PHM1140 Law & Ethics for Pharmacy Techs, Federal Regulation, Chapter 3, De More
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| show | tampering with or contaminating a substance
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| fraud | show 🗑
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| fraudulent | show 🗑
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| show | drugs used to provide detailed inquiry or systematic examination of their effects
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| show | prescription drug
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| misbranding | show 🗑
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| National Drug Code (NDC) | show 🗑
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| orphan drug | show 🗑
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| over-the-counter (OTC) | show 🗑
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| phocomelia | show 🗑
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| show | causing genetic defects
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| show | Prohibited interstate commerce in adulterated or misbranded food, drink & drugs.
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| Harrison Narcotics Tax Act 1914 | show 🗑
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| show | manufacturers have to ensure the purity, strength, safety and packaging of drugs; ensures approved drugs are safe and effective.
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| Durham-Humphrey Amendment 1951 | show 🗑
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| show | Requires drug manufacturers to provide proof of safety and effectiveness before marketing the drug
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| Poison Prevention Packaging Act 1970 | show 🗑
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| Orphan Drug Act 1983 | show 🗑
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| show | Defined the scope of health information that may and may not be shared among health providers without patient consent and provided for broad and stringent regulations to protect patients' right to privacy.
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| show | Class I: serious adverse effects or death; Class II: cause temporary but reversible effects; Class III: not likely to cause adverse effects
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| show | Thalidomide had been widely tested around the world as a tranquilizer, sedative and anti-nauseant during pregnancy, but was found to be teratogenic and cause phocomelia when used during pregnancy. It was withdrawn from the market in late 1961.
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| show | requires the pharmaceutical industry to maintain physical security ans strict record keeping for many types of drugs. It classifies the levels of drugs that have potential for abuse into 5 schedules, from highest (Schedule I) to least (Schedule V).
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| show | requires all employers to ensure employee safety and health; includes regulations for physical workplaces, machinery and equipment, first aid and job related materials; intended to require safe workplace conditions.
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| Drug Listing Act of 1972 | show 🗑
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| show | the safety and effectiveness of life-sustaining and life-supporting devices were now required to have pre-market approval of the FDA
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| Resource Conservation and Recovery Act of 1976 | show 🗑
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| show | increase consumer protection; encourage drug innovation; increase consumer info; protect patient rights; improve FDA enforcement; promote competition/cost savings w/generics; increase FDA accountabiliy; make more drugs available; encourage research/traing
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| show | gave marketers of a generic drug the ability to file abbreviate dnew drug applications to seek new approval of the generic drug; created in order to offset time and money required to bring new innovative drugs to market.
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| show | . It's designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs. It was passed in response to the development of a wholesale sub-market for prescription drugs
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| Omnibus Budget Reconciliation Act of 1990 | show 🗑
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| show | gives FDA ability to regulate medical devices and products used for medical diagnosis; requires medical device reports be filed on a timely basis; established procedure for new devices prior to market availability and increased penalties for violations
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| show | allowed Controlled Substances Act of 1990 to regulate anabolic steroids; offered harsher penalties for abuse and misuse of anabolic steroids by athletes
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| show | prohibits discrimination against disabled persons; focuses on issues and rights - areas that concern employment, public services, transportation, commercial facilities telecommunications, and more; oversees what's needed to live as normally as possible
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| show | the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed.
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| FDA Modernization Act Act 1997 | show 🗑
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| Medicare Prescription Drug, Improvement and Modernization Act of 2003 | show 🗑
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| show | proposed (but not passed); designed to restrict the distribution of isotretinoin (Accutane) because of the drug's side effects (severe birth defects, fetal death, depression, psychosis and suicide)
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