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Drug Regulation Ch3
| Question | Answer |
|---|---|
| Food and Drug Act of 1906 | Prohibited interstate commerce, audlterated/misbranded food, drug, drink; gov pre-approval of drugs required |
| 1914 Harrison Tax Act | Manufacturers, pharmacists, importers and physicians prescribing narcotics shld be licensed & required to pay tax |
| 1927 Food, Drug & Insecticide Administration | Law agency formed that later renamed to Food & Drug Administration; 1930 |
| 1938 Food, Drug & Cosmetic (FDC) Act | response to fatal poisoning of 107, primarily kids, by sulfanilamide concoction; requires new drugs be shown safe |
| 1950 Alberty Food Products v. US | US Court of Appeals rules purpose a drug is to be used must be included on label |
| 1951 Durham-Humphrey Amendment | law defines what drugs require prescription & requires legend on label |
| Legend from Durham-Humphrey Amendment | "Caution: Federal Lawprohibits dispensing without a presciption" or "Rx Only" |
| 1962 Kefauver-Harris Amendment | Requires manufacturers provide proof of safety & effectiveness |
| 1966 Fair Packaging & Labeling Act | requires consumer products in interstate commerce to be honestly & informatively labeled |
| 1970 Controlled Substances Act (CSA) | classifies 5 levels of drugs having potential for abuse; DEA established by this & enforces its regulations. |
| 1976 Medical Device Amendment | pre-market approval for safety & effectiveness of life-sustaining devices |
| 1987 Prescription Drug Marketing Act | restricts distribution of prescription drugs to legitimate channels & requires wholesalers to be licensed by state |
| 1990 Omnibus Budget Reconciliation Act (OBRA) | among other things, requires pharmacists to offer counseling to Medicaid PT |
| 1990 Anabolic Steriod control Act | passed to "address abuse of ___ by athletes, esp teenagers" |
| 1970 Poison Prevention Packaging Act | requires child-proof packaging; non-child-proof only upon request |
| 1983 Orphan Drug Act | provides incentives to promote research, approval & marketing of drugs needed for rare diseases |
| 1984 Drug Price Competition & Patent Term Restoration Act (Hatch-Waxman) | act allowed both extension of patent terms & quicker intro of generic |
| 1996 Health Insurance Portability & Accountability Act | primarily defined info that may/may not be shared without pt consent; electronic 4/14/03 |
| Thalidomide Lesson | 1962, sleeping pillfound to cause severe birth dects; resulted in Kefauver-Harris Amendment, 1962 |
| Only 25% of Drugs complete this testing | Testing Phases in Humans |
| Animal testing | once lab testing finished this testing begins; only fraction of a % of drugs make it to testing in humans |
| Phase 1 of Human Testing | 20-100 PTs; Months; purpose: mainly safety |
| Phase 2 of Human Testing | several hundred PTs; Months to 2 years; purpose: short-term safety but mainly effectiveness |
| Phase 3 of Human Testing | several 100s to 1000s of PTs; 1 to 4 years; purpose: safety, dosage & effectiveness |
| Center for Devices & Radiological Health (CDRH) | responsible for testing & approval for med devices |
| Center for Biologics Evaluation & Research (CBER) | responsible for biological products made from living organisms (testing & approval) |
| A New Drug is defined as: | any drug proposed for marketing after 1938; not already recognized as safe/effective |
| Clinical trials | involve testing drug on people |
| Pediatric Labeling Rule 1994 | mandated drugs have pediatric dosing & safety info if drug has potential use for peds pts |
Created by:
jlauderman
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