RAC DRUGS FINAL EXAM STUDY
GUIDE 2026 COMPLETE QUESTIONS
WITH CORRECT DETAILED ANSWERS ||
100% GUARANTEED PASS <RECENT
VERSION>
Module 1: US Regulatory Framework and Ethics
1. What is the primary legislative act that prohibits the adulteration and
misbranding of drugs and foods in the United States?
A. Food, Drug, and Cosmetic Act of 1938
B. Pure Food and Drug Act of 1906
C. Kefauver-Harris Amendments of 1962
D. Prescription Drug User Fee Act of 1992
Answer: B. The Pure Food and Drug Act of 1906 was the first federal law to
prohibit the interstate commerce of adulterated and misbranded drugs and foods.
2. Which amendment to the FD&C Act was enacted in response to the elixir
sulfanilamide tragedy, requiring proof of safety before a drug could be
marketed?
A. Kefauver-Harris Amendments
B. Drug Efficacy Study Implementation (DESI)
C. Food, Drug, and Cosmetic Act of 1938
D. Dietary Supplement Health and Education Act (DSHEA)
Answer: C. The FD&C Act of 1938 replaced the 1906 Act and mandated pre-
market approval of new drugs based on safety.
3. The Kefauver-Harris Amendments of 1962 were a direct response to what
event?
A. The Elixir Sulfanilamide tragedy
,B. The Thalidomide crisis
C. The Tylenol tampering case
D) The Fen-Phen withdrawals
Answer: B. The thalidomide crisis in Europe, which caused severe birth defects,
led to the 1962 amendments that required drugs to be proven both safe
and effective.
4. Under which act was the Prescription Drug User Fee Act (PDUFA) first
established?
A. Food and Drug Administration Modernization Act of 1997 (FDAMA)
B. Food and Drug Administration Amendments Act of 2007 (FDAAA)
C. Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA)
D. The original PDUFA was a standalone act in 1992
Answer: D. PDUFA was first enacted as a standalone act in 1992, authorizing the
FDA to collect fees from industry to fund the drug review process.
5. Which of the following is NOT a primary goal of PDUFA?
A. To shorten FDA review times for NDAs/BLAs
B. To provide industry with more predictable application review cycles
C. To fund post-market safety initiatives
D. To mandate the use of electronic submission standards
Answer: D. While PDUFA has encouraged electronic submissions, the mandate is
primarily driven by other regulations and guidances (e.g., eCTD mandate).
PDUFA's core goals are focused on review performance and safety.
6. The "Deeming Rule" is associated with the regulation of which product
category?
A. Biosimilars
B. Orphan Drugs
C. Tobacco Products
D. Medical Foods
Answer: C. The "Deeming Rule" extended the FDA's authority to all tobacco
products, including e-cigarettes, cigars, and hookah.
, 7. Which of the following actions would most likely constitute a violation of
the FDA's regulations on promoting an unapproved drug?
A. Discussing off-label uses in response to an unsolicited question.
B. Distributing reprints of a journal article on an unapproved use to a formulary
committee.
C. Including an unapproved use in the promotional materials for a marketed drug.
D. Presenting data on an unapproved use at a major scientific conference.
Answer: C. Actively promoting an unapproved use in promotional materials is a
clear violation. The other scenarios have specific, narrow safe harbors if all
regulatory conditions are met.
8. What is the primary purpose of an FDA Form 483?
A. To approve a New Drug Application (NDA)
B. To formally warn a company of impending regulatory action
C. To document observations made during an FDA inspection
D. To request a recall of a defective product
Answer: C. The FDA Form 483, "Inspectional Observations," is issued at the
conclusion of an inspection to list conditions that may violate the FD&C Act.
9. A Warning Letter from the FDA is:
A. Legally binding and requires an immediate shutdown of operations.
B. An informal notice with no regulatory significance.
C. A formal communication that alleges violations and demands corrective action.
D. Only issued after a product recall has been initiated.
Answer: C. A Warning Letter is a formal notice that establishes prior notice and
can lead to more severe enforcement action (e.g., injunction, seizure) if violations
are not promptly corrected.
