Drug Regulation -A Time Line Flashcards
Food and Drug Act of 1906
Prohibits interstate commerce in adulterated or misbranded food, drinks, and drugs. Government pre approval is required.
1914 Harrison Tax Act
Establishes that manufacturers, pharmacist, importers, and physicians prescribing narcotics should be licensed and required to pay a tax.
1927 Food, Drug and Insecticide Administration
Law enforcement agency is formed. Renamed in 1930 as the Food and Drug Administration.
1938 Food, Drug and Cosmetic (FDC) Act
Requires new drugs be shown to be safe before marketing
1950 Alberty food products v U.S.
The U.S. Court of Appeals rules that the purpose for which a drug is to be used must be included on the label
1951 Durham-Humphrey Amendment
Defines which drugs require a prescription by a licensed practitioner and requires them to include this legend on the label “Caution: Federal Law prohibits dispensing without a prescription” or “Rx only”
1962 Kefauver-Harris Amendment
Requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug
1965 Social Security Act
Establishes the Medicare Program
1966 Fair Packaging and Labeling Act
Requires all consumer products in interstate commerce to be honestly and informatively labeled
1970 Poison Prevention Packaging Act
Requires childproof Packaging on all controlled and most prescription drugs dispensed by pharmacies
1970 Controlled Substance Act
Classifies 5 levels of controlled substances that have potential for abuse and therefore restricts their distribution; establishes that Drug Enforcement Administration DEA
1976 Medical Device Amendment
Requires premarket approval for safety and effectiveness of life sustaining and life supporting medical devices
1983 Orphan Drug Act
Provides incentives to promote research, approval, and marketing of drugs needed for the treatment or rare diseases
1984 Drug price competition and patent term restoration act (Hatch-Waxman)
Allows for both the extension of drug patent terms and quicker introduction to lower cost generic drugs
1987 Prescription Drug Marketing Act
Restricts distribution of prescription drugs to legitimate commercial channels; requires drug wholesalers to be licensed by the states
1990 Omnibus Budget Reconciliation Act (OBRA)
Among other things, this act requires pharmacist to offer counseling to Medicaid patients regarding medication
1990 Anabolic Steroid Control Act
Passed to “ address the abuse of steroids by athletes, and especially youngster”
1996 Health Insurance Probability and Accountability Act
This Act defined the scope of health information that may and may not be shared among health care providers without patient consent and provided for broad and stringent regulations to protect patients right to privacy
2003 Medicare Modernization Act
Establishes the optional Medicare Part D to provide coverage for prescription drugs and Medication Therapy Management (MTM)
2005 Combat Methamphetamine Epidemic Act
Establishes strict controls of OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine
2010 Patient Protection and Affordable Care Act
Health-care reform legislation of the 111th United States Congress intended to expand health insurance access for uninsured Americans
2012 FDA Safety Innovation Act
Establishes user fees to enhance access to medications and medical devices and made provisions for addressing drug products shortages in the United States
