©THEBRIGHT EXAM SOLUTIONS
11/7/2024 12:35 PM
MPJE (Michigan Law) Exam Questions With
Correct Answers
Hatch-Waxman Act - answer✔In 1984 this allowed greater access for companies to dispense
generic drugs.
Drugs companies must submit this for a generic drug: - answer✔Abbreviated New Drug
Application (ANDA)
ANDA process - answer✔Does not require companies to repeat animal and clinical research on
ingredients.
ANDA Process applies to drugs made after: - answer✔1962
Generic drug has to match with the following: - answer✔Identity, Strength, Purity and Quality
(ISPQ)
If a drug has an NDC does it guarantee drug approval? - answer✔NO
Use of an unapproved drug such as Domperidone is: - answer✔Misbranding
Side effects statement: - 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? - answer✔NO
OTC Side Effect Statement: - answer✔If not statement, must have number to report it to
Font requirements for statements: - 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: - answer✔Nasal and
lidocaine
What is exempt from the Poison Prevention Packaging Act? - answer✔Samples and Starter
Packs
, ©THEBRIGHT EXAM SOLUTIONS
11/7/2024 12:35 PM
Any nose drop with this substance needs a PPPA: - answer✔Oxymetazolone
Market Withdrawal: - answer✔A firm removes the product from the market to correct a
violation
Michigan Samples - 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 - 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: - answer✔50 but they have to
declare it
PI (Package Insert) vs PPI (Patient Package Insert) - answer✔Package insert is just professional
information where patient package insert is required with all fills if medication requires it
Michigan Counseling - answer✔MUST offer counseling with each new drug patient is on
Are pharmacies able to compound and manufacture drugs at the same location? - answer✔NO
If a pharmacy ships more than 5% of compounded drugs they must: - answer✔Sign a
memorandum of understanding with the FA
Outsourcing Facility - 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: - answer✔It is on a
shortage list
An outsourcing facility has how many days to report an adverse event? - answer✔10 days
Is there a limit on the ratio of technicians and support staff to pharmacists - answer✔NO
Pharmacy intern to RPH ratio - answer✔2:1
Pharmacy Board Composition - answer✔6 pharmacists, 4 public members and 1 technician
Term length - answer✔Two terms of four-years along with one partial term
Disciplinary Subcommittee - answer✔Has to include 3 professional members (tech/RPH) and 2
public members
Disciplinary Subcommittee Requirement - answer✔One public person has to vote with the
majority otherwise the bill does not pass.
11/7/2024 12:35 PM
MPJE (Michigan Law) Exam Questions With
Correct Answers
Hatch-Waxman Act - answer✔In 1984 this allowed greater access for companies to dispense
generic drugs.
Drugs companies must submit this for a generic drug: - answer✔Abbreviated New Drug
Application (ANDA)
ANDA process - answer✔Does not require companies to repeat animal and clinical research on
ingredients.
ANDA Process applies to drugs made after: - answer✔1962
Generic drug has to match with the following: - answer✔Identity, Strength, Purity and Quality
(ISPQ)
If a drug has an NDC does it guarantee drug approval? - answer✔NO
Use of an unapproved drug such as Domperidone is: - answer✔Misbranding
Side effects statement: - 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? - answer✔NO
OTC Side Effect Statement: - answer✔If not statement, must have number to report it to
Font requirements for statements: - 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: - answer✔Nasal and
lidocaine
What is exempt from the Poison Prevention Packaging Act? - answer✔Samples and Starter
Packs
, ©THEBRIGHT EXAM SOLUTIONS
11/7/2024 12:35 PM
Any nose drop with this substance needs a PPPA: - answer✔Oxymetazolone
Market Withdrawal: - answer✔A firm removes the product from the market to correct a
violation
Michigan Samples - 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 - 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: - answer✔50 but they have to
declare it
PI (Package Insert) vs PPI (Patient Package Insert) - answer✔Package insert is just professional
information where patient package insert is required with all fills if medication requires it
Michigan Counseling - answer✔MUST offer counseling with each new drug patient is on
Are pharmacies able to compound and manufacture drugs at the same location? - answer✔NO
If a pharmacy ships more than 5% of compounded drugs they must: - answer✔Sign a
memorandum of understanding with the FA
Outsourcing Facility - 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: - answer✔It is on a
shortage list
An outsourcing facility has how many days to report an adverse event? - answer✔10 days
Is there a limit on the ratio of technicians and support staff to pharmacists - answer✔NO
Pharmacy intern to RPH ratio - answer✔2:1
Pharmacy Board Composition - answer✔6 pharmacists, 4 public members and 1 technician
Term length - answer✔Two terms of four-years along with one partial term
Disciplinary Subcommittee - answer✔Has to include 3 professional members (tech/RPH) and 2
public members
Disciplinary Subcommittee Requirement - answer✔One public person has to vote with the
majority otherwise the bill does not pass.
