Term
| Which drug law states the drugs must be "strong and pure" and prohibits mislabeling and adulteration? |
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Definition
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Term
Which drug law regulated importation, manufacture, sale, and use of opium?
Which law repealed and superseded it? |
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Definition
Harrison Narcotic Act
Controlled Substance Act |
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Term
| Which law forced registration of all parties involved in making and selling drugs? (Also required drugs to be safe) |
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Definition
| Food, Drug and Cosmetic Act |
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Term
| Which drug law separated drugs into legend and nonlegend |
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Definition
| Durham-Humphrey Amendments |
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Term
| What is a legend drug versus non-legend drug? |
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Definition
| Legend is a prescription and non legend is an OTC drug. |
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Term
| What phrase must all legend drugs contain on their label? |
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Definition
| "Caution: Federal law prohibits dispensing without a prescription." |
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Term
| Which drug law required a drug to be both safe and effective, set guidelines for clinical trials, and established the Drug Efficacy Study Implementation (DESI)? |
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Definition
| Kefauver-Harris Amendments |
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Term
| Which drug law established rehab programs, control (registration) and enforcement (DEA), and regulated export/import of controlled substances? |
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Definition
Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act)
This is a huge set of law that are always in flux |
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Term
| Which drug law introduced special packaging for drug to make it difficult for children under 5 to open? |
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Definition
| Poison Prevention Packaging Act |
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Term
Child-resistant containers are applied to which drugs?
Which drugs are in non-complying containers? |
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Definition
All control drugs, aspirin (and aspirin containing preparations), iron containing drugs, dietary supplements, all legend drugs except
sublingual nitroglycerin, oral contraceptives, effervescent tablets (aspirin containing) |
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Term
| Which drug law required proof of safety and efficacy of medical devices and established standards for existing devices? |
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Definition
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Term
| Which drug act allows for patents to be extended for 5 years (but not to exceed 14 years), and established Abbreviated New Drug Application (ANDA) procedure for making generic drugs? |
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Definition
| Drug Price Competition and Patent Restoration Act |
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Term
| Which drug law attempted to curb drug diversion by prohibiting purchase, sale, or trade of drug samples? |
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Definition
| Prescription Drug Marketing Act |
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Term
| Which drug law amended the 1965 Medicaid law and developed drug utilization review (DUR), patient counseling and participation of states in federal Medicaid program? |
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Definition
Omnibus Budget Reconciliation Act
*Always being amended; ensures education of the patient; DUR meets at the hospital and looks at all the drugs that the hospital uses - they get rid of the drugs they don't use very often. |
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Term
| How many different classifications (schedules) are there for drugs? |
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Definition
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Term
| Describe a schedule I drug. |
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Definition
High abuse potential
No accepted medical use in U.S.
Investigational drugs, opitates (heroin), hallucinogens (LSD, mescaline, peyote), marijuana, methaqualone (Quaalude) |
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Term
| The Food and Drug Administration Modernization Act of 1997 (FDAMA) did what? |
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Definition
| Allowed for fast tracking of drugs for serious illnesses, drug manufacturers have to give patients 6 months notice before discontinuing a drug, companies can inform patient of off-label uses |
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Term
| What drug laws promoted drug studies in children and set the stage for for pediatric drug trials? |
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Definition
| The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act |
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Term
TRUE OR FALSE:
A study drug is considered a schedule I drug. |
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Definition
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Term
| Describe a schedule II drug. |
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Definition
| Acceptable medical use, high abuse potential (resulting in severe physical/psychological dependence) |
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