MPJE (Michigan Law) Questions And Answers 100% Guaranteed Success.
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MPJE
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MPJE
MPJE (Michigan Law) Questions And Answers 100% Guaranteed Success.
Hatch-Waxman Act - correct answer. In 1984 this allowed greater access for companies to dispense generic drugs.
Drugs companies must submit this for a generic drug: - correct answer. Abbreviated New Drug ...
MPJE (Michigan Law) Questions And
Answers 100% Guaranteed Success.
Hatch-Waxman Act - correct answer. In 1984 this allowed greater access for
companies to dispense generic drugs.
Drugs companies must submit this for a generic drug: - correct answer. Abbreviated
New Drug Application (ANDA)
ANDA process - correct answer. Does not require companies to repeat animal and
clinical research on ingredients.
ANDA Process applies to drugs made after: - correct answer. 1962
Generic drug has to match with the following: - correct answer. Identity, Strength,
Purity and Quality (ISPQ)
If a drug has an NDC does it guarantee drug approval? - correct answer. NO
Use of an unapproved drug such as Domperidone is: - correct answer. Misbranding
Side effects statement: - correct answer. States to call doctor for medical advice
about SE. Alway may report SE to FDA. Included with new fills and refills
Does the side effect statement apply to inpatients and health care facility under the
order of a licensed practitioner? - correct answer. NO
OTC Side Effect Statement: - correct answer. If not statement, must have number to
report it to
Font requirements for statements: - correct answer. There isn't a specific
requirement for meds but for OTC must be a minimum of 6 point bold letter.
, Anything topical is exempt from Poison Prevention Packaging Act except: - correct
answer. Nasal and lidocaine
What is exempt from the Poison Prevention Packaging Act? - correct answer.
Samples and Starter Packs
Any nose drop with this substance needs a PPPA: - correct answer. Oxymetazolone
Market Withdrawal: - correct answer. A firm removes the product from the market to
correct a violation
Michigan Samples - correct answer. Under article 17 a physician may delegate to a
pharmacist in writing the receipt of a complimentary starter dose of drugs other than CS
CS to Foreign Countries - correct answer. Has to be registered as an exporter to
ship CS out of country.
US resident can bring up to how many CS units from overseas: - correct answer. 50
but they have to declare it
PI (Package Insert) vs PPI (Patient Package Insert) - correct answer. Package
insert is just professional information where patient package insert is required with all
fills if medication requires it
Michigan Counseling - correct answer. MUST offer counseling with each new drug
patient is on
Are pharmacies able to compound and manufacture drugs at the same location? -
correct answer. NO
If a pharmacy ships more than 5% of compounded drugs they must: - correct answer.
Sign a memorandum of understanding with the FA
Outsourcing Facility - correct answer. Has to be licensed by the state of Michigan as
a pharmacy but the FDA registration is "voluntary"
An outsourcing facility can compound copies of a medication when: - correct answer.
It is on a shortage list
An outsourcing facility has how many days to report an adverse event? - correct
answer. 10 days
Is there a limit on the ratio of technicians and support staff to pharmacists - correct
answer. NO
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