Advertisement Upgrade to remove ads

1) Which of the following reference sources include selected laws and regulations for controlled substances?
a) facts and comparisons
b) physician's desk reference
c) USP DI Volume I
d) USP DI Volume II
e) USP DI Volume Iii-

e) USP DI Volume III

2) The statement "Rx only" does NOT need to appear on the packing of
a) orphan drugs
b) controlled substances
c) legend drugs
d) OTC products
e) injectable products-

d) OTC products

3) Controlled substances prescriptions may be issued by prescribers
I. to obtain controlled substances for dispensing in their office
II. to prescribe drugs to be used by a patient for narcotic detoxification
III. to prescribe controlled substance for a patient with chronic pain

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

b) III only

4) Which government body is responsible for funding and overseeing state Medicaid programs?
a) DHHS
b) CMS
c) FDA
d) NABP
e) USP/NF-

b) CMS

5) A pt presents a prescription for 60 Empirin w/ codeine tables No. 4 to his local pharmacy and indicates that he would only like to get 30 of the tablets now and will return for the other 30 in a week. The pharmacist should:
a) call the prescriber to get permission to dispense 30
b) dispense 30 as requested by the pt
c) advise the pt that the full 60 tablets must be supplied at one time
d) fill the prescription as requested by the pt but advise the pt that the balance must be picked up within 72 hours
e) dispense 30 tabs of Empirin w/ codeine No.2-

b) dispense 30 as requested by the patient

6) In 2002, the FDA ruled that the nonprescription drug ingredient, cascara sagrada belongs in the OTC category II. Products containing this ingredient will be considered by the FDA to be
a) adulterated
b) expired
c) safe and effective
d) potentially toxic
e) misbranded-

e)misbranded

7) Which of the following incentives is used to encourage pharmaceutical companies to conduct studies of their drugs in the pediatric populations?
a) grants of money from the FDA
b) tax credits for subsequent years
c) refunds of income tax
d)extension of patent protection
e) letter of commendation from the President

d) extension of patent protection

8) Permission to not use a child resistant closure on a prescription may be granted by the
I. Pharmacist
II. Prescriber
III. Patient

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

d) II & III only

9) Which of the following barbiturates are classified as Schedule II controlled substances?
I. amobarbital
II. pentobarbital
III butabarbital

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & II

c) I & II only (amobarbital & pentobarbital)

10) In which of the following situations are child-resistant closure NOT required?
I) when a community pharmacist dispenses fewer than 10 tablets of a drug product
II) when a hospital pharmacy is filling a prescription for an outpatient
III) when a hospital pharmacy fills a prescription for an inpatient

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

b) III when a hospital pharmacy fills a prescription for an inpatient

11) Under which one of the following circumstances may a pharmacist refuse to fill a prescription?

a) the quantity of the controlled drug has been changed
b) the pharmacists does not know the pt
c) the pt is an alcoholic
d) the prescription was written a week ago
e) the prescriber is from another city-

a) the quantity of the controlled drug has been changed

12) What is the longest "beyond use" expiration date that a pharmacist may place on a prescription container if the original drug container label states "expiration date 1/2013"? Assume pharmacist fills the prescription on January 2, 2010

a) 7/2/10
b) 1/2/11
c) 7/2/11
d) 1/1/13
e) 1/31/13-

b) 1/2/11

13) The organization responsible for overseeing the selection of a non-propriety name for a new drug is the:
a) FDA
b) FTC
c) APhA
d) USF/NF
e) USAN-

e) USAN United Stated Adopted Names

14) Which of the following entities must register in order to participate in the prescribing or dispensing of isotretinoin

I. Prescribers
II. Pharmacies
III. Drug wholesalers

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

e) I, II, & III

15) The use of an FDA approved drug for a use that is not approved for the drug is best described as being:

a) Illegal
b) terminal
c) orphan
d) off-label
e) unprofessional-

d) off-label

16) Controlled substance prescriptions
I. may be written by typewriter (except for the prescriber's signature)
II. Must have the name of the physician printed, stamped typed, or hand-printed on it.
III. may be prepared by an agent of the prescriber for the prescriber's signature

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

e) I, II, & III

17) A physician shares with your pharmacy a topical moisturizing formula which contains a prescription drug. Which of the following would be appropriate action for your pharmacy to take?

I) Fill prescriptions written by the physician for 120 grams of this formula
II) Prepare a pound of the formula in anticipation of additional prescription refills
III) Prepare 50x120 g of the formula for sale from the physician's office

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

c) I & II only
I) Fill prescriptions written by the physician for 120 grams of this formula
II) Prepare a pound of the formula in anticipation of additional prescription refills

18) Mr. Hess has not picked up a prescription that was filled last week. Which of the following actions is (are) legal for the pharmacist to take?

