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Drug Regulations

Drug laws, Acts, and Amendments

QuestionAnswer
Food and Drug Act of 1906 Prohibited interstate commerce in adulterated or misbranded food, drinks and drugs. Government re-approval of drugs is required.
Harrison Tax Act 1914 In response to growing addiction to opiates and cocaine-containing medicines, the Harrison Tax Act established that manufacturers,pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax.
Food, Drug and Insecticide Administration 1927 The law enforcement agency is formed that would be renamed in 1930 as the Food and Drug Administration (FDA)
Food, Drug and Cosmetic (FDC) Act 1938 In response to the fatal poisoning of 107 people, primarily children, by an untested sulfanilamide concoction, this comrehensive law requres new drugs be shown to be safe before marketing.
Alberty Food Products v. U.S. The United States Court of Appeals rules that the purpose for which a drug is to be used must be included on the label.
Durhan-Humphrey Amendment 1951 This law definded what drugs required a prescription by a licensed practitioner and required them to include this Legend: "Federal Law Prohibits Dispensing Without a Prescription" or the more recent: "Rx Only".
Kefauver-Harris Amendment 1962 Requires the drug manufacturer to provide proof of both safety and effectiveness before marketing the drug.
Fair Packaging and Labeling Act 1966 This requires all consumer products in interstate commmerce to be honestly and informatively labeled.
Poison Prevention Packaging Act 1970 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.
Controlled Substance Act (CSA) 1970 The CSA classifies five levels of drugs (Controlled Substances) that have potential for abuse and therefore restricts their distribution. The Drug Enforement Aministration (DEA) as a division established by the CSA and enforces if regulations.
Medical Device Amendment 1976 Requires pre-market approval for safety and effectiveness of life-sustaing and life-supporting medical devices.
Orphan Drug Act 1983 Provides incentives to promote research, approval, and marketing of drugs needed for te treatment of rare diseases.
Drug Price Competition and Patent Term Restoration Act (Hatch- Waxman) 1984 This act allowed for both the extension of drug patent terms and quicker introduction of low-cost generic drugs.
Prescription Drug Marketing Act 1987 Rescticts distribution of prescription drugs to legitamat commercial channels and requires drug wholesalers to be licensed by the states.
Omnibus Budget Reconcilliatin Act 1990 Among other things, this act requires pharmacists to offer counseling to Medicaid Patiets reqarding medications.
anabolic Steroid Control Act 1990 This act was passed to "Address the abuse of steroids by athletes and especially youngsters and teenagers."
Health Insurance Portability and Accountability Act 1996 Among other things this act defines the scope of health information that may or may not be shared among healthcare providers without patient consent and provided for broad and stringent regulations to protect patents'right to privacy. ETC.
Created by: sharutmey
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