Pharmacy Law

1. For problems due to:
• Product design
• Manufacturing quality or distribution/storage
• Counterfeit product
FDA 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

True

False

Submit

3. The printed material on the immediate prescription container is a part of the LABELING.

True

False

the label IS part of the labeling

Explanation

the label IS part of the labeling

Submit

5. Which is the most serious class of drug recall?

Class I

Class II

Class III

6. 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.

True

False

7. FDA considers its inspections to fall within boundaries of warrantless searches.

True

False

8. Which of the following are required for estrogen containing medications?

PPI

MedGuide

REMS

CMI

9. 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).

25% of the manufacturer's expiration date

10 days

14 days

28 days

30 days

One year

10. We can take prescriptions over the telephone because of what law?

Kefauver Harris

Waxman Hatch

Durham Humphrey

PDUFA

Prescription Drug Marketing Act (PDMA)

11. Community pharmacy may obtain tax-free 95% (190 proof) ethyl alcohol from a liquor wholesaler or drug wholesaler (licensed) for compounding purposes.

True

False

12. 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.

Six months from the date the drug is packaged into the single-unit or unit-dose container

90 days from the date the drug is packaged into the single-unit or unit-dose container

One year from the date the drug is packaged into the single-unit or unit-dose container

13. Manually measuring & mixing 3 manufactured products to IV is considered:

Low risk

Medium risk

High risk

14. Which act came about when we applied market-based principles to government activities?

ANDA

PDUFA

Monograph Process

DESI

15. An approved drug can become a new drug if:

It contains a new substance

It is a combination of two already approved drugs

The proportion of ingredients change

A new use is indicated

The dose changed

The duration of action changed

Submit

16. Which branch promulgates regulations (creating law) that interpret and define statutes and does so by method of “Notice and Comment Rulemaking?”

Judicial

Legislative

Executive

17. Which of the following are true regarding statutory law?

Authority by interstate Commerce clause of theConstitution

Administrative agencies under the executive branch makes statutes

Administrative agencies under the legislative branch makes statutes

Administrative agencies make regulations

Explanation

Administrative agencies make regulations

18. Which of the following falls under a misbranding violation?

Refilled without authorization

Packaging violates poison prevention packaging act

Fails to have "adequate directions for use"

Fails to meet compendial standards

Fails to meet cGMP

Label is false/misleading

Submit

19. Due to REMS, the FDA may require variety of procedures for drugs with high risk to benefit, including which of the following?

MedGuides

Specialized provider training

Limit dispensing to specialized practice settings

Patient monitoring or testing

Submit

20. Which term means that there is insufficient data to determine equivalency?

AA

AB

AB1

AO

AX

BB

BB1

BO

BX

21. Med Guides would fall best under which reason why we regulate pharmacy.

Incentivize production and provision of products and R&D for the public good

Minimize direct and indirect harm to public by production or consumption of products

Promote efficiency in “natural monopolies”

Information asymmetry

22. Drug products are considered pharmaceutically equivalent if:

Contain the same inactive ingredients

Same dosage form

Identical in strength or concentration

Same route of administration

Submit

23. Which of the following are true regarding dietary supplements after DSHEA 1994.

Products may be marketed without proven efficacy

Products on market do not have to have proven safety

May be intended to for diagnosis, treatment, or prevention of a disease

Dietary supplements must be intended for ingestion (taken by mouth)

Submit

24. Which is true regarding the monograph process?

FDA evaluates on the basis of therapeuticcategory rather than individual drugs

Recommendations published in the Federal Register

Final Monograph identifies active ingredientsgenerally recognized as safe and effective

Submit

25. DESI...

Evalutes Rx drugs only for safety that were marketed between 1938 and 1962

Evalutes Rx and OTC drugs for safety that were marketed between 1938 and 1962

Evalutes Rx drugs only for safety that were marketed between 1938 and 1982

Evalutes Rx and OTC drugs for safety that were marketed between 1938 and 1982

None of the above are correct

Evaluates efficacy...not safety! Drugs have been safe since 1938.

Explanation

Evaluates efficacy...not safety! Drugs have been safe since 1938.

