Pharmacy Law MPJE Exam: Federal Law UPDATED ACTUAL Exam Questions and CORRECT Answers
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Pharmacy Law MPJE
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Pharmacy Law MPJE
Pharmacy Law MPJE Exam: Federal Law
UPDATED ACTUAL Exam Questions and
CORRECT Answers
What did the Federal Controlled Substances Act do? Why was it implemented? - CORRECT
ANSWER- Legislators very concerned in the 1960s about legal and illegal drugs being
abused
They were given the opportun...
Pharmacy Law MPJE Exam: Federal Law
UPDATED ACTUAL Exam Questions and
CORRECT Answers
What did the Federal Controlled Substances Act do? Why was it implemented? - CORRECT
ANSWER- ✔✔Legislators very concerned in the 1960s about legal and illegal drugs being
abused
They were given the opportunity to design an act/law
Created the DEA to promulgate and enforce the law
Created a closed system between: manufacturer, distributors, prescriber, dispenser, and
patient.
What did the Pure Food and Drug Act of 1906 do? - CORRECT ANSWER- ✔✔Prohibited
the adulteration and misbranding of foods and drugs in interstate commerce; DID NOT have
to be proven safe or effective; did not require the label to list ingredients, directions for use,
or provide warnings
What did the Food, Drug, and Cosmetic Act do? (started in 1938) - CORRECT ANSWER-
✔✔Provides for the comprehensive regulation of all drugs introduced into interstate (and
most intrastate) commerce
Under this act no new drug may be marketed and sold unless it has been proved SAFE ONLY
for its intended use and approved by the FDA
Labels must contain adequate directions for use and warnings about habit-forming properties
of certain drugs
Describe the FDCA - CORRECT ANSWER- ✔✔The purpose of the FDCA is to protect
consumers from adulterated or misbranded foods, drugs, cosmetics, or devices; provided that
no new drug could be marketed until proven safe for use under the conditions described on
the label and approved by the FDA; also started the labeling requirements; applies to devices
as well; all drugs before 1938 are exempt from the requirement that new drugs be proven safe
,If you get in trouble with the board of pharmacy can you get in trouble with the government
too? What about the a lawsuit with a patient? - CORRECT ANSWER- ✔✔Yes, you can have
an administrative lawsuit, a civil lawsuit, and a criminal lawsuit separately for the same
offense
What did the Durham-Humphrey Amendment of 1951 do? - CORRECT ANSWER-
✔✔Established 2 classes of drugs; prescription and OTC
Allows refills on prescriptions and oral prescriptions
Per the Durham-Humphrey Amendment; what must be labeled on a prescription medication -
CORRECT ANSWER- ✔✔Caution: federal law prohibits dispensing without a Rx; they do
not need adequate directions for use like OTC (talking about the MANUFACTURERS label
here; there is no take this medication x amount of times daily on the manufacturer labeling)
What did the Kefauver-Harris Amendment of 1962 do? - CORRECT ANSWER-
✔✔Required all drugs to not only be proven safe but also EFFECTIVE
Transferred the regulation of drug advertising from the FTC to the FDA
The efficacy requirement made by the Kefauver-Harris Amendment included all drugs
marketed during what time period - CORRECT ANSWER- ✔✔1938-1962; drugs produced
before 1938 were just grandfathered in and did not have to prove their efficacy
What did the Orphan Drug Act of 1983 do? - CORRECT ANSWER- ✔✔Provided tax and
exclusive licensing incentives for manufacturers to develop agents for the treatment of rare
disease or conditions (those conditions that affect < 200,000 Americans)
What did the Drug Price Competition and Patent Term Restoration Act of 1984 do? -
CORRECT ANSWER- ✔✔Made generic drugs more readily available to the public and at
the same time provided incentives for manufacturers to develop new drugs
Eliminated the need for generic to prove safety and efficacy thus allowing new generics to get
approved more easily
,What did the Prescription Drug Marketing Act of 1987 do? - CORRECT ANSWER-
✔✔Established sales restrictions and recordkeeping requirements for prescription drug
samples
Prohibits hospitals and other healthcare entities from selling drugs to other businesses
(because the hospitals were getting the drugs for a discount then reselling them)
Requires state licensing of wholesalers
Prohibits ANY SAMPLES for any reason in a retail pharmacy
Bans importation of prescription drugs except by manufacturers and for emergency use
Mandates record keeping requirements for drug samples for 3 years
What is the Prescription Drug User Fee Act of 1992 - CORRECT ANSWER- ✔✔Drug
companies volunteered to pay tax and the money was used to hire more FDA scientist in
hopes to speed up NDA reviews; however the price of drugs just went up to cover the fee
being paid by the drug manufacturers
What did the Dietary Supplement Health and Education Act (DSHEA) of 1994 do? -
CORRECT ANSWER- ✔✔Provided laws on the regulation of dietary supplements; forced
the FDA to treat these products more as food than drugs
Define dietary supplement per the law - CORRECT ANSWER- ✔✔A product that is
intended for *ORAL* ingestion, intended to supplement the diet, and contains any one or
more of the following: a vitamin, mineral, herb or other botanical, an amino acid, dietary
substance or use by humans to supplement the diet by increasing the total dietary intake and a
concentrate, metabolite, constituent, extract or combination of the previous.
All dietary supplements must be claimed as - CORRECT ANSWER- ✔✔A dietary
supplement; they CANNOT say they are drugs or anything else on the labeling
, Dietary supplement manufacturers may not make these claims - CORRECT ANSWER-
✔✔Disease Claims
Dietary supplement manufacturers may only make these types of claims - CORRECT
ANSWER- ✔✔Structure / Function
The label can't say that it will cure or prevent but it can say "will support or maintain"
Dietary Supplements must have this on the labeling - CORRECT ANSWER- ✔✔"This
statement has not been evaluated by the FDA. This product is not intended to diagnose, treat,
cure or prevent any disease."
Who enforces drug advertising? - CORRECT ANSWER- ✔✔FDA
Who enforces dietary supplement advertising - CORRECT ANSWER- ✔✔FTC
Do dietary supplements have to be safe and/or effective? - CORRECT ANSWER- ✔✔No
How does a dietary supplement get pulled off the market? - CORRECT ANSWER- ✔✔The
FDA cannot act until the dietary supplement is proven to be dangerous; the products should
not be adulterated or misbranded (passed in 2007); however since little to no testing is
conducted on these products it would be difficult to tell if they are adulterated or misbranded
Can you put a bunch of publications regarding how awesome a dietary supplement is on the
self with the dietary supplement to get people to purchase the product? - CORRECT
ANSWER- ✔✔No; here are the rules:
Dietary supplement publications must be reprinted in their ENTIRETY
You cannot have any information that is FALSE or MISLEADING
Must be present with other publications, if available, to present a balanced view
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