Drug Regulation

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Drug Regulation
2012-02-03 10:29:23

Drug regulation timeline
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  1. Food and Drug Act of 1906
    Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Govt pre-approval of drugs is required
  2. 1914 Harrison Tax Act
    Also known as Narcotic Drug Act. Growing addiction to opiates and cocaine-containing medications. Harrison Tax Act established that manufacturers, pharmacists, importers, and physicians prescribing NARCOTICS should be licensed and required to pay a tax.
  3. 1927 Food, Drug and Insecticide Administration
    The law enforcement agency is formed that would be renamed in 1930 as the Food and Drug Administration
  4. 1938 Food, Drug and Cosmetic (FDC) Act
    In response to the fatal poisoning of >100 people, primarily children by an untested sulfanilamide concoction, this law required new drugs be shown to be safe before marketing. This law created FDA.
  5. 1950 Alberty Food Products v. US
    The US Court of Appeals rules that the purpose for which a drug is to be used must be included on the LABEL
  6. 1951 Durham-Humphrey Amendment
    Distinguish between OTC and legend drugs. This law defines what drugs require prescription by a licensed practitioner and requires them to include the legend on the label: "Caution: Federal Law prohibits dispensing without a prescription" or "Rx Only."
  7. 1962 Kefauver-Harris Amendment
    Requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug
  8. 1966 Fair Packaging and Labeling Act
    This requires all consumer products in interstate commerce to be honestly and informatively labeled
  9. 1970 Poison Prevention Packaging Act (PPPA)
    • Requires child-proof packaging on all controlled and most prescription drugs dispensed by pharmacies. Non-child proof containers may only be used if the prescriber or patient requests one.
    • PPPA exempts: NTG, oral contraceptives, prednisone, methylprednisolone, isosorbide dinitrate
  10. 1970 Controlled Substances Act (CSA)
    The CSA classifies five levels of drugs (controlled substances) that have potential for abuse and therefore restricts their distribution. CSA created the DEA (Drug Enforcement Administration) to enforce laws and fight drug abuse
  11. 1976 Medical Device Amendment
    Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices
  12. 1983 Orphan Drug Act
    Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases (1/ 200,000)
  13. 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)
    • This act allowed for both the extension of drug patent terms and quicker introduction of lower-cost generic drugs.
    • Patent = 20 years from filing date.
  14. 1987 Prescription Drug Marketing Act
    Restricts distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be licensed by the states
  15. 1990 Omnibus Budget Reconciliation Act (OBRA)
    Among other things, this act requires pharmacists to offer counseling to Medicaid patients regarding medications
  16. 1990 Anabolic Steroid Control Act
    This act was passed to "address the abuse of steroids by athletes, youngsters, teenagers."
  17. 1996 Health Insurance Portability and Accountability Act (HIPPA)
    • Among other things this act defined the scope of health information that may or may not be shared among health care providers without patient consent and provided for broad and stringent regulations to protect patients' right to privacy. All "covered entities", meaning any health care provider using electronic claims transmissions, billing or other electronic transfer of patient information, were required to be compliant with HIPPA privacy and security regulations by April 14, 2003. These regulations govern the transfer of patient health information electronically, on paper, or orally.
    • PHI= Protected health information
  18. 2003 Medicare Prescription Drug, Improvement, and Modernization Act (MMA)
    Also known as Medicare Part D, allows patients with Medicare health insurance to add prescription drug coverage, which may lower their prescription drug costs and help protect against higher costs in the future.
  19. 2006 Combat Methamphetamine Epidemic Act
    CMEA regulates the over-the-counter sales of ephedrine, pseudoephedrine, and phenylpropanolamine products which are precursors in making methamphetamines and amphetamines. Daily sales limits = 3.6 g and monthly limit = 9g by each purchaser. Medications must be locked, a valid ID must be presented.