I. Call the pt at home and leave a message w/ his son
II. call the pt and leave a message on his home answering machine
III. Send an e-mail to the pt

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

e) I, II, & III

19) When a schedule II prescription is partially filled for a LTCF patient

I. the prescription is valid not more than 60 days from the issue date
II. the pharmacist must write "LTCF patient" on the prescription
III. the total quantity dispensed cannot exceed 100 dosage units

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

c) I & II
I. the prescription is valid not more than 60 days from the issue date
II. the pharmacist must write "LTCF patient" on the prescription

20) The Marketing Act of 1987 guarantees a company that discovers, patents, and develops a new drug exclusive marking rights for up to:

a) 50 years
b) 10 years
c) 17 years
d) 20 years
e)100 years-

d) 20 years

21) Which of the following products are Schedule III controlled substances?

I. Percodan tablets
II. Fiorinal Capsules
III. Tylenol with Codeine #4

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

d) II & III only

22) Certain drug products are exempt from the requirement therapeutic equivalence because of:

I. the grandfather clause
II. their use in chemotherapy
III. Their hi therapeutic index

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

a) I only (the grandfather clause)

23) The selling of drug samples in pharmacies is prohibited by which one of the following Federal acts?

a) DSHEA
b) Prescription drug marketing act
c) Durham Humphrey Amendment
d) Sherman Act
E) Drug price competition act-

b) prescription drug marketing act

24) Which of the following actions is (are) NOT allowed in a community pharmacy with respect to prescription drug samples?

I. Storing
II. Ordering based upon a specific prescriber's request
III. dispensing upon receipt of a prescription

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

e) I, II, & III

25) The drug patent of an innovator company has expired. Which one of the following must a second drug company submit to place a generic form of the drug product onto the market?

a) Investigational new drug application
b) Abbreviated new drug application
c)New drug application
d)Generic drug application
e) Supplemental new drug application-

b) abbreviated new drug application

26) Which of the following forms are used to apply for a new DEA registration for a community pharmacy?

I. Form 224
II. Form 222a
III. Form 222

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

a) Form 224

27) When listing an ingredient on a product label, all of the following references may be used by manufacturers as primary sources for names EXCEPT:

a) CRFA Cosmetic Ingredient Dictionary
b) Facts and Comparisons
c) Food Chemicals Codex
d) USAN
E) USP dictionary of Drug

b) Facts & Comparison's

28) Which of the following clinical trial stages is conducted exclusively in healthy humans?

a) phase I
b) phase II
c) phase III
d) phase IV
e) phase I and II-

a) phase I

29) the presence of which of the following drugs or adjuvants in a commercial drug product requires a special label warning?

I. methylparaben
II. sulfites
III. aspartame

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III-

d) II & III only (sulfites & aspartate)

30) All of the following drugs fall into the category of "grandfathered drugs" EXCEPT

a) thyroid
b) ephedrine
c) epinephrine
d) phenobarbital
e) ampicillin

e) ampicillin

31)The statement: "Caution: Federal la prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" is not required for

I. controlled substances dispensed for use in "blinded" clinical investigations
II. dispensing Schedule V drugs
III. dispensing controlled substances to be administered to a pt in an institution

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

e) I, II, & III
I. controlled substances dispensed for use in "blinded" clinical investigations
II. dispensing Schedule V drugs
III. dispensing controlled substances to be administered to a pt in an institution

32) the National Drug Code (NDC) consists of a series of

a) letters only
b) letters and numbers
c) numbers only
d) numbers and symbols
e) symbols only

c) numbers only

33) Hospital inpatients receiving oral estrogen therapy must receive pt package inserts

a) every day
b) only with the first dose
c) only at the first dose and when being discharged
d) at least every 7 days
e) at least every 30 days

e) at least every 30 days

34) Which of the following was the first to require that pharmaceutical manufacturers prove the safety of prescription drugs before marketing?

a) Durham-Humphrey Amendment of 1951
b) Prescription Drug Marketing Act of 1987
c) Kefauver-Harris Amendment of 1962
d) F D & C of 1938
e) Pure food and drug act of 1906

D) FD & C of 1938

D) 12 months

35) To be admitted to a comprehensive maintenance program, narcotic-dependent individuals must have been physiologically dependent on narcotics for at least

a) 30 days
b) 90 days
c) 180 days
d) 12 months
e) 18 months

e) each state

36) Who is responsible for the retrospective drug utilization reviews established by OBRA 90/

a) all dispensing pharmacists
b) consultant pharmacists
c) individual community pharmacies
d) hospital pharmacies
e) each state

D) used in manufacturing a controlled substance

37) A "listed chemical" is defined by the controlled substances act as any chemical that is

a) a controlled substance
b) listed in the USP/NF
c) listed in the USP DI
d) used in manufacturing a controlled substance
e) listed in the electronic orange book

a) misbranding

38) A pharmacist dispense a refill for a prescription that originally was written for Adalat but labels the refill as Procardia. This action may be considered:

a) misbranding
b) adulteration
c) misbranding since the generic name was not included
d) proper since the correct drug was dispensed
e) negligent only if the prescriber is not informed

