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23 Cards in this Set
- Front
- Back
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The study of the effects of chemical substances on living tissue.
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Pharmacology
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Chemical substances classified as drugs can be derived from____, ____, or ____.
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Plants, animals, or inorganic compounds
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Some drugs are formulated through _______ or are _________.
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Genetic engineering or synthetically produced
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Also referred to as clinical pharmacology, is the application of pharmacology to prevent disease.
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Pharmacotherapeutics
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Passed to protect the public by controlling sales of drugs which adulterated, dangerous and falsely labeled.
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Federal Food and Drug Act 1906
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Designed as the official publication for drug standards.
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United States Pharmacopeia
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Designed as the official listing of all drugs legally available in the US.
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National Formulary
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Published quarterly to impart new information to health practitioners involved in prescribing or dispensing drugs.
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Food and Drug Administration Drug Bulletin
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Passed to prohibit drug companies from making false claims about their products.
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Federal Food and Drug Act - Sherley Amendment 1912
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Defined the legal term "narcotic" and regulated the importation, manufacturing and sale of opium, cocaine and their derivatives This was the first narcotic act for any nation.
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Harrison Narcotic Act 1914
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This legislation was prompted by more than 100 deaths in 1937 from a toxic sulfanilamide elixir. Pharmaceutical companies were mandated to submit an investigational new drug (IND) application to the FDA and conduct toxicity testing.
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Federal Food, Drug and Cosmetic Act 1938 (The renamed Federal Food and Drug Act)
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Distinguished between perscription (legend) drugs and over-the-counter (OTC) drugs. Also, controlled substances can not be refilled w/o a prescription and restrict the dispensing of drugs.
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Durham-Humphrey Amendment
(Federal Food, Drug and Cosmetic Act 1951) |
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Physicians and certain other health care practitioners _____ medications and nurses ______ medications.
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Prescribe, administer
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Required that drugs be effective as well as safe.
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Kefauver-Harris Amendment (Federal Food, Drug and Cosmetic Act 1962)
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Categorized addictive drugs into five schedules according to their abuse potential. Schedule I are considered most addictive.
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Comprehensive Drug Abuse Prevention and Control Act 1970
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Responsible for the enforcement of legislation concerning controlled substances.
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Drug Enforcement Agency (DEA)
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Passed after capsules of Tylenol were poisoned. OTC drugs have to be packaged in such a way that it is obvious to the consumer if the container has been opened.
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Tamper Proof Packaging Requirement 1982
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Offered substantial tax credits to pharmaceutical companies to develop drugs to treat rare diseases or which have a limited market.
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Orphan Drug Act 1983
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Enabled pharmaceutical companies to manufacture and market a drug under the generic name and to apply their own trade name once the patent expired.
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Generic Drug Law 1984
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The _______ is required to have the same active ingredients and bioequivalency as the original drug.
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Generic Drug
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Enabled the review process of investigational new drugs to be accelerated if the drugs will be used to treat HIV, AIDS or cancer.
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Drug Relations Act 1992
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Required testing of certain drugs for safety and effectiveness in children.
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Pediatric Research Equity Act 2003
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Provides financial assistance to senior citizens to purchase prescription drugs.
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Medicare Prescription Drug Improvement and Modernization Act 2003
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