PTCB - Pharmacy Laws Exam Questions And Answers
Pure food and drugs act of 1906 - Answer prohibit the interstate transportation or sale of
adulterated or misbranded food or drugs
What does Adulterated mean? - 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 is Misbranding? - 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 - 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) - created the US Food and Drug
Administration (FDA)
-required all new drug applications be filed with the FDA
-Defined clearly Adulteration and misbranding
Kefauver-Harris Amendment of 1962- all medication in the US to be pure, safe, and
effective
Comprehensive drugs abuse prevention and control act of 1970- "Controlled substance"
rating
DEA
It separated the controlled substance into 5 Schedules based on the potential for abuse
and accepted medical use in the US.
Prescription monitoring programs. the federal National All Schedules Prescription
Electronic Reporting Act in 2005 - 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 - Answer to decrease accidental poisoning in
children.
Requires most OTC and legend drugs be packaged in child-resistant containers -->
unable to be opened by 80% of children <5 yrs old but able to be opened by 90% of
adults.
Occupational safety and health act (OSHA) of 1970 - Answer Created the Occupational
Safety and Health Administration (OSHA)
OSHA ensures a safe and healthful workplace for all employees _
Pure food and drugs act of 1906 - Answer prohibit the interstate transportation or sale of
adulterated or misbranded food or drugs
What does Adulterated mean? - 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 is Misbranding? - 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 - 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) - created the US Food and Drug
Administration (FDA)
-required all new drug applications be filed with the FDA
-Defined clearly Adulteration and misbranding
Kefauver-Harris Amendment of 1962- all medication in the US to be pure, safe, and
effective
Comprehensive drugs abuse prevention and control act of 1970- "Controlled substance"
rating
DEA
It separated the controlled substance into 5 Schedules based on the potential for abuse
and accepted medical use in the US.
Prescription monitoring programs. the federal National All Schedules Prescription
Electronic Reporting Act in 2005 - 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 - Answer to decrease accidental poisoning in
children.
Requires most OTC and legend drugs be packaged in child-resistant containers -->
unable to be opened by 80% of children <5 yrs old but able to be opened by 90% of
adults.
Occupational safety and health act (OSHA) of 1970 - Answer Created the Occupational
Safety and Health Administration (OSHA)
OSHA ensures a safe and healthful workplace for all employees _
