QUESTIONS WITH SOLUTIONS GRADED A+
● 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 does Misbranding mean?. 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. 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). 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. Answer: Requires all
medication in the US to be pure, safe, and effective
● Comprehensive drugs abuse prevention and control act of 1970.
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. Answer: The Act