Arizona MPJE Correct Questions &
Solutions(RATED A+)
Pure Food and Drug Act - ANSWER 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 - ANSWER 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: - ANSWER 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 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: - ANSWER 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 - ANSWER • 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 - ANSWER • Also known as the "Drug Efficacy
Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their
drugs before approval .
,• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
Medical Device Amendment of 1976 - ANSWER 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 - ANSWER Provided incentives for the development of orphan
drugs for treatment of rare diseases
Drug Price Competition and Patent Restoration Act of 1984 - ANSWER fill in later
Prescription Drug Marketing Act of 1987 - ANSWER 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 - ANSWER 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
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 - ANSWER 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? - ANSWER 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");
3. Characterize the mechanism of action by which a product acts to maintain
body structure or function;
, 4. Describers the general well‐being from consumption
Food and Drug Modernization Act of 1997 - ANSWER FDAMA was passed primarily to
streamline regulatory procedures at the FDA; Extended the FDA's authority over over‐
the‐counter (OTC) drugs and new labeling requirements; Created a fast‐track approval
process for drugs treating serious or life‐threatening illnesses; Created databank of
information on clinical trials; Expanded rights of manufacturers to disseminate off‐label
use information
Child resistant packaging: - ANSWER 80% of children less than 5 years old CANNOT
open it, but 90% of adults CAN
open it
Poison Prevention Packaging Act of 1970 - ANSWER • Also known as the PPPA
• Designed to reduce the risk of children ingesting dangerous substances.
• Required locking caps on most prescriptions
OBRA 90 - ANSWER Requires pharmacists to provide Drug Utilization Review (offer to
counseling and other requirements for Medicaid patients); Funded studies to measure
the effectiveness of pharmacist‐provided DUR; Manufacturer rebates to Medicaid
Do FDA inspectors or board members require a warrant for an inspection in Arizona? -
ANSWER FDA inspectors DO NOT NEED a warrant to perform an inspection during
business hours
They DO NOT NEED to state the reason for the inspection; Two Arizona Board of
Pharmacy employees are credentialed as commissioned
officers of the FDA, allowing the FDA to share secure information with them; State
Board Inspectors, like FDA agents, do not need a warrant to perform an inspection
during business hours and they don't have to give a reason for inspection.
Who is the Arizona State Board of Pharmacy made up of? - ANSWER 1 tech, 6
pharmacists (at least 1 hospital and 1 retail) and 2 consumers (lay people)
What is a supplemental new drug application (SNDA) typically used for? - ANSWER to
add new indications to a drug or to change from RX to OTC
Abbreviated New Drug Application (ANDA) - ANSWER Different company submits to
market generic drug after innovator company patent expires. New drug requires proof of
similar pharmacokinetic properties, bioavailability, clinical activity.
What must be on the label of a dispensed Rx? - ANSWER Drug product name,
Established name (generic or chemical), Strength, Quantity, Recommended dosage (or
reference to package insert), Lot number, Expiration Date (For MM/YYYY format, drug
expires on the last day of that month), Legend statement ("Rx only" or "Caution: Federal
law prohibits dispensing without prescription"), Type of container to be used when
dispensing, Name and address of manufacturer/packager/distributor
Solutions(RATED A+)
Pure Food and Drug Act - ANSWER 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 - ANSWER 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: - ANSWER 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 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: - ANSWER 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 - ANSWER • 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 - ANSWER • Also known as the "Drug Efficacy
Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their
drugs before approval .
,• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
Medical Device Amendment of 1976 - ANSWER 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 - ANSWER Provided incentives for the development of orphan
drugs for treatment of rare diseases
Drug Price Competition and Patent Restoration Act of 1984 - ANSWER fill in later
Prescription Drug Marketing Act of 1987 - ANSWER 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 - ANSWER 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
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 - ANSWER 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? - ANSWER 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");
3. Characterize the mechanism of action by which a product acts to maintain
body structure or function;
, 4. Describers the general well‐being from consumption
Food and Drug Modernization Act of 1997 - ANSWER FDAMA was passed primarily to
streamline regulatory procedures at the FDA; Extended the FDA's authority over over‐
the‐counter (OTC) drugs and new labeling requirements; Created a fast‐track approval
process for drugs treating serious or life‐threatening illnesses; Created databank of
information on clinical trials; Expanded rights of manufacturers to disseminate off‐label
use information
Child resistant packaging: - ANSWER 80% of children less than 5 years old CANNOT
open it, but 90% of adults CAN
open it
Poison Prevention Packaging Act of 1970 - ANSWER • Also known as the PPPA
• Designed to reduce the risk of children ingesting dangerous substances.
• Required locking caps on most prescriptions
OBRA 90 - ANSWER Requires pharmacists to provide Drug Utilization Review (offer to
counseling and other requirements for Medicaid patients); Funded studies to measure
the effectiveness of pharmacist‐provided DUR; Manufacturer rebates to Medicaid
Do FDA inspectors or board members require a warrant for an inspection in Arizona? -
ANSWER FDA inspectors DO NOT NEED a warrant to perform an inspection during
business hours
They DO NOT NEED to state the reason for the inspection; Two Arizona Board of
Pharmacy employees are credentialed as commissioned
officers of the FDA, allowing the FDA to share secure information with them; State
Board Inspectors, like FDA agents, do not need a warrant to perform an inspection
during business hours and they don't have to give a reason for inspection.
Who is the Arizona State Board of Pharmacy made up of? - ANSWER 1 tech, 6
pharmacists (at least 1 hospital and 1 retail) and 2 consumers (lay people)
What is a supplemental new drug application (SNDA) typically used for? - ANSWER to
add new indications to a drug or to change from RX to OTC
Abbreviated New Drug Application (ANDA) - ANSWER Different company submits to
market generic drug after innovator company patent expires. New drug requires proof of
similar pharmacokinetic properties, bioavailability, clinical activity.
What must be on the label of a dispensed Rx? - ANSWER Drug product name,
Established name (generic or chemical), Strength, Quantity, Recommended dosage (or
reference to package insert), Lot number, Expiration Date (For MM/YYYY format, drug
expires on the last day of that month), Legend statement ("Rx only" or "Caution: Federal
law prohibits dispensing without prescription"), Type of container to be used when
dispensing, Name and address of manufacturer/packager/distributor
