Federal MPJE Practice Questions

The MPJE exam covers federal and state pharmacy law. The following practice test includes an assortment of review questions which focus on federal pharmacy law. After each question the answer is provided along with a detailed explanation.

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Question 1

Which of the following ingredients has special labeling requirements if it is included in a product?

A
Gelatin
B
FD&C Yellow No. 5
C
High fructose corn syrup
D
Sorbitol
E
Xanthan gum
Question 1 Explanation: 
Several ingredients such as FD&C Yellow No. 5, aspartame, wintergreen oil, mineral oil, salicylates, sulfites, Ipecac syrup, and alcohol have special labeling requirements under federal regulations. The presence of FD&C Yellow No. 5 must be disclosed and the product must include a warning in the “precautions” section about the potential for allergic reaction in certain susceptible patients.
Question 2

A pharmacy dispenses and distributes a total of 50,000 doses of controlled substances in a 12 month period. How many doses is the pharmacy able to transfer to another pharmacy without registering as a distributor?

A
500 doses
B
1,000 doses
C
2,500 doses
D
5,000 doses
E
10,000 doses
Question 2 Explanation: 
The 5% rule states that a pharmacy does not have to register with the DEA as a distributor if the total quantity of controlled substances distributed during a 12-month period does not exceed 5% of the total quantity of all controlled substances dispensed and distributed during that period.
Question 3

Over-the-counter (OTC) drug advertising is regulated by:

A
Federal Trade Commission
B
Food and Drug Administration
C
Drug Quality and Security Commission
D
Consumer Product Safety Commission
E
None of the above
Question 3 Explanation: 
OTC drug advertising is regulated by the Federal Trade Commission (FTC). Prescription drug advertising is regulated by the Food and Drug Administration (FDA).
Question 4

Which law first required new drugs to be proven safe and effective for their claimed use?

A
Food, Drug, and Cosmetic Act
B
Durham-Humphrey Amendment
C
Kefauver-Harris Amendment
D
Prescription Drug Marketing Act
E
Drug Quality and Security Act
Question 4 Explanation: 
The Kefauver-Harris Amendment of 1962 required new drugs to be proven safe and effective for their claimed use. It also established good manufacturing practices for manufacturing of drugs, and gave FDA jurisdiction over prescription drug advertising.
Question 5

A patient is admitted to a hospital and does not remember the names of the medications that she takes at home. The hospital pharmacist calls the patient’s outpatient pharmacy to obtain a list of medications. Which of the following is true?

A
This is a HIPAA violation unless the patient has given signed consent for the information to be given to the hospital pharmacy
B
This is a HIPAA violation unless the patient has given verbal consent for the information to be given to the hospital pharmacy
C
This is a HIPAA violation unless the patient has given written and verbal consent for the information to be given to the hospital pharmacy
D
This is not a HIPAA violation because HIPAA does not apply to patients being treated in a hospital setting
E
This is not a HIPAA violation because the information is being given to the hospital pharmacy for treatment purposes
Question 5 Explanation: 
HIPAA permits the use of protected health information (PHI) for treatment purposes. This information can be given to anyone involved in the patient’s care, and does not require written or verbal consent.
Question 6

Anabolic steroids are classified under which schedule?

A
Schedule I
B
Schedule II
C
Schedule III
D
Schedule IV
E
Schedule V
Question 6 Explanation: 
Anabolic steroids are classified as Schedule III controlled substances.
Question 7

What act set the requirement for child-resistant closures for all prescription drugs, non-prescription drugs, and hazard household products?

A
Poison Prevention Packaging Act
B
Child Drug Safety Act
C
Prevention of Hazardous Consumption Act
D
Children Poison Prevention Act
E
Hazardous Materials Safety Act
Question 7 Explanation: 
The Poison Prevention Packaging Act set the requirement that all prescription drugs, non-prescription drugs, and hazardous household products must have a child-resistant closure. The purpose was to protect children less than 5 years old from accidental poisoning from accidental ingestion or exposure. However, patients may specifically ask to not have safety caps on their medications.
Question 8

A patient calls and says they just got home from the hospital after having broken their leg and cannot make it to the pharmacy to pick up their prescription for a schedule II controlled medication that was on file from when they dropped it off a few days beforehand. The patient wants to know if the pharmacy can mail the prescription to the house. How should the pharmacist respond?

A
Controlled medications cannot be mailed
B
Only schedule III–V controlled medications can be mailed
C
Controlled substances can only be mailed to the prescriber for office pickup
D
The prescription can be sent to the patient through mail
E
The prescription can be sent to the patient as long as the drug name is posted on the package
Question 8 Explanation: 
The prescription can be mailed to the patient with no issues. Controlled substances used to not be able to go through mail, but this is no longer the case. The package must contain an inner package with the prescription and appropriate labeling, but must be placed in a plain outer container. The outside cannot contain information about the contents of the package.
Question 9

A warning stating “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed” is required on the label for which of the following prescription types?

A
Schedule II controlled substances only
B
Schedule II–IV controlled substances only
C
Schedule II–V controlled substances only
D
Schedule III–V controlled substances only
E
All prescriptions require this warning under federal law
Question 9 Explanation: 
The Federal Transfer Warning (“Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”) is required to be on the label of Schedule II–IV controlled substances when dispensed to a patient. Most pharmacies comply with this requirement by including this warning on all prescription labels. However, it is not legally required on prescription labels for Schedule V controlled substances or non-controlled substances.
Question 10

In the case of theft of controlled substances from a pharmacy, which form must be submitted to the DEA?

A
DEA Form 106
B
DEA Form 222
C
DEA Form 397
D
DEA Form 41
E
None of the above; a form is not required to be sent to the DEA
Question 10 Explanation: 
A DEA Form 106 is used to report theft or significant loss of controlled substances to the DEA. Filling out a Form 106 immediately is not required, but the DEA must be notified in writing within one business day of discovery. Once the investigation is complete, a Form 106 must be sent.
Question 11

What act set the requirement for tamper-evident packaging for some over-the-counter products in order to avoid risk of contamination?

A
Safe Drug Packaging Act
B
Federal Anti-Tampering Act
C
Drug Contamination Prevention Act
D
Federal Anti-Contamination Act
E
Tamper-Evident Packaging Act
Question 11 Explanation: 
The Federal Anti-Tampering Act was set to have requirement of tamper-evident packaging of some over-the-counter products and cosmetics in order to avoid contamination issues and limit access. If the items were tampered with, it would be evident due to the packaging of these products.
Question 12

A drug is considered to be an orphan drug if it is for rare diseases or conditions that impact fewer than how many people in the U.S.?

A
500
B
100,000
C
200,000
D
500,000
E
1,000,000
Question 12 Explanation: 
A drug is considered to be an orphan drug if it is for rare disease or conditions that impact fewer than 200,000 people in the U.S. Sometimes this designation can be given to other drugs if the cost of manufacturing is not likely to be regained by sales.
Question 13

In which case(s) must an exact count be taken while performing a controlled substance inventory?

I.     It is a schedule II controlled substance

II.    The bottle holds more than 1000 tablets or capsules

III.   Containers are sealed or unopened

A
I only
B
II only
C
I and II
D
II and III
E
I, II, and III
Question 13 Explanation: 
An exact count must be made on controlled substances if it is a scheduled I or II controlled substance, if it is a controlled substance where the bottle contains more than 1000 tablets or capsules, and if the containers are sealed or unopened. Sealed or unopened containers do not need to be opened and counted, but the number marked as the container quantity must be used as an exact count.
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