MULTISTATE PHARMACY
JURISPRUDENCE EXAM (MPJE)
REVIEW (FEDERAL LAW) WITH 304
QUESTIONS AND CORRECT ANSWERS
RATED A+ 2026/2027[VERIIED
ANSWERS]
What act established the FDA in 1970?
DEA (created 1973)
Drug Enforcement Administration
Prescription Drug Marketing Act of 1987
PDMA
Omnibus Budget Reconciliation Act of 1990
OBRA 90 - what does it stand for
Adulteration
Misbranding
Placing into interstate commerce unapproved new drugs
What 3 illegal acts did the Pure Food and Drug Act of 1906 establish
Federal Food, Drug, and Cosmetic Act of 1938
Mandated tests for drug toxicity and provided means for recall of drugs;
established procedures for introducing new drugs; gave FDA the power of
enforcement
Intended Use
A drug is dependent on _____________
,Provider, not the user
Intended use is determined by the___________, not the __________
1. In USP, or NF, or Homeopathic P.
2. Articles INTENDED FOR use in the
Diagnosis
Cure
Mitigation
Treatment or Prevention of Disease in man or animal
3. Articles intended to affect the STRUCTURE or FUNCTION of the body (other
than food)
4. Any component of the above
Drug
Device
Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent
A drug works through a chemical reaction and is dependent on metabolism. ;
Devices are only recognized in the USP or NF (Not homeopathic)
What is the difference between how a drug works and a device works
I. Reasonable assurance of safety and effectiveness (referred to as GENERAL
CONTROLS device)
II. Insufficient info for reasonable assurance safety and effectiveness
III. Pre-market approval
What are the 3 classes of devices
Class I
Device class - Reasonable assurance of safety and effectivenss
Class III
Pre-market approval
cosmetic
,Something applied to the body for Cleansing, Beauty, Altering, Appearance. (NOT
SOAP)
True
True or False: A item can be both a drug AND cosmetic
Label
Written, printed, or graphic on the container or accompanying it
Label
What must always accompany the container because it conveys intended use
True
True or False: A patient may be given a package insert
FDA
Labelling must be ________ approved
Contraindications
Warnings
Precautions
Adverse Reactions
What is the order of importance of what is included in a package insert
Essential scientific information; not false or promotional evidence of safe and
effective clinical pharmacology
What is the required content of a package insert
New Drug
Any drug after June 25, 1938 that was subject to the Food and Drug Act of 1906
NDA (New Drug Application
Required of all new drugs
ANDA (Abbreviated New Drug Application)
Required of all generic drugs
, Same:
Entity
Strength
Dosage Form
And MUST BE BIOEQUIVALENT
What are the requirements of an ANDA
False - just new drugs (prior to interstate commerce)
True or False: Both new drugs and generic drugs must be proven to be safe and
effective
Adulterated
Food and Drug Administration
a federal agency in the Department of Health and Human Services established to
regulate the release of new foods and health-related products
(P)FDA
Pure Food and Drug Act of 1906
Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38)
FDCA
Poison Prevention Packaging Act of 1970
PPPA
Controlled Substance of 1970
CSA
Controlled Substance Act of 1970
What a drug is corrupt, debase or made impure by the addition of a foreign or
inferior substance or element
Misbranding
JURISPRUDENCE EXAM (MPJE)
REVIEW (FEDERAL LAW) WITH 304
QUESTIONS AND CORRECT ANSWERS
RATED A+ 2026/2027[VERIIED
ANSWERS]
What act established the FDA in 1970?
DEA (created 1973)
Drug Enforcement Administration
Prescription Drug Marketing Act of 1987
PDMA
Omnibus Budget Reconciliation Act of 1990
OBRA 90 - what does it stand for
Adulteration
Misbranding
Placing into interstate commerce unapproved new drugs
What 3 illegal acts did the Pure Food and Drug Act of 1906 establish
Federal Food, Drug, and Cosmetic Act of 1938
Mandated tests for drug toxicity and provided means for recall of drugs;
established procedures for introducing new drugs; gave FDA the power of
enforcement
Intended Use
A drug is dependent on _____________
,Provider, not the user
Intended use is determined by the___________, not the __________
1. In USP, or NF, or Homeopathic P.
2. Articles INTENDED FOR use in the
Diagnosis
Cure
Mitigation
Treatment or Prevention of Disease in man or animal
3. Articles intended to affect the STRUCTURE or FUNCTION of the body (other
than food)
4. Any component of the above
Drug
Device
Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent
A drug works through a chemical reaction and is dependent on metabolism. ;
Devices are only recognized in the USP or NF (Not homeopathic)
What is the difference between how a drug works and a device works
I. Reasonable assurance of safety and effectiveness (referred to as GENERAL
CONTROLS device)
II. Insufficient info for reasonable assurance safety and effectiveness
III. Pre-market approval
What are the 3 classes of devices
Class I
Device class - Reasonable assurance of safety and effectivenss
Class III
Pre-market approval
cosmetic
,Something applied to the body for Cleansing, Beauty, Altering, Appearance. (NOT
SOAP)
True
True or False: A item can be both a drug AND cosmetic
Label
Written, printed, or graphic on the container or accompanying it
Label
What must always accompany the container because it conveys intended use
True
True or False: A patient may be given a package insert
FDA
Labelling must be ________ approved
Contraindications
Warnings
Precautions
Adverse Reactions
What is the order of importance of what is included in a package insert
Essential scientific information; not false or promotional evidence of safe and
effective clinical pharmacology
What is the required content of a package insert
New Drug
Any drug after June 25, 1938 that was subject to the Food and Drug Act of 1906
NDA (New Drug Application
Required of all new drugs
ANDA (Abbreviated New Drug Application)
Required of all generic drugs
, Same:
Entity
Strength
Dosage Form
And MUST BE BIOEQUIVALENT
What are the requirements of an ANDA
False - just new drugs (prior to interstate commerce)
True or False: Both new drugs and generic drugs must be proven to be safe and
effective
Adulterated
Food and Drug Administration
a federal agency in the Department of Health and Human Services established to
regulate the release of new foods and health-related products
(P)FDA
Pure Food and Drug Act of 1906
Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38)
FDCA
Poison Prevention Packaging Act of 1970
PPPA
Controlled Substance of 1970
CSA
Controlled Substance Act of 1970
What a drug is corrupt, debase or made impure by the addition of a foreign or
inferior substance or element
Misbranding
