PTCB - PHARMACY LAWS QUESTIONS
AND ANSWERS WITH VERIFIED
SOLUTIONS 100% CORRECT RATED A+
1. What is the Pure Food and Drugs Act of 1906?
Answer:
It prohibits the interstate transportation or sale of adulterated or misbranded food
and drugs.
2. What does "Adulterated" mean?
Answer:
Adulterated refers to substances that are:
Filthy, decomposed, or putrid.
Prepared, packed, or held under unsanitary conditions.
Packaged in containers made of harmful substances.
Contain unsafe color additives.
Differ in strength, quality, or purity from recognized standards.
3. What does "Misbranding" mean?
Answer:
Misbranding refers to:
False labeling or no label at all.
Missing the name or place of business of the
manufacturer/packer/distributor.
Inaccurate quantity of contents.
No warning about habit-forming properties.
Lack of directions for use or warnings for certain health conditions.
, Products that are dangerous under the labeled dosage.
Missing ingredient/alcohol content when alcohol is present.
Failing to include the official name of the drug.
4. What is the Durham-Humphrey Act of 1951?
Answer:
An amendment to the 1938 Food, Drugs, and Cosmetics Act (FDCA) that:
Required all products to have directions for use unless dispensed via
prescription.
Separated drugs into "Legend" (prescription) and "Nonlegend" (over-the-
counter).
Allowed verbal prescriptions and refills to be called in from a doctor's office.
5. What is the Food, Drugs, and Cosmetics Act of 1938 (FDCA)?
Answer:
The FDCA created the U.S. Food and Drug Administration (FDA) and:
Required new drug applications to be filed with the FDA.
Clearly defined adulteration and misbranding.
6. What was the Kefauver-Harris Amendment of 1962?
Answer:
This amendment required all medications in the U.S. to be:
Pure, safe, and effective.
7. What is the Comprehensive Drug Abuse Prevention and Control Act of
1970?
Answer:
This act:
AND ANSWERS WITH VERIFIED
SOLUTIONS 100% CORRECT RATED A+
1. What is the Pure Food and Drugs Act of 1906?
Answer:
It prohibits the interstate transportation or sale of adulterated or misbranded food
and drugs.
2. What does "Adulterated" mean?
Answer:
Adulterated refers to substances that are:
Filthy, decomposed, or putrid.
Prepared, packed, or held under unsanitary conditions.
Packaged in containers made of harmful substances.
Contain unsafe color additives.
Differ in strength, quality, or purity from recognized standards.
3. What does "Misbranding" mean?
Answer:
Misbranding refers to:
False labeling or no label at all.
Missing the name or place of business of the
manufacturer/packer/distributor.
Inaccurate quantity of contents.
No warning about habit-forming properties.
Lack of directions for use or warnings for certain health conditions.
, Products that are dangerous under the labeled dosage.
Missing ingredient/alcohol content when alcohol is present.
Failing to include the official name of the drug.
4. What is the Durham-Humphrey Act of 1951?
Answer:
An amendment to the 1938 Food, Drugs, and Cosmetics Act (FDCA) that:
Required all products to have directions for use unless dispensed via
prescription.
Separated drugs into "Legend" (prescription) and "Nonlegend" (over-the-
counter).
Allowed verbal prescriptions and refills to be called in from a doctor's office.
5. What is the Food, Drugs, and Cosmetics Act of 1938 (FDCA)?
Answer:
The FDCA created the U.S. Food and Drug Administration (FDA) and:
Required new drug applications to be filed with the FDA.
Clearly defined adulteration and misbranding.
6. What was the Kefauver-Harris Amendment of 1962?
Answer:
This amendment required all medications in the U.S. to be:
Pure, safe, and effective.
7. What is the Comprehensive Drug Abuse Prevention and Control Act of
1970?
Answer:
This act:
