PHARMACY LAW EXAM 2025 WITH 100%
ACCURATE SOLUTIONS
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 - ✅✅✅CORRECT -a. 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. - ✅✅✅CORRECT -e. 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 - ✅✅✅CORRECT -d. 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 - ✅✅✅CORRECT -e. 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. - ✅✅✅CORRECT -a. 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 - ✅✅✅CORRECT -e. 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 - ✅✅✅CORRECT -e. 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 - ✅✅✅CORRECT -a. 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 - ✅✅✅CORRECT -e. 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 - ✅✅✅CORRECT -a. 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.
ACCURATE SOLUTIONS
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 - ✅✅✅CORRECT -a. 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. - ✅✅✅CORRECT -e. 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 - ✅✅✅CORRECT -d. 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 - ✅✅✅CORRECT -e. 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. - ✅✅✅CORRECT -a. 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 - ✅✅✅CORRECT -e. 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 - ✅✅✅CORRECT -e. 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 - ✅✅✅CORRECT -a. 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 - ✅✅✅CORRECT -e. 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 - ✅✅✅CORRECT -a. 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.
