SOLUTIONS GRADED A+
◉ In order to transport prescription drugs, which of the following
entities must obtain a permit from the department of business and
professional regulation's (DBPR)? Answer: Freight forwarders
◉ A Director, officer, trustee, partner or committee member of an
applicant or at subsidiary is known as? Answer: And affiliated party
and someone requires to file a personal information statement
◉ The five largest natural shareholders must own at least
___________% of the applicants to meet the definition of an "affiliated
party" Answer: 5%
◉ If a drug has a label, identifying mark or imprint that was not
authorized by the manufacturer, the drug would be considered:
Answer: Contraband and counterfeit
◉ If one license wholesaler A, transfer a prescription drug to
another wholesaler B, at no charge, this transaction would be best
known as? Answer: A wholesale distribution
,◉ Which of the following entities could be considered a
Manufacturer as defined by Chapter 499? Answer: A person who
owns the ANDA or NDA, And an affiliate of the person who owns the
ANDA or NDA and An entity that manufactures the product
◉ If a certified designated representative is to have an " authorized
absence ", he/she must meet the following requirements: Answer:
◉ Who would be considered an " authorized recipient of
prescription drugs on an ocean going vessel"? Answer: A license ship
captain and first officer of the ship
◉ A broker only prescription drug wholesale distributor can only
possess the following prescription drugs: Answer: They can never
possess prescription drugs
◉ If a wholesale distributor sells a portion of his business to a new
partner, the new partner would have to purchase more than ______%
Of the controlled interest to be considered a charge of ownership by
the department? Answer: 50%
◉ Readily retrievable, as it relates to audit trail records of
prescription drug transactions for in-state Florida permits, has been
defined by the Florida rules as which of the following? Answer:
Retrievable in minutes
, ◉ The following alterations to a container would be repackaging
under Florida laws and rules: Answer: Changing the label on the
bottle, changing the labeling insert contained in the packaging,
breaking a multi unit pack and selling an individual fully labeled
unit.
◉ It is unlawful to perform which of the following acts in Florida?
Answer: Adulterating or this branding a drug, device or cosmetic.
Constructive refusal to allow the department to inspect your car if it
is transports drugs or devices or cosmetics. Not allow a department
agent to take samples of drugs devices or cosmetics
◉ Who must allow inspection of any record of the establishment and
allow a department inspector to enter and inspect during operating
hours even in the absence of the owner and/or the CDR. Answer:
The Establishment that manufactures, processes, packages,
repackages, sells, brokers drugs devices or cosmetics.
◉ Prescription drugs can be purchased properly by a licensed entity
using which of the following methods? Answer: Credit card and
check
◉ What does authorized trading partner mean? Answer: The entity
is properly permitted or licensed.