MPJE Mock Exam (2026/2027) – Multistate
Pharmacy Jurisprudence Examination |
Questions, Answers & Explanations
What are characteristics of the Durham-Humphrey Amendment? *Select all
that apply.*
A. Allowed faxed prescriptions
B. Allowed phoned prescriptions
C. Allowed refills on prescriptions
D. Distinguished between OTC and prescription medications
E. Required that drugs be both effective and safe - ANSWERS-What are
characteristics of the Durham-Humphrey Amendment? *Select all that apply.*
A. Allowed faxed prescriptions
*B. Allowed phoned prescriptions*
*C. Allowed refills on prescriptions*
*D. Distinguished between OTC and prescription medications*
E. Required that drugs be both effective and safe
Explanation: Most pharmacists associate the Durham-Humphrey amendment
with creating the distinction between OTC and prescription drug products.
The amendment also allowed phoned prescriptions and refills on
prescriptions. The requirement for drugs to be both effective and safe came
under the Kefauver-Harris Amendments.
*References:*
•Food Drug and Cosmetic Act Section 503.
,A hospital nurse noticed a problem with an automatic blood pressure device.
The device did not shut off automatically and the patient suffered serious
injury. Under the circumstances, what is/are required by the hospital?
I. Notify the manufacturer within 10 days.
II. Notify the FDA within 10 days if the manufacturer is not known.
III. Notify the State Board of Medicine within 10 days.
A. I only
B. III only
C. I and II
D. II and III
E. I, II, and III - ANSWERS-A hospital nurse noticed a problem with an
automatic blood pressure device. The device did not shut off automatically
and the patient suffered serious injury. Under the circumstances, what is/are
required by the hospital?
Which of the following statements regarding NDC numbers is/are true?
I. They are required on all OTC and prescription drug products.
II. They signify that a drug has been approved by the FDA.
III. They are required in the barcode of drugs sold to hospitals.
A I only
B III only
C I and II
D II and III
,E I, II, and III - ANSWERS-Which of the following statements regarding NDC
numbers is/are true?
I. They are required on all OTC and prescription drug products.
II. They signify that a drug has been approved by the FDA.
III. They are required in the barcode of drugs sold to hospitals.
A I only
*B III only*
C I and II
D II and III
E I, II, and III
Explanation: Many pharmacists believe that NDC numbers are not only
required on prescription and over-the-counter products and that an NDC
number signifies that a drug has been approved by the FDA. That is not the
case. NDC numbers are highly recommended, but not mandated on drug
packaging. Moreover, NDC numbers are assigned by the FDA for
administrative purposes and there is no correlation between an NDC number
and drug approval. In fact, it is considered a misbranding offense if an NDC
number is used to denote or imply an FDA approval of a drug. On the other
hand, according to an FDA Guidance Document, biological products and over-
the-counter drug products that are dispensed pursuant to an order and are
commonly used in hospitals are subject to the barcode requirement, which
requires at a minimum, the inclusion of the NDC number.
References:
•21 CFR § 207.35.
•21 CFR § 207.37.
•21 CFR § 201.25.
, I. Notify the manufacturer within 10 days.
II. Notify the FDA within 10 days if the manufacturer is not known.
III. Notify the State Board of Medicine within 10 days.
A. I only
B. III only
*C. I and II*
D. II and III
E. I, II, and III
*Explanation:* Whenever a device user facility receives or otherwise
becomes aware of information that reasonably suggests that a device has or
may have caused or contributed to a patient's serious illness or serious
injury, the facility must, as soon as practicable but not later than 10 working
days after becoming aware, report the information to the manufacturer of
the device or to the Secretary of HHS (FDA) if the identity of the
manufacturer is not known. Whenever a device user facility such as a
hospital becomes aware of information that reasonably suggests that a
device has or may have caused or contributed to the death of a patient of
the facility, the facility must, as soon as practicable but not later than 10
working days after becoming aware, report the information to the Secretary
of HHS (FDA) and to the manufacturer of the device if the identity of the
manufacturer is known.
*References:* Title 21 United States Code 360i.
You open up your pharmacy one morning and realize that all of your stock of
Sudafed has been stolen. What are you reporting obligations?