26. Which of the following are true regarding post-marketing surveillance?

Causality is a prerequisite for reporting

It is voluntary for industry and providers

You may report serious adverse events

You may report suspect counterfeit

You may report device use errors

causality is NOT a prerequisite
it is MANDATORY for industry

Explanation

causality is NOT a prerequisite
it is MANDATORY for industry

Submit

27. Which of the following is true regarding regulations?

Easy to enact and change

Violation usually results in criminal penalties

Detail implementation of statutes

Submit

28. Which is true regarding the USP/NF?

Private, independent organization

Standards enforceable by FDA under FDCA

Submit

29. What did PDMA do?

Require state licensing of drug wholesalers

Limit re-importation of exported US drugs to the manufacturer

Changed the "legend" requirement to "rx only"

Placed controls over drug sampling

Placed restrictions on resale of drugs by hospitals and other health care entities

legend to rx was FDA modernization act

Explanation

legend to rx was FDA modernization act

Submit

30. Which drugs do you not have to dispense in a child resistant packaging?

Any non-oral drugs

Birth control

Sublingual NTG

Prednisone

Z-pak

Questran

Submit

31. Which of the following is true regarding ipecac?

It must ALWAYS be sold with a child-resistant cap

One can only sell up to 30ml OTC

Ipecac is not synonymous with ipecac fluid extract

Submit

32. Which of the following are true with regard to our authority to regulate.

Intrastate Commerce Clause of the Constitutiongives authority to U.S. Congress and federaladministrative agencies

In some areas, neither federal nor stategovernments have power to act – left to individuals

INTERstate

Explanation

INTERstate

Submit

33. Which of the following is true regarding advertising?

Prescription drug advertising is enforced by the FTC

Reminder ads do not need to have a fair balance and include SEs, etc.

Submit

34. Which of the following are true regarding civil cases?

The burden of proof for a civil case is beyond a reasonable doubt

The purpose of enforcement is compliance

Civil cases are usually brought on by individuals

Can occur if one breaks regulations

Can occur if one breaks statutes

burden of proof - preponderance of evidence
purpose of enforcement - compensation

Explanation

burden of proof - preponderance of evidence
purpose of enforcement - compensation

Submit

35. Which of the following is true regarding notice and comment rulemaking?

Federal Register is printed weekly

Code of Federal Regulations is printed annually

Notice and Comment Rulemaking occurs at the federal level

Notice and Comment Rulemaking occurs at the state level

Promulgating regulations may be out of the scope of the agency's authority

Submit

36. What did the FDA Modernization Act of 97 do?

Renew PDUFA

Changed "legend" to "rx only"

Clarify the parameters of pharmacy compounding

Submit

37. The Kefauver Harris amendment did what?

Required safety

Required efficacy

Set more controls for clinical trials

Established cGMP

Differentiated Rx and OTC drugs

Required the label "legend only"

Submit

38. Which of the following is true regarding the orange book?

It is an official compendium

Includes drugs that have never been marketed

Does not include OTC drugs

Provides therapeutic equivalence evaluations for single source drugs

Includes pre-1938 drugs

39. A drug is therapeutically equivalent if:

Safe

Effective

Bioequivalent

Adequately labeled

Comply with cGMP

Pharmaceutically equivalent

Submit

40. Which of the following is true regarding patient directed labeling?

PPIs are limited to estrogen containing oral products only

MedGuides are required to accompany drugs that pose serious and significant public health concerns

MedGuides are required for new prescriptions

MedGuides are required for refilled prescriptions

REMS are required for thalidomide, clozapine, and olosetron (lotronex)

IPledge is an example of a REMS

Submit

41. Waxman-Hatch or PTRA did which of the following?

Sped up the approval of generic drugs

Made manufacturers pay for their own ANDA

Grants manufacturers incentives to continue reserach and development

Set up additional post marketing surveillance programs (such as VAERS)

Made a list of bioequivalent drugs

Set standards for expiration dating and beyond use dating of medications

Codify ANDA process

PDUFA made mfg pay for ANDA
USP/NF sets standards for expiration and beyond use dating

Explanation

PDUFA made mfg pay for ANDA
USP/NF sets standards for expiration and beyond use dating

Submit

42. Which is true regarding the FDA?

Primary agency that enforcesFDCA through regulation andissuance of guidance documents

Component of the Department ofHealth and Human Services(DHHS)

FDA Commissioner appointed bythe President and confirmed bythe Senate

Submit

43. Which are true regarding the NDC?

Must be included on the labeling as a linear barcode

Serves to facilitate automated processing of drugclaims and drug distribution

Contains 9 digits

Required on all prescription labels &labeling

Required on all OTC labels &labeling

Indicates that the product haseither NDA or ANDA approval

Submit