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Indiana MPJE 2023 /405 Questions And Answers 100% Score!!!
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Indiana MPJE 2023 /405 Questions And Answers 100%Score!!!
Quiz :Law - Answer :a written law enacted by the legislature (congress or local
municipalities, governor, president) ELECTED OFFICIALS)
Quiz :T/F LAWS GO THROUGH A PUBLIC COMMENT AND REVISION PROCESS -
Answer :FALSE
Quiz :Where are federal laws found? - Answer :United States Code (USC)
Quiz :Where are Indiana laws found? - Answer :Indiana Code (IC)
Quiz :What is a Regulation/Rule? - Answer :having the force of a law issued by
an administrative agency- FDA, DEA, BOP (NON ELECTED )
Quiz :Where are federal regulations published? - Answer :Code of Federal
Regulations (CFR)
Quiz :Where are indiana Regulations found? - Answer :Indiana Administrative
Code (IAC)
Quiz :How would Titile 21 Section 353, subsection b be written in USC( united
states code)? - Answer :21 USC ss353 (b)
Quiz :What is the definition of a drug? - Answer :1) Articles recognized by U.S.
Pharmacopeia (USP), National formulary (NF), Homeopathic Pharmacopeia of
U.S (HPUS)
AND
2) Used to diagnose, cure, mitigate, treat, or prevent disease
AND
3) intended to affect the chemical structure/function of the body
Quiz :prescription drugs - Answer :a drug intended to be used by man, which
A- because of its toxicity or other potentiality for harmful effect, or method of
its use , or collateral measures necessary to its use, is not safe for use except
under supervision of a practitioner licensed by law to administer such drug
OR
,B- is limited by an approved application under sec 355 of this title to use under
the professional supervision of a practitioner licensed by law to administer
such drug (NEW DRUG)
Quiz :T/F Prescription drugs must have the symbol "RX only" on the product
label? - Answer :TRUE
Quiz :What are OTC Drugs? - Answer :drugs that are safe and effective
without a prescriber supervision for certain conditions
Quiz :The law specifically defines controlled substances as - - Answer :a drug
or other substance , or immediate precursor, included in schedule 1-5
a drug that has dependence liability and/or potential for abuse
Quiz :What is an orphan drug? - Answer :A drug used to treat
A-a rare disease affecting fewer than 200,000 Americans
OR
B-a condition that affects >200,000 people for which there is no reasonable
expectation that the cost of developing will be recovered from sales.
Quiz :What is a dietary supplement? - Answer :a- Vitamin
OR
B- mineral
OR
c-Herb /Botanical
OR
d-Amino Acid
OR
E- used by man or supplement the diet by increasing the total dietary intake
OR
F- concentrate metabolite, constituent, extract, or combination of ABCDE
above
Quiz :What is a NEW drug? - Answer :drug that is a drug that is not generally
recognized as safe and effective for the condition or in the dosage form it
would be prescribed under
OR
a drug that has been recognized as safe and effective, but has not been used
in the condition or in the dosage form for the sufficient amount of time.
,DRUG THAT HAS NOT COMPLETED THE PRE MARKET APPROVAL PROCESS
Quiz :T/F a new drug application is tied to its dosage form, in order to make a
already established tablet drug an injectable it must apply for approval again -
Answer :TRUE
Quiz :NDA (New Drug Application) - Answer :post-clinical trials to FDA, asking
if ok to market
Quiz :IND (Investigational New Drug Application) - Answer :Successful animal
testing. Premission for human testing (clinical trials)
Quiz :ANDA (Abbreviated New Drug Application) - Answer :the process by
which applicants must scientifically demonstrate to the FDA that their generic
product is bioequivalent and has acceptable manufacturing practices.
Quiz :What is an established name for a drug? - Answer :applicable official
name designated by sec 358 in this title
OR
recognized in official compendium (USP etc)
Quiz :What is a label? - Answer :printed , written, or graphic material on the
ACTUAL product CONTAINER
Quiz :What is labeling? - Answer :all labels and written, printed, or graphic
materialon the container , wrapper, or anything accompanying the product
Quiz :T/F the defiiniton of labeling INCLUDES the label itself - Answer :TRUE
Quiz :What is special packing? - Answer :packing designed to be significantly
difficult for children under 5 to open or obtain toxic/harmful amount within a
reasonable time,
AND
not difficult for normal adults to use properly
Quiz :T/F with special packaging children under 5 yo may still be able to get
into the packaging - Answer :TRUE- only stops them for a "reasonable amount
of time" does not mean they cannot open completely if given a lot of time
, Quiz :T/F special packaging only focuses on children under 5 yo -
Answer :TRUE
Quiz :What are pharmaceutical equivalents? - Answer :products with the
same active ingredient, dose form, and strength
Quiz :What are therapeutic equivalents? - Answer :Pharmaceutical
equivalents that are likely to have the same clinical and safety profile
Quiz :What is a "Person" defined by law? - Answer :individual, partner,
corporation, association
Quiz :What is a "state" defined by law? - Answer :any state or territory of the
US, including District of colombia and PR
Quiz :T/F Puerto rico is a territory as defined by law - Answer :FALSE its a
State
Quiz :FDCA (Federal Food, Drug, and Cosmetic act) - Answer :regulates all
drugs introduced into interstate commerce; oriented towards manufacturers
intent = protect consumers from adulterated or misbranded items
Quiz :In Indiana FDCA is adopted into the - Answer :Uniform Drug Act-
contains the same provisions with a few additions
Quiz :A drug is adulterated if: - Answer :1. consists in whole or in part of any
filthy, putrid, or decomposed substance
2. Made or held under unsanitary conditions.
3. Container made of poisonous, deleterious substance.
4. Contains coal-tar color, for coloring only, other than from a certified batch.
5. Differs from strength, quality, purity in compendium
6. Mixed with substance that would reduce its quality/strength.
7. where it is manufactured or stored limits , delays, denies, or limits
inspection.
LRS Title 40 chapter 4 - Food and Drugs - 616
Quiz :T/F A drug is considered adulterated if it was held in conditions where it
MAY have been contaminated , but it is not contaminated - Answer :TRUE
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