RAC EXAM PRACTICE EXAM WITH
CORRECT 88 ACTUAL QUESTIONS AND
CORRECTLY WELL DEFINED ANSWERS
LATEST ALREADY GRADED A+ 2025 - 2026
Which of the following was NOT a criterion for OTC marketing according to
the Durham-Humphrey Amendments? a) Limitations of marketing approval
b) Habit-forming characteristics c) Lack of product side effects d) Need for
physician supervision(16:1) - ANSWERS-C. Lack of product side effects.
If a product contains both a drug active ingredient and a dietary supplement
can it be marketed as a dietary supplement? a) Yes b) No c) Only if it makes
no drug claims d) Only if contains both Drug Facts labeling and Supplement
Facts labeling(16:2) - ANSWERS-c) Only if it makes no drug claims.
Which of the following is not a route for OTC marketing approval? a)
Affirmation by the manufacturer that it can be labeled adequately for
consumer use. b) Petition to include the active ingredient in a monograph c)
New Drug Application d) Abbreviated New Drug Application(16:3) -
ANSWERS-a) Affirmation by the manufacturer that it can be labeled
adequately for consumer use.
,FDA interprets its regulatory authority over labeling to include: a) Bottle
labels b) Package inserts c) Medication Guides d) Promotional materials e) a b
and c f) a b c and d(17:1) - ANSWERS-f) a (bottle labels) b (Package inserts) c
(Medication Guides) and d (Promotional materials)
Which of the following is NOT true about Medication Guides? a) Medication
Guides are required to be distributed to a patient each time that the
prescription drug product is dispensed. b) Medical Guides are created for
products for which FDA has determined a serious and significant public heath
concern exists.c) Medication Guides have standard content and format
requirements. d) Medical Guides must be printed in a minimum 12-point
font.(17:2) - ANSWERS-d) Medical Guides must be printed in a minimum 12-
point font.
True or False: PLR format is recommended for any new NDA or labeling
supplement submitted in 2009.(17:3) - ANSWERS-False.
Drugs may be eligible for over-the-counter status when: a) They have been
marketed to a material extent b) They have been marketed for a material
time c) Are generally recognized as safe d) All of the above(2:4) - ANSWERS-D:
All of the above
Biologics are cleared for marketing through which process ?a) Establishment
License Application (ELA)b) Product License Application (PLA)c) Biologics
License Application (BLA)d) All of the above(2:5) - ANSWERS-C: Biologics
License Application (BLA)
, A Special 510(k) relies on the following information: a) Design control
documentation b) Guidance documents c) Consensus standards d) All of the
above(2:6) - ANSWERS-A: Design control documentation
Which act required rulemaking meetings to be open to the public? a)
Moonshine Act b) Government in the Sunshine Act c) Food Drug and
Cosmetics Act d) Administrative Amendments Act(2:7) - ANSWERS-B:
Government in the Sunshine Act
Which of the following does not distinguish the development of drugs for
animal use from those for human use: a) The ability to use known data from
the development of a drug for use in humans or other animal species as
applicable. b) Generally safety and efficacy studies require only 10s of
animals per group compared to the 100s of patients per group required for
human drugs. c) Does not have user fees for NADAs. d) Species class and
breed of animals as well as geographical differences are more relevant.(3:1) -
ANSWERS-C: Does not have user fees for NADAs.
A generic drug is deemed bioequivalent to the RLD if in clinical
bioequivalence studies the 90% confidence intervals for the ratio of
population geometric means between the two treatments based on log-
transformed data is contained within the equivalence limits of ____% - ____%
for AUC and Cmax. a) 80 120 b) 75 125 c) 90 110 d) 80 125(3:2) - ANSWERS-D:
80% and 125%
What is the definition of a biologic?(3:3) - ANSWERS-A substance derived
from or made with the aid of living organisms.