Pharmacy Jurisprudence Examination |
Questions, Answers & Explanations
What are characteristics of the Durham-Humphrey Amendment? *Select all
that apply.*
A. Allowed faxed prescriptions
B. Allowed phoned prescriptions
C. Allowed refills on prescriptions
D. Distinguished between OTC and prescription medications
E. Required that drugs be both effective and safe - ANSWERS-What are
characteristics of the Durham-Humphrey Amendment? *Select all that apply.*
A. Allowed faxed prescriptions
*B. Allowed phoned prescriptions*
*C. Allowed refills on prescriptions*
*D. Distinguished between OTC and prescription medications*
E. Required that drugs be both effective and safe
Explanation: Most pharmacists associate the Durham-Humphrey amendment
with creating the distinction between OTC and prescription drug products.
The amendment also allowed phoned prescriptions and refills on
prescriptions. The requirement for drugs to be both effective and safe came
under the Kefauver-Harris Amendments.
*References:*
•Food Drug and Cosmetic Act Section 503.
,A hospital nurse noticed a problem with an automatic blood pressure device.
The device did not shut off automatically and the patient suffered serious
injury. Under the circumstances, what is/are required by the hospital?
I. Notify the manufacturer within 10 days.
II. Notify the FDA within 10 days if the manufacturer is not known.
III. Notify the State Board of Medicine within 10 days.
A. I only
B. III only
C. I and II
D. II and III
E. I, II, and III - ANSWERS-A hospital nurse noticed a problem with an
automatic blood pressure device. The device did not shut off automatically
and the patient suffered serious injury. Under the circumstances, what is/are
required by the hospital?
Which of the following statements regarding NDC numbers is/are true?
I. They are required on all OTC and prescription drug products.
II. They signify that a drug has been approved by the FDA.
III. They are required in the barcode of drugs sold to hospitals.
A I only
B III only
C I and II
D II and III
,E I, II, and III - ANSWERS-Which of the following statements regarding NDC
numbers is/are true?
I. They are required on all OTC and prescription drug products.
II. They signify that a drug has been approved by the FDA.
III. They are required in the barcode of drugs sold to hospitals.
A I only
*B III only*
C I and II
D II and III
E I, II, and III
Explanation: Many pharmacists believe that NDC numbers are not only
required on prescription and over-the-counter products and that an NDC
number signifies that a drug has been approved by the FDA. That is not the
case. NDC numbers are highly recommended, but not mandated on drug
packaging. Moreover, NDC numbers are assigned by the FDA for
administrative purposes and there is no correlation between an NDC number
and drug approval. In fact, it is considered a misbranding offense if an NDC
number is used to denote or imply an FDA approval of a drug. On the other
hand, according to an FDA Guidance Document, biological products and over-
the-counter drug products that are dispensed pursuant to an order and are
commonly used in hospitals are subject to the barcode requirement, which
requires at a minimum, the inclusion of the NDC number.
References:
•21 CFR § 207.35.
•21 CFR § 207.37.
•21 CFR § 201.25.
, I. Notify the manufacturer within 10 days.
II. Notify the FDA within 10 days if the manufacturer is not known.
III. Notify the State Board of Medicine within 10 days.
A. I only
B. III only
*C. I and II*
D. II and III
E. I, II, and III
*Explanation:* Whenever a device user facility receives or otherwise
becomes aware of information that reasonably suggests that a device has or
may have caused or contributed to a patient's serious illness or serious
injury, the facility must, as soon as practicable but not later than 10 working
days after becoming aware, report the information to the manufacturer of
the device or to the Secretary of HHS (FDA) if the identity of the
manufacturer is not known. Whenever a device user facility such as a
hospital becomes aware of information that reasonably suggests that a
device has or may have caused or contributed to the death of a patient of
the facility, the facility must, as soon as practicable but not later than 10
working days after becoming aware, report the information to the Secretary
of HHS (FDA) and to the manufacturer of the device if the identity of the
manufacturer is known.
*References:* Title 21 United States Code 360i.
You open up your pharmacy one morning and realize that all of your stock of
Sudafed has been stolen. What are you reporting obligations?