10. The concept that a company is responsible for the actions of its contractors
and agents in regulatory matters is known as:
A. Strict Liability
B. Vicarious Liability
GUIDE 2026 COMPLETE QUESTIONS
WITH CORRECT DETAILED ANSWERS ||
100% GUARANTEED PASS <RECENT
VERSION>
Module 1: US Regulatory Framework and Ethics
1. What is the primary legislative act that prohibits the adulteration and
misbranding of drugs and foods in the United States?
A. Food, Drug, and Cosmetic Act of 1938
B. Pure Food and Drug Act of 1906
C. Kefauver-Harris Amendments of 1962
D. Prescription Drug User Fee Act of 1992
Answer: B. The Pure Food and Drug Act of 1906 was the first federal law to
prohibit the interstate commerce of adulterated and misbranded drugs and foods.
2. Which amendment to the FD&C Act was enacted in response to the elixir
sulfanilamide tragedy, requiring proof of safety before a drug could be
marketed?
A. Kefauver-Harris Amendments
B. Drug Efficacy Study Implementation (DESI)
C. Food, Drug, and Cosmetic Act of 1938
D. Dietary Supplement Health and Education Act (DSHEA)
Answer: C. The FD&C Act of 1938 replaced the 1906 Act and mandated pre-
market approval of new drugs based on safety.
3. The Kefauver-Harris Amendments of 1962 were a direct response to what
event?
A. The Elixir Sulfanilamide tragedy
,B. The Thalidomide crisis
C. The Tylenol tampering case
D) The Fen-Phen withdrawals
Answer: B. The thalidomide crisis in Europe, which caused severe birth defects,
led to the 1962 amendments that required drugs to be proven both safe
and effective.
4. Under which act was the Prescription Drug User Fee Act (PDUFA) first
established?
A. Food and Drug Administration Modernization Act of 1997 (FDAMA)
B. Food and Drug Administration Amendments Act of 2007 (FDAAA)
C. Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA)
D. The original PDUFA was a standalone act in 1992
Answer: D. PDUFA was first enacted as a standalone act in 1992, authorizing the
FDA to collect fees from industry to fund the drug review process.
5. Which of the following is NOT a primary goal of PDUFA?
A. To shorten FDA review times for NDAs/BLAs
B. To provide industry with more predictable application review cycles
C. To fund post-market safety initiatives
D. To mandate the use of electronic submission standards
Answer: D. While PDUFA has encouraged electronic submissions, the mandate is
primarily driven by other regulations and guidances (e.g., eCTD mandate).
PDUFA's core goals are focused on review performance and safety.
6. The "Deeming Rule" is associated with the regulation of which product
category?
A. Biosimilars
B. Orphan Drugs
C. Tobacco Products
D. Medical Foods
Answer: C. The "Deeming Rule" extended the FDA's authority to all tobacco
products, including e-cigarettes, cigars, and hookah.
, 7. Which of the following actions would most likely constitute a violation of
the FDA's regulations on promoting an unapproved drug?
A. Discussing off-label uses in response to an unsolicited question.
B. Distributing reprints of a journal article on an unapproved use to a formulary
committee.
C. Including an unapproved use in the promotional materials for a marketed drug.
D. Presenting data on an unapproved use at a major scientific conference.
Answer: C. Actively promoting an unapproved use in promotional materials is a
clear violation. The other scenarios have specific, narrow safe harbors if all
regulatory conditions are met.
8. What is the primary purpose of an FDA Form 483?
A. To approve a New Drug Application (NDA)
B. To formally warn a company of impending regulatory action
C. To document observations made during an FDA inspection
D. To request a recall of a defective product
Answer: C. The FDA Form 483, "Inspectional Observations," is issued at the
conclusion of an inspection to list conditions that may violate the FD&C Act.
9. A Warning Letter from the FDA is:
A. Legally binding and requires an immediate shutdown of operations.
B. An informal notice with no regulatory significance.
C. A formal communication that alleges violations and demands corrective action.
D. Only issued after a product recall has been initiated.
Answer: C. A Warning Letter is a formal notice that establishes prior notice and
can lead to more severe enforcement action (e.g., injunction, seizure) if violations
are not promptly corrected.
10. The concept that a company is responsible for the actions of its contractors
and agents in regulatory matters is known as:
A. Strict Liability
B. Vicarious Liability
