Federal Pharmacy Law

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

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

A cosmetic hand lotion consists of an oil-in-water emulsion. The first ingredient listed on its label is most likely to be the: A. oil that is present B. water C. coloring agent D. surfactant E. perfume

B. water

Which of the following are Schedule I controlled substances? I. mescaline II. peyote III. dextroamphetamine

I and II only. Mescaline and peyote.

Which of the following drug products is (are) NOT classified as a controlled substance? I. Toviaz II. Ramelteon III. Actiq

I and II only. Toviaz and ramelteon

The primary objective or charge for an 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

Copy 3 of DEA Form 222 is eventually kept by the A. purchaser B. supplier C. DEA D. prescriber E. FDA

A. purchaser

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

D. ATF 1447

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 six months D. maintain a running inventory of the volume E. take a year-end inventory

D. maintain a running inventory of the volume

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

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

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

D. once a year

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

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 drugs frequently dispensed 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 208 therapeutic categories

E. at least one drug from each 208 therapeutic categories

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

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

E. not a controlled substance

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

I and II only. Starter packs and vouchers intended for filling from the pharmacy's stock

Which of the following are Schedule IV controlled substances? I. zolpidem II. buprenorphine III. methylphenidate

I only. Zolpidem

Which one 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

I, II, and III. Pharmacists, registered nurses, and licensed practical nurses

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

I, II, and III. Prescribers, pharmacies, drug wholesalers.

The ADA protects an employee if an employer attempts to enforce: I. random locker room searches for illegal drugs II. IQ tests III. weight reduction programs

II and III only. IQ tests and weight reduction programs

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

III only. Volume III

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 the 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

III only. write the entire prescription except for signing the prescriber's name

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

B. II

How often must a pharmacy have a patient sign a new notice that he/she has been informed of the pharmacy's privacy practices under HIPAA requirements? A. No requirements are specified by HIPAA 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 HIPAA

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

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. CTFA Cosmetic Ingredient Dictionary B. Facts and Comparisons C. Food Chemicals Codex D. USAN E. USP Dictionary of Drug Names

B. Facts and Comparisons

A prescriber may authorize a maximum of how many refills on a prescription for Percodan tablets? A. 0 B. 1 C. 2 D. 5 E. 10

A. 0

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

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

Which one of the following acronyms will eventually replace the AWP when calculating drug product prices under the MMA? A. ASP B. BDP C. ESP D. NARD E. SP

A. ASP

Prescription drug package inserts include all of the following types of information EXCEPT: A. AWPs B. contraindications C. symptoms and treatment of overdosing D. adverse reactions E. date of most recent revision of the labeling

A. AWPs

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

A. CMS

Enforcement of the PPPA is basically under the jurisdiction of the: A. Consumer Product Safety Commission (CPSC) B. Federal Trade Commission (FTC) C. Food and Drug Administration (FDA) D. Federal Alcohol, Tobacco and Firearms Agency E. Health Care Financing Administration (HCFA)

A. Consumer Product Safety Commission (CPSA)

Which one of the following acronyms is most closely associated with health care reimbursement? A. DRG B. DEA C. GMP D. JCAHO E. PPI

A. DRG

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 prescription 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

A prescriber writes a prescription for a drug product and specifies a use that is not recognized as an indication for the drug in the product insert. Which of the following actions is most appropriate? A. Fill the prescription. B. Fill the prescription but inform the patient that it is not for an appropriate use. C. Inform the prescriber that it is illegal to write such a prescription. D. Request that the prescriber write on the prescription face the term "off-label use". E. Refuse to fill the prescription since it is illegal to do so.

A. Fill the prescription.

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

Which of the following was the first to require that pharmaceutical manufacturers prove the efficacy of prescription drugs 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

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

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

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 of 1951 C. F D&C Act of 1938 D. DSHEA E. Kefauver-Harris Amendment of 1962

A. Prescription Drug Marketing Act of 1987

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

A. Secretary of HHS

Under which one of the following circumstances may a pharmacist refuse to fill a prescription? A. The quantity of the uncontrolled drug has been changed. B. The pharmacist does not know the patient. C. The patient is an alcoholic. D. The prescription was written a week ago. E. The prescriber is from another city.

