pharmacology
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Created by:
Grifgrl02 on October 31, 2010
Subjects:
ch.4 cultural, legal, and ethical considerations
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17 terms
Terms | Definitions |
|---|---|
 Federal food and drug act of 1906 | required drug manufacturers to list on the drug lable any dangerous or addicting substances |
| Sherley Amendment 1912 | prohibited fraudulent claims for drug products |
| Harrison Narcotic Act 1914 | Established the legal term narcotic and regulated the manufacture and sale of habit forming drugs |
| Federal, Food, Drug, and Cosmetic act 1938 | required drug manufacturers to provide data proving drug safety with FDA review, established the new drug application process |
| Durham Humphrey Amendment 1951 | Established legend drugs or perscription drugs; drug labels must carry the legend "Caution- federal law prohibits dispensing without a perscription. (You have to have a perscription to get a drug) |
| Kefauver-Harris Amendments 1962 | Required manufactures to demonstrate both therapeutic efficacy and safety of new drugs |
| Controlled Substance Act 1970 | Established "schedules" for controlled substances promoted addiction education, research, and treatment |
| Orphan Substance Act 1970 | enabled the FDA to promote research and marketing of orphan drugs used to treat rare diseases |
| Accelerated Drug Review Regulations 1991 | enabled faster approval by the FDA of drugs to treat life-threatening illnesses (prompted by the HIV/AIDS epidemic) |
| Health Insurance Protability and Accountability Act (1996) | HIPPA required health-related organizations, schools, to maintain privacy of protected health infromation |
| Medicare prescription drug improvement and modernization act 2003 | Medicare part D, provides seniors and disabled persons with an insurance benefit program for perscription drugs, federal gorvernment shares the cost |
| c1 controlled substances | only with approved protcol (pot) |
| c2 controlled substances | written perscription only, no perscription refills, container must have warning label (codeine, morphine, oxycodone,methadone) |
| c3/c4 controlled substances | written or oral perscription that expires in 6 months no more then 5 refills in 6 month period |
| what does each perticipant in a drug study have to know before signing the consent form | - have the right to withdrawl from the study at any time no matter what -possible risks -possible benefits - possibilty of getting a placebo |
| Phase 1 of the drug approval process | usually done on healthy people - purpose is to determine optimal range |
| phase 2 drug approval process | small number of people with disease |
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