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Federal Pharmacy Law 2011

STUDY
PLAY
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
150) The federal act that specifically limits the reimportation of drug products that were previously exported by a pharmaceutical manufacturer is the:
A) Prescription Drug Marketing Act of 1987
B) Durham-Humphrey Amendment 1951
C) FD & C Act of 1938
D) DSHEA
E) Kefauver-Harris Amendment of 1962
A) Prescription Drug Marketing Act of 1987
151) Which of the following may a nurse in a doctor's office perform, with the prescriber's permission, with regard to a Schedule II prescription?
I. write the prescription and sign prescriber's name
II. write the prescription except for the drug name, strength, quantity and prescriber's name
III write the entire prescription except for signing the prescriber's name

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III write the entire prescription except for signing the prescriber's name
152) A pharmaceutical company requests the names and addresses of patients who have received a certain antidepressant drug during the past month
I. Honoring this request will represent a breach of privacy based upon the Federal Health Insurance Portability and Accountability Act
II. The request is appropriate if the company only wishes to send the patients information concerning depression
III. The request may be honored if the company gives the pharmacist an affidavit that a list of the patients' names and addresses will not leave the company

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. Honoring this request will represent a breach of privacy based upon the Federal Health Insurance Portability and Accountability Act
153) Which of the following are mid-level practitioners?
I. Podiatrists
II. Nurse Midwives
III. Nurse Practitioners

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. Nurse Midwives
III. Nurse Practitioners
154) Which of the following is true of Schedule V substances
I. They all contain codeine
II. When they are dispensed by the pharmacist, the federal transfer warning must be on the container labeling
III. Some states may permit sale of these products without a prescription
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. Some states may permit sale of these products without a prescription
155) Which of the following are permissible when taking a controlled substance inventory
I. assistance of a technician to count tablets
II. use of a tape recorder
III. permanent storage of the inventory on a tape recorder

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. assistance of a technician to count tablets
II. use of a tape recorder
156) Which of the following was the first to require that pharmaceutical manufacturers prove the efficacy of prescription drug before marketing?
A) Kefauver-Harris Amendment of 1962
B) F D & C Act of 1938
C) Durham-Humphrey Amendment of 1951
D) Prescription Drug Marketing Act of 1987
E) Pure Food and Drug Act of 1906
A) Kefauver-Harris Amendment of 1962
157) A client request a refill on a prescription written for diphenhydramine 25 mg #30 with a Sig reading "one cap 1h before bedtime and 1 hs if needed." There was no indications of refills on the prescription. Which one of the following actions is most appropriate for the pharmacist?
A) Refuse the refill since no refills were indicated
B) Suggest that the client visit a nearby ER for a new prescription
C) Give an emergency supply of only 4 capsules
D) Refill the prescription since it is for an OTC drug
E) Suggest that the patient purchase an herbal product for sleep
D) Refill the prescription since it is for an OTC drug
158) Under which of the following situations would a drug product be considered misbranded?
I. An original bottle labeled 50 tablets contains 60 tablets
II. The concentration of tetracaine ointment 5% W/W is only 2%
III. The manufacturer can not prove the sterility of a labeled "sterile Diphenhydramine Injection

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. An original bottle labeled 50 tablets contains 60 tablets
159) Which of the following is (are) true of practitioners who prescribe controlled substances electronically?
I. They must provide appropriate two-factor authentication credentialing
II. They may issue prescriptions for up to 3 patients simultaneously with a single signature
III. They may only prescribe Schedule III, IV, and V drugs electronically

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. They must provide appropriate two-factor authentication credentialing
160) Which of the following employees may administer or dispense drugs to patients as part of a narcotic treatment program?
I. Pharmacists
II. Registered Nurses
III. Licensed practical nurses

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. Pharmacists
II. Registered Nurses
III. Licensed practical nurses
161) Who must be registered with the DEA in order for a hospital pharmacy to dispense controlled substances?
I. Every pharmacist who dispenses on a regular basis
II. The chief pharmacist
III. The hospital pharmacy

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. The hospital pharmacy
162) While presenting a talk on drug abuse, a pharmacist is asked for information concerning the "date-rape drug". Her response may include which of the following?
I. The drug is a schedule II substance
II. The generic name for the drug is gamma-hydroxybutyric acid
III. The therapeutic classification of the drug is as a behavioral depressant and hypnotic

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. The therapeutic classification of the drug is as a behavioral depressant and hypnotic
163) Which of the following drug products are controlled substances?
I. Lyrica
II. Versed
III. Risperdal
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. Lyrica
II. Versed
164) which of the products listed below would be considered to be Schedule II controlled substance?
I. A product that contains 90 mg of codeine per dose
II. A product that contains 15 mg of hydrocodone per dose
III. A product that contains 2.5 mg of diphenoxylate and 25 mcg of atropine sulfate per dose

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. A product that contains 90 mg of codeine per dose
II. A product that contains 15 mg of hydrocodone per dose
165) A physician wishes to prescribe a schedule II controlled substance for a patient residing in a hospice. How many the prescription be conveyed to a pharmacy
I. As a written prescription
II. By fax
III. By email

