PTCB - PHARMACY LAWS / EXAM NEWEST ACTUAL
QUESTIONS AND ANSWERS (A+ GUIDE SOLUTION)
Terms in this set (43)
Pure food and drugs act of prohibit the interstate transportation or sale of adulterated or
1906 misbranded food or drugs
What does Adulterated Consists of any filthy, decomposed, putrid susbtance
mean? 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
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
, Durham-Humphrey Act of Amendment of FDCA 1938
1951 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 Created the US Food and Drug Administration (FDA)
Cosmetic Act of 1938 Required all new drug applications be filed with the
(FDCA) FDA
Clearly defined Adulteration and misbranding
Kefauver-Harris Requires all medication in the US to be pure, safe, and effective
Amendment of 1962
Comprehensive drugs Established "Controlled substance" rating
abuse prevention and Created the Drug Enforcement Agency (DEA) Separated the
control act of 1970 controlled substance into 5 Schedule based on potential for
abuse and accepted medical use in the US
Prescription monitoring The Act establish an electronic system for practitioner
programs. the federal monitoring of the dispensing of controlled substances in SCH
2, 3, 4. The act would require specific information to be
National All Schedules
reported. But the act was never enacted at the federal level.
Prescription Electronic But many states have enacted similar legislation.
Reporting Act in 2005
to reduce accidental poisoning in children. Requires that
Poison prevention packaging most OTC and legend drugs be packaged in child-
act of 1970 resistant containers --> can't be opened by 80% of
children <5 yrs old but can be opened by 90% of adults.
QUESTIONS AND ANSWERS (A+ GUIDE SOLUTION)
Terms in this set (43)
Pure food and drugs act of prohibit the interstate transportation or sale of adulterated or
1906 misbranded food or drugs
What does Adulterated Consists of any filthy, decomposed, putrid susbtance
mean? 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
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
, Durham-Humphrey Act of Amendment of FDCA 1938
1951 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 Created the US Food and Drug Administration (FDA)
Cosmetic Act of 1938 Required all new drug applications be filed with the
(FDCA) FDA
Clearly defined Adulteration and misbranding
Kefauver-Harris Requires all medication in the US to be pure, safe, and effective
Amendment of 1962
Comprehensive drugs Established "Controlled substance" rating
abuse prevention and Created the Drug Enforcement Agency (DEA) Separated the
control act of 1970 controlled substance into 5 Schedule based on potential for
abuse and accepted medical use in the US
Prescription monitoring The Act establish an electronic system for practitioner
programs. the federal monitoring of the dispensing of controlled substances in SCH
2, 3, 4. The act would require specific information to be
National All Schedules
reported. But the act was never enacted at the federal level.
Prescription Electronic But many states have enacted similar legislation.
Reporting Act in 2005
to reduce accidental poisoning in children. Requires that
Poison prevention packaging most OTC and legend drugs be packaged in child-
act of 1970 resistant containers --> can't be opened by 80% of
children <5 yrs old but can be opened by 90% of adults.
