Pharmacy Law
- 1.
Med Guides would fall best under which reason why we regulate pharmacy.
- A.
Incentivize production and provision of products and R&D for the public good
- B.
Minimize direct and indirect harm to public by production or consumption of products
- C.
Promote efficiency in “natural monopolies”
- D.
Information asymmetry
Correct Answer
D. Information asymmetry -
- 2.
Which of the following are true with regard to our authority to regulate.
- A.
Intrastate Commerce Clause of the Constitution gives authority to U.S. Congress and federal administrative agencies
- B.
State governments may regulate in areas not delegated to the Federal government and enact laws to promote the health, safety, and welfare of its people (general intrastate; professional practice).
- C.
In some areas, neither federal nor state governments have power to act – left to individuals
Correct Answer(s)
B. State governments may regulate in areas not delegated to the Federal government and enact laws to promote the health, safety, and welfare of its people (general intrastate; professional practice).
C. In some areas, neither federal nor state governments have power to act – left to individualsExplanation
INTERstateRate this question:
-
- 3.
Supremacy Clause of the Constitution (AKA the _______ doctrine) assures that "federal will win out."
Correct Answer(s)
preemption
Preemption
PREEMPTION - 4.
Which of the following are true regarding statutory law?
- A.
Authority by interstate Commerce clause of the Constitution
- B.
Administrative agencies under the executive branch makes statutes
- C.
Administrative agencies under the legislative branch makes statutes
Correct Answer
A. Authority by interstate Commerce clause of the ConstitutionExplanation
Administrative agencies make regulationsRate this question:
-
- 5.
Which branch promulgates regulations (creating law) that interpret and define statutes and does so by method of “Notice and Comment Rulemaking?”
- A.
Judicial
- B.
Legislative
- C.
Executive
Correct Answer
C. Executive -
- 6.
Which of the following is true regarding notice and comment rulemaking?
- A.
Federal Register is printed weekly
- B.
Code of Federal Regulations is printed annually
- C.
Notice and Comment Rulemaking occurs at the federal level
- D.
Notice and Comment Rulemaking occurs at the state level
- E.
Promulgating regulations may be out of the scope of the agency's authority
Correct Answer(s)
B. Code of Federal Regulations is printed annually
C. Notice and Comment Rulemaking occurs at the federal level
D. Notice and Comment Rulemaking occurs at the state level -
- 7.
Which of the following is true regarding regulations?
- A.
Easy to enact and change
- B.
Violation usually results in criminal penalties
- C.
Detail implementation of statutes
Correct Answer(s)
A. Easy to enact and change
C. Detail implementation of statutes -
- 8.
Which of the following are true regarding civil cases?
- A.
The burden of proof for a civil case is beyond a reasonable doubt
- B.
The purpose of enforcement is compliance
- C.
Civil cases are usually brought on by individuals
- D.
Can occur if one breaks regulations
- E.
Can occur if one breaks statutes
Correct Answer(s)
C. Civil cases are usually brought on by individuals
D. Can occur if one breaks regulations
E. Can occur if one breaks statutesExplanation
burden of proof - preponderance of evidence
purpose of enforcement - compensationRate this question:
-
- 9.
Which is true regarding the FDA?
- A.
Primary agency that enforces FDCA through regulation and issuance of guidance documents
- B.
Component of the Department of Health and Human Services (DHHS)
- C.
FDA Commissioner appointed by the President and confirmed by the Senate
Correct Answer(s)
A. Primary agency that enforces FDCA through regulation and issuance of guidance documents
B. Component of the Department of Health and Human Services (DHHS)
C. FDA Commissioner appointed by the President and confirmed by the Senate -
- 10.
The Kefauver Harris amendment did what?
- A.
Required safety
- B.
Required efficacy
- C.
Set more controls for clinical trials
- D.
Established cGMP
- E.
Differentiated Rx and OTC drugs
- F.
Required the label "legend only"
Correct Answer(s)
B. Required efficacy
C. Set more controls for clinical trials
D. Established cGMP -
- 11.
The letter "P" stands for _____ while the letter "S" stands for standard.
Correct Answer(s)
priority
Priority
PRIORITY - 12.
