Which of the following entities could be considered a Manufacturer as defined by
Chapter 499? - ✔✔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 manufacture
...
Which of the following entities could be considered a Manufacturer as defined by
Chapter 499? - ✔✔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
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
B) Complimentary Prescription Drug
C) Active Pharmaceutical Ingredients (API)
D) Medical Gases
E) All of the above are correct EXCEPT B.*
Which of the following statements/definitions are correctly stated? - ✔✔A) An
Intracompany transfer is the sale of a prescription drug between two companies owned
by the same company.
B) The definition of a "sale" includes a gift if ownership transfers.
C) An authorized recipient includes any entity that is properly permitted to purchase,
recieve, distribute, etc. prescription drugs.
D) All of the above are correct*
E) None of the above are correct.
The following alterations to a container would be "repackaging" under Florida laws and
rules: - ✔✔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*
If a Certified Designated Representative is to have an "authorized absence", he/she
must meet the following requirements: - ✔✔A) 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.
B) Cannot exceed 90 calendar days in a 365 day period for specifically defined family
issues.
C) All extended absences are permitted as long as they are in writing and authorized
by the owner and/or manager of the permittee.
D) Cannot exceed 60 calendar days in a 365 day period for specifically defined family
issues.*
E) Answers A & C are correct
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