Page | 1
Pharm Law Exam 1 Questions with Detailed
Verified Answers
Question: Manufacturers of OTC products may market one size of an
OTC drug that is not compliant with the poison prevention packaging act
as long as it's adequately labeled.
Ans✅ ✅: True
Question: A 503B outsourcing facility may compound medications based
on patient-specific prescriptions
Ans✅ ✅: True
Question: Intentionally adding refills not authorized by the prescriber is
an example of misbranding
Ans✅ ✅: True
Question: According to medicare requirements for pharmacist
consultants in long term care facilities, the consultant should perform
drug regimen review at least quarterly.
Ans✅ ✅: False
Question: In which instance below may a pharmacy perform
anticipatory compounding?
Ans✅ ✅: It can be done based on the history of receiving prescriptions for the
medication
It can be done a limited basis
Question: The label for an over-the-counter drug must contain which of
the following?
, Page | 2
Ans✅ ✅: Adequate directions for use
Cautions in warning
Manufacturer or distributor name and address
Question: Pursuant to the compounding quality act of 2013, a
pharmacist who compounds a prescription for an individual patient is
exempt from which of the following?
Ans✅ ✅: Compliance with current good manufacturing practice (CGMP) regulations
Certain labeling requirements
Prior FDA approval of the compounded drug
Question: Which of the following represents the lawful practice of
compounding under the compounding quality act of 2013?
Ans✅ ✅: A community pharmacy compounding non-sterile medications in
conformance with USP 795.
Question: The food and drug administration (FDA) regulate prescription
drug advertising whereas the federal trade commission (FTC) regulates
the advertising of over-the-counter drug.
Ans✅ ✅: True
Question: A class III drug recall is issued if use of the recalled drug is
not likely to cause an adverse health consequence.
Ans✅ ✅: True
Question: OBRA '90 required states that participate in the Medicaid
program to do which of the following?
Pharm Law Exam 1 Questions with Detailed
Verified Answers
Question: Manufacturers of OTC products may market one size of an
OTC drug that is not compliant with the poison prevention packaging act
as long as it's adequately labeled.
Ans✅ ✅: True
Question: A 503B outsourcing facility may compound medications based
on patient-specific prescriptions
Ans✅ ✅: True
Question: Intentionally adding refills not authorized by the prescriber is
an example of misbranding
Ans✅ ✅: True
Question: According to medicare requirements for pharmacist
consultants in long term care facilities, the consultant should perform
drug regimen review at least quarterly.
Ans✅ ✅: False
Question: In which instance below may a pharmacy perform
anticipatory compounding?
Ans✅ ✅: It can be done based on the history of receiving prescriptions for the
medication
It can be done a limited basis
Question: The label for an over-the-counter drug must contain which of
the following?
, Page | 2
Ans✅ ✅: Adequate directions for use
Cautions in warning
Manufacturer or distributor name and address
Question: Pursuant to the compounding quality act of 2013, a
pharmacist who compounds a prescription for an individual patient is
exempt from which of the following?
Ans✅ ✅: Compliance with current good manufacturing practice (CGMP) regulations
Certain labeling requirements
Prior FDA approval of the compounded drug
Question: Which of the following represents the lawful practice of
compounding under the compounding quality act of 2013?
Ans✅ ✅: A community pharmacy compounding non-sterile medications in
conformance with USP 795.
Question: The food and drug administration (FDA) regulate prescription
drug advertising whereas the federal trade commission (FTC) regulates
the advertising of over-the-counter drug.
Ans✅ ✅: True
Question: A class III drug recall is issued if use of the recalled drug is
not likely to cause an adverse health consequence.
Ans✅ ✅: True
Question: OBRA '90 required states that participate in the Medicaid
program to do which of the following?
