Chapter 4 CPhTE

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  1. What is the significance of The Federal Food and Drug Act of 1906?
    It was the first Act to demand purity of products and to make distributors submit scientific evidence for the claims they made on their products.
  2. What is the significance of the Federal, Food, and Cosmetic Act (FDCA)?
    It was the first act to demand the product to be safe for the purpose of its use.
  3. What is the significance of the Durham-Humphrey Ammendment?
    This ammendment created the class known as legend drugs. (Legend drugs are drugs are too dangerous to be used with only printed instructions, and can only be obtained through prescriptions.)
  4. What is the significance of the Kefauver- Harris Ammendment?
    It was the first ammendment that required proof of effectiveness and regulated drug advertisement.
  5. What is the significance of the Medical Device Ammendment?
    Medical devices were required to get pre-market approval from the FDA.
  6. What is the significance of the Harrison Narcotic Act?
    The Act made it that all narcotics sold legally most have "tax stamps". If a narcotic didn't have a tax stamp, it was subject to seizure.
  7. What is the significance of The Drug Abuse Control Ammendment?
    This Amendment expands Harrison to include barbiturates and stimulant drugs. Also, no longer was the enforcement via a tax levy, now it was based on Congress' ability to regulate interstate commerce.
  8. What is the significance the Bureau of Narcotics and Dangerous Drugs?
    In 1968, the Harrison Act and the DACA were combined under the jurisdiction of the newly formed Bureau of Narcotics and Dangerous Drugs. In 1973, The bureau was renamed to The Drug Enforcement Administration.
  9. What is the significance of the Comprehensive Drug Abuse prevention and Control Act?
    The CSA repealed and replaced Harrison and DACA, but like DACA it relied on Congress' regulation of interstate trade for its power. The new approach of the CSA depends on record keeping and registration requirements of sufficient detail to be able to track transactions between manufacturers, suppliers, practitioners, and consumers.
  10. What is the significance of the Poison Prevention Packaging Act?
    The Poison Prevention Packaging Act was intended to decrease accidental poisonings from prescription medications. It requires locking caps on all prescriptions dispensed from the pharmacy with only three exceptions. First, when a patient asks for a non-safety lid. Second, when a prescriber asks for a non-safety lid. And third, when the drug dispensed is an exempted drug.
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Chapter 4 CPhTE
Pharmacy Flash Cards
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