D) Attorney General of the US

39) The authority for determining the schedule for a potentially new controlled substance belongs to the:
a) Director of the FDA
b) President of the US
c) Director of the DEA
d) Attorney General of the United States
e) Director of HHS

A) I only (for future possible use during accidental poisoning)

40) Under which of the following circumstances may Ipecac Syrup be sold w/o a prescription

I. For future possible use during accidental poisoning
II. Only if the household does not have small children
III. For limited use in a weight-loss program

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

B) Supplier

41) The original portion of the Form 222 is eventually kept on file by the
A) DEA
B) Supplier
C) FDA
D) Purchaser
E) Prescriber

C) I & II only
I. Electronic Orange Book
II. USP/DI

42) Which of the following reference sources contain significant information concerning the bioequivalence of drug products?
I Electronic Orange book
II USP/DI
III USP/NF

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

E) USP/NF

43) Which one of the following reference sources is the first choice when a manufacturer is determining the preferred name of an additive for a product label?
A) CTFA Cosmetic Ingredient Dictionary
B) Food Chemical Codex
C) USAN
D) USP Dictionary of Drug Names
E) USP/NF

C) I & II
I. Name of the dispensing pharmacy
II. address of the dispensing pharmacy

44) According to federal law, a pharmacist must include which of the following on a prescription label?
I Name of dispensing pharmacy
II address of dispensing pharmacy
III name of dispensing pharmacist

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

B) III only
III. Upon written request from a physician

45) Under which of the following conditions may a pharmaceutical sales representative distribute samples of a prescription drug product?
I Upon written request from a community pharmacy
II Upon written request from a hospital pharmacy
III Upon written request from a physician

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C) provided special economic incentives for the manufacturer

46) An orphan drug is one that has
A) been removed from the market because of toxicity
B) has been discontinued because of poor sales
C) provided special economic incentives for the manufacturer
D) has a low therapeutic index
E) has been developed and imported from a foreign country

A) 3

47) Into how many segments is the NDC number on a pharmaceutical package divided?
A) 3
B) 2
C) 4
D) 5
E) 7

C) tamper-evident

48) Packaging for a nonprescription products that is designed to prevent the addition of foreign material into the final product is best described as being:
A) tamper-resistant
B)tamper-proof
C) tamper-evident
D) hermetically sealed
E) Air-tight

E) I, II, & III
I. the original annual deductible
II. the monthly premium
III. the "donut hole"

49)When explaining the Medicare Plan D program to a married couple, the pharmacist should emphasize that which of the following applies to each individual?
I. the original annual deductible
II. the monthly premium
III. the "donut hole"

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C) 12/1/2015

50) A customer had a prescription originally filled on December 1, 2009 and at that time acknowledged receiving the pharmacy's notice of privacy rights under HIPAA. She also receives a refill dispensed January 2, 2009. What is the earliest date that the pharmacy may discard the patient's acknowledgement?
A) 12/1/10
B) 1/2/10
C) 12/1/15
D) 1/2/14
E) never

C) I & II only
I. A US Army physician
II. A US Public Health Service physician

51) Which of the following are exempt from registration under the Controlled Substance Act?
I. A US Army physician
II. A US Public Health Service physician
III. A foreign-trained physician

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C) GRAS

52) Recipients included in pharmaceutical dosage forms are usually found on which of the following lists?
A) DSHEA
B) HPLC
C) GRAS
D) Top 200
E) USP

A) Means that the directions will be clear to a layperson for safe use of the product

53) The requirement for over-the-counter drugs to have "adequate directions for use"
A) Means that the directions will be clear to a layperson for safe use of the product
B) Applies only to products intended for oral consumption
C) applies only to products for pediatric use
D) includes the listing of potential side effects and toxicity
E) includes the presence of bilingual directions

C) I & II only
I pregnant women
II nursing women

54) Labels of OTC products that are for systemic use must include a warning specifically intended to protect:
I pregnant women
II nursing women
III geriatric women

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C) I & II only
I only a pharmacist may dispense the product to the consumer
II a non-pharmacist may "ring up" the sale and collect payment for the product

55) Which of the following is/are true regarding the sale of codeine-containing schedule V cough medicine without a prescription
I only a pharmacist may dispense the product to the consumer
II a non-pharmacist may "ring up" the sale and collect payment for the product
III Not more than 120mL or 24 dosage units of this product may be sold to the same purchaser in any 7 day period

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

E) I, II, & III
I. Schedule II's
II. Schedule III's
III. Schedule IV's

56) Which of the following controlled drugs may a pharmacist mail through the US postal service
I. Schedule II's
II. Schedule III's
III. Schedule IV's

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) 4

57) What number is given to the clinical trial phase that consist of post-marketing surveillance of a drug that was recently introduced to the market
A) 1
B) 2
C) 3
D) 4
E) 5

