1) This act required all foods and drugs to meet a standard of strength and purity. a) 1906: the Pure Food and Drug Act (PFDA) b) 1938: The Federal Food, Drug, and Cosmetic Act (FFDCA) 2) 1962: The Kefauver-Harris Amendments clarified the distinction between prescription and over the counter (OTC) drugs based on whether or not the drugs were habit-forming, narcotic, hypnotic, or potentially harmful. a) true b) false 3) 1951: The Kefauver-Harris Amendments to the FFDCARequired drug manufacturers to prove the safety and efficacy of their products before approval was given by the FDA for marketing. a) true b) false 4) Which Amendment to the FFDCA clarified the distinction between prescription and OTC drugs based on if the drugs were habit-forming, narcotic, hypnotic, or potentially harmful a) 1951: Durham-Humphrey b) 1962: Kefauver-Harris 5) Which Act regulated importation, sale, manufacture, and use of drugs that produced or sustained physical or psychological dependence. (opium, marijuana, synthetic agents, derivatives) a) 1970: Controlled Substances Act (CSA) b) 1914: the Harrison Narcotic Act 6) What did the 1938: Federal Food, Drug, and cosmetic Act (FFDCA) require? a) Manufacturers of drugs and cosmetics must prove that their products are safe, as well as devices be effective. b) Required registered drug establishments to provide the FDA with list of all drugs manufactured, prepared, propagated, compounded or processed by it for commercial distribution. 7) What Act required child-proof packaging? a) Poison Prevention Packaging Act b) Child Poisoning Prevention Act 8) Which Act classified drugs based on their potential for abuse into Schedule I, II, III, IV, & V and Must be labeled “Federal Law prohibits the transfer of this drug to any person other than patient for whom prescribed.” a) 1970: Controlled Substances Act (CSA) b) 1972: Drug Listing Act 9) Which act was created to assure safe and healthful working conditions by setting, enforcing standards and providing training, outreach, education and assistance? a) 2005: the Patient Safety and Quality Improvement Act b) 1970: Occupational Safety and Health Act 10) 1972: The Drug Listing Act did what? a) Addresses certain marketing practices that contribute to the diversion of drugs into a secondary gray market. (sale or distribution of free samples and of greatly discounted drugs intended for healthcare entities) b) Required registered drug establishments to provide the FDA with list of all drugs manufactured, prepared, propagated, compounded or processed by it for commercial distribution. 11) Which act was passed to expedite development of drugs for rare diseases such as Huntington’s disease, ALS (Lou Gehrig’s Disease), and muscular dystrophy. a) 1983: Orphan Drug Act b) 1997: FDA Modernization Act 12) Which act is this? PDMA is a part of the FDC Act, which was enacted to address certain prescription drug marketing practices that have contributed to the diversion of drugs into a secondary gray market. Examples include: the sale or distribution of free samples and the sale of deeply discounted drugs intended for health care entities. a) Prescription Drug Marketing Act of 1987 b) Prescription Drug Manufacturing Act of 1987 13) 1990: Omnibus budget Reconciliation Act (OBRA-90) required pharmacists to offer counseling to all patients regarding medications a) true b) false 14) This act places “any drug or hormonal substance chemically and pharmacologically related to testosterone” under regulatory provisions of the controlled Substance Act. a) The combat Methamphetamine Epidemic Act of 2005 (CMEA) b) The Anabolic Steroids Control Act of 1990 15) Which Act is enacted the privacy rule on April 14, 2003 and was the first federal regulation to safeguard the privacy of protected health information (PHI)? a) 1996 Health Insurance Portability and Accountability Act b) 2005: the Patient Safety and Quality Improvement Act 16) 1997: FDA Modernization Act did what? a) Changed the legend requirements to “Rx only” b) It was created to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients. 17) 2005: The Combat Methamphetamine Epidemic Act of 2005 (CMEA) was to regulate, retail OTC sales of drugs used illegally to make methamphetamine and amphetamine. Those OTC drugs are: a) Ephedrine, Pseudoephedrine, Phenylpropanolamine products b) Acetaminophen, salicyclic acid, naproxen 18) Which act was created to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affected patients? a) 2005: the Patient safety and Quality Improvement Act b) 1970: Occupational Safety and Health Act 19) Which Act, aka Track and Trace outlined steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US and protects consumers from exposure to drugs that may be counterfeit, stolen, contaminated, harmful a) 2013 Drug Supply Chain Security Act (DSCSA) b) 1972: Drug Listing Act

Pharmacy Law 1 - Acts & Amendments

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