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. As a written prescription
II. By fax
166) Therapeutic substitution is allowed only if an institution is:
A) nonprofit
B) for profit
C) licensed to do so
D) using a formulary system
E) under the supervision of a PharmD graduate
D) using a formulary system
167) A faxed Schedule II prescription from the prescriber to a pharmacy is permitted
I. at any time as long as it is followed by a written "cover" prescription
II. If a patient is a resident of a LTCF
III. If the patient is a hospice patient

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. If a patient is a resident of a LTCF
III. If the patient is a hospice patient
168) All of the following would be considered as incidences of misbranding EXCEPT
A) one of the active drug in a product is not identified on the label
B) the original bottle of 60 contains only 50 tablets
C) the names of inactive ingredients are not on the label
D) the level of alcohol in the product is 5% V/V but the label states 15% V/V
E) the pharmacist dispenses a drug product without the required prescription authorization
D) the level of alcohol in the product is 5% V/V but the label states 15% V/V
169) Which of the following drug products is/are NOT classified as a controlled substance?
I. Toviaz
II. Ramelteon
III. Actiq

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. Toviaz
II. Ramelteon
170) A pharmacist may refuse to accept or fill a prescription under all of the following circumstances EXCEPT when:
A) the prescription is suspected to be either forged or fictitiously written
B) the pharmacist believes that the drug product may be harmful to the patient
C) the pharmacist believes that he will be violating the law by filling the prescription
D) the drug or drug product is not in stock
E) the patient is known to be HIV positive
E) the patient is known to be HIV positive
171) A product that contains not more than 1.8 g of codeine per 100 mL is considered to be in Schedule
A) I
B) II
C) III
D) IV
E) V
C) III
172) A pharmacist may issue a Power of Attorney to an individual in order to permit the individual to
I. fill controlled substance prescriptions
II. conduct a narcotic treatment facility
III. complete DEA Form 222 orders

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. complete DEA Form 222 orders
173) Which of the following apply to prescription for Accutane?
I . not more than a one month supply may be dispensed
II. The prescription must be filled within 30 days of issue
III. Not more than 3 refills may be authorized on the original prescription
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I . not more than a one month supply may be dispensed
174) When inspecting a chain pharmacy, a DEA inspector may audit which of the following records?
I. financial records of prescription sales and profits
II. invoices for controlled substances
III. prescription files

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. invoices for controlled substances
III. prescription files
175) Prescription for which of the following controlled substances may be partially filled upon request of the patient:
I. Empirin w/codeine #4
II. Ritalin
III. Dilaudid

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. Empirin w/codeine #4
176) Which one of the following dosage forms is LEAST likely to present bioequivalence problems?
A) capsule
B) tablet
C) suspension
D) transdermal patch
E) IV solution
E) IV solution
177) The term in the HIPAA privacy rules to describe the removal of patient identifying information when discussing a specific clinical case in public is:
A) de-indentification
B) debriefing
C) document erasure
D) depersonalization
E) Anti-terrorist protection
A) de-indentification
178) A pharmacist may partially fill a Schedule II prescription
I. and the remaining portion of the prescription may be filled within 72 hr of the partial fill
II. if the pharmacist does not have enough medication in stock to completely fill the prescription
III. If the patient only wants some of the medication prescribed.
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. and the remaining portion of the prescription may be filled within 72 hr of the partial fill
II. if the pharmacist does not have enough medication in stock to completely fill the prescription
179) A statement that a specific OTC product has a tamper evident feature may be placed in any of the following locations EXCEPT on the:
A) closure
B) front of the package
C) back of the package
D) under the product name
E) on the tamper evident device
E) on the tamper evident device
180) A pharmacy that compounds large numbers of prescriptions may be cited by the FDA if its volume of prescriptions being sent out-of-state is in excess of ___%
A) 25
B) 75
C) 40
D) 10
E) 5
E) 5
181) Pharmacists are required to periodically inventory supplies of which of the following drug products?
I. Sonata capsules
II. Entex Liquid
III. Sudafed Plus Liquid

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
A) I only
I. Sonata capsules
182) Which of the following categories of drugs require the legend "Rx only" to be on the manufacturer's package
I. Schedule V controlled drugs
II. Schedule II controlled drugs
III Schedule III and IV controlled drugs

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. Schedule II controlled drugs
III Schedule III and IV controlled drugs
183) The iPLEDGE program is intended to assure appropriate and safe dispensing of which one of the following drugs
A) pravastatin
B) isotretinoin
C) neviraprine
D) sildenafil
E) thalidomide
B) isotretinoin
184) A pharmacist confides in his hospital's chief pharmacist that he has tested positive for HIV. Which of the following statements is(are) true?
I. the pharmacist may be terminated due to a potentially contagious condition
II. The pharmacist's access to the preparation of parenteral admixtures may be limited
III. The pharmacist may be considered disabled under the Americans with Disabilities Act

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. The pharmacist may be considered disabled under the Americans with Disabilities Act
185) Which of the following organizations is directly responsible for Medicare programs?
A) CMS
B) FDA
C) HMO
D) JCAHO
E) AARP
A) CMS
186) Which of the following must be imprinted on each commercial oral tablet?
A) Company name
B) Name and strength of the drug
C) date of manufacturing
D) An expiration date
E) A code identifying each of the above
E) A code identifying each of the above
187) Original packages of NTG that are exempt from the requirements of the Poison Prevention Packaging Act include:
I. SL tablets
II. oral tablets
III. ointments

