MPJE: Federal Pharmacy Law (Q &A)

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

A) 3

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

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

185) Which of the following organizations is directly responsible for Medicare programs? A) CMS B) FDA C) HMO D) JCAHO E) AARP

A) CMS

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

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) FTC only

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

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

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

A) I only

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

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

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 only

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

A) I only

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

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

A) I only

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

A) I only

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 NOTE: If he does not specify federal law only, the correct answer should actually be c) I & II only

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

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

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

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

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) Medicare Part D

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

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

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

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

A) Protection of the general public

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

A) Secretary of HHS

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

139) Samples of prescription drugs received from the pharmaceutical companies may be A) given 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) given to patients by the prescriber

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

A) inert gas

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

A) often not listed in the Orange Book

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

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

A) orphan drug

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

246) Copy 3 of DEA form 222 is eventually kept by the A) purchaser B) supplier C) DEA D) prescriber E) FDA

A) purchaser

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

B) 5 %

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

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

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

B) HHS

274) Methamphetamine is an example of a drug in controlled substance category A) I B) II C) III D) IV E) V

B) II

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

B) III only

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

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

B) III only

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

B) III only

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

B) III only

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

B) III only

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

B) III only

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

B) III only NOTE: But, if you also figure in the state requirements, the correct answer would be D) II & III only

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

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

B) Phase II

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) Schedule III

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

B) Supplier

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

B) Tartrazine (Yellow No. 5)

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

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

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

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

B) marijuana

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

B) total sodium content of both active and inactive ingredients

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) 12/1/2015

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

C) 120

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

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

C) 7 months

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) FD & C Act of 1938

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) FDA

52) Excipients 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

C) GRAS

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

C) I & II

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

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

C) I & II only

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

C) I & II only

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) I & II only

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

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

C) I & II only

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

C) I & II only

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 actual answer should be I & III only

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

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

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) Schedule IV

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

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

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

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

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

C) does not indicate number of tablets present

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

C) may prescribe controlled substances using the hospital DEA number plus an assigned suffix

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

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

C) provided special economic incentives for the manufacturer

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

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

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

C) tamper-evident

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

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. I & II only

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) 10 or 11

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

D) 12 months

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

D) 30 mL

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

D) 4

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

D) ATF 1447

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

D) Additives listed separately from the active ingredients

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

D) Attorney General of the US

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

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) F D & C of 1938

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

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

D) HSD

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

D) II & III

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

D) II & III only

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

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

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

D) II & III only

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

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

D) II & III only

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

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

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

D) July 31st

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

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) Once a year

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

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

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

D) an independent organization

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

D) as a requisition form for Form 222

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

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

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 of the volume

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

D) manufacturer

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

301) Evidence indicates that a marketed drug 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

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

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

D) used in manufacturing a controlled substance

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

222) The discontinuation of use of phenylpropranolamine in OTC products is best described as a: A) Class I recall B) Class II recall C) Class III recall D) voluntary discontinuation

D) voluntary discontinuation

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

E )I, II, & III

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

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

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

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

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

E) Aerosol

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) Continue to fill the prescriptions

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

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

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

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

E) I, II, & III

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

E) I, II, & III

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

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

E) I, II, & III

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

E) I, II, & III

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

E) I, II, & III

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

E) I, II, & III

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

E) I, II, & III

98) When conducting controlled substance inventory, the registrant I. must make an exact count of open containers 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

E) I, II, & III

285) A prescription order is written "NTG injection 5 mg/mL". Which of the following statements is(are) true based upon Figure C (page 335)? 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, and III

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

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

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

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

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

E) NDC number

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

E) Patient counseling

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

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

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

E) USP/NF

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

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

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

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 from 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

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

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

E) manufacturer's expiration date

270) Percogesic is an example of a product that is A) in Schedule II B) in Schedule III C) in Schedule IV D) in Schedule V E) not a controlled substance

E) not a controlled substance

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

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

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

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

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

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

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

a) I only

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

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

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

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

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

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

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

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

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

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

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

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

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

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 and 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

22) Certain drug products are exempt from the requirement therapeutic equivalence because of: I. the grandfather clause II. their use in chemotherapy III. their high therapeutic index a) I only b) III only c) I & II only d) II & III only e) I, II, & III-

a) I only

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

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

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 the 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

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) I only

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

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

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

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 - pages 334 and 335) 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

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 - page 335) 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

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

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

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

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

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 note 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

38) A pharmacist dispenses 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

a) misbranding

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

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

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

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

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

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 only

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

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

b) III only

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

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

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

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

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

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

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

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

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

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

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

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

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

263) A prescriber request 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

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

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

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

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

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

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

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

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 the correct answer would probably actually have to be D) II & III only as both of those are delivered sublingually to treat narcotic dependence (reference: Lexi-Comp)

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

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

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

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

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

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

164) which of the products listed below would be considered to be Schedule III 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

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

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

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

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

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 only

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

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

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

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

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 - page 314) 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

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

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

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

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 not 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

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

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

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

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

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

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

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

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

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

201) Major objectives for developing a formulary include: I. give prescribers a greater latitude of drug seletion 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

207) Which of the following products are exempt from the FDA regulations concerning expirration 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

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

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

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

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

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

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

d) II & III only

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

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

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

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

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 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

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

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

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

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

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

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

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

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

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

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

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

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 - page 314) 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

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

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

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

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

243) Schedule III, IV, and V 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

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

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

284) Which of the following companies' 0.2 mg/hr nitroglycerin patches are considered to be interchangeable when substituting? (Figures B and C - pages 334 and 335) 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

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 - page 335) 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

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 - page 334) 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

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

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

31)The statement: "Caution: Federal law 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

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

e) I, II, & III

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

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

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

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

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

e) each state

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