PTCB - Pharmacy Laws Exam with all Correct & 100%
Verified Answers |Latest Version |Already Graded A+
Pure food and drugs act of 1906 ✔Correct Answer-prohibit the interstate transportation or
sale of adulterated or misbranded food or drugs
What does Adulterated mean? ✔Correct Answer-Consists of any filthy, decomposed, putrid
susbtance
Perpared, packed, or help under unsanitary conditions
Perpared in containers composed of any poisonous or deleterious substance
Containing unsafe color additives
Recognized in an official compendium but differing in strength, quality, or purity of the drugs
What does Misbranding mean? ✔Correct Answer-False labeling
No label
Label lacks Name, place of business of the manufacturer/packer/distributor, lack accurate
quantity of contents.
No Warning if the product is habit forming
No labeled direction for use and no warning against certain pathological conditions
Products that are dangerous to health under the labeled dosage
No ingredient/alcohol content if have alcohol
Failed to bear the established name of the drug
Durham-Humphrey Act of 1951 ✔Correct Answer-Amendment of FDCA 1938
Require all products to have adequate directions for use
Don't need to have adequate directions for use if the drug/products must be dispense with a
prescription (not over-the-counter)
Separated drugs into Legend and Nonlegend (over the counter)
Allows verbal prescriptions over the phone
Allows refills to be called in from a doctors' office
Food, Drugs, and Cosmetic Act of 1938 (FDCA) ✔Correct Answer-Created the US Food and
Drug Administration (FDA)
Required all new drug applications be filed with the FDA
Clearly defined Adulteration and misbranding
Kefauver-Harris Amendment of 1962 ✔Correct Answer-Requires all medication in the US to
be pure, safe, and effective
Comprehensive drugs abuse prevention and control act of 1970 ✔Correct Answer-Established
"Controlled substance" rating
Created the Drug Enforcement Agency (DEA)
, Separated the controlled substance into 5 Schedule based on potential for abuse and accepted
medical use in the US
Prescription monitoring programs. the federal National All Schedules Prescription Electronic
Reporting Act in 2005 ✔Correct Answer-The Act establish an electronic system for
practitioner monitoring of the dispensing of controlled substances in SCH 2, 3, 4. The act would
require specific information to be reported. But the act was never enacted at the federal level.
But many states have enacted similar legislation.
Poison prevention packaging act of 1970 ✔Correct Answer-to reduce accidental poisoning in
children.
Requires that most OTC and legend drugs be packaged in child-resistant containers --> can't be
opened by 80% of children <5 yrs old but can be opened by 90% of adults.
Occupational safety and health act (OSHA) of 1970 ✔Correct Answer-Created the
Occupational Safety and Health Administration (OSHA)
OSHA ensures a safe and healthful workplace for all employees
Ensures job safety and health standards for employees
Maintain a reporting system for job-related injuries and illness, reduce hazards in the
workplace, and conduct audits to ensure compliance with the Act
Address Air contaminants, flammable, and combustible liquids, eye and skin protection, and
hazard communication standards.
Requires the MSDS to be use
Drug listing act of 1972 ✔Correct Answer-Establish the NDC (National Drug Code) number
5-4-2
First 5: the manufacturer
2nd 4: the drug product
Final 2: package size and packaging
Orphan Drug Act of 1982 ✔Correct Answer-Provides tax incentives and exclusive licensing of
products for manufacturers to develop and market orphan medication
Orphan medication ✔Correct Answer-medications for treatment of diseases or conditions of
which there are fewer than 200,000 cases in the world.
Drug Price Competition and Patent term restoration act of 1984 ✔Correct Answer-
encouraged the creation of both generic and new medications
streamlining the process for generic drug approval and by extending patent licenses.