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. SL tablets
II. oral tablets
188) Under which of the following situations would a drug product be considered adulterated?
I. an herbal product that contains American ginseng rather than Chinese ginseng listed on the label
II A product on the shelf for sale past its expiration date
III A sterile parenteral solution contains a few microorganisms
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. an herbal product that has the wrong type of ginseng listed
II. A product on the shelf for sale past its expiration date
III. A sterile perenteral solutions contains a few microorganisms
189) Proposed regulations from the FDA are first published in the:
A) Federal Register
B) Congressional Record
C) New York Times and Wall Street Journal
D) USP/NF
E) Supplements of the USP/NF
A) Federal Register
190) Which of the drug products used to treat narcotic dependence is (are) administered sublingually?
I. Methadone
II. Subutex
III Suboxone

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III Suboxone
191) Under which of the following circumstances may Ipecac Syrup be sold without a prescription
I. If the purchaser signs a pharmacy log book for the sale
II. only if the household does not have small children
III. for future potential use during accidental poisoning

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. for future potential use during accidental poisoning
192) A pharmaceutical manufacturer requests from a community pharmacy the names and addresses of patients receiving the company's antidepressant so that a special discount coupons may be provided for future prescriptions. The scenario is probably in violation of which of the following laws
A) DSHEA
B) FDA Modernization Act 1997
C) OBRA 90
D) HIPAA
E) Sherman Antitrust Act
D) HIPAA
193) Which of the following drug products may be purchased by a pharmacy WITHOUT the use of a DEA Form 222?
I. Lortabs
II. Marinol Capsules
III. Stadol Injections

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. Lortabs
194) How often must a pharmacy have a patient sign a new notice that s/he has been informed of the pharmacy's privacy practices under HIPAA requirements?
A) NO requirements are specified by HIPPA
B) Every time a refill is dispensed
C) Every 6 Months
D) Every year
E) every time a new prescription is filled
A) NO requirements are specified by HIPPA
195) The classification of drugs into controlled substance schedules by the federal government is based upon the drug's
I. potential for abuse and dependence
II. therapeutic index
III. toxicity

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. potential for abuse and dependence
196) Which of the following items provided by pharmaceutical companies are legal for community pharmacies to possess for the dispensing of prescription drugs?
I. starter packs
II. vouchers intended for filling from the pharmacy's stock
III. Drug samples that are properly labeled

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. starter packs
II. vouchers intended for filling from the pharmacy's stock
197) Which of the following are Schedule IV controlled substances?
I. chlordiazepoxide
II. halazepam
III. zolpidem

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. chlordiazepoxide
II. halazepam
III. zolpidem
198) A hospital pharmacy director is informed that an employee has been convicted of selling cocaine on the street. Which of the following actions may the director take based upon the Federal Anti-drug Abuse Act of 1988?
I. warn the employee not to possess or sell illegal drugs in the future
II. place a letter of reprimand in the employee's personnel file
III. terminate the employment of the individual

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. warn the employee not to possess or sell illegal drugs in the future
II. place a letter of reprimand in the employee's personnel file
III. terminate the employment of the individual
199) Which of the following is TRUE of Schedule II controlled substances?
I. They may be dispensed by a community pharmacist only pursuant to a written prescription signed by the practitioner
II. They may be administered or dispensed by a physician without a prescription to a patient with chronic pain
III. They may be administered by an institutional pharmacists pursuant to an order for immediate administration to the ultimate user

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. They may be dispensed by a community pharmacist only pursuant to a written prescription signed by the practitioner
II. They may be administered or dispensed by a physician without a prescription to a patient with chronic pain
III. They may be administered by an institutional pharmacists pursuant to an order for immediate administration to the ultimate user
200) A patient presents a prescription for MS Contin 30 mg tablets #60 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 if the medication agrees with him. The pharmacist should
A) call the prescriber to get permission to dispense 30
B) dispense 30 tablet as requested by the patient
C) advise the patient that the full 60 tablets must be supplied at one time
D) fill the prescription as requested by the patient but advise the patient that the balance must be picked up within 72 hours
E) dispense 30 tablets of the 60 mg strength of MS Contin
C) advise the patient that the full 60 tablets must be supplied at one time
201) Major objectives for developing a formulary include:
I. give prescribers a greater latitude of drug selection
II. Allow therapeutic substitution
III. reduce drug inventory

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. Allow therapeutic substitution
III. reduce drug inventory
202) Which of the following are Schedule IV controlled substances?
I. zolpidem
II. buprenorphine
III. methylphenidate

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. zolpidem
203) Which of the following statements on a cranberry extract label would be acceptable under DSHEA regulations
I. To help maintain a healthy urinary tract in females
II. To reduce the incidence and duration of UTIs
III. TO reduce E coli counts during a UTI
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. To help maintain a healthy urinary tract in females
204) Any physician is permitted to
I. administer drugs to relieve acute narcotic withdrawal symptoms
II. prescribe drugs to relieve acute narcotic withdrawal symptoms
III. administer drugs to provide narcotic drug-dependent patients with maintenance treatment