Which act came about when we applied market-based principles to government activities?
- A.
ANDA
- B.
PDUFA
- C.
Monograph Process
- D.
DESI
Correct Answer
B. PDUFA -
- 13.
Which is true regarding the monograph process?
- A.
FDA evaluates on the basis of therapeutic category rather than individual drugs
- B.
Recommendations published in the Federal Register
- C.
Final Monograph identifies active ingredients generally recognized as safe and effective
Correct Answer(s)
A. FDA evaluates on the basis of therapeutic category rather than individual drugs
B. Recommendations published in the Federal Register
C. Final Monograph identifies active ingredients generally recognized as safe and effective -
- 14.
DESI...
- A.
Evalutes Rx drugs only for safety that were marketed between 1938 and 1962
- B.
Evalutes Rx and OTC drugs for safety that were marketed between 1938 and 1962
- C.
Evalutes Rx drugs only for safety that were marketed between 1938 and 1982
- D.
Evalutes Rx and OTC drugs for safety that were marketed between 1938 and 1982
- E.
None of the above are correct
Correct Answer
E. None of the above are correctExplanation
Evaluates efficacy...not safety! Drugs have been safe since 1938.Rate this question:
-
- 15.
An approved drug can become a new drug if:
- A.
It contains a new substance
- B.
It is a combination of two already approved drugs
- C.
The proportion of ingredients change
- D.
A new use is indicated
- E.
The dose changed
- F.
The duration of action changed
Correct Answer(s)
A. It contains a new substance
B. It is a combination of two already approved drugs
C. The proportion of ingredients change
D. A new use is indicated
E. The dose changed
F. The duration of action changed -
- 16.
Which of the following are true regarding dietary supplements after DSHEA 1994.
- A.
Products may be marketed without proven efficacy
- B.
Products on market do not have to have proven safety
- C.
May be intended to for diagnosis, treatment, or prevention of a disease
- D.
Dietary supplements must be intended for ingestion (taken by mouth)
Correct Answer(s)
A. Products may be marketed without proven efficacy
B. Products on market do not have to have proven safety
D. Dietary supplements must be intended for ingestion (taken by mouth) -
- 17.
The printed material on the immediate prescription container is a part of the LABELING.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
the label IS part of the labelingRate this question:
-
- 18.
The side effect statement required as of July 1, 2009 that says "Call your doctor...You may report side effects to the FDA..." may be on an auxillary label or in a med guide.
- A.
True
- B.
False
Correct Answer
A. True -
- 19.
Which are true regarding the NDC?
- A.
Must be included on the labeling as a linear bar code
- B.
Serves to facilitate automated processing of drug claims and drug distribution
- C.
Contains 9 digits
- D.
Required on all prescription labels & labeling
- E.
Required on all OTC labels & labeling
- F.
Indicates that the product has either NDA or ANDA approval
Correct Answer(s)
A. Must be included on the labeling as a linear bar code
B. Serves to facilitate automated processing of drug claims and drug distribution
D. Required on all prescription labels & labeling
E. Required on all OTC labels & labeling -
- 20.
Which is true regarding the USP/NF?
- A.
Private, independent organization
- B.
Standards enforceable by FDA under FDCA
Correct Answer(s)
A. Private, independent organization
B. Standards enforceable by FDA under FDCA -
- 21.
Which of the following falls under a misbranding violation?
- A.
Refilled without authorization
- B.
Packaging violates poison prevention packaging act
- C.
Fails to have "adequate directions for use"
- D.
Fails to meet compendial standards
- E.
Fails to meet cGMP
- F.
Label is false/misleading
Correct Answer(s)
A. Refilled without authorization
B. Packaging violates poison prevention packaging act
C. Fails to have "adequate directions for use"
F. Label is false/misleading -
- 22.
Which of the following are true regarding post-marketing surveillance?
- A.
Causality is a prerequisite for reporting
- B.
It is voluntary for industry and providers
- C.
You may report serious adverse events
- D.
You may report suspect counterfeit
- E.
