PTCB - Pharmacy Laws Questions with
Correct Answers 2025
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.
Correct Answers 2025
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.