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. administer drugs to relieve acute narcotic withdrawal symptoms
205) The main responsibility for oversight of prescription drug advertising rests with the
A) FTC
B) FDA
C) HCFA
D) DEA
E) USP/NF
B) FDA
206) Sponsors of Medicare Plan D programs must provide a broad choice of formulary drugs for each of the following drug categories EXCEPT:
A) anticonvulsants
B) antidepressants
C) antihyperlipidemics
D) antineoplastics
E) antipsychotics
C) antihyperlipidemics
207) Which of the following products are exempt from the FDA regulations concerning expiration dating?
I. USP/NF drug products
II. dietary supplements
III. vitamins

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. dietary supplements
III. vitamins
208) A drug product consisting of tablets may be declared misbranded under all of the following guidelines EXCEPT:
A) portion of the label is misleading
B) label does not indicate number of tablets present
C) official names of certain ingredients not used
D) name and location of manufacturer is missing
E) tablets do not meet assay limits
E) tablets do not meet assay limits
209) Which of the following commercial products intended for oral intake need identification codes on the individual units?
I. Nonprescription tablets
II. Prescription tablets
III. Prescription capsules

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. Nonprescription tablets
II. Prescription tablets
III. Prescription capsules
210) Which of the following drug products must be purchased using a DEA Form 222?
I. Methadone
II. Methylphenidate
III. Fentanyl

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. Methadone
II. Methylphenidate
III. Fentanyl
211) Which of the following prescriptions for Accutane must bear the yellow sticker?
I. Rx for an unmarried 16 y.o. female
II. Rx for a 60 y.o female
III. Rx for a 30 y.o male

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. Rx for an unmarried 16 y.o. female
II. Rx for a 60 y.o female
III. Rx for a 30 y.o male
212) The Consumer Product Safety Commission is responsible for which one of the following?
A) Federal Food, Drug and Cosmetic Act
B) DSHEA
C) Prescription drug to OTC status
D) Good Manufacturing Practice Program
E) Poison Prevention Packaging Act
E) Poison Prevention Packaging Act
213) Which one of the following acronyms is most closely associated with healthcare reimbursement?
A) DRG
B) DEA
C) GMP
D) JCAHO
E) PPI
A) DRG
214) Orphan drugs are drugs that are
A) intended for use under the age of 16
B) chemically dissimilar to any other marketed drug moiety
C) used in the treatment of rare diseases
D) intended for use in children under the age of 5
E) administered to children w/o the permission of their parents
C) used in the treatment of rare diseases
215) For which one of the following drugs must a patient sign an informed consent before receiving an original prescription?
A) sumatriptan
B) morphine sulfate, sust. Release
C) paroxetine
D) isotretinoin
E) vancomycin
D) isotretinoin
216) How may a physician obtain cocaine HCl powder for use as a local anesthetic in his office?
I. He may order it directly from a supplier using DEA Form 222
II. He may write an order for the drug in an institutional setting an d label it "for office use"
III. He may write a prescription for the drug and write "for office use" on its face

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. He may order it directly from a supplier using DEA Form 222
217) A neighboring community pharmacy requests Alcohol USP/NF form your hospital pharmacy, which has tax-free alcohol. Under what circumstances may you supply the alcohol?
A) any circumstances is permissible
B) Limiting your sale to not more than one pint
C) By making a simple loan of alcohol
D) it is never permissible
E) By charging the pharmacy the purchase price plus the alcohol tax
D) it is never permissible
218) 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 patient at home and leave a message with his son
II. Call the patient and leave a message on his home answering machine
III. send an e-mail to the patient

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. call the patient at home and leave a message with his son
II. Call the patient and leave a message on his home answering machine
III. send an e-mail to the patient
219) A prescription is written for Coumadin tablets 5 mg with an indication that substitution is desired. Which of the following manufacturers have suitable products? (Figure A)
I. Bristol Myers Squibb (makes Coumadin)
II. Invamed (makes warfarin)
III. Barr (makes warfarin)

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. Invamed (makes warfarin)
III. Barr (makes warfarin)
220) A prescription is written for warfarin tablets 2 mg with an indication that substitution is desired. Which of the following manufacturers have suitable products (Figure A)
I. Bristol Myers Squibb
II. Invamed
III. Barr

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. Bristol Myers Squibb
II. Invamed
III. Barr
221) In order to be considered bioequivalent with Bristrol Myers Squibb's Coumadin tablets, Barr's warfarin sodium tablets must have about the same (figure A)
I. Color
II. excipients
III. AUC

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. AUC
222) The discontinuation of use of phenylpropranolamine in TOC products is best described as a:
A) Class I recall
B) Class II recall
C) Class III recall
D) voluntary discontinuation
D) voluntary discontinuation
223) Which of the following products are approved for the treatment of narcotic dependence?
I. Methadone
II. Buprenorphine
III. Subutex

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

I. Methadone
II. Buprenorphine
III. Subutex
224) IN which of the following locations would you NOT find pharmaceutical manufacturer's drug samples?

