NEVADA MPJE 2026 PRACTICE QUESTION SET
ONE
◉ Misbranding or adulteration: contains unsafe color additive.
Answer: adulteration
◉ Misbranding or adulteration: OTC drug not packaged in tamper-
resistant packaging. Answer: Adulteration
◉ Misbranding or adulteration: subject to deterioration and label
does not warn Answer: misbranding
◉ Misbranding or adulteration: package or drug is misleading in the
way ait is filled or formed or is imitative of another drug. Answer:
misbranding
◉ Misbranding or adulteration: health endangering if used in the
manner suggested by the labeling. Answer: misbranding
◉ What is the difference between consumer medication information
(CMI) and MedGuides? Answer: CMI - mandated that written
information is provided to the patient for every drug every time a
new prescription is dispensed (key information: how to take it,
storage, etc). MedGuides - manufacturers are required to provide for
,drugs that pose a "serious and significant" concern to the public;
requires FDA approval, is part of the labeling. Provided by the
manufacturer.
◉ What is a Class I recall? Answer: use will likely result in serious
adverse health consequences or death.
◉ What is a class II recall? Answer: use may cause temporary or
medically reversible adverse health consequences.
◉ What is a class III recall? Answer: use is not likely to cause
adverse health consequences.
◉ In a recall, what is the withdrawal process? Answer: Mfr must
contact seller. Seller is responsible for contacting the consumer.
Either the manufacturer or the FDA can initiate a recall. Pharmacists
are responsible for knowing which drugs have been recalled.
◉ What are current good manufacturing practices? Answer: cGMP
are a set or regulations that estabilishes minimum requirements for
the methods, facilities, or controls used in the manufacture,
processesing, packing, or holding of a drug product. Helsp ensure
drugs are safe and meet the quality and purity requirements - if they
don't, drugs are adulterated.
,◉ What is the new drug development process? Answer: Pre-clinical
testing in animals. File IND (investigational new drug). Clinical trials.
Phase I = healthy volunteers, looks at safety. Phase II = limited trials
in patients with the disease, looks at efficacy. Phase III = large-scale
clinical trials. File NDA (new drug application). Followed by Phase
IV: post-marketing trials.
◉ What is the pure food and drug act of 1906? Answer: prohibits the
adulteration and misbranding of foods and drugs. Labels not
required to list ingredients. Misbranding provisions of the law didn't
prevent false or misleading efficacy claims; only prevented false
statements as to the drugs identity. Did not provide authority to ban
unsafe drugs. Did not regulate cosmetics or medical devices.
◉ What is the food, drug and cosmetic act of 1938? Answer:
required that new drugs cannot be marketed until proven SAFE for
use under the conditions described on the label. Labels must know
contain adequate directions for use. Warnings included about
medications that may be habit forming.
◉ What is the Durham-Humphrey Amendment of 1951? Answer:
Estrablished 2 classes of drugs - RX and OTC.
◉ What is the Kefauver-Harris Amendment of 1961? Answer:
required drugs be proven safe AND effective. Established cGMP.
Established new drug approval process, including informed consent.
, ◉ What is the poison prevention packaging act of 1970? Answer:
requires all OTC and rx drugs be subject to special packaging
requirements - child-resistant container. Not required if prescriber
authorizes or the patient requests.
◉ What is the Medical Devices Act of 1976? Answer: FDCA amended
to provide authority regarding the safety and efficacy of medical
devices. Class I - low risk of harm, no pre-market testing (tongue
depressors, bandges, etc). Class II - safety and efficacy must be
evaluated (hearing aids, forceps). Class III - usually life-supporting
devices, pre-market approval is necessary (soft contact lenses,
pacemakers, replacement heart valves).
◉ What is the Orphan Drug Act of 1983? Answer: provided tax and
licensing incentives for manufacturers to develop and market drugs
or biologicals for the treatment of rare disease or conditions" that
affect relatively few people. (rare < 200,000 people in the US)
◉ What is the drug price competition and patent term restoration
act of 1984? Answer: streamlined the generic drug approval process
(created ANDA, allowed generics to be more readily available to the
public). Extended patent extensions to innovator drugs - the
manufacturer of the innovator drug has 5 years of patent restoration
or at least 5 years of exclusive marketing once the drug has been
approved by the FDA.