B) Phase II

58) The first phase of a clinical trial, which evaluates the efficacy of the drug in treating a specific disease, is:
A) phase I
B) phase II
C) phase III
D) phase IV
E) phase V

E) I, II, & III
A) morphine tablets
B) fentanyl injection
C)secobarbital capsules

59) Which of the following are Schedule II controlled substances?
A) morphine tablets
B) fentanyl injection
C)secobarbital capsules
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C) does not indicate number of tablets present

60) A drug product consisting of tablets may be declared adulterated for all of the following reasons EXCEPT:
A) active drug has undergone partial decomposition
B) contains an unapproved color additive
C) does not indicate number of tablets present
D) inactive ingredient has undergone partial decomposition
E) manufactured in a plant that fails to meet GMP's

B) tartrazine

61) the presence of which of the following adjuvants in a commercial drug product requires a special label warning?
A) antioxidants
B) tartrazine
C) sodium benzoate
D) surfactants
E) artificial flavors

E) I, II, & III
I prescription drugs
II biological
III nonprescription drugs

62) which of the following types of products in a hospital pharmacy must be barcoded?
I prescription drugs
II biological
III nonprescription drugs

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) July 31st

63) the expiration on a commercial pharmaceutical product is July 2013. The actual date that this product will be considered expired will be after:
A) June 30th
B) July 1st
C) July 15th
D) July 31st
E) August 1st

B) III only
III. must be made for each registered location

64) Controlled substance inventories
I. may be done at any time during the workday
II must be taken at least once each year
III must be made for each registered location

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C) I & II only
II Insurance companies may limit prescription drug quantities to 30 day supplies for some drugs
III Insurance companies may require participants to receive prescriptions from mail order pharmacies

65) Which of the following statements concerning Medicare Plan D is/are correct?
I The plan is voluntary for persons on Medicare
II Insurance companies may limit prescription drug quantities to 30 day supplies for some drugs
III Insurance companies may require participants to receive prescriptions from mail order pharmacies

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

A) Protection of the general public

66) The primary objective or charge for individual state boards of pharmacy is the
A) protection of the general public
B) protection of the profession
C) protection of individual pharmacists
D) enforcement of federal laws
E) serving as an intermediary between chain, independent and institutional pharmacies

E) Aerosol

67) two generic companies manufacture a specific drug in several dosage forms. Which one of the dosage forms is MOST likely to present problems with bioequivalence?
A) tablet
B) capsule
C) oral solution
D) parenteral solution
E) Aerosol

D) ATF 1447

68) Hospitals that plan on using large quantities of tax-free grain alcohol should obtain which of the following forms?
A) ATF 11
B) ATF 222
C) DEA 222
D) ATF 1447
E) DEA 1447

e) I, II, & III
I Lysergic acid diethlamide
II Mescaline
III Peyote

69) Which of the following are examples of Schedule I substances?
I Lysergic acid diethylamide
II Mescaline
III Peyote

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) Additives listed separately from the active ingredients

70) Which one of the following is the correct format for the listing of ingredients on a product label?
A) The additives and active ingredients intermixed but in alphabetical sequence
B) Additives and active ingredients intermixed but ranked by decreasing concentrations
C) Additives and active ingredients intermixed but ranked by increasing concentrations
D) Additives listed separately from the active ingredients
E) Additives listed separately by decreasing concentrations

A) I only
I. NDC numbers

71) Which of the following information must be included in the bar code of drug products being sold to hospitals?
I NDC numbers
II Lot numbers
III Expiration dates

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

A) I only
I inventories for schedule II controlled substances must be kept separately from all other records of the pharmacy

72) Which of the following is true of controlled substance inventories?
I inventories for schedule II controlled substances must be kept separately from all other records of the pharmacy
II controlled substance inventories must be performed annually
III The registrant must be keep inventory records for at least 5 years from the date preformed

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

A) I only
I. A pescription serial number

73) According to federal law, a pharmacist must include which of the following on a prescription label?
I A prescription serial number
II The name of the manufacturer
III Expiration date from the manufacturer's label

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) II & III only
II the plastic container
III The plastic closure

74) When refilling a prescription that requires a child-resistant container, the pharmacist must always replace which of the following
I the glass container
II the plastic container
III The plastic closure

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

B) HHS

75) HCFA is under the jurisdiction of the
A) Attorney General
B) HHS
C) JCAHO
D) FDA
E) Dept. of Justice

B) 5 %

76) A pharmacy that compounds many prescriptions may be cited by the FDA of the volume of its prescriptions being sent out-of-state is in excess of ______%
A) 2
B) 5
C) 10
D) 20
E) 50

A) FTC only

77) the advertising to the general public of OTC drugs is basically under the regulatory responsibilities of the:
A) FTC only
B) FDA and FTC
C) FDA only
D) DEA
E) HCFA