A. The quantity of the uncontrolled drug has been changed

The designation of "off-label" for a drug indicates which of the following? A. Therapeutic use not approved by the FDA. B. Therapeutic use that is listed on the drug product's label but not found in the product insert. C. Formerly approved drug product recently withdrawn from the market. D. A former therapeutic use of a drug, which is no longer recognized. E. A therapeutic use suggested by the manufacturer on TV but not included in the product insert.

A. Therapeutic use not approved by the FDA.

Which one of the following designations indicates that a new drug possesses significant advancement over present drug therapy? A. Type 1 B. Type 2 C. Type 4 D. Type A E. Type AB

A. Type 1

Phase 1 clinical trials involve subjects that A. are healthy humans without disease B. are lower species of animals C. are primates D. are in a state of disease remission E. have active cases of a disease

A. are healthy humans without disease

Samples of prescription drugs received from pharmaceutical companies may be A. given to patients by a 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 a prescriber

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

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

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

"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

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

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

A. orphan drug

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

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

B. HHS

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 the pharmacist fills the prescription on January 2, 2010. A. 7/2/2010 B. 1/2/2011 C. 7/2/2011 D. 1/1/2013 E. 1/31/2013

B. 1/2/2011

A clinical pharmacist in a hospital setting is most likely to participate in which phase of pre-marketing clinical testing? A. 1 B. 3 C. 5 D. 6 E. 8

B. 3

How many phases of clinical testing must be conducted before a new drug application must be submitted to the FDA? A. 2 B. 3 C. 4 D. 5 E. 8

B. 3

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

B. 30 mL

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

B. 5

What percentage of the controlled substance doses dispensed each year may be transferred to another pharmacy without requiring registration as a wholesaler? A. 0 B. 5 C. 7 D. 10 E. 20

B. 5

Which of the following digits would make the following an authentic DEA number BC445987 ? A. 6 B. 7 C. 8 D. 9 E. 0

B. 7

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

An individual will become eligible for Medicare Plan D on July 4th of a certain year. Which of the following is the maximum time span for her to enroll in a PDP without penalty? A. July 4th to December 31st B. April 1st to October 31st C. January 1st to December 31st. D. July 1st to July 31st E. July 1st to September 30th

B. April 1st to October 31st

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

Which one of the following laws first required the statement "Caution: Federal law prohibits dispensing without a prescription" on drug product packaging? A. F D&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

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

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

Which one 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.

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

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

A product that contains 60 mg of codeine 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

Which one 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

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

The general guideline for listing ingredients on a cosmetic product label consists of listing the additives A. and active ingredients intermixed but in the alphabetical sequence. B. and active ingredients intermixed but ranked by decreasing concentrations. C. and active ingredients intermixed but ranked by increasing concentrations. D. separately from active ingredients by increasing concentration. E. separately from the active ingredients by decreasing concentrations.

B. and active ingredients intermixed but ranked by decreasing concentrations.

A patient presents a prescription for 60 Empirin with codeine tablets 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 tablets 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 Empirin with codeine No. 2

B. dispense 30 tablets as requested by the patient

Labels on cosmetic packages must have ingredients listed: A. in ascending order of concentration B. in descending order of concentration C. alphabetically D. any random order E. with the most active listed first

B. in descending order of concentration

The iPLEDGE program is intended to assure appropriate and safe dispensing of which one of the following drugs? A. pravastatin B. isotretinoin C. nevirapine D. sildenafil E. thalidomide

B. isotretinoin

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

The major objective of the Electronic Orange Book is to compare drug products that are A. official in the USP/NF B. multi-source C. chemically unique D. most economical E. therapeutically unique

B. multi-source

The prime purpose of Phase 1 clinical trials is to evaluate the drug's A. therapeutic index B. safety C. adverse effects in diseased patients D. efficacy in diseased patients E. marketability

