Florida CDR Exam Practice Questions &
Answers with Rationales | Pass Your 20 FL X
Certified Designated Representative Exam
Question 1
Wholesalers need a permit granted from the state and are also required to register
with the FDA. True or false
Correct Answer
True
Question 2
Embargo is better known as:
Correct Answer
Stop Sale
Question 3
Excluding soap, anything intended to beautify, cleansing, promoting attractiveness or
altering appearance is known as?
Correct Answer
A cosmetic
Question 4
It is illegal to purchase in Florida from a non-US wholesaler. true or false
Correct Answer
True
Page 1 of 102
,Question 5
Which of the following are characteristics of misbranded product?
Correct Answer
Prescription label does not bear the statement "RX Only" or similar notation,
contents in terms of weight or numerical count is inaccurate, if it is color additive is
not in conformity with the packaging .
Question 6
Contains seal/labeling of which without authorization bears the trademark, tradename
or other identifying marks, imprint or any likeness therefore falsely represents to be
the product
Correct Answer
Counterfeit
Question 7
What does CDR stand for?
Correct Answer
Certified designated representative
Question 8
A drug is considered adulterated if the strength, quantity and or purity falls below
that of which is in the official compendium (USP). True or false
Correct Answer
True
Question 9
The new drug application is also known as?
Correct Answer
NDA
Page 2 of 102
,Question 10
They manufacture outside the US can apply for a __________ manufacturer permit.
Correct Answer
Non resident
Page 3 of 102
, Question 11
Any person who manufactures, packages, three packages, labels or relabels a drug in
the state must register such drug annually with the department. True or false
Correct Answer
False
Question 1: Under Florida Statute Chapter 499, which of the following best
describes the primary responsibility of a Certified Designated Representative
(CDR) for a prescription drug wholesale distributor operating in the state?
A. Overseeing only the financial auditing of inventory transactions
B. Ensuring exclusive compliance with federal DEA registration requirements
C. Managing the physical security of the facility without involvement in record-
keeping
D. Serving as the primary point of contact responsible for the wholesale distributor’s
compliance with all applicable state and federal laws governing the distribution of
prescription drugs
CORRECT ANSWER: D. Serving as the primary point of contact responsible for
the wholesale distributor’s compliance with all applicable state and federal
laws governing the distribution of prescription drugs
Rationale: Florida law designates the CDR as the individual accountable for ensuring
the wholesale distributor adheres to Chapter 499, F.S., and related federal
requirements, including pedigree, storage, record retention, and reporting
obligations. The CDR must be knowledgeable of and responsible for the day-to-day
compliance operations of the establishment.
Question 2: According to Florida Board of Pharmacy rules applicable to
Certified Designated Representatives, what is the minimum number of hours
of continuing education that a CDR must complete during each two-year
renewal cycle?
A. 10 hours of general pharmacy law
B. 15 hours with at least 5 hours focused on Florida drug wholesale distribution law
C. 20 hours of any ACPE-approved continuing education
D. 24 hours including 2 hours of HIV/AIDS and 2 hours of medical errors
CORRECT ANSWER: B. 15 hours with at least 5 hours focused on Florida drug
wholesale distribution law
Rationale: Florida administrative rules require CDRs to complete 15 hours of
continuing education every two years, of which a minimum of 5 hours must
specifically address Florida laws and rules governing prescription drug wholesale
distribution to maintain certification.
Page 4 of 102
Answers with Rationales | Pass Your 20 FL X
Certified Designated Representative Exam
Question 1
Wholesalers need a permit granted from the state and are also required to register
with the FDA. True or false
Correct Answer
True
Question 2
Embargo is better known as:
Correct Answer
Stop Sale
Question 3
Excluding soap, anything intended to beautify, cleansing, promoting attractiveness or
altering appearance is known as?
Correct Answer
A cosmetic
Question 4
It is illegal to purchase in Florida from a non-US wholesaler. true or false
Correct Answer
True
Page 1 of 102
,Question 5
Which of the following are characteristics of misbranded product?
Correct Answer
Prescription label does not bear the statement "RX Only" or similar notation,
contents in terms of weight or numerical count is inaccurate, if it is color additive is
not in conformity with the packaging .
Question 6
Contains seal/labeling of which without authorization bears the trademark, tradename
or other identifying marks, imprint or any likeness therefore falsely represents to be
the product
Correct Answer
Counterfeit
Question 7
What does CDR stand for?
Correct Answer
Certified designated representative
Question 8
A drug is considered adulterated if the strength, quantity and or purity falls below
that of which is in the official compendium (USP). True or false
Correct Answer
True
Question 9
The new drug application is also known as?
Correct Answer
NDA
Page 2 of 102
,Question 10
They manufacture outside the US can apply for a __________ manufacturer permit.
Correct Answer
Non resident
Page 3 of 102
, Question 11
Any person who manufactures, packages, three packages, labels or relabels a drug in
the state must register such drug annually with the department. True or false
Correct Answer
False
Question 1: Under Florida Statute Chapter 499, which of the following best
describes the primary responsibility of a Certified Designated Representative
(CDR) for a prescription drug wholesale distributor operating in the state?
A. Overseeing only the financial auditing of inventory transactions
B. Ensuring exclusive compliance with federal DEA registration requirements
C. Managing the physical security of the facility without involvement in record-
keeping
D. Serving as the primary point of contact responsible for the wholesale distributor’s
compliance with all applicable state and federal laws governing the distribution of
prescription drugs
CORRECT ANSWER: D. Serving as the primary point of contact responsible for
the wholesale distributor’s compliance with all applicable state and federal
laws governing the distribution of prescription drugs
Rationale: Florida law designates the CDR as the individual accountable for ensuring
the wholesale distributor adheres to Chapter 499, F.S., and related federal
requirements, including pedigree, storage, record retention, and reporting
obligations. The CDR must be knowledgeable of and responsible for the day-to-day
compliance operations of the establishment.
Question 2: According to Florida Board of Pharmacy rules applicable to
Certified Designated Representatives, what is the minimum number of hours
of continuing education that a CDR must complete during each two-year
renewal cycle?
A. 10 hours of general pharmacy law
B. 15 hours with at least 5 hours focused on Florida drug wholesale distribution law
C. 20 hours of any ACPE-approved continuing education
D. 24 hours including 2 hours of HIV/AIDS and 2 hours of medical errors
CORRECT ANSWER: B. 15 hours with at least 5 hours focused on Florida drug
wholesale distribution law
Rationale: Florida administrative rules require CDRs to complete 15 hours of
continuing education every two years, of which a minimum of 5 hours must
specifically address Florida laws and rules governing prescription drug wholesale
distribution to maintain certification.
Page 4 of 102
