FL CDR Sample questions module 1-8

FL CDR Sample questions module 1-8

Which of the following entities could be considered a Manufacturer as defined by Chapter 499?(- a. 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

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?(- A) Veterinary Prescription Drug

• Complimentary Prescription Drug
• Active Pharmaceutical Ingredients (API)
• Medical Gases
• All of the above are correct EXCEPT B.*

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.

The following alterations to a container would be "repackaging" under

Florida laws and rules:

(-

• Changing the label in the bottle
• Changing the labeling insert contained in the packaging 1 / 2

• Breaking a multi-unit pack and selling an individual fully labeled unit
• Only A & B
• All of the above*

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.

• Cannot exceed 60 calendar days in a 365 day period for specifically

defined family issues.*

• Answers A & C are correct.

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*

A broker only prescription drug wholesale distributor can only possess the

following prescription drugs:

(-

• Sample packages
• Returns for destruction
• No prescription drugs at all*
• Starter packs and sample packages only
• / 2