Pharmacy law/acts

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Heidi5
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162177
Filename:
Pharmacy law/acts
Updated:
2012-07-11 21:26:09
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Pharmacy law acts
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Pharmacy law/acts
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  1. - require that labels not contain false info of a drug's strength and purity.
    - first Federal law regulating drugs
    - Prevented the manufacture, sale or distribution of innacurately labeled food and drugs across state lines  
    PURE FOOD AND DRUG ACT (1906)
  2. - Called for the creation of the FDA
    - Required all drug manufactures to file a new drug application (NDA) to provide evidence of a drug's safety before any frug could be approved for the market.
    FOOD, DRUG, AND COSMETIC ACT (1938)
  3. - this amendment to the Food, Drug, and Cosmetic Act established clear criteria for the classification of prescription or nonprescription OTC meds
    - Also authorized the taking of verbal prescriptions and the refilling of prescriptions 
    DURHAM-HUMPHREY AMENDMENT (1951)
  4. - This amendment required that all medications be pure, safe and effective for use in humans
    - Also required all drug manufacturers to file an investigation new drug application (INDA) before starting a clinical trial to humans 
    KEFAUVER-HARRIS AMENDMENT (1963)
  5. - Also known as the controlled substance act
    - required the pharmaceutical industry to keep records and implement measures for certain medications to prevent and controll drug abuse
    - divided controlled substances into 5 schedules, or classes based on their potential for abuse  
    COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT (1970)
  6. - Established standards for Child-resistant packaging
    - required that some OTC meds and almost all legend drugs be packaged in child resistant containers
    POISON PREVENTION PACKAGING ACT (1970)
  7. Assigns a unique drug code to each medication as the NAtional Drug Code (NDC)
    DRUG LISTING ACT (1972)
  8. - also known as the Drug Price Competition and Patent-Term Restoration Act
    -Ensured that brand-name drug manufacturers would have patent protection
    - also created a generic drug-approval process and established .......
    WAXMAN-HATCH ACT (1984)
  9. -Focused on reforming the regulation of food, medical products and cosmetics
    - Changed labeling requirements of all legend drugs from "Caution: Federal Law..... " to "RX only"
    FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT (1997)
  10. - requires that pharmacies that fill prescriptions for Medicaid, obtain, record and maintain basic patient information
    - Also says that each state must require pharmacists to offer counseling on all aspects of drug therapy to patients
    OMNIBUS BUDGET RECONCILIATION ACT (OBRA) (1990)

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