WOTF is TRUE regarding FDA regulations that require "adequate directions for
use?"
a. These are required for prescription drugs only and not required for OTC
products.
b. They mandate that directions must be written clearly so that a layperson can
use the OTC drug safely for appropriate purposes.
c. They mandate that the instruction be written at an eighth-grade level.
d. They do not need to include either the dosing, preparation, frequency,
duration, time, and route of administration if the product is in common use as
an OTC product; this is at the discretion of the manufacturer. Answer - b. They
mandate that directions must be written clearly so that a layperson can use the
OTC drug safely for appropriate purposes.
A drug company is marketing an over-the-counter drug Coldimmune Health
Formula as a product that will prevent colds. Which regulatory body is
responsible for enforcing the accuracy of this claim? Answer - Federal Trade
Commission
Each of the following statements concerning the NDC number is correct
EXCEPT:
,a. The third segment identifies the package size of the drug
b. The first segment identifies the company that prepared the drug or packaged
it.
c. NDC stands for National Drug Code
d. The second segment identifies the strength, dosage and formulation of the
drug
e. NDCs identify prescription drugs only; OTC drugs are not assigned NDC
numbers. Answer - e. NDCs identify prescription drugs only; OTC drugs are not
assigned NDC numbers.
A unit dose label for Invokana does not have a beyond use date (BUD) on it.
The drug is considered: (SATA)
a. Ok to dispense
b. Misbranded
c. Adulterated
d. Expired Answer - Pending (i.e. Mercer faculty never followed up with correct
answer(s) nor reasoning)
Answered only "b. misbranded" and got it wrong
WOTF drugs is considered "misbranded"? (SATA)
, a. An insulin vial is stored at room temperature for over 60 days and contents
appeared discolored
b. The manufacturer's container is labeled as containing 100 tablets, but the
bottle only contains 80
c. The manufacturer's label on a container of metformin is missing the
statement "Rx only"
d. Filling a drug in a dirty vial
e. A compounded drug prepared in a pharmacy with rat droppings on the floor
Answer - --
b. The manufacturer's container is labeled as containing 100 tablets, but the
bottle only contains 80
c. The manufacturer's label on a container of metformin is missing the
statement "Rx only"
--
--
WOTF drugs is considered "misbranded"? (SATA)
a. A prescription container label claims to contain the brand name drug, but
the contents in the bottle are generic
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