B. safety

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

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

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

At what interval may a patient with a Medicare PDP or MA-PD card change his/her provider? A. Every month B. Every 6 months C. Once a year D. Whenever he/she desires E. Never

C. Once a year

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 on January 2, 2010. What is the earliest date that the pharmacy may discard the patient's acknowledgment? A. 12/1/2010 B. 1/2/2010 C. 12/1/2015 D. 1/2/2014 E. never

C. 12/1/2015

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

The requirements of the ADA must be followed if what minimum number of employees is employed in a pharmacy? A. 2 B. 10 C. 15 D. 50 E. 100

C. 15

The number of categories of drug recalls is ? with recall number ? the most serious. A. 4 and 1 B. 3 and 3 C. 3 and 1 D. 4 and 4 E. 5 and 1

C. 3 and 1

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

A pharmaceutical company plans to market a generic version of a drug produce whose patent has expired. Which type of documentation must be submitted to the FDA? A. IND B. NDA C. ANDA D. SNDA E. Letter of intent

C. ANDA

Which one of the following organizations is responsible for establishing names for ingredients used in cosmetic formulations? A. ASHP B. AHPA C. CTFA D. HCFA E. RDA

C. CTFA

The term "Grandfathered" refers to drugs that were marketed before A. DSHEA B. Durham-Humphrey Amendment of 1951 C. F D&C Act of 1938 D. Kefauver-Harris Amendment of 1962 E. Poison Prevention Act

C. F D&C Act of 1938

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

C. FDA

A client presents a prescription for an antidiabetic drug written for his cousin living in France. Which one of the following actions is MOST appropriate for the pharmacist to take? A. Refuse to fill the prescription stating that the condition is not life-threatening. B. Fill the prescription after obtaining a written guarantee that the drug will be shipped abroad. C. Fill the prescription using professional judgment to determine that it is a legitimate prescription. D. Refuse to fill the prescription stating that both federal and state laws prohibits such dispensing. E. Fill the prescription after obtaining permission from the FDA.

C. Fill the prescription using professional judgment to determine that it is a legitimate prescription.

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

A pharmaceutical manufacturer requests from a community pharmacy the names and addresses of patients receiving the company's antidepressant product so that special discount coupons may be provided to the patients. This scenario is probably in violation of which of the following laws? A. DSHEA B. FDA Modernization Act of 1997 C. HIPAA D. OBRA E. Sherman Antitrust Act

C. HIPAA

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

A suppository dosage form of secobarbital is likely to be classified in which of the following controlled substance schedules? A. I B. II C. III D. IV E. V

C. III

Which one of the following is TRUE for a client who becomes eligible for Medicare Plan D on April 1st of the present year? A. Cannot enroll into the program until her next birthday B. May enroll at anytime without penalty C. Must enroll within a certain time span without a penalty D. Must wait until January 1st of the following year E. May sign up immediately but benefits will not start until April of the following year

C. Must enroll within a certain time span without a penalty

The requirement that pharmacists must offer to counsel patients concerning their prescriptions was included in which of the following congressional actions? A. Durham-Humphrey Amendment of 1951 B. F D&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

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 per 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.

Commercial oral tablets must have which of the following types of information imprinted on each dosage unit? A. name of the manufacturer B. name and strength of the drug C. a code identifying each of the above D. the expiration date E. date of manufacturing

C. a code identifying each of the above

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 tablets 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.

When reviewing the choices of drugs covered in various Plan D programs, a beneficiary is likely to find only a limited choice of brand name products in which of the following categories of drugs? A. anticonvulsants B. antidepressants C. antihyperlipidemics D. antineoplastics E. antipsychotics

C. antihyperlipidemics

Under the Poison Prevention Packaging Act (PPPA), the use of closures that are "reversible", i.e. not child-resistant in one direction but child-resistant in the opposite position is A. permitted only for use in prescriptions intended for geriatric patients. B. illegal. C. discouraged but not prohibited under the PPPA. D. permitted only for use in nursing homes. E. permitted only for use in hospice patients.

