Pharmacy laws and regulations

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Last updated 10:02 PM on 9/18/22
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20 Terms

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1906- Pure food and drug act
stop sale of inaccurately labeled drugs, true information
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1914- Harrison narcotic act
restricted sale of opium slightly
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1938- Federal food, drug, and cosmetic act
companies include PPI, legal status for FDA, "warning: may be habit forming"
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1951- Durham-Humphrey Amendment
"prescription drug act", "caution: federal law prohibits...", distinction between legend and non-legend drugs
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1962- Kefauver-Harris Amendment
ensure safety and effectiveness of new drugs
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1970- Comprehensive Drug Abuse Prevention and Control Act
"controlled substances act", created schedule CI-CV
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1970- Poison Prevention Packaging Act
childproof caps on most medication
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1972- Drug Listing Act
gave each drug an NDC number
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1973- DEA
enforce laws concerning controlled substances, prescribers and pharmacies have NDC numbers
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1976- Medical Device Amendment
FDA approves devices
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1983- Orphan Drug Act
provide incentive to create drugs for rare diseases
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1987- Prescription Drug Marketing Act
limit counterfeit drugs from entering supply chain
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1990- OBRA 90
offer counsel to elderly medicaid patients
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1997- HIPAA
private health information
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2000- Drug Addiction Treatment Act
physicians can prescribe CIII-CV to treat opioid addiction
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2003- Medicare Modernization Act
automatic medicare to people over 65, disability, end-stage renal disease
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2005- Combat Methamphetamine Epidemic Act
regulates manufacturing/ sale of pseudoephedrine
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2007- FDA amendment
ensure benefit outweigh risk, require REMS
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2010- Affordable Care Act
preventative care more accessible and affordable
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2013- Drug Quality and Security Act
FDA oversight of bulk compounding