I. hospital pharmacy
II. physician's office
III. chain or community pharmacy

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. chain or community pharmacy
225) A physician telephones a pharmacy and prescribes 40 Percodan tablets, 1 TID. Which of the following is/are true?
I. It may only be dispensed in an emergency
II. A written "cover" prescription must be received before the pharmacist may dispense the mediation
III Not more than a 7 day supply may be prescribed orally

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. It may only be dispensed in an emergency
226) Which of the following designations indicate that drug products of the same strength and dosage form may be interchangeable?
I. BC
II. AB
III. A

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. AB
III. A
227) A pharmacy providing services under the Medicare Modernization Act of 2003, that uses the program's discount cards, may establish a formulary limiting the drugs to which of the following?
A) the top 200 frequently dispensed drugs
B) only drugs available generically
C) only brand-name drugs
D) 100 brand-name drugs plus their equivalent generic products
E) at least one drug from each of 208 therapeutic categories
E) at least one drug from each of 208 therapeutic categories
228) A customer enters your pharmacy and requests 25x 260 mg quinine tablets. Which of the following responses by the pharmacist would be appropriate?
I. Quinine tablets can no longer be sold over-the-counter
II. OTC quinine is considered to be unsafe for the prevention of malaria
III. OTC quinine is considered ineffective for the treatment of nocturnal leg cramps

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
229) Which of the following is true about DEA Form 222?
I. It may be used by any pharmacy in the same chain
II. It may be partially filled by the supplier
III. A physician may use it to order Schedule II controlled substance

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. It may be partially filled by the supplier
III. A physician may use it to order Schedule II controlled substance
230) The statement, "Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" is required on prescription containers for which of the following categories of drugs?
I. Schedule II
II. Schedule III
III. Schedule IV

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
II. Schedule III
III. Schedule IV
231) Which of the following is true?
I. Prescribers must keep records of all controlled substances that they dispense directly to the patient
II. Prescribers must keep records of all controlled substances administered in the course of narcotic detoxification treatment
III Prescribers must keep records of all controlled substances that they receive as samples

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. Prescribers must keep records of all controlled substances that they dispense directly to the patient
II. Prescribers must keep records of all controlled substances administered in the course of narcotic detoxification treatment
232) Blood and/or urine tests are frequently performed on participants in comprehensive narcotic maintenance treatment programs in order to detect
I. continued abuse of drugs
II. hepatotoxicity
IIII drug toxicity

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. continued abuse of drugs
233) A new cough syrup contains 15 mg of codeine phosphate and 100 mg of guaifensesin in each 10 mL dose. A 4 fluid ounce container of this product would likely be classified as
A) Schedule II
B) Schedule III
C) Schedule IV
D) Schedule V
E) Noncontrolled
D) Schedule V
234) A filled DEA Form 222 must be kept by the
I. DEA for 10 years
II. purchaser for 3 years
III. supplier for 2 years

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. supplier for 2 years
235) Based upon the Federal Anti-drug Abuse Act of 1988, a pharmacy employee who is convicted of criminal possession of illegal drugs must:
A) resign his/her position form a pharmacy
B) inform his/her employer within one year of the conviction
C) volunteer to enter a drug rehabilitation program
D) Volunteer to perform at least 1000 hours of community service
E) inform his/her employer within 5 days of the conviction
E) inform his/her employer within 5 days of the conviction
236) Which of the following action is (are) permissible under the FDA rules for prescription compounding by pharmacies?
I. Advertising to dermatologists that the pharmacy can compound topical antifungal ointments
II. Sending brochures to nurse practitioners that the pharmacy compounds topical lotions for psoriasis
III Informing an allergist that the pharmacy can economically compound 50 mg diphenhydramine capsules

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. Advertising to dermatologists that the pharmacy can compound topical antifungal ointments
II. Sending brochures to nurse practitioners that the pharmacy compounds topical lotions for psoriasis
237) Short-term narcotic detoxification is defined as treatment that is for a period of less than
A) 30 days
B) 60 days
C) 90 days
D) 180 days
E) 1 year
A) 30 days
238) DEA registration numbers that are assigned to mid-level practitioners generally begin with which of the following letters
A) A
B) B
C) X
D) F
E) M
E) M
239) Refusal of a patient to provide medical information for a patient prescription profile means that the pharmacist:
I. can fill the prescription at his/her discretion
II. must call the patient's physician to confirm
III. must tell the patient that he prescription may not be filled without the requested information
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. can fill the prescription at his/her discretion
II. must call the patient's physician to confirm
240) Prescription drug package inserts include all of the following types of information EXCEPT:
A) AWPs
B) contraindications
C) symptoms and treatments of overdosing
D) adverse reactions
E) date of most recent revision of the labeling
A) AWPs
241) The minimum requirements that a community pharmacist must follow when filling a controlled substance prescription written for an outpatient by a hospital resident is that the
I. drug belongs to either Schedule III or IV
II. resident must have a DEA number
III. hospital must have a DEA number

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. hospital must have a DEA number
242) Which of the following laws first required the statement "caution: federal law prohibits dispensing without a prescription" on drug product packaging?
A) FD & C Act of 1938
B) Durham-Humphrey Amendment of 1951
C) Kefauver-Harris Amendment
D) Prescription Drug Marketing Act
E) Pure Food and Drug Act of 1906
b) Durham-Humphrey Amendment of 1951
243) Schedule III, IV, and controlled substance prescriptions may be issued to a community pharmacy pursuant to
I. a fax of written, signed prescription transmitted by the prescriber to the pharmacy
II. an oral prescription called in by a prescriber
III. a written prescription signed by the prescriber

