(Updated) EXCPT Pharmacy Technician Exam Study Guide with complete solutions |Latest 2024/2025

(Updated) EXCPT Pharmacy Technician Exam Study Guide with complete solutions |Latest 2024/2025 1. Pure Food and Drug Act (1906) Prohibits interstate commerce of misbranded and adulterated drugs and foods. 2. Misbranded a drug product is misbranded if its labeling is inaccurate, incomplete, or misleading 3. Adulterated a drug product that fails to meet quality, strength, or purity standards 4. Federal Food, Drug, and CosRequires drug manufacturers to provide the FDA with evidence of safety by submitting a New Drug Application metic Act of 1938 before marketing them. This act essentially created the FDA and started a new system of drug regulation. If the FDA does not take any action within 60 days, the drug is automatically approved. (Note: the Kefauver-Harris Amendment of 1962 invalidated this aspect of the Act.) 5. Durham-Humphreydefines two categories for drug products: legend drugs Amendment of 1951 6. Kefauver-Harris Amendment of 1962 7. Controlled substances act (CSA) (1970) 8. controlled substances have 5 schedules 9. drugs are places in their prespectivee schedules based on (prescription-only) and OTC medication requires drug manufacturers to scientifically prove a medication is not only save but effective federal drug policy that regulates the manufacture, importation, possession, use and distribution of controlled substances I , II, III, IV, V medical use and potential for abuse or dependence 2 / 17 EXCPT Exam Study Guide with complete solutions (Updated) 10. legend drugs only dispensed with a proper prescription 11. Schedule I drugs Have high potential for abuse with no accepted medical use 12. Schedule II drugs 13. Schedule II drugs examples 14. Schedule III Substances 15. Schedule IV Controlled Substances (anxiety, sleep) - Drugs have high potential for abuse - Drugs have currently accepted medical uses Most ADHD medications (Adderall, Ritalin, methamphetamines) oxycodone, codeine, morphine, methylphenidate moderate to low potential for physical dependence but potential for psychological dependence lower potential for abuse but can still lead to addiction. EX) benzo's, carisoprodol, tramadol, and zolpidem