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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Which of the following ingredients has special labeling requirements if it is included in a product?
FD&C Yellow No. 5
High fructose corn syrup
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?
Over-the-counter (OTC) drug advertising is regulated by:
Federal Trade Commission
Food and Drug Administration
Drug Quality and Security Commission
Consumer Product Safety Commission
None of the above
Which law first required new drugs to be proven safe and effective for their claimed use?
Food, Drug, and Cosmetic Act
Prescription Drug Marketing Act
Drug Quality and Security Act
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?
This is a HIPAA violation unless the patient has given signed consent for the information to be given to the hospital pharmacy
This is a HIPAA violation unless the patient has given verbal consent for the information to be given to the hospital pharmacy
This is a HIPAA violation unless the patient has given written and verbal consent for the information to be given to the hospital pharmacy
This is not a HIPAA violation because HIPAA does not apply to patients being treated in a hospital setting
This is not a HIPAA violation because the information is being given to the hospital pharmacy for treatment purposes
Anabolic steroids are classified under which schedule?
What act set the requirement for child-resistant closures for all prescription drugs, non-prescription drugs, and hazard household products?
Poison Prevention Packaging Act
Child Drug Safety Act
Prevention of Hazardous Consumption Act
Children Poison Prevention Act
Hazardous Materials Safety Act
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?
Controlled medications cannot be mailed
Only schedule III–V controlled medications can be mailed
Controlled substances can only be mailed to the prescriber for office pickup
The prescription can be sent to the patient through mail
The prescription can be sent to the patient as long as the drug name is posted on the package
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?
Schedule II controlled substances only
Schedule II–IV controlled substances only
Schedule II–V controlled substances only
Schedule III–V controlled substances only
All prescriptions require this warning under federal law
In the case of theft of controlled substances from a pharmacy, which form must be submitted to the DEA?
DEA Form 106
DEA Form 222
DEA Form 397
DEA Form 41
None of the above; a form is not required to be sent to the DEA
What act set the requirement for tamper-evident packaging for some over-the-counter products in order to avoid risk of contamination?
Safe Drug Packaging Act
Federal Anti-Tampering Act
Drug Contamination Prevention Act
Federal Anti-Contamination Act
Tamper-Evident Packaging Act
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.?
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
I and II
II and III
I, II, and III