What are the major categories of ICH guidelines?(3:4) - ANSWERS-Quality
Safety Efficacy Multidisciplinary
CORRECT 88 ACTUAL QUESTIONS AND
CORRECTLY WELL DEFINED ANSWERS
LATEST ALREADY GRADED A+ 2025 - 2026
Which of the following was NOT a criterion for OTC marketing according to
the Durham-Humphrey Amendments? a) Limitations of marketing approval
b) Habit-forming characteristics c) Lack of product side effects d) Need for
physician supervision(16:1) - ANSWERS-C. Lack of product side effects.
If a product contains both a drug active ingredient and a dietary supplement
can it be marketed as a dietary supplement? a) Yes b) No c) Only if it makes
no drug claims d) Only if contains both Drug Facts labeling and Supplement
Facts labeling(16:2) - ANSWERS-c) Only if it makes no drug claims.
Which of the following is not a route for OTC marketing approval? a)
Affirmation by the manufacturer that it can be labeled adequately for
consumer use. b) Petition to include the active ingredient in a monograph c)
New Drug Application d) Abbreviated New Drug Application(16:3) -
ANSWERS-a) Affirmation by the manufacturer that it can be labeled
adequately for consumer use.
,FDA interprets its regulatory authority over labeling to include: a) Bottle
labels b) Package inserts c) Medication Guides d) Promotional materials e) a b
and c f) a b c and d(17:1) - ANSWERS-f) a (bottle labels) b (Package inserts) c
(Medication Guides) and d (Promotional materials)
Which of the following is NOT true about Medication Guides? a) Medication
Guides are required to be distributed to a patient each time that the
prescription drug product is dispensed. b) Medical Guides are created for
products for which FDA has determined a serious and significant public heath
concern exists.c) Medication Guides have standard content and format
requirements. d) Medical Guides must be printed in a minimum 12-point
font.(17:2) - ANSWERS-d) Medical Guides must be printed in a minimum 12-
point font.
True or False: PLR format is recommended for any new NDA or labeling
supplement submitted in 2009.(17:3) - ANSWERS-False.
Drugs may be eligible for over-the-counter status when: a) They have been
marketed to a material extent b) They have been marketed for a material
time c) Are generally recognized as safe d) All of the above(2:4) - ANSWERS-D:
All of the above
Biologics are cleared for marketing through which process ?a) Establishment
License Application (ELA)b) Product License Application (PLA)c) Biologics
License Application (BLA)d) All of the above(2:5) - ANSWERS-C: Biologics
License Application (BLA)
, A Special 510(k) relies on the following information: a) Design control
documentation b) Guidance documents c) Consensus standards d) All of the
above(2:6) - ANSWERS-A: Design control documentation
Which act required rulemaking meetings to be open to the public? a)
Moonshine Act b) Government in the Sunshine Act c) Food Drug and
Cosmetics Act d) Administrative Amendments Act(2:7) - ANSWERS-B:
Government in the Sunshine Act
Which of the following does not distinguish the development of drugs for
animal use from those for human use: a) The ability to use known data from
the development of a drug for use in humans or other animal species as
applicable. b) Generally safety and efficacy studies require only 10s of
animals per group compared to the 100s of patients per group required for
human drugs. c) Does not have user fees for NADAs. d) Species class and
breed of animals as well as geographical differences are more relevant.(3:1) -
ANSWERS-C: Does not have user fees for NADAs.
A generic drug is deemed bioequivalent to the RLD if in clinical
bioequivalence studies the 90% confidence intervals for the ratio of
population geometric means between the two treatments based on log-
transformed data is contained within the equivalence limits of ____% - ____%
for AUC and Cmax. a) 80 120 b) 75 125 c) 90 110 d) 80 125(3:2) - ANSWERS-D:
80% and 125%
What is the definition of a biologic?(3:3) - ANSWERS-A substance derived
from or made with the aid of living organisms.
What are the major categories of ICH guidelines?(3:4) - ANSWERS-Quality
Safety Efficacy Multidisciplinary
