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Laws
| Term | Definition |
|---|---|
| Schedule I | No accepted medical use. Extremely high potential for abuse. High potential for psychological and physical dependency. A few examples are: Marijuana, Heroin and MDMA (Extasy). |
| Schedule II | Does have medical use. High potential for abuse. Relative potential for psychological and physical dependency. A few examples are: Oxycodone, Codeine and Ritalin. |
| Schedule III | Does have medical use. Moderate abuse potential exists, but less than Sch II. Examples are: Vicodin and Tylenol w/Codeine. |
| Schedule IV | Abuse potential exists, but less than Sch III. Examples are: Ambien, Darvocet and Lorazepam. |
| Schedule V | Lowest abuse potential of the DEA Sch. Abuse potential exists, but less than Sch IV. Example: Cough medicine w/codeine or anti-diarrheals. |
| D.E.A. Form 222 | must be used whenever Sch I or II drugs are bought, sold or transferred between pharmacies or qualified distributors. |
| Refills | DEA Schedule II NO REFILLS ALLOWED DEA Schedule III thru V up to 5, but only 5 times* Legend Drugs up to 12 Months worth |
| Generic Substitutions | Generic drug substitutions may not be used unless the prescriber has authorized it. |
| Schedule II drug prescriptions also: | Must be manually signed by the practitioner. No exceptions. May not be Faxed or Called in, except for a valid emergency. May not have any refills. |
| Federal Food and Drug Act of 1906 | Known as the Pure Food and Drug Act. Provided authority for federal inspection of meat products and prohibited the sale of adulterated foods. |
| Narcotic Tax Act of 1914 | Known as the Harrison Narcotic Act. Provided authority for Internal Revenue Service to collect tax on Opiates thru Tax Stamps. Required that any entity which produced, distributed, dispensed or sold opiates be registered with the IRS. |
| Federal Food, Drug and Cosmetic Act of 1938 | Known as FDCA 1938. (Replaced the Food and Drug act of 1906) Provided better clarification about misbranding definitions. Provided better clarification about adulteration definitions. Authority to require adequate testing of new drugs for safety. |
| The Durham-Humphrey Amendment of 1951 | Created a distinction between "OTC" and "Legend Drugs". Legend Drugs can only be dispensed with a valid Prescription.. Required Legend Drugs to carry the statement |
| Caution Federal Law | Prohibits dispensing without a prescription. Most people refer to Legend drugs simply as "Prescription Drugs" The emphasis on this act was to insure safety thru qualified medical supervision. |
| The Kefauver-Harris Amendment of 1962 | Known as the "Drug Efficacy Amendment". Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval . Required advertising to be more closely regulated and disclose accurate information about side effects |
| The Bureau of Narcotics and Dangerous Drugs (BNDD) | Predecessor agency of the DEA. In 1973 the BNDD merged into the DEA. DEA (Drug Enforcement Administration) |
| Drug Abuse Prevention / Control Act of 1970 | Known as the Controlled Substances Act (CSA) Completely replaced the Harrison Act. Required the use of DEA Numbers Required comprehensive record keeping and transaction tracking. Enforced by the DEA under the US Dept. of Justice |
| Poison Prevention Packaging Act of 1970 | Known as the PPPA Designed to reduce the risk of children ingesting dangerous substances. Required locking caps on most prescriptions |
| Combat Methamphetamine Epidemic Act (2005) | Identity and address of each purchaser to be kept for two years. Daily sales of regulated products not to exceed 3.6 grams. 30 day purchase limit not to exceed 9 grams 30 day purchase via mail order not to exceed 7.5 grams |
| Class I | Would be used in a case where there is a probability that, the use of or exposure to a violative product will cause serious adverse health consequences or death. |
| Class II | Would be used in a case where use of a violative product may cause temporary health problems and the probability of serious adverse health consequences is remote. |
| Class III | May be used in a situation in which use of a violative product is NOT likely to cause adverse health consequences, but has violated some FDA regulation. |
| Phase I | Involves a small number of healthy volunteers (25-100). Safely tolerated dosages determined. Identification of major side-effects Emphasis on safety and maximum tolerated dosages. |
| Phase II | Involves many more volunteers (100-300). Emphasis on the drugs effect against what it's designed to treat. Effects compared with similar patients receiving different treatments. |
| Phase III | Involves volunteers. Emphasis on the drugs effect. Effects compared with patients unknowingly taking placebos Study of different populations and different dosages. Testing the drug in combination with other drugs. Last Phase before showing the FDA |
| Phase IV | Ongoing/Post approval trials. Health-care professionals to report any adverse findings. This phase lasts eternally, as long as the drug is on the market. |
| Time the process takes for a medication to be approved by the FDA | This process can usually take 12-15 years. Keep in mind that a Patent only lasts 20 years from the time the application for patent was filed |
Created by:
vmont50
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