A) I only
I. For patients of other prescribers based upon written prescriptions

78) A pharmacy has been compounding a psoriasis cream in 30 gram jars based upon prescriptions written by physicians at a local dermatology clinic. Under which of the following circumstance could the pharmacy also dispense the jars?
I For patients of other prescribers based upon written prescriptions
II To the original dermatology clinic for dispensing by the dermatologists
III To other pharmacies provided they provided a written purchase order

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

E) Patient counseling

79) The acronym, DUR, is most closely associated with which of the following
A) Drug clinical trials
B) Medicare reimbursement
C) MedWatch
D) Drug nomenclature
E) Patient counseling

D) II & III only
II. Homeopathic Pharmacopeia of the US
III. USP/NF

80) Which of the following reference book(s) are legal documents recognized by the federal government?
I. Remington's Pharmaceutical Sciences
II. Homeopathic Pharmacopeia of the US
III. USP/NF

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) II & III only
II Injectable
III Capsule

81) Which dosage forms of secobarbital must be ordered using a DEA form 222?
I suppository
II Injectable
III Capsule

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

A) Secretary of HHS

82) Who is authorized to designate the "official" name of a new drug?
A) Secretary of HHS
B) Executive Director of APhA
C) Director of HCFA
D) Director FDA
E) US congress

B) Schedule III

83) A product that contains 60 mg of coedine and 325 mg of acetaminophen is most likely to be classified as
A) Schedule II
B) Schedule III
C) Schedule IV
D) Schedule V
E) Noncontrolled

B) III only
III. the DEA in writing and request renewal forms

84) A pharmacist who does not receive a registration renewal form from DEA within 45 days before the expiration of his/her registration must notify
I his/her state's board of pharmacy
II the regional FDA
III the DEA in writing and request renewal forms

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) 30 mL

85) The maximum volume of Ipecac Syrup that may be sold without a prescription is
A) 15 mL
B) 120 mL
C) 60 mL
D) 30 mL
E) 240 mL

B) III only
III. Oral

86) Patients treated in an ambulatory care comprehensive narcotic treatment program may receive methadone doses by which of the following routes?
I IV
II IM
III oral

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) 10 or 11

87) The total number of digits in the NDC number present on a pharmaceutical package may be:
A) 2 or 3
B) 5 or 6
C) 8 or 9
D) 10 or 11
E) 15 or 16

d) II & III only
II The hospital must store the samples separate from the regular stock
III A licensed practitioner must have requested the samples from the company

88) Which of the following protocols must a hospital pharmacy follow in order to possess pharmaceutical manufacturer's drug samples?
I The hospital must be registered as a drug wholesaler
II The hospital must store the samples separate from the regular stock
III A licensed practitioner must have requested the samples from the company

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

B) III only
III limiting the choice of pharmacies to only one community chain

89) Which of the following actions by a company offering Medicare Plan D coverage is(are) NOT permitted?
I charging a $250 deductible
II eliminating an deductible charge to the patient
III limiting the choice of pharmacies to only one community chain
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

E) I, II, & III only

90) A pharmacist telephones a patient's home concerning the availability of a prescription refill. With which of the following may the message be left?
I patient's wife
II patient's mother
III patient's brother-in-law

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) manufacturer

91) the first series of digits in the NDC for a drug product represents the:
a) drug name
b) drug strength
c) package size
d) manufacturer
e) therapeutic use

B) III only
III. contact lens solution

92) Which of the following OTC products must be in a tamper resistant package?
I topical lotion
II hair shampoo
III contact lens solution

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C) 120

93) A 35- year old customer wishes to know how many 30 mg Sudafed tablets he can purchase at one time. Which of the following is the correct answer?
A) 12
B) 60
C) 120
D) 240
E) 300

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C) Kefauver-Harris Amendment of 1962

94) The term "grandfathered" refers to drugs that were marketed before
A) DSHEA
B) Durham-Humphrey Amendment of 1951
C) FD and C act of 1938
D) Kefauver-Harris Amendment of 1962
E) Poison Prevention Act

C) The label does not indicate that the product is a dietary supplement

95) Under which of the following conditions may practitioners of "Traditional Chinese Medicine" sell ephedra-containing products?
A)The level of ephedra is less than 1 mg/dose
B) Only a 10 day supply of product is sold
C) The label does not indicate that the product is a dietary supplement
D) A prescription is issued for the product
E) Sales are not legal

B) total sodium content of both active and inactive ingredients

96) Which of the following must be present on the labels of nonprescription drug products intended for oral use?
A) Sodium content of active ingredients
B) total sodium content of both active and inactive ingredients
C) Sodium chloride content of active ingredients
D) Total sodium chloride content of both active and inactive ingredients
E) no requirements have been established

