Federal Law - Amendment and Act
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| Pure Food and Drug Act 1906 | show 🗑
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| show | Regulates drug quality, requires new drugs be proven safe before marketing, labels need "adequate directions for use", warnings of habit forming properties
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| show | Prescription meds don't need "adequate directions for use", two classes of drugs: OTC and prescription, Oral prescriptions, refills, Rx label needs "Caution: Federal law prohibits dispensing w/o prescription."
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| Kefauver-Harris Amendment of 1962 | show 🗑
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| Poison Prevention Packing Act of 1970 | show 🗑
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| show | Safety and efficacy requirements of med. devices, Classes of devices, Class I - low risk, Class II - risk evaluated, CIII - Premarket required! (life-support, etc)
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| Orphan Drug Act of 1983 | show 🗑
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| Prescription Drug Marketing Act of 1987 | show 🗑
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| show | Purpose: SAVE MONEY, Drug Utilization Review Programs: Prospective DUR - 3 components: 1) Screening Rxs prior to dispensing, 2) Patient counseling by pharmacist, 3) Pharmacist documentation of relevant information
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| show | Regulates dietary supplements
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| Food and Drug Administration Modernization Act of 1997 | show 🗑
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| HIPAA | show 🗑
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