Pharmacy MPJE Exam-Federal Law (Correct Answers)
What did the Federal Controlled Substances Act do? Why was it implemented?Correct
AnswersLegislators 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 AnswersProhibited 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
AnswersProvides 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 FDCACorrect AnswersThe 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 AnswersYes, 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 AnswersEstablished
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
medicationCorrect AnswersCaution: 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 AnswersRequired 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 periodCorrect Answers1938-1962; 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 AnswersProvided 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 AnswersMade 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 AnswersEstablished
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 1992Correct AnswersDrug 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 AnswersProvided laws on the regulation of dietary supplements; forced the FDA
to treat these products more as food than drugs
Define dietary supplement per the lawCorrect AnswersA 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 asCorrect AnswersA dietary supplement; they
CANNOT say they are drugs or anything else on the labeling
Dietary supplement manufacturers may not make these claimsCorrect AnswersDisease
Claims
Dietary supplement manufacturers may only make these types of claimsCorrect
AnswersStructure / 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 labelingCorrect Answers"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 AnswersFDA
Who enforces dietary supplement advertisingCorrect AnswersFTC
Do dietary supplements have to be safe and/or effective?Correct AnswersNo
How does a dietary supplement get pulled off the market?Correct AnswersThe 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
AnswersNo; 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
All publications must be PHYSICALLY SEPARATE from the product
What did the Food and Drug Modernization Act of 1997 do?Correct Answers1)
Renewed the Prescription Drug User Fee Act
2) Compounding by pharmacists was finally clarified
3) Manufacturer only has to do 1 clinical trial to supplement their NDA
4) Established inactive OTC ingredients requirement
5) Pharmacists can do nuclear compounding
6) Fast track approval process for drugs used for serious or life-threatening diseases
(initial drugs for this were HIV/AIDS medications)
What organization is the primary enforcer of the FDCA?Correct AnswersFDA
The FDA is a component of what organization?Correct AnswersDHHS
Is the USP a government agency?Correct AnswersNo, it is an independent agency that
sets purity standards
A drug recognized in the USP/NF must meet all standards or it will be
consideredCorrect AnswersMisbranded or adulterated
What are the 2 major offenses of the FDCA?Correct Answers1) Adulteration
2) Misbranding
These violations are of "strict liability nature", what does that mean?Correct
AnswersAdulteration or misbranding results in violation of the FDCA regardless of the
person's knowledge or intentions
Describe a Class I RecallCorrect AnswersMost serious; issued when there is
reasonable probability that the product will cause serious, adverse health consequences
or death; must contact patients
What did the Federal Controlled Substances Act do? Why was it implemented?Correct
AnswersLegislators 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 AnswersProhibited 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
AnswersProvides 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 FDCACorrect AnswersThe 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 AnswersYes, 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 AnswersEstablished
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
medicationCorrect AnswersCaution: 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 AnswersRequired 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 periodCorrect Answers1938-1962; 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 AnswersProvided 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 AnswersMade 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 AnswersEstablished
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 1992Correct AnswersDrug 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 AnswersProvided laws on the regulation of dietary supplements; forced the FDA
to treat these products more as food than drugs
Define dietary supplement per the lawCorrect AnswersA 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 asCorrect AnswersA dietary supplement; they
CANNOT say they are drugs or anything else on the labeling
Dietary supplement manufacturers may not make these claimsCorrect AnswersDisease
Claims
Dietary supplement manufacturers may only make these types of claimsCorrect
AnswersStructure / 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 labelingCorrect Answers"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 AnswersFDA
Who enforces dietary supplement advertisingCorrect AnswersFTC
Do dietary supplements have to be safe and/or effective?Correct AnswersNo
How does a dietary supplement get pulled off the market?Correct AnswersThe 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
AnswersNo; 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
All publications must be PHYSICALLY SEPARATE from the product
What did the Food and Drug Modernization Act of 1997 do?Correct Answers1)
Renewed the Prescription Drug User Fee Act
2) Compounding by pharmacists was finally clarified
3) Manufacturer only has to do 1 clinical trial to supplement their NDA
4) Established inactive OTC ingredients requirement
5) Pharmacists can do nuclear compounding
6) Fast track approval process for drugs used for serious or life-threatening diseases
(initial drugs for this were HIV/AIDS medications)
What organization is the primary enforcer of the FDCA?Correct AnswersFDA
The FDA is a component of what organization?Correct AnswersDHHS
Is the USP a government agency?Correct AnswersNo, it is an independent agency that
sets purity standards
A drug recognized in the USP/NF must meet all standards or it will be
consideredCorrect AnswersMisbranded or adulterated
What are the 2 major offenses of the FDCA?Correct Answers1) Adulteration
2) Misbranding
These violations are of "strict liability nature", what does that mean?Correct
AnswersAdulteration or misbranding results in violation of the FDCA regardless of the
person's knowledge or intentions
Describe a Class I RecallCorrect AnswersMost serious; issued when there is
reasonable probability that the product will cause serious, adverse health consequences
or death; must contact patients
