PTCB Review 2020-2021 Latest Update Already Passed

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PTCB Review 2020-2021 Latest Update Already Passed Pure Food and Drug Act of 1906 Correct Answer-All manufacturers are required to properly label a drug with truthful information, prove effectivene... ss, 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 Correct Answer-Stop the recreational use of opium. Implemented to regulate and tax the distribution, importation, and production of opiates. Sulfanilamide Tragedy of 1937 Correct Answer-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 Correct Answer-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 Correct Answer-• 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 Correct Answer-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 Correct Answer-• 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) Correct Answer-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 Correct Answer-Requires use of child-resistant containers for prescription and nonprescription drugs Occupational Safety and Health Act (OSHA) of 1970 Correct Answer-Establishes mandatory workplace safety regulations. Drug Listing Act of 1972 Correct Answer-Establish the NDC (National Drug Code) number 5 - 4 - 2 First 5: the manufacturer/labeler 2nd 4: the drug product/product code Final 2: package size and packaging Medical Device Amendment of 1976 Correct Answer-Established three regulatory classes for medical devices. • Class III - the most regulated and pose high risks for human use; require premarket approval applications that are the equivalent to a new drug application. • Class II - are performance-standard devices that are considered moderate risk for human use. • Class I - are general controlled dives with low risk for human use. Resource Conservation and Recovery Act (RCRA) of 1976 Correct Answer-Gives the Environmental Protection Agency (EPA) complete authority in the disposal of hazardous substances. Including their generation, transportation, treatment, storage, and disposal. Orphan Drug Act of 1983 Correct Answer-Regulates orphan drugs, which are pharmaceuticals developed specifically for rare diseases. Incentive from the government to create orphan drug. Drug Price Competition and Patent Term Restoration Act of 1984 Correct Answer-Encourages the manufacturing of generic drugs by drug companies and formed the modern system of generic drug regulation in the United States. • Outlines the process for drug companies to file an Abbreviated New Drug Application (ANDA) to receive approval of a generic drug. • First company that files an ANDA for a generic drug has 180 days of exclusive rights to market the generic alternative to the brand drug. Prescription Drug Marketing Act of 1987 Correct Answer-Helps prevent counterfeit drugs by providing legal safeguards in the chain of distribution of pharmaceuticals. It was designed to prevent the sales of discontinued, counterfeit, misbranded, subpar, an [Show More]

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