PTCB Pharmacy Law

  1. tort
    • civic wrongdoing;
    • injury (physical or non) inflicted on one person by another
  2. FDA
    • Food and Drug Administration;
    • regulatory body dealing directly with the manufacture & review of medications
  3. Pure Food and Drug Act
    • prohibits the interstate distribution of adulterated or improperly labeled food or drugs;
    • first law regulating drugs
  4. FD&C Act
    • Food, Drug, and Cosmetic Act;
    • requires all drug manufacturers to file a New Drug Application with the FDA before any drug can be approved for the market;
    • also have to ensure the purity, safety, packaging and strength of a medication;
    • requires proper labeling of products
  5. Durham-Humphrey Act
    • prohibits legend drugs without a prescription;
    • "Caution: Federal law prohibits dispensing this medication without a prescription"
  6. legend drugs
    prescription drugs
  7. Kefauver-Harris Amendment
    requires that all medications be pure, effective, and safe to use on humans
  8. CSA
    • Controlled Substances Act or Comprehensive Drug Abuse Prevention and Control Act;
    • requires pharmaceutical industry to keep records and maintain security measures for certain medications;
    • divided control substances into 5 classes
  9. schedule I (CI)
    • drugs having no accepted medical use in the US;
    • high abuse potential
  10. schedule II (CII)
    • drugs having an accepted medical use and a high abuse potential;
    • severe psychic or physical dependence liability
  11. schedule III (CIII)
    drugs having an accepted medical use and an abuse potential less than those in schedules I and II
  12. schedule IV (CIV)
    drugs having an accepted medical use and an abuse potential less than those listed in schedule III
  13. schedule V (CV)
    drugs having an accepted medical use and and abuse potential less than those listed in schedule IV
  14. Form to order schedule II drugs
    DEA Form 222
  15. Poison Prevention Packaging Act
    • created standards for child-resistant packaging;
    • cannot be opened by 80% of children younger than 5, and can be opened by 90% of adults
  16. OSHA
    • Occupational Safety and Health Act;
    • prevents workplace diseease and injuries
  17. Drug Listing Act
    assigns a unique and permanent drug code to each medication (NDC)
  18. FHSA
    • Federal Hazardous Substance Act;
    • involves the use and disposal of hazardous material in the pharmacy setting
  19. Orphan Drug Act
    offers financial incentives to organizations that develop and market medications that were not previously avialable in the US
  20. orphan drugs
    medications/treatments that treat a small part of the population
  21. OBRA
    • Omnibus Budget Reconciliation Act;
    • requires pharmacies that fill prescription orders for Medicaid patients to obtain, record, and maintain basic patient info;
    • requires pharmacists to offer counseling to patients, and perform drug utilization reviews
  22. DUR
    • drug utilization reviews;
    • reviews of a patient profile to ensure that medications dispensed to a patient in the past were correct
  23. Anabolic Steroids Control Act
    • allows the CSA (Controlled Substances Act) to regulate anabolic steroids;
    • made steroids schedule III;
  24. HIPAA
    • Health Insurance Portability and Accountability Act;
    • privacy regulations to establish patients' rights with regard to their own info;
    • ensures confidentiality of the protected health information (PHI)
  25. FDA Modernization Act
    • reformed the regulation of cosmetics, food, and medical products;
    • main focus is safe pharmacy compounding and regulation of medical devices
  26. Combat Methamphetamine Epidemic Act
    • regulates drug trafficking that is used to finance terrorism;
    • limits amount of pure ephedrine or pseudoephedrine to 3.6g purchased per person at one time, and 7.5g per month
  27. BOP
    • state board of pharmacy;
    • establish state-specific pharmacy laws and regulations
  28. DEA
    • Drug Enforcement Agency;
    • responsible for enforcing controlled substance legislation;
    • focuses on major violators of the Controlled Substances Act
  29. MedWatch
    system utilized by the FDA to receive info about adverse events or product problems
  30. JCAHO
    • Joint Commission on Accreditation of Healthcare Organizations;
    • accredits and certifies healthcare organizations in the US to increase patient safety
  31. National Association of the Boards of Pharmacy
    • assists the boards of pharmacy in each state to protect public health by developing uniform standards;
    • implements standards that reduce the likelihood of errors and public harm due to the complexities of medications
  32. governed by the judicial branch
    common/case law
  33. enforced by a state representative
    criminal law
  34. enforced in civil court
    contract law
  35. drawn from the Constitution and Bill of rights
    constitutional law
  36. drawn from the legislative branch
    statutory/legislative law
  37. drawn from the executive branch
    administrative law
Card Set
PTCB Pharmacy Law
PTCB Pharmacy Law