You may report device use errors
Correct Answer(s)
C. You may report serious adverse events
D. You may report suspect counterfeit
E. You may report device use errorsExplanation
causality is NOT a prerequisite
it is MANDATORY for industryRate this question:
-
- 23.
For problems due to:• Product design• Manufacturing quality or distribution/storage• Counterfeit productFDA can:• Work with manufacturer to issue a recall of product • Request a modification in product design • Request a modification in manufacturing process • Improve instructions or warnings for use
- A.
True
- B.
False
Correct Answer
A. True -
- 24.
Which is the most serious class of drug recall?
- A.
Class I
- B.
Class II
- C.
Class III
Correct Answer
A. Class I -
- 25.
Due to REMS, the FDA may require variety of procedures for drugs with high risk to benefit, including which of the following?
- A.
MedGuides
- B.
Specialized provider training
- C.
Limit dispensing to specialized practice settings
- D.
Patient monitoring or testing
Correct Answer(s)
A. MedGuides
B. Specialized provider training
C. Limit dispensing to specialized practice settings
D. Patient monitoring or testing -
- 26.
Waxman-Hatch or PTRA did which of the following?
- A.
Sped up the approval of generic drugs
- B.
Made manufacturers pay for their own ANDA
- C.
Grants manufacturers incentives to continue reserach and development
- D.
Set up additional post marketing surveillance programs (such as VAERS)
- E.
Made a list of bioequivalent drugs
- F.
Set standards for expiration dating and beyond use dating of medications
- G.
Codify ANDA process
Correct Answer(s)
A. Sped up the approval of generic drugs
C. Grants manufacturers incentives to continue reserach and development
E. Made a list of bioequivalent drugs
G. Codify ANDA processExplanation
PDUFA made mfg pay for ANDA
USP/NF sets standards for expiration and beyond use datingRate this question:
-
- 27.
Which of the following is true regarding the orange book?
- A.
It is an official compendium
- B.
Includes drugs that have never been marketed
- C.
Does not include OTC drugs
- D.
Provides therapeutic equivalence evaluations for single source drugs
- E.
Includes pre-1938 drugs
Correct Answer
B. Includes drugs that have never been marketed -
- 28.
A drug is therapeutically equivalent if:
- A.
Safe
- B.
Effective
- C.
Bioequivalent
- D.
Adequately labeled
- E.
Comply with cGMP
- F.
Pharmaceutically equivalent
Correct Answer(s)
A. Safe
B. Effective
C. Bioequivalent
D. Adequately labeled
E. Comply with cGMP
F. Pharmaceutically equivalent -
- 29.
Drug products are considered pharmaceutically equivalent if:
- A.
Contain the same inactive ingredients
- B.
Same dosage form
- C.
Identical in strength or concentration
- D.
Same route of administration
Correct Answer(s)
B. Same dosage form
C. Identical in strength or concentration
D. Same route of administration -
- 30.
Which term means that there is insufficient data to determine equivalency?
- A.
AA
- B.
AB
- C.
AB1
- D.
AO
- E.
AX
- F.
BB
- G.
BB1
- H.
BO
- I.
BX
Correct Answer
I. BX -
- 31.
Which of the following is true regarding advertising?
- A.
Prescription drug advertising is enforced by the FTC
- B.
Reminder ads do not need to have a fair balance and include SEs, etc.
- C.
Guidance allows brief summary of risks as long as “adequate provision” for obtaining information included (such as a toll free number, webpage, referral to magazine or health care provider)
Correct Answer(s)
B. Reminder ads do not need to have a fair balance and include SEs, etc.
C. Guidance allows brief summary of risks as long as “adequate provision” for obtaining information included (such as a toll free number, webpage, referral to magazine or health care provider) -
- 32.
We can take prescriptions over the telephone because of what law?
- A.
Kefauver Harris
- B.
Waxman Hatch
- C.
Durham Humphrey
- D.
PDUFA
- E.
Prescription Drug Marketing Act (PDMA)
Correct Answer
C. Durham Humphrey -
- 33.
Which of the following are required for estrogen containing medications?
- A.
PPI
- B.
MedGuide
- C.
REMS
- D.
CMI
Correct Answer
A. PPI -
- 34.
What did PDMA do?