C. discouraged but not prohibited under the PPPA.

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

A physician who is a resident in a hospital and does not have a DEA registration number A. may not prescribe controlled substances B. may only prescribe controlled substances for outpatients 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

If a specific lot of 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

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

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

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

C. special economical incentives for the manufacturer

Packaging for 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

The Electronic Orange Book uses the abbreviation RLD to indicate: A. a bioequivalence problem. B. no bioequivalence problem. C. that the drug product is used as the reference standard. D. the least expensive drug product. E. the drug product that is preferred by most pharmacists for substitution.

C. that the drug product is used as the reference standard.

A specific drug product has a NDC of 0137-0145-10. The 0137 in this designation represents: A. the generic name of the drug B. the location of the company C. the name of the company D. the trade name of the drug E. a unit dose package

C. the name of the company

Orphan drugs are drugs that are A. intended for use in children 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 without the permission of their parents

C. used in the treatment of rare diseases

A therapeutic substitution is permitted only if an institution is: A. nonprofit B. for profit C. using a formulary system D. under the supervision of a PharmD E. approved to do so by the FDA

C. using a formulary system

A new cough syrup contains 15 mg of codeine phosphate and 100 mg of guaifenesin 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

A customer had a prescription originally filled on December 1, 2009 and acknowledged receiving the pharmacy's notice of privacy rights under HIPAA. She also receives a refill dispensed on January 2, 2010. What is the earliest date that the pharmacy may discard the patient's acknowledgment? A. 12/1/2010 B. 1/2/2011 C. 12/1/2015 D. 1/2/2016 E. Never

D. 1/2/2016

The total number of digits in the NDC numbers 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

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

The Marketing Act of 1987 guarantees a company that discovers, patents, and develops a new drug exclusive marketing rights for up to: A. 50 years B. 10 years C. 17 years D. 20 years E. 100 years

D. 20 years

Post-marketing surveillance of a new drug product is sometimes referred to as the Phase ? clinical trial. A. 1 B. 2 C. 3 D. 4 E. 5

D. 4

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

D. 4

Which of the following types of drug products are NOT required to be dispensed in a poison prevention package? A. An analgesic for a child over the age of two. B. An analgesic for a child over the age of five. C. An analgesic for an adult. D. A bronchodilator in a metered aerosol container. E. Estrogen tablets for a female over the age of 65.

D. A bronchodilator in a metered aerosol container.

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

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 US E. Director of HHS

D. Attorney General of the US

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

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 Act of 1938 E. Pure Food and Drug Act of 1906

D. F D&C act of 1938

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

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

D. IV

The expiration date 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

The USP/NF classification system used to describe preparation of HSD's (home-use sterile drug products) uses 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.

The statement "Rx only" does NOT need to appear on the packaging of A. orphan drugs B. controlled substances C. legend drugs D. OTC products E. injectable products

D. OTC products

A client requests a refill on a prescription written for diphenhydramine 25 mg #30 with a Sig reading "one cap 1 h before bedtime and 1 hs if needed". There were 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.

A pharmaceutical company that wishes to lengthen the expiration date of a drug product based upon additional stability data should submit to the FDA a(n): A. IND B. NDA C. ANDA D. SNDA E. Letter of intent

D. SNDA

A pharmaceutical manufacturer includes a color additive, that is not FDA approved, in a topical cream formulation. The product could be removed from the market as being: A. misbranded B. contaminated C. improperly labeled D. adulterated E. hyperallergenic

D. adulterated

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

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

The term used in the HIPAA Privacy Rules to describe the above action (removing patient identifying information when discussing a specific clinical case) is: A. debriefing B. depersonalization C. document erasure D. de-identification E. anti-terrorist protection

D. de-identification

Which one of the following incentives is used to encourage pharmaceutical companies to conduct studies of their drugs in the pediatric population? 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

For which one of the following drugs must a patient sign an informed consent before receiving an original prescription? A. sumatriptan B. morphine sulfate, sustained release C. paroxetine D. isotretinoin E. vancomycin

