Pharmacy Law Practice Exam
Questions With Detailed Questions
And Correct Answers||Latest
Exam||Already Graded A+
Which FDCA amendment exempted certain drugs from the "adequate directions for
use" labeling requirement if they bear "Rx only" on their labels?
a. Durham Humphrey
b. Kefauver-Harris
c. Prescription Drug Marketing
d. Waxman-Hatch -ANSWERa. Durham Humphrey
The FDCA defines a "new drug" as a previously approved drug entity with a new:
a. route of administration.
b. indication for use.
c. combination of ingredients.
d. a and b
e. a, b and c. -ANSWERe. route of administration, indication for use, combination of
ingredients.
Which of the following circumstances would be considered "adulteration" under the
FDCA?
a. A drug is prepared and packaged under unsanitary conditions.
b. The drug's manufacturing procedures do not conform to GMP standards.
c. The drug is subject to the Poison Prevention Packaging Act and is not packaged
accordingly.
d. a and b
e. a, b and c -ANSWERd. A drug is prepared and packaged under unsanitary conditions,
The drug's manufacturing procedures do not conform to GMP standards.
Which of the following circumstances would be considered "misbranding" under the
FDCA?
a. A drug's label or labeling is false or misleading.
b. A prescription for a legend drug is refilled without the prescriber's authorization.
c. A drug is subject to the Poison Prevention Packaging Act is not packaged
accordingly.
d. a and b
e. a, b and c -ANSWERe. A drug's label or labeling is false or misleading, A prescription
for a legend drug is refilled without the prescriber's authorization, A drug is subject to
the Poison Prevention Packaging Act is not packaged accordingly.
,The purpose of DESI was to prove efficacy of prescription and OTC drugs that were
marketed:
a. between 1938 and 1962.
b. before 1938.
c. after 1962.
d. none of the above. -ANSWERa. between 1938 and 1962.
6. The label on the container of an OTC drug intended for sale directly to a patient must
include:
a. adequate directions for safe and effective use.
b. cautions and warnings needed for the protection of the user.
c. net contents of the package
d. name and address of the manufacturer, packer, or distributor
e. all of the above
f. only a, b and c -ANSWERe. adequate directions for safe and effective use; cautions
and warnings needed for the protection of the user; net contents of the package; name
and address of the manufacturer, packer, or distributor
Which of the below is(are) officially recognized by the FDCA?
a. USP/DI
b. USP/NF
c. Homeopathic Pharmacopeia
d. a and b
e. b and c -ANSWERe. USP/NF, Homeopathic Pharmacopeia
According to the Prescription Drug marketing Act of 1987, no person may sell,
purchase, or trade:
a. prescription drug samples.
b. OTC drug samples.
c. starter packages of prescription drugs.
d. a and b
e. a, b, and c -ANSWERa. prescription drug samples.
When a pharmacy repackages a drug product in unit-dose packages, a record should
be maintained which includes among other things the:
a. pharmacy's identification number if different from the manufacturer's lot number.
b. product's manufacturer or supplier.
c. expiration date of the original container.
d. a and b
e. a, b, and c -ANSWERe. pharmacy's identification number if different from the
manufacturer's lot number, product's manufacturer or supplier, expiration date of the
original container.
Which of the following situations may require a pharmacy to register with the FDA, be
subject to FDA inspections, and comply with CGMP?
, a. Community pharmacist compounds large bulk quantities of inhaler solution and ships
the product to
numerous out-of-state pharmacies for dispensing.
b. Hospital pharmacy repackages and relabels a drug product in unit-dose packaging
for routine use for inpatients.
c. Community pharmacist compounds drugs in anticipation of prescription drug orders
based on routine prescribing patterns.
d. a and b
e. a, b, and c -ANSWERa. Community pharmacist compounds large bulk quantities of
inhaler solution and ships the product to numerous out-of-state pharmacies for
dispensing.
According to the Poison Prevention Packaging Act of 1970, a pharmacist may reuse:
a. a glass container on a prescription refill, provided a new child-resistant closure is
used.
b. plastic non-child-resistant containers and lids on prescriptions for which the patient
has requested waiver.
c. plastic child-resistant containers and lids on prescription refills.
d. a and b
e. a, b and c -ANSWERd. a glass container on a prescription refill, provided a new child-
resistant closure is used, plastic non-child-resistant containers and lids on prescriptions
for which the patient has requested waiver.
It is not necessary to dispense an oral prescription drug for human use in a child-
resistant container if the:
I. patient requests standard packaging.
II. prescriber requests standard packaging on the prescription for a specific patient.
III. prescriber requests a blanket waiver for child-resistant packaging for all of the
prescriptions of one
patient.
IV. pharmacist, in his/her professional judgment, deems it is not necessary.
a. I
b. I and II
c. II and III
d. II, III and IV -ANSWERb.
