PTCB Exam 2025 – Pharmacy Laws &
Regulations Study Guide with Practice
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 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
Regulations Study Guide with Practice
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 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
