©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
Arizona MPJE Exam Study Guide with Complete Solutions
Pure Food and Drug Act - ✔️✔️1906 - Forbade the manufacture or sale of mislabeled or
adulterated food or drugs, it gave the government broad powers to ensure the safety
and efficacy of drugs in order to abolish the "patent" drug trade. Still in existence as the
FDA.
The Food Drug and Comestic Act of 1938 - ✔️✔️Established the Food and Drug
Administration (FDA). Primarily regulates drug development, manufacturing, and
marketing- focus on quality. Only safe and properly labeled drugs may be introduced
into interstate commerce. Defined label and labeling (Labels must contain adequate
directions for use and warning if habit‐forming). Expanded the definition of misbranding
and adulteration (US Supreme court ruled that FDCA applies to drugs sold by the
pharmacy to the consumer. Also ruled that the outer container must tell consumers of
the contents, otherwise, it is misbranded). Defines what is considered a "food," "drug,"
"cosmetic," "dietary supplement," and "devices"
A drug is adulterated if: - ✔️✔️It consists of any filthy, putrid, or decomposed substance; it
has been prepared , packed, or held under unsanitary conditions or not in conformity
with current good manufacturing practices; if it's container is composed of any
poisonous substance; the drug strength, quality or purity of the drug differs from that on
1
,©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
the label; the drug strength, quality or purity of the drug differs from compendia
standards (unless variations stated on the label; contains an unsafe color additive
A drug is misbranded if: - ✔️✔️It's labeling is false or misleading in any way; required
information is missing from the label such as: established name of drugs of both active
and inactive ingredients, adequate directions for use, adequate information for use,
name and place of business of the manufacturer, packer, or distributor, or Rx only is
missing
Durham-Humphrey Amendment of 1951 - ✔️✔️• Created a distinction between "OTC"
and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
Kefauver-Harris Amendment of 1962 - ✔️✔️• Also known as the "Drug Efficacy
Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their
drugs before approval .
2
,©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
Medical Device Amendment of 1976 - ✔️✔️Classification of device according to their
function. Requires life-sustaining and life-supporting devices to have pre-market
approval from the FDA
Orphan Drug Act of 1983 - ✔️✔️Provided incentives for the development of orphan drugs
for treatment of rare diseases
Drug Price Competition and Patent Restoration Act of 1984 - ✔️✔️fill in later
Prescription Drug Marketing Act of 1987 - ✔️✔️States must license drug wholesalers;
banned the re-importation of drugs, except by the manufacturer; banned the sale, trade,
purchase of prescription drug samples; set standards for distribution, storage, records of
prescription drug samples; no pharmacy can distribute samples (exception is hospital or
healthcare entity pharmacy where a practitioner authorizes the sample and adequate
records are kept); banned trafficking in prescription drug coupons; prohibited the resale
of drugs purchased by hospitals or health care facilities
Dietary Supplement Health and Education Act of 1994 - ✔️✔️Provided a new definition of
"dietary supplement."; Even if an item is called a supplement, it may be considered a
drug by the FDA if
3
, ©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
there are drug claims in the item's promotion (i.e., cure, treatment and/or prevention
claims are made); The product must contain the disclaimer on the label, in regards to
any statements
about the product; Unfortunately, this act may blur the line between foods and drugs,
and may
complicate any of the FDA's enforcement over dietary supplements; Stripped FDA of
premarket approval authority
Definition of dietary supplement - ✔️✔️A product intended for ingestion, is intended to
supplement the diet, and contains any one or more of the following: A vitamin, A
mineral, An herb or other botanical, An amino acid, A dietary substance for use by
humans to supplement the diet by increasing the total dietary intake, A concentrate,
metabolite, constituent, extract, or combination of the previous
What 4 claims are dietary supplements allowed to make under the Dietary Supplement
Health and Education Act of 1994? - ✔️✔️1. A benefit relating to a classic nutrient
deficiency disease; must disclose
prevalence of the disease in the US
2. Describe how a product affects any part of the structure of the human body,
(e.g., "Glucosamine helps promote connective tissue"), or any function of the
human body (e.g., "Echinacea helps support the immune system");
4
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
Arizona MPJE Exam Study Guide with Complete Solutions
Pure Food and Drug Act - ✔️✔️1906 - Forbade the manufacture or sale of mislabeled or
adulterated food or drugs, it gave the government broad powers to ensure the safety
and efficacy of drugs in order to abolish the "patent" drug trade. Still in existence as the
FDA.
