3/13/25, 11:26 AM PTCB - PHARMACY LAWS / EXAM NEWEST ACTUAL QUESTIONS AND ANSWERS (A+ GUIDE SOLUTION) Flashcards | Quizlet
PTCB - PHARMACY LAWS / EXAM NEWEST
ACTUAL QUESTIONS AND ANSWERS (A+ GUIDE
SOLUTION)
Save
Terms in this set (43)
Pure food and drugs act prohibit the interstate transportation or sale of
of 1906 adulterated or misbranded food or drugs
Consists of any filthy, decomposed, putrid susbtance
Perpared, packed, or help under unsanitary conditions
Perpared in containers composed of any poisonous
What does Adulterated
or deleterious substance
mean?
Containing unsafe color additives
Recognized in an official compendium but differing in
strength, quality, or purity of the drugs
False labeling
No label
Label lacks Name, place of business of the
manufacturer/packer/distributor, lack accurate
quantity of contents.
What does Misbranding No Warning if the product is habit forming
mean? 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
https://quizlet.com/1017737296/ptcb-pharmacy-laws-exam-newest-actual-questions-and-answers-a-guide-solution-flash-cards/?new 1/8
, 3/13/25, 11:26 AM PTCB - PHARMACY LAWS / EXAM NEWEST ACTUAL QUESTIONS AND ANSWERS (A+ GUIDE SOLUTION) Flashcards | Quizlet
Amendment of FDCA 1938
Require all products to have adequate directions for
use
Don't need to have adequate directions for use if the
Durham-Humphrey Act of drug/products must be dispense with a prescription
1951 (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
Created the US Food and Drug Administration (FDA)
Food, Drugs, and
Required all new drug applications be filed with the
Cosmetic Act of 1938
FDA
(FDCA)
Clearly defined Adulteration and misbranding
Kefauver-Harris Requires all medication in the US to be pure, safe, and
Amendment of 1962 effective
Established "Controlled substance" rating
Comprehensive drugs Created the Drug Enforcement Agency (DEA)
abuse prevention and Separated the controlled substance into 5 Schedule
control act of 1970 based on potential for abuse and accepted medical
use in the US
The Act establish an electronic system for practitioner
Prescription monitoring
monitoring of the dispensing of controlled substances
programs. the federal
in SCH 2, 3, 4. The act would require specific
National All Schedules
information to be reported. But the act was never
Prescription Electronic
enacted at the federal level. But many states have
Reporting Act in 2005
enacted similar legislation.
to reduce accidental poisoning in children.
Requires that most OTC and legend drugs be
Poison prevention
packaged in child-resistant containers --> can't be
packaging act of 1970
opened by 80% of children <5 yrs old but can be
opened by 90% of adults.
https://quizlet.com/1017737296/ptcb-pharmacy-laws-exam-newest-actual-questions-and-answers-a-guide-solution-flash-cards/?new 2/8
PTCB - PHARMACY LAWS / EXAM NEWEST
ACTUAL QUESTIONS AND ANSWERS (A+ GUIDE
SOLUTION)
Save
Terms in this set (43)
Pure food and drugs act prohibit the interstate transportation or sale of
of 1906 adulterated or misbranded food or drugs
Consists of any filthy, decomposed, putrid susbtance
Perpared, packed, or help under unsanitary conditions
Perpared in containers composed of any poisonous
What does Adulterated
or deleterious substance
mean?
Containing unsafe color additives
Recognized in an official compendium but differing in
strength, quality, or purity of the drugs
False labeling
No label
Label lacks Name, place of business of the
manufacturer/packer/distributor, lack accurate
quantity of contents.
What does Misbranding No Warning if the product is habit forming
mean? 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
https://quizlet.com/1017737296/ptcb-pharmacy-laws-exam-newest-actual-questions-and-answers-a-guide-solution-flash-cards/?new 1/8
, 3/13/25, 11:26 AM PTCB - PHARMACY LAWS / EXAM NEWEST ACTUAL QUESTIONS AND ANSWERS (A+ GUIDE SOLUTION) Flashcards | Quizlet
Amendment of FDCA 1938
Require all products to have adequate directions for
use
Don't need to have adequate directions for use if the
Durham-Humphrey Act of drug/products must be dispense with a prescription
1951 (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
Created the US Food and Drug Administration (FDA)
Food, Drugs, and
Required all new drug applications be filed with the
Cosmetic Act of 1938
FDA
(FDCA)
Clearly defined Adulteration and misbranding
Kefauver-Harris Requires all medication in the US to be pure, safe, and
Amendment of 1962 effective
Established "Controlled substance" rating
Comprehensive drugs Created the Drug Enforcement Agency (DEA)
abuse prevention and Separated the controlled substance into 5 Schedule
control act of 1970 based on potential for abuse and accepted medical
use in the US
The Act establish an electronic system for practitioner
Prescription monitoring
monitoring of the dispensing of controlled substances
programs. the federal
in SCH 2, 3, 4. The act would require specific
National All Schedules
information to be reported. But the act was never
Prescription Electronic
enacted at the federal level. But many states have
Reporting Act in 2005
enacted similar legislation.
to reduce accidental poisoning in children.
Requires that most OTC and legend drugs be
Poison prevention
packaged in child-resistant containers --> can't be
packaging act of 1970
opened by 80% of children <5 yrs old but can be
opened by 90% of adults.
https://quizlet.com/1017737296/ptcb-pharmacy-laws-exam-newest-actual-questions-and-answers-a-guide-solution-flash-cards/?new 2/8
