FL CDR SAMPLE QUESTI ONS

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FL CDR SAMPLE QUESTI ONS

MODULE 1-8 GRADED A+

Question : Which of the following entities could be

considered a Manufacturer as defined by Chapter 499?

• a person who owns the ANDA or NDA
• an affiliate of a person who owns the ANDA or NDA
• an entity that manufactures the product
• all of the above*
• answers A and C are correct

Correct answer: d. all of the above*

Question : 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?

• Veterinary Prescription Drug
• Complimentary Prescription Drug
• Active Pharmaceutical Ingredients (API)
• Medical Gases

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• All of the above are correct EXCEPT B.*

Correct answer: E) All of the above are correct EXCEPT

B.*

Question : Which of the following statements/definitions

are correctly stated?

• An Intracompany transfer is the sale of a prescription

drug between two companies owned by the same company.

• The definition of a "sale" includes a gift if ownership

transfers.

• An authorized recipient includes any entity that is

properly permitted to purchase, recieve, distribute, etc.prescription drugs.

• All of the above are correct*
• None of the above are correct.

Correct answer: D) All of the above are correct*

Question : The following alterations to a container would

be "repackaging" under Florida laws and rules:

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• Changing the label in the bottle
• Changing the labeling insert contained in the

packaging

• Breaking a multi-unit pack and selling an individual

fully labeled unit

• Only A & B
• All of the above*

Correct answer: E) All of the above*

Question : If a Certified Designated Representative is to

have an "authorized absence", he/she must meet the

following requirements:

• Inform their employer they will not be at work that

day and when they will return. If they are the owner, then inform the manager they will not be at work that day and when they will return.

• Cannot exceed 90 calendar days in a 365 day period

for specifically defined family issues.

• All extended absences are permitted as long as they

are in writing and authorized by the owner and/or manager of the permittee.

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• Cannot exceed 60 calendar days in a 365 day period

for specifically defined family issues.*

• Answers A & C are correct.

Correct answer: D) Cannot exceed 60 calendar days in a

365 day period for specifically defined family issues.*

Question : Who would be considered an "authorized

recipient" of prescription drugs on a ocean going vessel

• A licensed Ship Captain
• The First Officer of the ship
• An Agent of the ship
• Any marine broker
• Both A & B above are correct*

Correct answer: E) Both A & B above are correct*

Question : A broker only prescription drug wholesale

distributor can only possess the following prescription

drugs:

• Sample packages
• Returns for destruction