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Trafficking in contraband prescription drugs is defined
as a person who
knowingly sells, purchases, manufactures, delivers, or brings
into this State any
amount of contraband drug worth in excess of $____________. -
ANSWERS -A) $5,000.00
B) $10,000.00
C) $15,000.00
D) $20,000.00
E) $25,000.00*
In determining if a drug registration application is complete the
Department can review the following: - ANSWERS -A) The
Federal, Food, Drug and Cosmetic Act to assure the product
also complies with this Act.
B) Catalogs and labeling for the Product
C) Nothing is required other than the application if the products
are already registered with the FDA.
D) DESI listing and other literature as needed.
,E) A, B and D all include required review items*
A repackaged prescription drug must follow the rules of the
Federal Act and must include all of the following on the
label. - ANSWERS -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.
Any person who manufactures, packages, repackages, labels or
relabels a drug in this State must register such drug annually
with the department. - ANSWERS True
False*
A Florida product registration for prescription drugs must be
renewed how often? - ANSWERS -A) Biennially
B) Every 2 years
C) Annually
D) Biannually
E) A & B are correct*
A prescription drug for which the required Transaction history,
information or statement is missing or incomplete is
considered: - ANSWERS -A) Adulterated
B) Misbranded
C) Contraband
, D) Only A & C*
E) All of the above
If a prescription drug is expired it is considered to be
_________________. - ANSWERS -A) Adulterated*
B) Misbranded
C) Counterfeit
D) Proprietary
True of False: A drug is considered adulterated if the strength,
quantity and/or purity falls below that of which is in the official
compendium (USP). - ANSWERS A) True*
B) False
A drug is considered "misbranded" if it has which of the
following characteristics? - ANSWERS -A) The label of the
product has not been reviewed by the State.
B) The product is expired.
C) The label of the product is in anyway false or misleading.*
D) The product is contaminated.
Which of the following are characteristics of a misbranded
product? - ANSWERS
-A) Prescription label does not bear the statement "Rx only" or
similar notation.
B) Contents in terms of weight or numerical count
is inaccurate.