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. a fax of written, signed prescription transmitted by the prescriber to the pharmacy
II. an oral prescription called in by a prescriber
III. a written prescription signed by the prescriber
244) For which one of the following drugs must a patient sign an informed consent before receiving the original prescription?
A) vancomycin
B) morphine sulfate, sustained release
C) paroxetine
D) sumatriptan
E) isotretinoin
E) isotretinoin
245) Which of the following categories of pregnancy warnings is the most severe?
A) Category A
B) Category D
C) Category III
D) Category X
E) Category NR
D) Category X
246) Copy 3 of DEA form 222 is eventually kept by the
A) purchaser
B) supplier
C) DEA
D) prescriber
E) FDA
A) purchaser
247) According to Federal regulations, a color additive may not be added to which one of the following dosage forms?
A) parenteral solutions
B) capsules
C) syrups
D) tablets
E) topical lotions
A) parenteral solutions
248) the Electronic Orange Book uses the symbol "RLD," in a series of similar drug products to indicate:
A) the drug products that have not been assessed
B) that there is no bioequivalence problem
C) the drug product that is preferred by most pharmacists for substitution
D) the least expensive drug product
E) the product used as reference standard
E) the product used as reference standard
249) Which one of the following actions is permissible in a hospital that has tax-free alcohol?
A) sell pint quantities to physician offices
B) loan pint quantities to community pharmacies
C) loan pint quantities to other hospitals
D) sell pint quantities to community pharmacies
E) dispensing to inpatients in the form of a tonic
E) dispensing to inpatients in the form of a tonic
250) Short-term detoxification treatment is defined as treatment that does not exceed
A) 24 hours
B) 7 days
C) 30 days
D) 90 days
E) 180 days
C) 30 days
251) Oral authorization for additional refills on a schedule III prescription are acceptable as long as
I. The total quantity authorized does not exceed five refills within a six month period from the date of issue of the original prescription
II. the quantity of each additional refill authorized is not greater than the quantity authorized for the initial filling of the prescription
III. the pharmacist gets a "cover" prescription form the prescriber within 7 days of the oral authorization

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. The total quantity authorized does not exceed five refills within a six month period from the date of issue of the original prescription
II. the quantity of each additional refill authorized is not greater than the quantity authorized for the initial filling of the prescription
252) According to the present DSHEA, an herbal product such as saw palmetto may be labeled to state:
A) cures prostatitis
B) help treat prostatitis
C) will return the prostate to normal size
D) helps in prevention of prostate cancer
E) for the prostate
E) for the prostate
253) Based upon federal law, which of the following schedules of controlled substances may be dispersed throughout the prescription drug stock of a community pharmacy?
I. Schedule II's
II. Schedule III's
III. Schedule IV and V's

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 and V's
254) Pharmacists may transfer prescription information on a one-time basis for the purpose of dispensing a refill for which of the following drug products?
I. lomotil tablets
II. Dalmane capsules
III. Tylenol w/ codeine capsules
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
E) I, II & III
I. lomotil tablets
II. Dalmane capsules
III. Tylenol w/ codeine capsules
255) Partial filling of a schedule IV controlled substance prescription is permissible, provided that
I. each partial filling is recorded
II. the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed
III. the total price charge for the partial filings does not exceed the total price the patient would have paid with a complete filling of the prescription

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. each partial filling is recorded
II. the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed
256) A pharmacy chain with stores in several states must obtain
A) a DEA number in each state that it owns a store
B) a DEA number for each individual pharmacy location
C) just one DEA number for the entire chain
D) a DEA number for each of the chain's regional offices
E) a DEA number for each Pharmacy Supervisor in the chain
B) a DEA number for each individual pharmacy location
257) The requirement that pharmacists must offer to counsel patient concerning their prescriptions was included in which of the following congressional actions
A) Durham-Humphrey Amendment of 1951
B) FD & C Act of 1938
C) Omnibus Reconciliation Act of 1990
D) Prescription Drug Marketing Act of 1987
E) Kefauver-harris Amendment of 1962
C) Omnibus Reconciliation Act of 1990
258) Which of the following drugs are considered to be "basic class" drugs under the controlled substances act?
I. dextroamphetamine
II. codeine
III. Phenobarbital

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. dextroamphetamine
II. codeine
259) Labels of commercial drug products that are intended for electrolyte replacement must contain the concentration expressed in terms of:
I. weight or concentration
II. Miliequivalents
III. millimoles

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. weight or concentration
II. Miliequivalents
260) A pharmacist receives a prescription for a drug indication which she recognizes as not a recognized indication but recently described in the local newspaper. Which of the following actions is most appropriate for the pharmacist?
A) Fill the prescription
B) Fill the prescription but inform the patient that it is not for an appropriate use
C) Call the prescriber and inform him that it is illegal to write such a prescripition
D) Request that the prescriber indicate on the prescription face "off the label use"
E) Refuse to fill the prescription since it is illegal to fill
A) Fill the prescription
261) Every new drug placed on the market will have a designated
I. generic name
II. tradename
III. brandname

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. generic name
262) Davis Labs is the first to place a new drug product on the market. This product would be described in the Electronic Orange Book as:
I. a reference drug product
II. B rated
III. AB rated

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. a reference drug product
263) A prescriber requests information concerning the "off-label" therapeutic use of a drug. In which of the following sources may a pharmacist find such information?
I. TV advertisement sponsored by the drug manufacturer
II. Product Insert
III. AHFS

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. AHFS
264) Schedule II prescriptions
I. may only be refilled once
II. may be partially filled under certain conditions
III. written for a hospice patient may be faxed to a pharmacy