ONE
◉ Misbranding or adulteration: contains unsafe color additive.
Answer: adulteration
◉ Misbranding or adulteration: OTC drug not packaged in tamper-
resistant packaging. Answer: Adulteration
◉ Misbranding or adulteration: subject to deterioration and label
does not warn Answer: misbranding
◉ Misbranding or adulteration: package or drug is misleading in the
way ait is filled or formed or is imitative of another drug. Answer:
misbranding
◉ Misbranding or adulteration: health endangering if used in the
manner suggested by the labeling. Answer: misbranding
◉ What is the difference between consumer medication information
(CMI) and MedGuides? Answer: CMI - mandated that written
information is provided to the patient for every drug every time a
new prescription is dispensed (key information: how to take it,
storage, etc). MedGuides - manufacturers are required to provide for
,drugs that pose a "serious and significant" concern to the public;
requires FDA approval, is part of the labeling. Provided by the
manufacturer.
◉ What is a Class I recall? Answer: use will likely result in serious
adverse health consequences or death.
◉ What is a class II recall? Answer: use may cause temporary or
medically reversible adverse health consequences.
◉ What is a class III recall? Answer: use is not likely to cause
adverse health consequences.
◉ In a recall, what is the withdrawal process? Answer: Mfr must
contact seller. Seller is responsible for contacting the consumer.
Either the manufacturer or the FDA can initiate a recall. Pharmacists
are responsible for knowing which drugs have been recalled.
◉ What are current good manufacturing practices? Answer: cGMP
are a set or regulations that estabilishes minimum requirements for
the methods, facilities, or controls used in the manufacture,
processesing, packing, or holding of a drug product. Helsp ensure
drugs are safe and meet the quality and purity requirements - if they
don't, drugs are adulterated.
,◉ What is the new drug development process? Answer: Pre-clinical
testing in animals. File IND (investigational new drug). Clinical trials.
Phase I = healthy volunteers, looks at safety. Phase II = limited trials
in patients with the disease, looks at efficacy. Phase III = large-scale
clinical trials. File NDA (new drug application). Followed by Phase
IV: post-marketing trials.
◉ What is the pure food and drug act of 1906? Answer: prohibits the
adulteration and misbranding of foods and drugs. Labels not
required to list ingredients. Misbranding provisions of the law didn't
prevent false or misleading efficacy claims; only prevented false
statements as to the drugs identity. Did not provide authority to ban
unsafe drugs. Did not regulate cosmetics or medical devices.
◉ What is the food, drug and cosmetic act of 1938? Answer:
required that new drugs cannot be marketed until proven SAFE for
use under the conditions described on the label. Labels must know
contain adequate directions for use. Warnings included about
medications that may be habit forming.
◉ What is the Durham-Humphrey Amendment of 1951? Answer:
Estrablished 2 classes of drugs - RX and OTC.
◉ What is the Kefauver-Harris Amendment of 1961? Answer:
required drugs be proven safe AND effective. Established cGMP.
Established new drug approval process, including informed consent.
, ◉ What is the poison prevention packaging act of 1970? Answer:
requires all OTC and rx drugs be subject to special packaging
requirements - child-resistant container. Not required if prescriber
authorizes or the patient requests.
◉ What is the Medical Devices Act of 1976? Answer: FDCA amended
to provide authority regarding the safety and efficacy of medical
devices. Class I - low risk of harm, no pre-market testing (tongue
depressors, bandges, etc). Class II - safety and efficacy must be
evaluated (hearing aids, forceps). Class III - usually life-supporting
devices, pre-market approval is necessary (soft contact lenses,
pacemakers, replacement heart valves).
◉ What is the Orphan Drug Act of 1983? Answer: provided tax and
licensing incentives for manufacturers to develop and market drugs
or biologicals for the treatment of rare disease or conditions" that
affect relatively few people. (rare < 200,000 people in the US)
◉ What is the drug price competition and patent term restoration
act of 1984? Answer: streamlined the generic drug approval process
(created ANDA, allowed generics to be more readily available to the
public). Extended patent extensions to innovator drugs - the
manufacturer of the innovator drug has 5 years of patent restoration
or at least 5 years of exclusive marketing once the drug has been
approved by the FDA.
