PTCB Review Questions and Answers 100% Pass

PTCB Review Questions and Answers 100% Pass Pure Food and Drug Act of 1906 All manufacturers are required to properly label a drug with truthful information, prove effectiveness, prohibited the adulteration and misbranding of food and drugs in interstate commerce. • Helped passed by chief chemist for the Bureau of Chemistry, Harvey Wiley. Harrison Narcotics Tax Act of 1914 Stop the recreational use of opium. Implemented to regulate and tax the distribution, importation, and production of opiates. Sulfanilamide Tragedy of 1937 Led to the passage of the Food, Drug, and Cosmetic Act of 1938, more than 100 people died after the use of sulfanilamide. Dissolved sulfanilamide into diethylene glycol (antifreeze). Food, Drug, and Cosmetic Act of 1938 Banned false claims, required package inserts with directions to be included with products, and required exact labeling on the product. Addictive substances to be labeled with the statement, Warning: May be Habit Forming. 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. Thalidomide Tragedy of 1962 10,000 children died from a Thalidomide side effect, was marketed as a sedative and hypnotic used for insomnia, anxiety and gastritis. Led to stricter drug research, development, and regulations. Kefauver-Harris Amendment of 1962 • Also known as the "Drug Efficacy Amendment". • Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval . • Required drug advertising to be more closely regulated and disclose accurate information about side effects Comprehensive Drug Abuse Prevention and Control Act of 1970 or Controlled Substances Act (CSA) Strictly controls the manufacture, importation, possession, use, and distribution of certain controlled substances. Narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and other regulated chemicals. • The DEA and FDA oversee the CSA. • The CSA implemented a scheduled class of narcotics based on abuse potential and safety. • CI - CV Poison Prevention Packaging Act of 1970 Requires use of child-resistant containers for prescription and nonprescription drugs Occupational Safety and Health Act (OSHA) of 1970 Establishes mandatory workplace safety regulations. Drug Listing Act of 1972 Establish the NDC (National Dru