D. isotretinoin

A neighboring community pharmacy requests Alcohol USP/NF from your hospital pharmacy, which has tax-free alcohol. Under what circumstances may you supply the alcohol? A. any circumstances are permissable B. limiting your sale to not more than one pint C. by making a simple loan of the alcohol D. it is never permissible E. by charging the pharmacy the purchase price plus the alcohol tax

D. it is never permissible

A client in a pharmacy complains about her hypersensitivity to many ingredients found in cosmetic lotions. When reading the label of a sunscreen lotion, which one of the following ingredients is not required to be listed by the manufacturer? A. antimicrobial preservative B. coloring agent C. suncreen agent D. perfuming oil E. water

D. perfuming oil

Which one of the following pieces of information is 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

Evidence indicates that 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

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

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

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

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 E. mandatory discontinuation

D. voluntary discontinuation

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

Which one of the following must be imprinted on each commercial oral tablet? A. Company name B. Name and strength of 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

Hospital inpatients receiving oral estrogen therapy must receive patient 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

The term "donut hole" refers to which of the following situations? A. Prescription drug costs to the beneficiary before reaching the catastrophic coverage B. The period of time during which a person may enroll in Plan D C. The period of time during which a beneficiary may change health insurance companies D. The portion of prescription drug costs charged to the insurance company E. A dollar range in which the beneficiary must pay for all prescription drugs

E. A dollar range in which the beneficiary must pay for all prescription drugs

A pharmacy begins to receive prescriptions for a capsule mixture that is not available commercially. The usual prescription is for a total of 14 capsules with 2 refills and the patient is to take one capsule daily. What is the maximum number of capsules the pharmacist may compound under FDA guidelines? A. 14 only B. 28 only C. 42 only D. Not more than 100 E. A sufficient quantity to meet anticipated prescriptions and refills.

E. A sufficient quantity to meet anticipated prescriptions and refills.

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

A pharmacy providing services under MMA 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 8 therapeutic categories

E. At least one drug from each of 8 therapeutic categories

After dispensing prescriptions for several months for a Schedule II analgesic, the pharmacist realizes that the patient with severe pain from bone cancer is addicted to the drug. Which one of 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 any further prescriptions. E. Continue to fill the prescriptions.

E. Continue to fill the prescriptions.

When using a DEA Form 222, the center portion of the 3-part form ultimately ends up with the A. purchaser B. state board of pharmacy C. supplier D. regional poison control center E. DEA

E. DEA

In the US 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. Physicians' Desk Reference D. Remington - The Science and Practice of Pharmacy E. Herbs of Commerce

E. Herbs of Commerce

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

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 capsule are dispensed B. If a physician writes the prescription specifying "medically necessary" C. If the capsule strength is 1/2 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

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

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

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

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

Which of the following designations for drug products that require a prescription in the US has been 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

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

A product that contains not more than 200 mg of codeine per 100 mL of product is classified in controlled substance category: A. noncontrolled B. Schedule II C. Schedule III D. Schedule IV E. Schedule V

E. Schedule V

How often must a pharmacy have a patient sign a new notice that he/she has been informed of the pharmacy's privacy practices? A. Every time a new prescription is filled. B. Every time a refill is dispensed. C. Every 6 months. D. Every year. E. There is no such requirements in HIPAA regulations.

E. There is no such requirements in HIPAA regulations.

The organization responsible for overseeing the selection of a nonproprietary name for a new drug is the A. FDA B. FTC C. APhA D. USP/NF E. USAN

E. USAN

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

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

Two generic companies manufacture a specific drug in several dosage forms. Which 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

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

According to the present DSHEA, an herbal product such as saw palmetto may be labeled to state: A. cure 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

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

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

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

A statement that a specific OTC product has 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

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

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

Some new drug applications are granted a "Type P" status by the FDA. This status implies that the drug A. is for parenteral use B. will be packaged in a novel container C. will receive a low priority (passive) review D. is intended for patients with AIDS E. will receive a priority review of the NDA

E. will receive a priority review of the NDA

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

I and II only. A US Army physician and a US Public Health Service physician.

