Federal Laws Flashcards
Food Drug and Cosmetic Act (FD&C)
Enacted: 1938
Requires all drug manufacturers to file a new drug application (NDA) with the FDA before it could be approved for the market. Requires proper labeling or branding of products.
Killed 100 patients when a company used antifreeze as a sweetener for an elixir.
Pure Food & Drug Act
Enacted: 1906
Prohibited distribution or sale of adulterated or misbranded foods and drugs.
Durham-Humphrey Amendment
Enacted: 1951
Prohibits dispensing legend drugs without a prescription.
Kefauver-Harris Amendment
Enacted: 1963
Requires all medicine both prescription and nonprescription to be purely effective and safe to use on humans.
Requires manufacturers to register to allow inspection of their manufacturing sites.
Controlled Substances Act (CSA)
Enacted: 1970
Requires the pharmaceutical industry to keep records and maintain security measures for certain medications.
Divided controlled substances into five classes or schedules. Schedule 1 substances have the highest abuse potential while schedule 5 have the least.
Poison Prevention Packaging Act (PPPA)
Enacted: 1970
Created standards for the child resistant packaging.
Occupation Safety and Health Act (OSHA)
Enacted: 1970
Was established to prevent workplace disease injuries.
Drug Listing Act
Enacted: 1972
Assigned a unique and permanent drug code to each medication also known as the National Drug Code (NDC).
Federal Hazardous Substance Act
Enacted: 1960
Disposal of hazardous material in the pharmacy setting.
Orphan Drug Act
Enacted: 1983
Develops and markets medications for rare diseases.
Omnibus Budget Reconciliation Act (OBRA)
Enacted: 1990
Requires pharmacies that fill prescription orders for Medicaid and Medicare patients to obtain, record, and maintain basic patient information.
Must perform Drug Utilization Reviews (DUR) which reviews of patient profiles to ensure medication dispensed to past patients are correct.
Anabolic Steroids Control Act
Enacted: 1990
Allows the Controlled Substance Act (CSA) to regulate anabolic steroids.
Health Insurance Portability and Accountability Act (HIPAA)
Enacted: 1996
Improve the effectiveness of Medicare and Medicaid implementing systems to share and store private health information.
FDA Modernization Act
Enacted: 1997
Reforms the regulation of cosmetics, food, and medical products.
Requires the labels of every Legend medication to bear the words “RX only”
Combat Methamphetamine Epidemic Act
Enacted: 2005
Intended to stop the use of illegal drug methamphetamine.
