Federal Laws to be familiar with for the PTCB exam.
Quiz yourself by thinking what should be in
each of the black spaces below before clicking
on it to display the answer.
Help!
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| HIPAA | show 🗑
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| show | 1951 | AKA "the Prescription Drug Amendment" - required Rx drugs bear the legend, "Caution: Federal law prohibits dispensing without a prescription." This is why Rx-only drugs are called "legend drugs"
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| show | 1970 | AKA "the Controlled Substances Act" - Established the DEA and CI-CV control schedules. Required DEA registration to prescribe, manufacture, dispense, import, compound, distribute, or do research with controlled substances.
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| Pure Food & Drug Act | 1906 | show 🗑
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| show | 1938 | Required manufacturers to prove (clinical trials) that drugs were safe before selling, list warnings and directions. Established Rx only and OTC status and who could prescribe. Required ingredients label.
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| The Kefauver-Harris Amendment | 1962 | show 🗑
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| show | 1970 | Required all legend and controlled drugs to be dispensed in a childproof container unless a documented request for easy-open is obtained. Exceptions include: SL NTG, hospital meds, certain emergency meds.
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| show | 1970 | The Occupational Safety and Health Act - Ensures worker and workplace safety. Established NIOSH (National Institute for Occupational Safety and Health).
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| The Drug Listing Act | show | Requires all human and veterinary drugs to be labeled clearly with unique, permanent NDC product code which identifies the manufactuerer, formulation, and the size/type of product packaging.
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| The Medical Device Amendment | show | Required for the 1st time that safety and effectiveness of life-sustaining and support devices have premarket approval from FDA.
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| The Orphan Drug Act | 1983 | show 🗑
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| Drug Price Competition and Patent Term Restoration Act | show | AKA Hatch-Waxman Act. established modern system of generic drugs and ANDA's (abbreviated new drug applications) for FDA approval of generic drugs.
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| The Prescription Drug Marketing Act | 1987 | show 🗑
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| The Anabolic Steroid Control Act | show | Placed anabolic steroids in CIII to address abuse of testosterone products.
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| DSHEA | show | Dietary Supplement Health and Education Act - vaguely defined dietary supplements, established framework for labeling, GMP and how to address safety issues.
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| HIPAA | 1996 | show 🗑
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| CMEA | 2005 | show 🗑
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| show | 1990 | Omnibus Budget Reconciliation Act - , mandated that the pharmacist perform DUR's and provide medication counseling to their patients.
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