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Pharmacy Law MPJE Exam: Federal Law| Questions with 100% Correct Answers
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Pharmacy Law MPJE Exam: Federal Law| Questions with 100% Correct Answers
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Pharmacy Law MPJE Exam: FederalLaw| Questions with 100% Correct
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What is another word for unapproved use? - ✔ ✔ Off Label
What is a prescription drug - ✔ ✔ Drug intended for use by man which, because of its toxicity
or potential for harmful effect or the method of use or the collateral measures necessary to its
use is not safe for use except under the supervision of a practitioner licensed by law to
administer such a drug. It is limited by an approval to use under professional supervision of a
practitioner licensed by law to administer such drug. Must have a written prescription, oral
prescription, faxed prescription, or refill to dispense such medications. Dispensing contrary to
these provisions is deemed MISBRANDING.
What is an OTC drug? - ✔ ✔ Drugs recognized as among experts to be safe and effective for
use. Must be manufactured under the FDA's good manufacturing standards and be labeled
with directions for the layperson that indicate their safe and effective use.
Compounding vs Manufacturing - ✔ ✔ Compounding / Manufacturing
1) Compounding on a particular basis (if compounding ahead of time in large quantities or
without prescriptions would be manufacturing)
2) Being compounded for an individual patient prescription (compounding large quantities
for office use or other uses would be manufacturing)
3) The geographic area of distribution (large area would be manufacturing)
,4) Whether any advertising is being used (may not advertise for compounding)
5) The % of gross income from sales of particular compounded drugs (large % gross
income would be more of a manufacturer than a pharmacy)
6) Whether drugs are being offered at wholesale prices
7) If they do not manufacturer, prepare, propagate, compound, or process drugs or devices
for sale other that in the regular course of their business dispensing or selling devices at retail
would be deemed manufacturing.
Misbranding is the same thing as - ✔ ✔ Mislabeling
What is the definition per the FDCA of adulterated drug? - ✔ ✔ Filthy, putrid,
decomposed product; Packed/held in unsanitary conditions; methods to produce/package
do not follow good manufacturing practice; does not meet compounding standards;
container is at all exposed to poisonous or deleterious substance; contains unsafe
coloring; new animal drug unsafe within the meaning; animal feed with unsafe drug.
What is strict liability / liability without fault? - ✔ ✔ The FD&C Act imposes strict liability
(liability without fault) on all who are affected by its provisions. (The specific prohibited acts
include misbranding and adulteration of drugs.) Criminal intention is not necessary to violate
the Act. It is not a defense to claim lack of knowledge or lack of intent to violate the law. (The
Act would be unenforceable if these pleas were acceptable.)
What is the safe harbor provision? - ✔ ✔ If pharmacies have a guarantee from the supplier
that the drug has not been misbranded or adulterated then the pharmacist will not be
responsible for a sealed medication bottle.
,Per the FDCA, define dietary supplements? - ✔ ✔ 1) Product other than tobacco intended to
supplement the diet that bears or contains one or more of the following dietary ingredients: a
vitamin, mineral, herb or other botanical, amino acid, a dietary substance for use by man to
metabolite, constituent, extract, or combination of any ingredient above.
2) A product intended for INGESTION in tablet, capsule, powder, softgel, gelcap, or liquid
form; or if not intended for ingestion in such a form is not represented as conventional food
and is not represented for use as a sole item of a meal or of the diet.
Who decides if a drug has a black box warning? - ✔ ✔ FDA
Who decides if a drug is a REMS drug? - ✔ ✔ FDA
What are the 5 pregnancy warnings? - ✔ ✔ A, B, C, D, and X
Does the presence of a NDC on a label indicated that a drug has been approved by the FDA -
✔ ✔ No, the FDA assigns NDC numbers simply for identification purposes
Name 7 instances when a drug would be approved as a new drug - ✔ ✔ 1) The drug
contains new substance
2) There is a new combination of approved drugs
3) The proportion of ingredients in combination is changed
4) There is a new intended use for the drug
5) The dosage, method, or duration of administration or application is changed
6) New packing materials
7) A new patient population
Describe the process for filing for an INDA - ✔ ✔ 1) File for INDA after animal testing for safety
, 2) If the FDA does not REJECT the INDA within 30 days then you may being human clinical
testing
What is the purpose of Phase 1 Clinical Trials? - ✔ ✔ To detect adverse events; not
determine efficacy
Who is enrolled in Phase 1 Clinical Trials? - ✔ ✔ Healthy patients; need written informed consent
What is the purpose of Phase 2 Clinical Trials? - ✔ ✔ To determine the efficacy of the drug and
to determine further safety
Who is enrolled in Phase 2 Clinical Trials? - ✔ ✔ Sick patients; need written informed consent
What is the purpose of Phase 3 Clinical Trials? - ✔ ✔ To test the drug in 100s - 1000s of
patients; verbal consent is sufficient and these trials often occur in actual clinical settings
If the phase 3 trial is successful what occurs next? - ✔ ✔ The drug manufacturer may submit
an NDA to the FDA
When can the FDA stop an IND? - ✔ ✔ At any time if the studies show the drug is too risky
All drug manufacturers must do what type of studies after the NDA has been submitted and/or
approved? - ✔ ✔ Post-Marketing Surveillance and conduct more clinical trials (Unofficially
called Phase IV trials)
Describe the ANDA - ✔ ✔ The ANDA is for generic drug manufacturers
1) Proof of safety and efficacy not required
2) Only proof of bioequivalence and proof of GMP is needed
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