Substitution is permitted for drug products with which of the following codes? I. A II. AB III. B

I and II only. A and AB

Which of the following designations indicate that drug products of the same strength and dosage form may be interchangeable? I. A II. AB III. B

I and II only. A and AB

Which of the following products must be packaged with a child-resistant closure? I. A commercial container of 30 acetaminophen 325 mg tablets. II. A commercial container of 10 ketoprofen (Actron) 12.5 mg tablets. III. An aerosol topical product containing 2% methyl salicylate.

I and II only. A commercial container of 30 acetaminophen 325 mg tablets and a commercial container of 10 ketoprofen (Actron) 12.5 mg tablets.

Misbranding would include which of the following? I. A pharmacy dispenses a prescription-only drug product without an authorized prescription. II. A pharmacy dispenses a refill for a prescription without authorization. III. A pharmacy dispenses a drug product which shows evidence of decomposition based on a color change.

I and II only. A pharmacy dispenses a prescription-only product without an authorized prescription and a pharmacy dispenses a refill for a prescription without authorization.

Which of the products listed below would be considered to be Schedule III controlled substances? 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 diphenoxylate and 25 mcg of atropine sulfate per dose

I and II only. A product that contains 90 mg of codeine per dose and a product that contains 15 mg of hydrocodone per dose

Which one of the following actions may a pharmacy specializing in extemporaneous compounding undertake? I. Advertise and promote its compounding services with a brochure. II. Describe its capabilities to prepare sterile parenteral admixtures. III. Describer dollar savings to customers of a compounded pilocarpine 2% opthalmic solution.

I and II only. Advertise and promote its compounding services with a brochure and describe its capabilities to prepare sterile parenteral admixtures.

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

I and II only. Amobarbital and pentobarbital.

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

I and II only. And the remaining portion of the prescription may be filled within 72 hr of the partial fill and if the pharmacist does not have enough medication in stock to completely fill the prescription.

A physician wishes to prescribe a Schedule II controlled substance for a patient residing in hospice. How may the prescription be conveyed to a pharmacy? I. as a written prescription II. by fax III. by email

I and II only. As a written prescription and by fax

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

I and II only. Assistance of a technician to count tablets and use of a tape recorder

Which of the following drugs are considered to be "Basic class" drugs under the Controlled Substances Act? I. dextroamphetamine II. codeine III. phenobarbital

I and II only. Dextroamphetamine and codeine

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.

I and II only. Do not exceed the expiration date on the original package, and do not exceed one year from the date of packaging.

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.

I and II only. Drugs stored in a warehouse for the registrant at a different location, and drugs ordered by a customer but not yet paid for.

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 charged for the partial fillings does not exceed the total price the patient would have paid with a complete filling of the prescription

I and II only. Each partial filling is recorded, and the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.

Which of the following are NOT controlled substances? I. ergotamine tartrate II. papaverine III. levorphanol

I and II only. Ergotamine tartrate and papaverine

A physician shares with your pharmacy a topical moisturizing formula which contains a prescription drug. Which of the following would be appropriate actions 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 prescriptions or refills III. Prepare 50 x 120 g of the formula for sale from the physician's office

I and II only. Fill prescriptions written by the physician for 120 grams of the formula and prepare a pound of the formula in anticipation of additional prescriptions or refills.

A pharmacy practitioner is preparing a research paper dealing with the side effects of LMW heparins in 20 of her patients. Which of the following patient information must be removed from the paper before submission for publication? I. home address II. social security number III. age

I and II only. Home address and social security number

Which of the following drug products are controlled substances? I. Lyrica II. Versed III. Risperdal

I and II only. Lyrica and versed

Which of the following items must be ordered from a wholesaler on DEA order form 222? I. morphine HCl injection 10 mL vials (10 mg/mL) II. meperidine HCl tablets 50 mg III. diazepam tablets 10 mg

I and II only. Morphine HCl injection 10 mL vials (10 mg/mL) and meperidine HCl tablets 50 mg

Which of the following OTC products must be packaged in a tamper-evident package? I. mouthwash II. contact lens solution III. insulin

I and II only. Mouthwash and contact lens solution

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

I and II only. Name of the dispensing pharmacy and address of the dispensing pharmacy.