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. may be partially filled under certain conditions
III. written for a hospice patient may be faxed to a pharmacy
265) Which of the following statements concerning bar coding of prescription drug labels is (are) accurate?
I. the drug name and strength must be included in the bar code
II. the products expiration date may be included in the bar code
III Labels of vaccine products must be bar coded
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
D) II & III only
II. the products expiration date may be included in the bar code
III Labels of vaccine products must be bar coded
266) the USP/NF classification system used to describe preparation of HSD's (home use sterile drug products) use which of the following terminology
A) Category A through E
B) Clean rooms 1 through 4
C) High volume versus low volume
D) Low risk versus high risk
E) Sterile versus almost sterile
D) Low risk versus high risk
267) Which of the following populations are covered under the Medicare Modernization Act of 2003?
I. Medicare beneficiaries
II. Medicaid beneficiaries
III. Nongovernmental employees

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. Medicare beneficiaries
268) A community pharmacy develops and prepares batches of 5,000 sustained release capsules similar to a commercially available product but at a lower price. The pharmacy may be cited for this activity based upon:
I. the formula may be considered a new drug
II. the preparation of 5,000 capsules may be considered manufacturing
III. the failure to follow GMPS

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. the formula may be considered a new drug
II. the preparation of 5,000 capsules may be considered manufacturing
III. the failure to follow GMPS
269) Which of the following is/are NOT required to be on a prescription for a controlled substance?
I. DEA number of the practitioner
II. The date on which the prescription was signed
III. The date of birth of the patient

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. The date of birth of the patient
270) Percogesic is an example of a product that is
A) in Schedule II
B) in Schedule III
C) in Schedule IV
D) Schedule V
E) not a controlled substance
E) not a controlled substance
271) Labels on cosmetic packages must be ingredients listed:
A) in ascending order of concentration
B) in descending order of concentration
C) alphabetically
D) an random order
E) with the most active listed first
B) in descending order of concentration
272) Which of the following statements is (are) true with respect to the National Drug Code?
I. NDC must be imprinted on tablets
II. NDC must be imprinted on capsules
III. All prescription drug products marketed in the US must have NDC's

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
B) III only
III. All prescription drug products marketed in the US must have NDC's
273) the organization responsible for the accreditation of many health institutions such as hospitals is the:
A) JCAHO
B) ASHP
C) HHS
D) FTC
E) APhA
A) JCAHO
274) Methamphetamine is an example of a drug in controlled substance category
A) I
B) II
C) III
D) IV
E) V
B) II
275) Which of the following are NOT true of electronic prescribing of controlled substances?
I. only Pharm. D. graduates may fill an electronic prescription for a controlled substance
II. After prescribing an electronic controlled substance prescription, it must be followed-up by a written prescription within 72 hours
III. All controlled substances must be prescribed electronically by 2014

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
E) I, II & III.
I. only Pharm. D. graduates may fill an electronic prescription for a controlled substance
II. After prescribing an electronic controlled substance prescription, it must be followed-up by a written prescription within 72 hours
III. All controlled substances must be prescribed electronically by 2014
276) When a patient begins a comprehensive narcotic treatment program, the first day's dose of methadone must generally not exceed
A) 0.5 mg
B) 1 mg
C) 5 mg
D) 20 mg
E) 40 mg
E) 40 mg
277) Which of the following are Schedule II controlled substances
I. sufentanyl
II. psilocin
III. midazolam

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
A) I only
I. sufentanyl
278) Which of the following is TRUE?
I. Original schedule III, IV, or V prescriptions may be transferred to one pharmacy to another for the purpose of refill dispensing
II. Information from schedule III, IV, or V prescriptions may not be transferred to another pharmacy unless authorized by the prescriber to do so
III. Pharmacies electronically sharing a real-time, online database may transfer refills to one another as long as the number of refills transferred does not exceed those authorized by the prescriber or the law
a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. Pharmacies electronically sharing a real-time, online database may transfer refills to one another as long as the number of refills transferred does not exceed those authorized by the prescriber or the law
279) Which one of the following pieces of information os NOT encoded into a drug product's NDC?
A) drug name
B) manufacturer
C) package size
D) product's expiration date
E) strength of a tablet
D) product's expiration date
280) Which of the following agents is an anabolic steroid?
I. hydrocortisone
II. fluticasone
III. nandrolone

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. nandrolone
281) The pharmacist counsels a customer concerning the purchase of a body lotion which does not contain the coloring agent, tartrazine, to which she is allergic. While examining product labels with the client, the pharmacist should explain that:
I. the concentration of tartrazine present may not be listed
II. the ingredients, including tartrazine, will be listed alphabetically
III. rather than list each individual coloring agent, the manufacturer may simple list "yellow dye"

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
A)
I. the concentration of tartrazine present may not be listed
282) Federal guidelines indicate that the pharmacist should indicate the date on which a prescription refill is dispensed
A) on the back of the prescription
B) on the front of the prescription
C) on the prescription label
D) in a special refill log book
E) on the counseling sheet given to the patient
A) on the back of the prescription
283) A prescription calls for Nitro-Dur transdermal patch 0.1 mg/hr. Which of the following transdermal products may be dispensed if substitution is required? (Figures B and C)
I. 3M's Minitran 0.1 mg/hr
II. Mylan's NTG 0.1 mg/hr
III. Novartis's NTG 0.1 mg/hr

