NEVADA MPJE LATEST EXAMINERS SET
QUESTIONS AND ANSWERS SURE A+
✔✔In a recall, what is the withdrawal process? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔Estrablished 2 classes of
drugs - RX and OTC.
✔✔What is the Kefauver-Harris Amendment of 1961? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? -
✔✔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.
✔✔What is the prescription drug marketing act of 1987? - ✔✔provides storage,
handling and record keeping requirements for drug samples. Bans the sale, trade, or
purchase of drug samples. Prohibits hospitals and healthcare entitites from reselling
pharmaceutical purchases.
✔✔What is the Omnibus Budget Reconciliation Act of 1990 (OBRA 90)? -
✔✔establishment of a federal drug policy requiring drug use review (DUR) to ensure
that drug therapy is as safe and effective as possible. Intent - cost savings and better
fiscal management of medicare/Medicaid.
, ✔✔What is the nutrition labeling and education act of 1990? - ✔✔amended the FDCA to
prohibit disease-prevention claims in food labeling unless it conforms to FDA drug
regulations.
✔✔What is the prescription drug user fee act of 1992? - ✔✔provides annual fees on
manufacturers and their products. Fees are appropriated to the FDA for improving the
regulatory process and speeding drug approvals.
✔✔What is the dietary supplement health and education act of 1994? - ✔✔established
a formal definition of "dietary supplement" - a product that is intended to supplement the
diet that bears or contains one or more of the following .... Vitamin, mineral,
herb/botanical, amino acid, etc.
✔✔Are supplements evaluated by the FDA? - ✔✔NO. in fact, their labeling must include
"this statement has not been evaluated by the FDA. The product is not intended to
diagnose, treat, cure, or prevent any disease."
✔✔What is the food and drug administration modernization act of 1997? - ✔✔designed
to overhaul the FDA. Allows for fastr-tracking of drugs intended for serious or life-
threatening diseases. Establishes a data base on clinical trials. Authorizes scientific
panels to review clinical investigations. Incentives for conducting pediatric clinical
studies. Pharmacy compounding regulations.
✔✔What is the best pharmaceutical for children act of 2002? - ✔✔designed to stimulate
additional research into pediatric data for pharmaceuticals - incentives in the form of
market exclusivity.
✔✔What is the dietary supplement and nonprescription drug consumer protection act of
2006? - ✔✔gives FDA more authority to remove unsafe dietary supplements and OTC
products.
✔✔What is the Privacy rule? - ✔✔addresses the us and disclosure of patients' health
information called "protected health information"
✔✔Medicare/Medicaid Fraud and Abuse Statute - ✔✔prohibits knowingly making a
false statement of a material fact in any application for a benefit or payment. Prohibits
kickbacks: knowingly and willfully soliciting, receiving, offering, or paying any
remuneration in exchange for inducing referrals or for furnishing any goods or services
paid for by medicare/Medicaid.
✔✔True or false: federal law states that written prescriptions (not including electronic,
oral or faxes) must be written on a tamper-resistant prescription pad. - ✔✔
QUESTIONS AND ANSWERS SURE A+
✔✔In a recall, what is the withdrawal process? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔Estrablished 2 classes of
drugs - RX and OTC.
✔✔What is the Kefauver-Harris Amendment of 1961? - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔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? -
✔✔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.
✔✔What is the prescription drug marketing act of 1987? - ✔✔provides storage,
handling and record keeping requirements for drug samples. Bans the sale, trade, or
purchase of drug samples. Prohibits hospitals and healthcare entitites from reselling
pharmaceutical purchases.
✔✔What is the Omnibus Budget Reconciliation Act of 1990 (OBRA 90)? -
✔✔establishment of a federal drug policy requiring drug use review (DUR) to ensure
that drug therapy is as safe and effective as possible. Intent - cost savings and better
fiscal management of medicare/Medicaid.
, ✔✔What is the nutrition labeling and education act of 1990? - ✔✔amended the FDCA to
prohibit disease-prevention claims in food labeling unless it conforms to FDA drug
regulations.
✔✔What is the prescription drug user fee act of 1992? - ✔✔provides annual fees on
manufacturers and their products. Fees are appropriated to the FDA for improving the
regulatory process and speeding drug approvals.
✔✔What is the dietary supplement health and education act of 1994? - ✔✔established
a formal definition of "dietary supplement" - a product that is intended to supplement the
diet that bears or contains one or more of the following .... Vitamin, mineral,
herb/botanical, amino acid, etc.
✔✔Are supplements evaluated by the FDA? - ✔✔NO. in fact, their labeling must include
"this statement has not been evaluated by the FDA. The product is not intended to
diagnose, treat, cure, or prevent any disease."
✔✔What is the food and drug administration modernization act of 1997? - ✔✔designed
to overhaul the FDA. Allows for fastr-tracking of drugs intended for serious or life-
threatening diseases. Establishes a data base on clinical trials. Authorizes scientific
panels to review clinical investigations. Incentives for conducting pediatric clinical
studies. Pharmacy compounding regulations.
✔✔What is the best pharmaceutical for children act of 2002? - ✔✔designed to stimulate
additional research into pediatric data for pharmaceuticals - incentives in the form of
market exclusivity.
✔✔What is the dietary supplement and nonprescription drug consumer protection act of
2006? - ✔✔gives FDA more authority to remove unsafe dietary supplements and OTC
products.
✔✔What is the Privacy rule? - ✔✔addresses the us and disclosure of patients' health
information called "protected health information"
✔✔Medicare/Medicaid Fraud and Abuse Statute - ✔✔prohibits knowingly making a
false statement of a material fact in any application for a benefit or payment. Prohibits
kickbacks: knowingly and willfully soliciting, receiving, offering, or paying any
remuneration in exchange for inducing referrals or for furnishing any goods or services
paid for by medicare/Medicaid.
✔✔True or false: federal law states that written prescriptions (not including electronic,
oral or faxes) must be written on a tamper-resistant prescription pad. - ✔✔