E) Continue to fill the prescriptions

97) After dispensing prescriptions for several months for a schedule II analgesic, the pharmacist realizes that a patient with severe pain from bone cancer is addicted to the drug. Which one for the following actions is the most appropriate for the pharmacist?
A) Report the situation to the state board of pharmacy
B) Report the situation to the state medical board
C) Report the situation to the DEA
D) Refuse to fill an further prescriptions
E) Continue to fill the prescriptions

E) I, II, & III
I. must make an exact count of open contains of schedule II substances
II. may estimate the count of a schedule IV substance in an open container that originally held 500 tablets
III. must make an exact count of all controlled substances in sealed, unopened containers

98) When conducting controlled substance inventory, the registrant
I. must make an exact count of open contains of schedule II substances
II. may estimate the count of a schedule IV substance in an open container that originally held 500 tablets
III. must make an exact count of all controlled substances in sealed, unopened containers
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) II & III only
II they may be ordered by the FDA
III They may be voluntary actions by the pharmaceutical manufacturer

99) Which of the following statements concerning drug recalls is (are) accurate?
I They occur only after fatalities have occurred
II they may be ordered by the FDA
III They may be voluntary actions by the pharmaceutical manufacturer

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) II & III only
II If an order cannot be filled by a supplier the form must be returned to the purchaser
III If any forms are lost, the loss must be reported to the DEA

100) Which of the following is true about DEA form 222?
I If it contains incorrect information the supplier may correct it and initial the correction
II If an order cannot be filled by a supplier the form must be returned to the purchaser
III If any forms are lost, the loss must be reported to the DEA

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

A) Medicare Part D

101) The term "donut hole" refers to a component of which one of the following?
A) Medicare Part D
B) National Drug Code
C) Medicare Part B
D) Poison Prevention Act
E) Prescription Drug Marketing Act of 1987

A) I only
I Purchase of that quantity of the antibiotic

102) The purchasing agent of your hospital suggests that the hospital purchase a two-year supply of a popular antibiotic at a special price. Which of the following are legal activities?
I Purchase of that quantity of the antibiotic
II Sell a portion of the antibiotic to another area hospital
III Sell a portion of the antibiotic to a community pharmacy

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C) I & II only
I Purchase of that quantity of the antibiotic
II Sell a portion of the antibiotic to another area hospital

103) A physician who is a resident in a hospital and does not have a DEA registration number
A) may not prescribe controlled substance
B) may only prescribe controlled substances
C) may prescribe controlled substances using the hospital DEA number plus an assigned suffix
D) May prescribe controlled substances only in schedule III-V
E) May prescribe only for inpatients

D) Once a year

104) How frequently may a patient with a Medicare-endorsed discount are change his/her provider?
A) every month
B) every 6 month
C) whenever he/she desires
D) once a year
E) never

D) as a requisition form for Form 222

105) A DEA form 222a is used
A) to order Schedule II controlled substances
B) to order all controlled substances
C) to return unused controlled substances
D) as a requisition form for Form 222
E) to register a practitioner with DEA

A) inert gas

106) The label of a parenteral product is not required to list the presence of a(an):
A) inert gas
B) buffer system
C) antimicrobial preservative
D) antioxidant
E)) chelating agent

E) I, II, & III
I Schedule II non-narcotics
II Benzodiazepines
III Schedule II narcotics

107) A pharmacist may fill prescriptions for and mail which of the following drugs through the US Postal Service?
I Schedule II non-narcotics
II Benzodiazepines
III Schedule II narcotics

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

D) II & III
II MS Contin
III Concerta

108) Which of the following drug products must be purchased by pharmacies using DEA Form 222?
I Strattera
II MS Contin
III Concerta

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

E) NDC number

109) Which one of the following types of information is useful but not mandatory on the labels of OTC products?
A) name of manufacturer
B) address of manufacturer
C) net contents
D) adequate directions for use
E) NDC number

B) marijuana

110) Dronabinol is a Schedule III controlled substance that is related most closely to
A) cocaine
B)marijuana
C) LSD
D) morphine
E) methylphenidate

E) I, II, & III
I May be used to transfer Schedule II drugs from one pharmacy to another
II May be used to return Schedule II drugs to the supplier
III It must contain the name and address of the supplier from whom schedule II controlled substances are being ordered

111) Which of the following is true of DEA Form 222?
I May be used to transfer Schedule II drugs from one pharmacy to another
II May be used to return Schedule II drugs to the supplier
III It must contain the name and address of the supplier from whom schedule II controlled substances are being ordered

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

B) III only
III. retrospective review

112) Which portion of the federal counseling regulations must be performed by a committee appointed within each individual state?
I meta-analysis review
II prospective review
III retrospective review

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C. I & II only
I mescaline
II peyote

113) Which of the following are schedule I controlled substances?
I mescaline
II peyote
III dextroamphetamine

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

C) Schedule IV

114) A new drug product is given the name "felorazepam." It is likely to be classified as
A) Schedule II
B) Schedule III
C) Schedule IV
D) Schedule V
E) noncontrolled