Prescription Drug marketing act of 1987 ✔Correct Answer-prohibits the re-importation of a
drug into the US by anyone except the manufacturer.
prohibits the sale or distribution of samples to anyone other than those licensed to prescribe
them
Verified Answers |Latest Version |Already Graded A+
Pure food and drugs act of 1906 ✔Correct Answer-prohibit the interstate transportation or
sale of adulterated or misbranded food or drugs
What does Adulterated mean? ✔Correct Answer-Consists of any filthy, decomposed, putrid
susbtance
Perpared, packed, or help under unsanitary conditions
Perpared in containers composed of any poisonous or deleterious substance
Containing unsafe color additives
Recognized in an official compendium but differing in strength, quality, or purity of the drugs
What does Misbranding mean? ✔Correct Answer-False labeling
No label
Label lacks Name, place of business of the manufacturer/packer/distributor, lack accurate
quantity of contents.
No Warning if the product is habit forming
No labeled direction for use and no warning against certain pathological conditions
Products that are dangerous to health under the labeled dosage
No ingredient/alcohol content if have alcohol
Failed to bear the established name of the drug
Durham-Humphrey Act of 1951 ✔Correct Answer-Amendment of FDCA 1938
Require all products to have adequate directions for use
Don't need to have adequate directions for use if the drug/products must be dispense with a
prescription (not over-the-counter)
Separated drugs into Legend and Nonlegend (over the counter)
Allows verbal prescriptions over the phone
Allows refills to be called in from a doctors' office
Food, Drugs, and Cosmetic Act of 1938 (FDCA) ✔Correct Answer-Created the US Food and
Drug Administration (FDA)
Required all new drug applications be filed with the FDA
Clearly defined Adulteration and misbranding
Kefauver-Harris Amendment of 1962 ✔Correct Answer-Requires all medication in the US to
be pure, safe, and effective
Comprehensive drugs abuse prevention and control act of 1970 ✔Correct Answer-Established
"Controlled substance" rating
Created the Drug Enforcement Agency (DEA)
, Separated the controlled substance into 5 Schedule based on potential for abuse and accepted
medical use in the US
Prescription monitoring programs. the federal National All Schedules Prescription Electronic
Reporting Act in 2005 ✔Correct Answer-The Act establish an electronic system for
practitioner monitoring of the dispensing of controlled substances in SCH 2, 3, 4. The act would
require specific information to be reported. But the act was never enacted at the federal level.
But many states have enacted similar legislation.
Poison prevention packaging act of 1970 ✔Correct Answer-to reduce accidental poisoning in
children.
Requires that most OTC and legend drugs be packaged in child-resistant containers --> can't be
opened by 80% of children <5 yrs old but can be opened by 90% of adults.
Occupational safety and health act (OSHA) of 1970 ✔Correct Answer-Created the
Occupational Safety and Health Administration (OSHA)
OSHA ensures a safe and healthful workplace for all employees
Ensures job safety and health standards for employees
Maintain a reporting system for job-related injuries and illness, reduce hazards in the
workplace, and conduct audits to ensure compliance with the Act
Address Air contaminants, flammable, and combustible liquids, eye and skin protection, and
hazard communication standards.
Requires the MSDS to be use
Drug listing act of 1972 ✔Correct Answer-Establish the NDC (National Drug Code) number
5-4-2
First 5: the manufacturer
2nd 4: the drug product
Final 2: package size and packaging
Orphan Drug Act of 1982 ✔Correct Answer-Provides tax incentives and exclusive licensing of
products for manufacturers to develop and market orphan medication
Orphan medication ✔Correct Answer-medications for treatment of diseases or conditions of
which there are fewer than 200,000 cases in the world.
Drug Price Competition and Patent term restoration act of 1984 ✔Correct Answer-
encouraged the creation of both generic and new medications
streamlining the process for generic drug approval and by extending patent licenses.
Prescription Drug marketing act of 1987 ✔Correct Answer-prohibits the re-importation of a
drug into the US by anyone except the manufacturer.
prohibits the sale or distribution of samples to anyone other than those licensed to prescribe
them
