FL CDR SAMPLE QUESTIONS MODULE 1-8 2025/2026: COMPLETE QUESTIONS AND ANSWERS, 100% CORRECT, GUARANTEED TO PAS…
P R O F E S S I O N A L P R A C T I C E M AT E R I A L S
FL CDR Sample Questions Module 1-8
2025/2026: Complete Questions and
Answers, 100% Correct, Guaranteed
to Pass, Already Passed, Actual Exam
Questions, Verified Answers
Verified Answers Exam Ready With Rationales
55 QUESTIONS
DOCUMENT OVERVIEW
This document provides 55 verified questions along with their correct answers, ensuring a comprehensive
resource for exam preparation. Covering regulatory and compliance aspects of pharmaceuticals in Florida, it
is suitable for study, review, and certification preparation. Students can utilize this material to enhance their
understanding and guarantee their success in the examination.
CONTENTS
Manufacturing Regulations Q1–Q13
Licensing and Permits Q14–Q23
Distribution and Wholesaling Q24–Q35
Record Keeping and Inspections Q36–Q45
Compliance and Violations Q46–Q55
E XA M Q U EST I O N S
Q1 QUESTION 1 OF 55
Which of the following entities could be considered a Manufacturer as defined by Chapter 499?
CORRECT ANSWER
a. a person who owns the ANDA or NDA
b. an affiliate of a person who owns the ANDA or NDA
c. an entity that manufactures the product
d. all of the above*
e. answers A and C are correct
Page 1
, Q2 QUESTION 2 OF 55
Which of the following items are generally acceptable to be purchased, stored, sold or brokered in or into the State of Florida by a properly
licensed Prescription Drug Wholesale Distributor?
CORRECT ANSWER
A) Veterinary Prescription Drug
B) Complimentary Prescription Drug
C) Active Pharmaceutical Ingredients (API)
D) Medical Gases
E) All of the above are correct EXCEPT B.*
Q3 QUESTION 3 OF 55
The following alterations to a container would be "repackaging" under Florida laws and rules:
CORRECT ANSWER
A) Changing the label in the bottle
B) Changing the labeling insert contained in the packaging
C) Breaking a multi-unit pack and selling an individual fully labeled unit
D) Only A & B
E) All of the above*
Q4 QUESTION 4 OF 55
The establishment that manufacturers, processes, packages, repackages, sells, brokers, drugs devices or cosmetics must:
CORRECT ANSWER
A) Allow inspection of ANY record of the establishment.
B) Allow a Department inspector to enter and inspect during operating hours even in the absence of the owner and/or CDR.
C) Both of the above*
D) Neither of the above
Q5 QUESTION 5 OF 55
Failure to deliver a complete and accurate transaction history, information and statement at the time of distribution of a prescription drug
makes the prescription drug a ________________ product.
CORRECT ANSWER
A) Mislabeled
B) Counterfeit
C) Misbranded
D) Contraband*
Q6 QUESTION 6 OF 55
A repackaged prescription drug must follow the rules of the Federal Act and must include all of the following on the label.
CORRECT ANSWER
A) Name of drug, strength, dosage form and expiration of the drug.
B) Name of drug, strength and expiration date of drug.
C) Manufacturer's name and lot #, name of drug, dosage form, strength and expiration of the drug.*
D) Maufacturer's name and lot #, name of drug, strength and dosage form of the drug.
Page 2
P R O F E S S I O N A L P R A C T I C E M AT E R I A L S
FL CDR Sample Questions Module 1-8
2025/2026: Complete Questions and
Answers, 100% Correct, Guaranteed
to Pass, Already Passed, Actual Exam
Questions, Verified Answers
Verified Answers Exam Ready With Rationales
55 QUESTIONS
DOCUMENT OVERVIEW
This document provides 55 verified questions along with their correct answers, ensuring a comprehensive
resource for exam preparation. Covering regulatory and compliance aspects of pharmaceuticals in Florida, it
is suitable for study, review, and certification preparation. Students can utilize this material to enhance their
understanding and guarantee their success in the examination.
CONTENTS
Manufacturing Regulations Q1–Q13
Licensing and Permits Q14–Q23
Distribution and Wholesaling Q24–Q35
Record Keeping and Inspections Q36–Q45
Compliance and Violations Q46–Q55
E XA M Q U EST I O N S
Q1 QUESTION 1 OF 55
Which of the following entities could be considered a Manufacturer as defined by Chapter 499?
CORRECT ANSWER
a. a person who owns the ANDA or NDA
b. an affiliate of a person who owns the ANDA or NDA
c. an entity that manufactures the product
d. all of the above*
e. answers A and C are correct
Page 1
, Q2 QUESTION 2 OF 55
Which of the following items are generally acceptable to be purchased, stored, sold or brokered in or into the State of Florida by a properly
licensed Prescription Drug Wholesale Distributor?
CORRECT ANSWER
A) Veterinary Prescription Drug
B) Complimentary Prescription Drug
C) Active Pharmaceutical Ingredients (API)
D) Medical Gases
E) All of the above are correct EXCEPT B.*
Q3 QUESTION 3 OF 55
The following alterations to a container would be "repackaging" under Florida laws and rules:
CORRECT ANSWER
A) Changing the label in the bottle
B) Changing the labeling insert contained in the packaging
C) Breaking a multi-unit pack and selling an individual fully labeled unit
D) Only A & B
E) All of the above*
Q4 QUESTION 4 OF 55
The establishment that manufacturers, processes, packages, repackages, sells, brokers, drugs devices or cosmetics must:
CORRECT ANSWER
A) Allow inspection of ANY record of the establishment.
B) Allow a Department inspector to enter and inspect during operating hours even in the absence of the owner and/or CDR.
C) Both of the above*
D) Neither of the above
Q5 QUESTION 5 OF 55
Failure to deliver a complete and accurate transaction history, information and statement at the time of distribution of a prescription drug
makes the prescription drug a ________________ product.
CORRECT ANSWER
A) Mislabeled
B) Counterfeit
C) Misbranded
D) Contraband*
Q6 QUESTION 6 OF 55
A repackaged prescription drug must follow the rules of the Federal Act and must include all of the following on the label.
CORRECT ANSWER
A) Name of drug, strength, dosage form and expiration of the drug.
B) Name of drug, strength and expiration date of drug.
C) Manufacturer's name and lot #, name of drug, dosage form, strength and expiration of the drug.*
D) Maufacturer's name and lot #, name of drug, strength and dosage form of the drug.
Page 2
