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FL CDR Sample Questions Module 9-15
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73 QUESTIONS
DOCUMENT OVERVIEW
This document contains 73 verified questions with correct answers provided, focusing on pharmaceutical
regulations and practices. It serves as a comprehensive resource for students preparing for certification
exams in the pharmaceutical field. Users can effectively utilize it for study and review, ensuring they grasp
essential concepts and meet examination requirements.
CONTENTS
Prescription Drug Regulations Q1–Q15
Storage and Handling Q16–Q26
Distribution Practices Q27–Q54
Destruction and Disposal Q55–Q60
Compliance and Inspections Q61–Q73
E XA M Q U EST I O N S
Q1 QUESTION 1 OF 73
A quarantine area at Prescription drug wholesale distributor is used to store:
CORRECT ANSWER
A) Expired drugs
B) Damaged drugs
C) Misbranded drugs
D) Adulterated drugs
E) All of the above*
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, Q2 QUESTION 2 OF 73
Upon receipt of a prescription drug, prior to accepting the permittees inventory, a prescription drug wholesale distributor must perform
which of the following tasks?
CORRECT ANSWER
A) Visually examine each outside shipping container for identity and to prevent accepting contaminated prescription drugs
B) Authenticate each and every transaction of the incoming pedigree
C) Create the corresponding outgoing pedigree noting the lot # of the incoming drugs
D) All of the above
E) Only A&B above*
Q3 QUESTION 3 OF 73
Any establishment that is permitted as a prescription drug wholesaler or repackager must notify the department in writing within _______
working days of discovery of a significant loss or theft of prescription drugs.
CORRECT ANSWER
A) 1
B) 2
C) 3*
D) 7
E) 10
Q4 QUESTION 4 OF 73
Ephedrine is best described as _______________ under Florida law?
CORRECT ANSWER
A) Restricted
B) Prescription*
C) Exempt
D) None of the abve
Q5 QUESTION 5 OF 73
The Drug Wholesale Distributor Advisory Council's purpose is to review the laws and rules and provide input to the Department and make
recommendations to improve the protection of prescription drugs.
CORRECT ANSWER
True*
False
Q6 QUESTION 6 OF 73
*Which of the following permits can a Florida licensed prescription drug distributor also obtain at their same location?
CORRECT ANSWER
A) Restricted Drug Distributor - Destruction Company
B) Retail Pharmacy Wholesaler
C) Complimentary Drug Distributor*
D) All of the above.
Q7 QUESTION 7 OF 73
Compressed Medical Oxygen is classified as which type of product?
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, CORRECT ANSWER
A) A Prescription Drug*
B) An Over the Counter Drug
C) A Medical Device
D) A Cosmetic
E) None of the above
Q8 QUESTION 8 OF 73
A Compressed Medical Oxygen Manufacturer must follow which of the following laws and rules regulating Medical Oxygen?
CORRECT ANSWER
A) FDA Good Manufacturing Practices
B) Detailed Written Policies and Procedures
C) Labeling that includes manufacturer, gas name, volume, lot#, usage directions, warning and a prescription statement.
D) Security
E) All of the above*
Q9 QUESTION 9 OF 73
Which of the following requirement must both a prescription drug manufacturer and a compressed medical gases manufacturer follow?
CORRECT ANSWER
A) Both must obtain and maintain a permit from the Deparment to manufacture their drugs
B) Both must draft and follow written policies and procedures compliant with Chapter 499, Fla. Stat.
C) Both must comply with State and Federal current good manufacturing practice regulations for prescription drug products
D) Both must label their products with an accepted derivation of "Rx only"
E) All of the above are required*
Q10 QUESTION 10 OF 73
Medical Oxygen Retail establishments are required to comply with which or the following requirements?
CORRECT ANSWER
A) Current good manufacturing practices as promulgated by the FDA.
B) Assure that oxygen is labeled as "Rx Only," or similar legend.
C) Obtain a Florida Prescription Drug Wholesale Distributor permit.
D) All of the above are required
E) Only A & B are required*
Q11 QUESTION 11 OF 73
The Department publishes to the public on at least a monthly basis a list of all wholesalers and other permittees upon which the Department
has started enforcement actions.
CORRECT ANSWER
True*
False
Q12 QUESTION 12 OF 73
Which of the following are true for an Prescription Drug wholesale distributor?
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