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Phat 151 Study Guide
Chapter 6
| Question | Answer |
|---|---|
| FDA | Food and Drug Administration - responsible for making sure drugs are safe, pure, and effective |
| DEA | Drug Enforcement Administration(Federal)Agency(state) - responsible for all drug trafficing. |
| FDCA | Federal Food, Drug, and Cosmetic Act 1906 - drugs have labels on them |
| Pure Food and Drug Act of 1906 | The law prohibited the adulteration and misbranding of foods in interstate commerce.(anything went across state line had to be labeled properly. |
| Food, drug, and Cosmetic Act of 1938 | The new law required that no new drug could be marketed until proven safe for use when used according to directions on the label.(passed because people were dieing and manufacturer used diethylene glycol(antifreeze) |
| Durham-Humphrey Amendment of 1951 | established 2 classes of drugs, over-the-counter and prescription, and mandated that labels of prescription drugs include"Caution:Federal law prohibits dispensing without a prescription." |
| Kefauver-Harris Amendment of 1962 | required that all new drugs marketed in United States had to be proven both safe and effective |
| Orphan Drug Act of 1983 | manufactors get a 7 yrs window to be the only manufactor of a drug. |
| CSA | Controlled Substances Act - classifies drugs into schudules based on abuse potental. Lower the number the higher the abuse potential. |
| Schedule I | highest abuse potential and no approved medical use in U.S.(marijuana and peyote) |
| Schedule II | most additive, must have written Rx every time, No refils.(emergency)written Rx to pharmacy in 7 days and filled in 72 hrs.(Adderall, Ritalin, OxyContin<APAP+oxycodone> |
| Schedule III | 5 refills in 6 mths (Lortab<APAP+hydrocodene) |
| Schedule IV | 5 refills in 6 mths (Xanax, Clonopin, Darvocet) |
| Schedule V | No Rx required. must be 18 yrs. valid ID and sign for Rx(Sudefede) |
| 4 DEA Forms | DEA Form 224 - distrubution of controlled subs.DEA Form 222- ordering controlled substancesDEA Form 106- lost or stolen itemsDEA Form 41- recall or destructionDEA Form |