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
284) Which of the following companies' 0.2 mg/hr nitroglycerin patches are considered to be interchangeable when substituting? (Figures B and C)
I Hercon Labs
II. Mylan
III. Novartis

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I Hercon Labs
II. Mylan
III. Novartis
285) A prescription order is written "NTG injection 5 mg/mL". Which of the following statements is(are) true based upon Figure C?
I. abbott's product may be used
II. Nitroglycerin injection by Novartis may be used
III. The AP classification indicates that the products are interchangeable

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
E) I, II & III
I. abbott's product may be used
II. Nitroglycerin injection by Novartis may be used
III. The AP classification indicates that the products are interchangeable
286) A prescription order is written "NTG transdermal patch 0.4 mg/hr. Do NOT substitute. Which of the following companies' product(s) could the pharmacist dispense (See figure C)
I. Novartis
II. Hercon
III. Mylan

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
E) I, II, & III
I. Novartis
II. Hercon
III. Mylan
287) A prescription order is written "Transderm-Nitro 0.4 mg/hr." Assuming that substitution is NOT permissible, which of the following companies' products could be used (Figure C)
I. Novartis
II. Hercon
III. Mylan

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
A) I only
I. Novartis
288) A pharmacy carries a complete stock of Nitro-Dur and Minitran patches. In which of the following strengths are these two lines considered bioequivalent? (Figure B)
I. 0.2 mg/hr
II. 0.4 mg/hr
III. 0.6 mg/hr

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. 0.2 mg/hr
II. 0.4 mg/hr
III. 0.6 mg/hr
289) Which of the following practice settings must include bar coding on pharmaceutical products?
I. Physician offices
II. Pharmacies
III. Hospitals

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. Hospitals
290) Which of the following effervescent products are exempted from the poison prevention packaging act?
I. ASA
II. APAP
III. KCL

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

Which of the following effervescent products are exempted from the poison prevention packaging act?
291) Which of the following is/are used in the treatment of narcotic dependence?
I. Naltrexone
II. Methadone
III. Burprenorphine

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
e) I, II, & III
I. Naltrexone
II. Methadone
III. Burprenorphine
292) Which of the following is NOT required on the prescription label when the pharmacist fills a controlled substance prescription?
I. Date of initial filling
II. Federal "Caution" warning
III. Number of dosage units dispensed

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

III. Number of dosage units dispensed
293) Drug products with which of the following codes may be substituted for one another?
I. B
II. AB
III. A

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
D) II & III only
II. AB
III. A
294) Which of the following actions are appropriate when mailing a narcotic drug filled using a valid prescription?
I. Package the drug container in a plain paper outer wrapping
II. Place the warning: "Narcotic, do not open while in transit" on the outer wrapping
III. Place a fictitious return address on the outer wrapping

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. Package the drug container in a plain paper outer wrapping
295) In the United States the name designated on the label of an herbal product must conform to that listed in which one of the following reference sources?
A) Herbal Medicine (german Commission E)
B) Tyler's Popular herbs
C) Physician's desk reference
D) Remington- The science of and practice of pharmacy)
E) Herbs of Commerce
E) Herbs of Commerce
296) The major objective of the Electronic Orange Book is to compare drug products that are
I. different dosage forms
II. most economical
III. multisourced

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
b) III only
III. multisourced
297) Which of the following is (are) a guideline for determining the expiration date for repackaging of a drug product by a pharmacy?
I. do not exceed the expiration date on the original package
II. do no exceed one year from the date of packaging
III. Use one-half of the time remaining on the original package

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
c) I & II only
I. do not exceed the expiration date on the original package
II. do no exceed one year from the date of packaging
298) Which of the following is true of DEA Form 222?
I. May be used to order syringes and hypodermic needles
II. only one product may be ordered on each line of the form
III. It is used to order Schedule II controlled substances

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
d) II & III only
II. only one product may be ordered on each line of the form
III. It is used to order Schedule II controlled substances
299) Narcotic drugs may be dispensed to treat narcotic dependence in which of the following facilities?
I. FDA and state approved narcotic treatment programs
II. any facility with a DEA certified narcotic treatment counselor
III. Any institutional pharmacy

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. FDA and state approved narcotic treatment programs
300) Which of the following barbiturates is classified in a controlled substance category IV?
I. Phenobarbital
II. Pentobarbital
iII. Amobarbital

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. Phenobarbital
301) Evidence indicates that a marketed rug product may have a new use for another condition. In order to claim this new indication, a drug manufacturer must:
A) submit an abbreviated NDA
B) apply for patent protection
C) submit a NDA
D) submit a supplemental NDA
E) inform FDA in writing of the revised labeling
D) submit a supplemental NDA
302) Which of the following actions should a pharmacist take if a patient refuses to be counseled about a new prescription?
I. Dispense the prescription but not in the prescription files that counseling was refused
II. Refuse to dispense the prescription
III. Dispense the prescription but inform the prescriber that counseling was refused

a) I only
b) III only
c) I & II only
d) II & III only
e) I, II, & III
a) I only
I. Dispense the prescription but not in the prescription files that counseling was refused
303) Who was a big contributor to this project (who wished to remain anonymous)

A) Becky Hoover
B) James Bigelow
C) Roger Hefflinger
BECKY HOOVER