C) FDA

115) Which organization is primarily responsible for evaluating the safety and effectiveness of drugs used in veterinary practices?
A) SPCA
B) FTC
C)FDA
D)humane society
E) HCFA

C) I & II only
II Papaverine
III levorphanol

116) Which of the following are NOT controlled substances?
I Ergotamine tartrate
II Papaverine
III levorphanol

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

E) If the pharmacy is willing to be cited for violations of FDA guidelines for compounding

117) A pharmaceutical manufacturer has withdrawn a drug from the market since it was deemed by the FDA to be ineffective. Under which one of the following conditions may a pharmacy volunteer to compound capsules of the drug for patients?
A) only if 14 day supplies of the capsules are dispensed
B) If a physician writes the prescription specifying "medically necessary"
C) If the capsule strength is one-half or less than the original commercial capsule
D)Only specific physicians write for the prescriptions
E) If the pharmacy is willing to be cited for violations of FDA guidelines for compounding

C) I & II only

118) When a pharmacist conducts a controlled substance inventory, which of the following must be included
I Drugs stored in a warehouse for the registrant at a different location
II Drugs ordered by a customer but not yet paid for
III All controlled substances dispensed over the past 30 days

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

E) manufacturer's expiration date

119) Which of the following is NOT required on the label of unit dose packages prepared in a hospital?
A) name of the drug
B) beyond-use expiration dating
C) control number
D) strength of drug
E) manufacturer's expiration date

A) often not listed in the Orange Book

120) "Grandfathered" drugs are
A) often not listed in the Orange Book
B) found in the Orange Book as Code B only
C) found in the Orange Book as Code AB only
D) to be prescribed only by generic name
E) found in the Orange Book as Code A only

C) 7 months

121) What is the time interval during which newly eligible individuals may enroll in Medicare Plan D without a penalty?
A) 3 months
B) 6 months
C) 7 months
D) 9 months
E) 1 year

D) an independent organization

122) The USP/NF is best described as a publication that is published by:
A) the HHS
B) the FDA
C) the Pharmaceutical Manufacturer's Association
D) an independent organization
E) a coalition of US pharmaceutical companies

a) I only

123) Uses for tax-free alcohol purchased by a hospital may include:
I. incorporation into formulas for inpatient orders
II. incorporation into prescriptions for recently discharged patients
III. selling of small amounts to independent pharmacies based upon their immediate prescription needs.

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

E) I, II, & III
I. Nitroglycerin
II. Nitrostat
III. Isordil

124) Which of the following sublingual tablets do NOT have to be dispensed in child resistant containers?
I. Nitroglycerin
II. Nitrostat
III. Isordil

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

E )I, II, & III

125) Which of the following drug products must be ordered using DEA for 222?
I. Methadone
II. Sufentanil
III. Percocet

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

b) III. in an emergency situation

126) Oral orders for Schedule II drugs may be accepted and dispensed by a pharmacist
I. if a patient is a regular customer of the pharmacy
II. if the physician is more than 100 miles away from the pharmacy
III. in an emergency situation

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

b) III only
III. Volume III

127) Which of the following volumes of the USP DI contains significant information concerning the bioequivalence of drug products?
I. Volume I
II. Volume II
III. Volume III

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

A) orphan drug

128) A drug that is marketed for the treatment of a relatively rare disease is referred to as a(n):
A) orphan drug
B) me-too drug
C) prodrug
D) USAN drug
E) first pass effect drug

D) HSD

129) What acronym is used by the USP to designate sterile products that are prepared in a home infusion pharmacy for delivery to a patient's home residence?
A) SP
B) LVP
C) PPI
D) HSD
E) TRP

C) should be administered only if the potential benefits are acceptable despite the potential risks

130) With respect to pregnancy warnings, category D indicates that the drug
A) is safe for 98% of all females during pregnancy
B) should not be used during the first trimester
C) should be administered only if the potential benefits are acceptable despite the potential risks
D) should not be used during pregnancy
E) does not pose any danger to either the mother or fetus

131) A hospital that has two 55-gallon drums of tax-free grain alcohol must:
A) report the amount remaining to the ATF every six months
B) inventory the stock every month
C) inventory the stock every 6 months
D) maintain a running inventory of the volume
E) take a year-end inventory

D) maintain a running inventory

132) the names of which of the following ingredients are required to be included on the labels of pharmaceutical products
I. flavoring oils
II coloring agents
III antimicrobial preservatives

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

d) II & III only
II coloring agents
III antimicrobial preservatives

133) If a specific lot of a pharmaceutical company's tablets fails to meet the expected expiration dating, the lot may be considered to be:
A) adulterated
B) unstable
C) misbranded
D) a class III recall
E) a felony

C) misbranded

134) A pharmacist who fills an oral morphine sulfate prescription in an emergency does not receive a "cover" prescription from the prescriber. The pharmacist must

