PTCB Review 2020-2021
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 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 - 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 - 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 - 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 - 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 - 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 - Related to COBRA, allows for
continuing coverage and benefits of group healthcare plans for an employee and family
based upon certain qualifying issues and events when benefits would otherwise be
terminated.
FDA Safe Medical Devices Act of 1990 - All medical devices are to be tracked and records
maintained for durable medical equipment.
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 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 - 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 - 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 - 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 - 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 - 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 - Related to COBRA, allows for
continuing coverage and benefits of group healthcare plans for an employee and family
based upon certain qualifying issues and events when benefits would otherwise be
terminated.
FDA Safe Medical Devices Act of 1990 - All medical devices are to be tracked and records
maintained for durable medical equipment.
