No animal studies or adverse effects, but no human studies. Benefits outweigh risks. D - Evidence of fetal risk, but benefits acceptable despite risk. X - Studies indicate fetal abnormalities, risk outweighs any possible benefit |
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Dietary Supplement Health and Education Act |
1994
Defined dietary supplements and ingredients Established safety framework Required ingredient and nutrition labeling Grants FDA authority to establish manufacturing practice regulations |
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Medicare Prescription Drug Improvement and Modernization Act |
3 Phases Discount card
Prescription drug benefits
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Medicare Part D |
2006
Discounts and subsidy programs
Prescription drug reuse/recycling
Electronic monitoring and prescribing |