I. notify the regional DEA office
II. notify the state board of medicine
III. call the patient and request that s/he obtain a written prescription to cover the oral order

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

a) I only
I. notify the regional DEA office

135) A prescription for methadone is issued for the purpose of managing a patient's narcotic addition by a physician employed by a narcotic treatment facility. The prescription
I. may be filled in most community pharmacies
II. may be filled only in outpatient institutional pharmacies
III. may not be filled

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

b) III only
III. may not be filled

136) What permanent identification must a pharmacy possess if it plans to electronically bill Medicare or Medicaid for prescriptions
A) NPI
B) NDC
C) FDA registration number
D) AWP
E) DEA number

A) NPI

137) A cosmetic company begins marketing an OTC topical cream that is claimed to reverse psoriatic lesions. This claim may be legally challenged by the:
A) FDA only
B) FDA and FTC
C) FTC only
D) DEA
E) HCFA

B) FDA and FTC

138) Which of the following conditions must exist for the inspection of a pharmacy by an authorized inspector?
I. inspection must be conducted during the regular business hours of the pharmacy
II. The owner of the pharmacy or a designated supervising pharmacist must be present
III. The inspector must have a search warrant

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

a) I only
I. inspection must be conducted during the regular business hours of the pharmacy

139) Samples of prescription drugs received from the pharmaceutical companies may be
A) give to patients by the prescriber
B) dispensed from a hospital pharmacy for inpatients
C) dispensed from a hospital to outpatients
D) sold through community pharmacies
E) traded to another pharmacy for other drugs

A) give to patients by the prescriber

140) Which of the following items must be ordered from a wholesaler on DEA order form 222?
I Morphine HCL injection 10 mL vials (10mg/mL)
II Meperidine HCL tablets 50 mg
III diazepam tablets 10 mg

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

c) I & II only
I. Morphine HCL injection 10 mL vials
II Meperidine HCL tablets 50 mg

141) Ephedra may no longer be present in which of the following products in a community pharmacy?
I) nonprescription drug products
II) Herbal teas
III) Dietary supplements

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

b) III only
III) Dietary supplements

142) Eszopiclone is an example of a drug product in controlled substance schedule
A) I
B) II
C) III
D) IV
E) V

D) IV

143) The label of a bottle of Ipecac Syrup sold OTC for accidental poisoning must:
I. have its warnings printed in red ink
II. contain the telephone number of the regional poison control center
III. state that the appropriate dose is the entire bottle followed by a full glass of water

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

a) I only
I. have it's warning printed in red ink

144) Which one of the following designations for drug products that require a prescription in the United States has replaced the designation "Caution: Federal law prohibits dispensing without a prescription"?
A) Do not dispense without a prescription
B) Do not transfer to a third party
C) Federal law prohibits use by anyone other than the original patient
D) Legend drug
E) Rx only

E) Rx only

145) An inspector from the FDA enters your community pharmacy. He/she may issue citations if which of the following are found?
I. Drug samples being sold/dispensed pursuant to prescription
II. Recalled prescription drugs among the stock
III. Samples stored in the drug stock

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

e) I, II, & III
I. Drug samples being sold/dispensed pursuant to prescription
II. Recalled prescription drugs among the stock
III. Samples stored in the drug stock

146) Which of the following is MOST important to consider in determining whether a community pharmacy is required to meet HIPAA regulations
A) The prescription volume is greater than 20,000 per year
B) Identifiable patient health information is transferred electronically
C) The pharmacy accepts Medicaid prescriptions
D) The store's annual income is greater than one million dollars
E) The pharmacy has more than 10 employees

B) Identifiable patient health information is transferred electronically

147) Which form must a community pharmacy use to purchase grain alcohol for compounding?
A) FDA 23a
B) ATF 222
C) DEA 222
D) DEA 23a
E) ATF 11

E) ATF 11

148) Schedule III, IV, or V controlled substances may be refilled
I. not more than 6 times
II. not more than for a 6 month period
III. only if authorized by the prescriber

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III

d) II & III only
II. not more than for a 6 month period
III. only if authorized by the prescriber

149) Phenobarbital is a drug that is classified as a(n)
A) Schedule III drug
B) OTC drug
C) Schedule V drug
D) non-controlled drug
E) schedule IV drug

E) schedule IV drug

See More

Please allow access to your computer’s microphone to use Voice Recording.

Having trouble? Click here for help.

We can’t access your microphone!

Click the icon above to update your browser permissions above and try again

Example:

Reload the page to try again!

Reload

Press Cmd-0 to reset your zoom

Press Ctrl-0 to reset your zoom

It looks like your browser might be zoomed in or out. Your browser needs to be zoomed to a normal size to record audio.

Please upgrade Flash or install Chrome
to use Voice Recording.

For more help, see our troubleshooting page.

Your microphone is muted

For help fixing this issue, see this FAQ.

Star this term

You can study starred terms together

NEW! Voice Recording

Create Set