p harmacy l aws. 1906 pure food and drug act enacted to stop sale of inaccurately labeled drugs all...
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PHARMACY LAWS
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1906 Pure Food and Drug Act Enacted to stop sale of inaccurately labeled drugs
All manufacturers required to put truthful info on labels
Required all food and drug meet standard of purity and strength
Gov’t pre-approval required
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1914 Harrison Narcotic Act
o Restricted to opium usageo Eventually extended to non-
narcotics: i,.e. cocaineo Limited opium transporto Available only with Rx, harder to
get
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1938 Food, Drug, and Cosmetic Act Provided legal status for
Food and Drug Administration (FDA)
Enacted because 1906 act didn’t include cosmetics, not worded strong enough
Required package inserts
All controlled substances labeled with warning
Required new drugs be safe before marketing
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1951 Durham-Humphrey Amendment Require label “Caution: Federal Law prohibits
dispensing without a prescription” an all controlled substances
Doctor order and supervision required; Dr. must authorize refills
Established difference btwn legend and OTC medications
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1962 Kefauver-Harris Amendments
Set label requirements for mftr and dispenser to pts
Required drug mftr to provide proof of safety and efficacy before marketing
FDA placed in charge of advertising
Stopped US selling of Thalidomide (until recent years)
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1962 Kefauver-Harris Amendments
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Thalidomide Tragedy
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1970 Comprehensive Drug Abuse Prevention Control Act or Controlled Substance Act
Drug Enforcement Agency (DEA) created to enforce laws about controlled substances
Drug Schedule introduced
Based on potential for abuse
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1970 Poison Prevention Packaging Act
Required child-proof packaging on ALL controlled substances and on most Rx drugs
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Occupational and Safety Act of 1970
Ensures safe and healthful workplace environment by reducing hazards
Gave rise to OSHA-Occupational Safety and Health Administration
All pharmacies should:Post phone number to poison controlHave Material Safety DataSheets (MSDS)
for “hazardous materials in the pharmacy” Should have reference guide for toxicities
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1983 Orphan Drug Act
Allowed drug companies to provide meds to persons /c rare diseases /s going through the long requirement of testing
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1987 Prescription Drug Marketing Act
Controlled use of drugs in animals by requiring veterinarians to write Rx
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1990 Anabolic Steroid Control Act
Increased regs dealing with abuse problems and misuse by athletes
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1990 Omnibus Budget Reconciliation Act (OBRA
90) Required pharmacists to counsel Medicaid
and Medicare patients getting new RxBoard of Pharmacy can fine pharmacies
AND pharmacists
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Health Insurance Portability and Accountability Act of 1996
(HIPAA) Provided broad and stringent regulation
to protect patient safety
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1997 FDA Modernization Act
Simplified the labeling requirements: “Rx only” symbol statement replaced the “Caution: Federal Law…” statement
Changed to legend requirement to “Rx only” phased in by Feb. 2003
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FDA
Main fxn: enforce guidelines for manufacturers to ensure safety and effectiveness
MedWatch program allows consumers and HCP to report discrepancies and adverse rxn with meds
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DEA
Created under Dept of JusticeTo prevent illegal distribution and
misuse of drugs Issues licenses to pharmacies,
practitioners, and manufacturers of controlled substances
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The Joint Commission (TJC)
Mission to improve quality of care provided to general public
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OSHA
Mission: to prevent work-related injuries, illnesses, and death by issuing and enforcing standards for workplace safety and health