PTCB Review 2020-2021 LATEST WELL
graded 100% CORRECT.
Pure Food and Drug Act of 1906 - answer 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 - answer Stop the recreational use of opium.
Implemented to regulate and tax the distribution, importation, and production of opiates.
Sulfanilamide Tragedy of 1937 - 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 - 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 - 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 - 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 - 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) - 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
, PTCB Review 2020-2021 LATEST WELL
graded 100% CORRECT.
Poison Prevention Packaging Act of 1970 - answer Requires use of child-resistant
containers for prescription and nonprescription drugs
Occupational Safety and Health Act (OSHA) of 1970 - answer Establishes mandatory
workplace safety regulations.
Drug Listing Act of 1972 - 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 - 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 - 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 - 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 - 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 - 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, and
expired prescription drugs.
Omnibus Budget Reconciliation Act (OBRA) of 1990 - answer Related to COBRA,
allows for continuing coverage and benefits of group healthcare plans for an employee
graded 100% CORRECT.
Pure Food and Drug Act of 1906 - answer 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 - answer Stop the recreational use of opium.
Implemented to regulate and tax the distribution, importation, and production of opiates.
Sulfanilamide Tragedy of 1937 - 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 - 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 - 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 - 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 - 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) - 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
, PTCB Review 2020-2021 LATEST WELL
graded 100% CORRECT.
Poison Prevention Packaging Act of 1970 - answer Requires use of child-resistant
containers for prescription and nonprescription drugs
Occupational Safety and Health Act (OSHA) of 1970 - answer Establishes mandatory
workplace safety regulations.
Drug Listing Act of 1972 - 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 - 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 - 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 - 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 - 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 - 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, and
expired prescription drugs.
Omnibus Budget Reconciliation Act (OBRA) of 1990 - answer Related to COBRA,
allows for continuing coverage and benefits of group healthcare plans for an employee