- A.
Require state licensing of drug wholesalers
- B.
Limit re-importation of exported US drugs to the manufacturer
- C.
Changed the "legend" requirement to "rx only"
- D.
Placed controls over drug sampling
- E.
Placed restrictions on resale of drugs by hospitals and other health care entities
Correct Answer(s)
A. Require state licensing of drug wholesalers
B. Limit re-importation of exported US drugs to the manufacturer
D. Placed controls over drug sampling
E. Placed restrictions on resale of drugs by hospitals and other health care entitiesExplanation
legend to rx was FDA modernization actRate this question:
-
- 35.
What did the FDA Modernization Act of 97 do?
- A.
Renew PDUFA
- B.
Changed "legend" to "rx only"
- C.
Clarify the parameters of pharmacy compounding
Correct Answer(s)
A. Renew PDUFA
B. Changed "legend" to "rx only"
C. Clarify the parameters of pharmacy compounding -
- 36.
Manually measuring & mixing 3 manufactured products to IV is considered:
- A.
Low risk
- B.
Medium risk
- C.
High risk
Correct Answer
A. Low risk -
- 37.
Community pharmacy may obtain tax-free 95% (190 proof) ethyl alcohol from a liquor wholesaler or drug wholesaler (licensed) for compounding purposes.
- A.
True
- B.
False
Correct Answer
B. False -
- 38.
FDA considers its inspections to fall within boundaries of warrantless searches.
- A.
True
- B.
False
Correct Answer
A. True -
- 39.
Which drugs do you not have to dispense in a child resistant packaging?
- A.
Any non-oral drugs
- B.
Birth control
- C.
Sublingual NTG
- D.
Prednisone
- E.
Z-pak
- F.
Questran
Correct Answer(s)
A. Any non-oral drugs
B. Birth control
C. Sublingual NTG
D. Prednisone
E. Z-pak
F. Questran -
- 40.
In the absence of stability data to the contrary, non-sterile solid and liquid dosage forms that are packaged in single-unit and unit-dose containers may bear a beyond-use date of (a) ____________ or (b) the expiration date on the manufacturer’s container, whichever is earlier.
- A.
Six months from the date the drug is packaged into the single-unit or unit-dose container
- B.
90 days from the date the drug is packaged into the single-unit or unit-dose container
- C.
One year from the date the drug is packaged into the single-unit or unit-dose container
Correct Answer
C. One year from the date the drug is packaged into the single-unit or unit-dose container -
- 41.
For Water-Containing Formulations (prepared from ingredients in solid form) –The beyond-use date is not later than ______ when stored at cold temperatures between 2º and 8º (36º and 46º F).
- A.
25% of the manufacturer's expiration date
- B.
10 days
- C.
14 days
- D.
28 days
- E.
30 days
- F.
One year
Correct Answer
C. 14 days -
- 42.
Which of the following is true regarding patient directed labeling?
- A.
PPIs are limited to estrogen containing oral products only
- B.
MedGuides are required to accompany drugs that pose serious and significant public health concerns
- C.
MedGuides are required for new prescriptions
- D.
MedGuides are required for refilled prescriptions
- E.
REMS are required for thalidomide, clozapine, and olosetron (lotronex)
- F.
IPledge is an example of a REMS
Correct Answer(s)
B. MedGuides are required to accompany drugs that pose serious and significant public health concerns
C. MedGuides are required for new prescriptions
D. MedGuides are required for refilled prescriptions
E. REMS are required for thalidomide, clozapine, and olosetron (lotronex)
F. IPledge is an example of a REMS -
- 43.
Which of the following is true regarding ipecac?
- A.
It must ALWAYS be sold with a child-resistant cap
- B.
One can only sell up to 30ml OTC
- C.
Ipecac is not synonymous with ipecac fluid extract
Correct Answer(s)
B. One can only sell up to 30ml OTC
C. Ipecac is not synonymous with ipecac fluid extract -
Quiz Review Timeline +
Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.
-
Current Version
-
Jan 23, 2013Quiz Edited by
ProProfs Editorial Team -
Feb 28, 2011Quiz Created by
Caitlinb
Back to top