©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
MPJE 2017- Federal Pharmacy Law
Questions and Answers (100% Pass)
Which situations are Child-Resistant closures required? - ✔️✔️- When community
pharmacist dispenses fewer than 10 tablets of drug product.
- When hospital pharmacy fills a Rx for an outpatient.
Who can give permission to omit use of child-resistant closure? - ✔️✔️Patient &
Prescriber.
Marketing act of 1987.... - ✔️✔️guarantees a company that discovers, patents and
develops a new drugs EXCLUSIVE marketing rights for up to 20 YEARS.
USP DI Vol III - United States Pharmacopeia-Drug Information.... - ✔️✔️- a reference
source included selected LAWS & REGULATIONS for CONTROLLED SUBSTANCES.
-contains BIOEQUIVALENCE info.
Facts & Comparisons... - ✔️✔️CANNOT be used when listing an ingredient on a
PRODUCT LABEL as PRIMARY source.
1
,©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
Which barbiturates are classified as CII? - ✔️✔️amobarbital & pentobarbital
What is the most appropriate reference source for manufacturer to determine preferred
name of an additive for a product label? - ✔️✔️USP/NF
United States Pharmacopeia and The National Formulary (USP-NF) is a book of public
pharmacopeial standards for chemical and biological drug substances, dosage forms,
compounded preparations, excipients, medical devices, and dietary supplements.
What do these drugs have in common?
- Fentanyl
- Vicodin
- Pentobarbital - ✔️✔️C IIs. Must be ordered using DEA form 222.
Which clinical stage is conducted exclusively in healthy human subjects? - ✔️✔️Phase I.
Which is the 1st phase of clinical trail that evaluates the efficacy of the drug in treating a
specific disease? - ✔️✔️Phase II.
When can a drug rep give samples of a prescription drug? - ✔️✔️Upon WRITTEN
REQUEST from a PHYSICIAN.
2
, ©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
A pharmacist realizes that his CII patient with severe pain from malignant bone cancer
is addicted to the drug. What should he do? - ✔️✔️Continue to fill the prescription.
How often may a patient with a Medicare-endorsed discount card change his/her
provider? - ✔️✔️once a year.
Which Federal acts prohibit selling of drug samples in pharmacies? - ✔️✔️Prescription
Drug Marketing Act
What is Cascara Sagrada? - ✔️✔️non-Rx ingredient belongs to OTC Category II.
Products containing this ingredient will be considered by the FDA to be MISBRANDED.
Use for constipation
Who is responsible for the retrospective drug utilization review established by OBRA
90? - ✔️✔️each state
What is HCFA? and under who's jurisdiction? - ✔️✔️Health Care Financing
Administration under HHS (Health and Human Services ) jurisdiction.
Which reference books are legal documents recognized by the Federal government? -
✔️✔️- USP/NF
3
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
MPJE 2017- Federal Pharmacy Law
Questions and Answers (100% Pass)
Which situations are Child-Resistant closures required? - ✔️✔️- When community
pharmacist dispenses fewer than 10 tablets of drug product.
- When hospital pharmacy fills a Rx for an outpatient.
Who can give permission to omit use of child-resistant closure? - ✔️✔️Patient &
Prescriber.
Marketing act of 1987.... - ✔️✔️guarantees a company that discovers, patents and
develops a new drugs EXCLUSIVE marketing rights for up to 20 YEARS.
USP DI Vol III - United States Pharmacopeia-Drug Information.... - ✔️✔️- a reference
source included selected LAWS & REGULATIONS for CONTROLLED SUBSTANCES.
-contains BIOEQUIVALENCE info.
Facts & Comparisons... - ✔️✔️CANNOT be used when listing an ingredient on a
PRODUCT LABEL as PRIMARY source.
1
,©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
Which barbiturates are classified as CII? - ✔️✔️amobarbital & pentobarbital
What is the most appropriate reference source for manufacturer to determine preferred
name of an additive for a product label? - ✔️✔️USP/NF
United States Pharmacopeia and The National Formulary (USP-NF) is a book of public
pharmacopeial standards for chemical and biological drug substances, dosage forms,
compounded preparations, excipients, medical devices, and dietary supplements.
What do these drugs have in common?
- Fentanyl
- Vicodin
- Pentobarbital - ✔️✔️C IIs. Must be ordered using DEA form 222.
Which clinical stage is conducted exclusively in healthy human subjects? - ✔️✔️Phase I.
Which is the 1st phase of clinical trail that evaluates the efficacy of the drug in treating a
specific disease? - ✔️✔️Phase II.
When can a drug rep give samples of a prescription drug? - ✔️✔️Upon WRITTEN
REQUEST from a PHYSICIAN.
2
, ©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
A pharmacist realizes that his CII patient with severe pain from malignant bone cancer
is addicted to the drug. What should he do? - ✔️✔️Continue to fill the prescription.
How often may a patient with a Medicare-endorsed discount card change his/her
provider? - ✔️✔️once a year.
Which Federal acts prohibit selling of drug samples in pharmacies? - ✔️✔️Prescription
Drug Marketing Act
What is Cascara Sagrada? - ✔️✔️non-Rx ingredient belongs to OTC Category II.
Products containing this ingredient will be considered by the FDA to be MISBRANDED.
Use for constipation
Who is responsible for the retrospective drug utilization review established by OBRA
90? - ✔️✔️each state
What is HCFA? and under who's jurisdiction? - ✔️✔️Health Care Financing
Administration under HHS (Health and Human Services ) jurisdiction.
Which reference books are legal documents recognized by the Federal government? -
✔️✔️- USP/NF
3