I. patient requests standard packaging.
II. prescriber requests standard packaging on the prescription for a specific patient.
While employed as a hospital pharmacy intern, you routinely repackage commercially
available prescription drugs into USP-quality unit-dose containers. On January 1, 2011,
you repackage Killacillin 200mg that carries an expiration date on the container of
January 2, 2013. According to FDA recommendations, which expiration date should you
place on the unit-dose packages?
a. February 1, 2011
b. April 1, 2011
c. January 1, 2012
Questions With Detailed Questions
And Correct Answers||Latest
Exam||Already Graded A+
Which FDCA amendment exempted certain drugs from the "adequate directions for
use" labeling requirement if they bear "Rx only" on their labels?
a. Durham Humphrey
b. Kefauver-Harris
c. Prescription Drug Marketing
d. Waxman-Hatch -ANSWERa. Durham Humphrey
The FDCA defines a "new drug" as a previously approved drug entity with a new:
a. route of administration.
b. indication for use.
c. combination of ingredients.
d. a and b
e. a, b and c. -ANSWERe. route of administration, indication for use, combination of
ingredients.
Which of the following circumstances would be considered "adulteration" under the
FDCA?
a. A drug is prepared and packaged under unsanitary conditions.
b. The drug's manufacturing procedures do not conform to GMP standards.
c. The drug is subject to the Poison Prevention Packaging Act and is not packaged
accordingly.
d. a and b
e. a, b and c -ANSWERd. A drug is prepared and packaged under unsanitary conditions,
The drug's manufacturing procedures do not conform to GMP standards.
Which of the following circumstances would be considered "misbranding" under the
FDCA?
a. A drug's label or labeling is false or misleading.
b. A prescription for a legend drug is refilled without the prescriber's authorization.
c. A drug is subject to the Poison Prevention Packaging Act is not packaged
accordingly.
d. a and b
e. a, b and c -ANSWERe. A drug's label or labeling is false or misleading, A prescription
for a legend drug is refilled without the prescriber's authorization, A drug is subject to
the Poison Prevention Packaging Act is not packaged accordingly.
,The purpose of DESI was to prove efficacy of prescription and OTC drugs that were
marketed:
a. between 1938 and 1962.
b. before 1938.
c. after 1962.
d. none of the above. -ANSWERa. between 1938 and 1962.
6. The label on the container of an OTC drug intended for sale directly to a patient must
include:
a. adequate directions for safe and effective use.
b. cautions and warnings needed for the protection of the user.
c. net contents of the package
d. name and address of the manufacturer, packer, or distributor
e. all of the above
f. only a, b and c -ANSWERe. adequate directions for safe and effective use; cautions
and warnings needed for the protection of the user; net contents of the package; name
and address of the manufacturer, packer, or distributor
Which of the below is(are) officially recognized by the FDCA?
a. USP/DI
b. USP/NF
c. Homeopathic Pharmacopeia
d. a and b
e. b and c -ANSWERe. USP/NF, Homeopathic Pharmacopeia
According to the Prescription Drug marketing Act of 1987, no person may sell,
purchase, or trade:
a. prescription drug samples.
b. OTC drug samples.
c. starter packages of prescription drugs.
d. a and b
e. a, b, and c -ANSWERa. prescription drug samples.
When a pharmacy repackages a drug product in unit-dose packages, a record should
be maintained which includes among other things the:
a. pharmacy's identification number if different from the manufacturer's lot number.
b. product's manufacturer or supplier.
c. expiration date of the original container.
d. a and b
e. a, b, and c -ANSWERe. pharmacy's identification number if different from the
manufacturer's lot number, product's manufacturer or supplier, expiration date of the
original container.
Which of the following situations may require a pharmacy to register with the FDA, be
subject to FDA inspections, and comply with CGMP?
, a. Community pharmacist compounds large bulk quantities of inhaler solution and ships
the product to
numerous out-of-state pharmacies for dispensing.
b. Hospital pharmacy repackages and relabels a drug product in unit-dose packaging
for routine use for inpatients.
c. Community pharmacist compounds drugs in anticipation of prescription drug orders
based on routine prescribing patterns.
d. a and b
e. a, b, and c -ANSWERa. Community pharmacist compounds large bulk quantities of
inhaler solution and ships the product to numerous out-of-state pharmacies for
dispensing.
According to the Poison Prevention Packaging Act of 1970, a pharmacist may reuse:
a. a glass container on a prescription refill, provided a new child-resistant closure is
used.
b. plastic non-child-resistant containers and lids on prescriptions for which the patient
has requested waiver.
c. plastic child-resistant containers and lids on prescription refills.
d. a and b
e. a, b and c -ANSWERd. a glass container on a prescription refill, provided a new child-
resistant closure is used, plastic non-child-resistant containers and lids on prescriptions
for which the patient has requested waiver.
It is not necessary to dispense an oral prescription drug for human use in a child-
resistant container if the:
I. patient requests standard packaging.
II. prescriber requests standard packaging on the prescription for a specific patient.
III. prescriber requests a blanket waiver for child-resistant packaging for all of the
prescriptions of one
patient.
IV. pharmacist, in his/her professional judgment, deems it is not necessary.
a. I
b. I and II
c. II and III
d. II, III and IV -ANSWERb.
I. patient requests standard packaging.
II. prescriber requests standard packaging on the prescription for a specific patient.
While employed as a hospital pharmacy intern, you routinely repackage commercially
available prescription drugs into USP-quality unit-dose containers. On January 1, 2011,
you repackage Killacillin 200mg that carries an expiration date on the container of
January 2, 2013. According to FDA recommendations, which expiration date should you
place on the unit-dose packages?
a. February 1, 2011
b. April 1, 2011
c. January 1, 2012