The Food Drug and Comestic Act of 1938 - ✔️✔️Established the Food and Drug
Administration (FDA). Primarily regulates drug development, manufacturing, and
marketing- focus on quality. Only safe and properly labeled drugs may be introduced
into interstate commerce. Defined label and labeling (Labels must contain adequate
directions for use and warning if habit‐forming). Expanded the definition of misbranding
and adulteration (US Supreme court ruled that FDCA applies to drugs sold by the
pharmacy to the consumer. Also ruled that the outer container must tell consumers of
the contents, otherwise, it is misbranded). Defines what is considered a "food," "drug,"
"cosmetic," "dietary supplement," and "devices"
A drug is adulterated if: - ✔️✔️It consists of any filthy, putrid, or decomposed substance; it
has been prepared , packed, or held under unsanitary conditions or not in conformity
with current good manufacturing practices; if it's container is composed of any
poisonous substance; the drug strength, quality or purity of the drug differs from that on
1
,©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
the label; the drug strength, quality or purity of the drug differs from compendia
standards (unless variations stated on the label; contains an unsafe color additive
A drug is misbranded if: - ✔️✔️It's labeling is false or misleading in any way; required
information is missing from the label such as: established name of drugs of both active
and inactive ingredients, adequate directions for use, adequate information for use,
name and place of business of the manufacturer, packer, or distributor, or Rx only is
missing
Durham-Humphrey Amendment of 1951 - ✔️✔️• Created a distinction between "OTC"
and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
Kefauver-Harris Amendment of 1962 - ✔️✔️• Also known as the "Drug Efficacy
Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their
drugs before approval .
2
,©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
Medical Device Amendment of 1976 - ✔️✔️Classification of device according to their
function. Requires life-sustaining and life-supporting devices to have pre-market
approval from the FDA
Orphan Drug Act of 1983 - ✔️✔️Provided incentives for the development of orphan drugs
for treatment of rare diseases
Drug Price Competition and Patent Restoration Act of 1984 - ✔️✔️fill in later
Prescription Drug Marketing Act of 1987 - ✔️✔️States must license drug wholesalers;
banned the re-importation of drugs, except by the manufacturer; banned the sale, trade,
purchase of prescription drug samples; set standards for distribution, storage, records of
prescription drug samples; no pharmacy can distribute samples (exception is hospital or
healthcare entity pharmacy where a practitioner authorizes the sample and adequate
records are kept); banned trafficking in prescription drug coupons; prohibited the resale
of drugs purchased by hospitals or health care facilities
Dietary Supplement Health and Education Act of 1994 - ✔️✔️Provided a new definition of
"dietary supplement."; Even if an item is called a supplement, it may be considered a
drug by the FDA if
3
, ©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
there are drug claims in the item's promotion (i.e., cure, treatment and/or prevention
claims are made); The product must contain the disclaimer on the label, in regards to
any statements
about the product; Unfortunately, this act may blur the line between foods and drugs,
and may
complicate any of the FDA's enforcement over dietary supplements; Stripped FDA of
premarket approval authority
Definition of dietary supplement - ✔️✔️A product intended for ingestion, is intended to
supplement the diet, and contains any one or more of the following: A vitamin, A
mineral, An herb or other botanical, An amino acid, A dietary substance for use by
humans to supplement the diet by increasing the total dietary intake, A concentrate,
metabolite, constituent, extract, or combination of the previous
What 4 claims are dietary supplements allowed to make under the Dietary Supplement
Health and Education Act of 1994? - ✔️✔️1. A benefit relating to a classic nutrient
deficiency disease; must disclose
prevalence of the disease in the US
2. Describe how a product affects any part of the structure of the human body,
(e.g., "Glucosamine helps promote connective tissue"), or any function of the
human body (e.g., "Echinacea helps support the immune system");
4
