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wkbk-chpt 3
drug reg & control
| Keyterm | Definition |
|---|---|
| Food & drug administration | the leading enforcement agency at the federal level for regulations concerning drug products |
| drug enforcement administration | the agency which controls the distribution of drugs that may easily be excused. |
| food and drug act 1906 | prohibited interstate commerce alductered or misbranded food, drinks and drugs. govt preapproved of drugs is required. |
| 1938 food, drug and cosmetic act | in response to the fatal poisining of 107 people, pirimarly children, by an untested sulfaminde conoction, this comprehensive law requires new drugs be shown to be safe before marketing. |
| 1951 Durham-Humphrey amendment | this law defines what drugs require a prescription by a licensed practiociner and requires them to include this legend on the label; caution federal law prohibits without a prescription |
| 1962 Kefauver-Harris amendments | requires drug manufactors to provide proof of both safety and effectiveness before marketing the drug |
| 1970 poison prevention packaging act | requires child proof packaging on all controlled and most prescription drugs dispensed by pharmacies |
| 1970 controlled substances act | classifies drugs that may be easily abused and restricts their distribution.its enforced by the drug enforcement adminstration within the justice dept |
| 1990 omnibus budget reconcilation act | among other things this act requires pharmaicst to offer couseling to medicaid patients regarding medication, effectiveley putting the common practice into law. |
| 1996 hippa | provided broad and stringent regs to protect patients privacy |
| placebos | inactive substances, not real medications, that are used to test the effectiveness of drugs |
| NDC | the number assigned by the manufacter, each ndc number has three parts; foirst set indicates the manufacter, next set the medication, the last set indicates the package size. |
| recall class I | where there is a strong likelihood that the product will cause serious adverse effects |
| recall class II | where a product may cause temp but reversible adverse effects or in which there is little likelihood of serious adverse effects |
| recall class III | where a product is not likely to cause adverse effects |
| medwatch | FDA reporting program for health care proffesioals to report adverse effects that occur from the use of an approved drug or other medical product. VOLUNTARY REPORTING FORM 3500 |
| Injuction | a court order preventing a specific action, such as the distribution of a potentially dangerous drug |
Created by:
creyesz07
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