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 120 mL or 24 dosage units of this product may be sold to the same purchaser in any 7-day period.

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

Which of the following reference sources contain(s) significant information concerning bioequivalence of drug products? I. Orange Book II. USP DI III. USP/NF

I and II only. Orange Book and USP DI

Permission to not use a poison prevention closure on a prescription may be granted by the I. patient II. prescriber III. pharmacist

I and II only. Patient and prescriber

Nonprescription products containing which of the following drugs must not be directly accessible to the consumer? I. phenylpropanolamine II. pseudoephedrine III. dextromethorphan

I and II only. Phenylpropanolamine and pseudoephedrine.

When refilling a prescription that requires a poison prevention container, the pharmacist must always replace a I. plastic closure II. plastic container III. glass container

I and II only. Plastic closure and plastic container

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

I and II only. Pregnant and nursing women.

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.

I and II only. Prescribers must keep records of all controlled substances that they dispense directly to the patient, and prescribers must keep records of all controlled substances administered in the course of narcotic detoxification treatment.

Major objectives for developing a formulary include I. Reducing drug inventory II. Allowing therapeutic substitution III. Giving prescribers greater latitude for drug selection

I and II only. Reducing drug inventory and allowing therapeutic substitution.

Which of the following is (are) NOT permissible under the MMA? I. Requiring a beneficiary to use a mail order pharmacy II. Requiring a beneficiary to use a mail order pharmacy for 90-day supplies of a maintenance drug III. Changing the price of a drug product one month after establishing a certain price

I and II only. Requiring a beneficiary to use a mail order pharmacy and requiring a beneficiary to use a mail order pharmacy for 90-day supplies of a maintenance drug.

Original packages of nitroglycerin that are exempt from the requirements of the Poison Prevention Act include: I. SL tablets II. oral tablets III. ointments

I and II only. SL tablets and oral tablets

DEA Form 222 must be used when which of the following classes of controlled substances are purchased? I. Schedule I II. Schedule II III. Schedule III

I and II only. Schedule I and II

Original packages of nitroglycerin, which are exempt from the requirements of the Poison Prevention Packaging Act, include: I. sublingual tablets II. ointments III. oral tablets

I and II only. Sublingual tablets and ointments.

According to federal regulations, which of the following must be placed on the prescription label? I. The name of dispensing pharmacy. II. A toll-free number for reporting side effects of the product. III. The name of the supervising or managing pharmacist.

I and II only. The name of dispensing pharmacy and a toll-free number for reporting side effects of the product.

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.

I and II only. The plan is voluntary for persons on Medicare, and insurance companies may limit prescription drug quantities to 30 day supplies for some drugs.

Which 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

I and II only. The prescription is valid not more than 60 days from the issue date and the pharmacist must write "LTCF patient" on the prescription

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 from the prescriber within 7 days of the oral authorization

I and II only. The total quantity authorized does not exceed five refills within a six-month period from the date of issue of the original prescription, and the quantity of each additional refill authorized is not greater than the quantity authorized for the initial filling of the prescription

Labels of commercial drug products that are intended for electrolyte replacement must contain the concentration expressed in terms of: I. weight or concentration II. milliequivalents III. millimoles

I and II only. Weight or concentration and millliequivalents

Under which of the following circumstances may Ipecac Syrup be sold without a prescription? I. For future use during accidental poisoning. II. Only if the household does not have small children. III. If the purchaser signs a pharmacy log book.

I only, for future use during accidental poisoning

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

I only. A prescription serial number

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

I only. A reference drug product

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

I only. Administer drugs to relieve acute narcotic withdrawal symptoms

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 a tetracaine ointment 5% W/W is only 2% III. The manufacturer can not prove the sterility of a solution labeled "Sterile Diphenhydramine Injection"

I only. An original bottle labeled 50 tablets contains 60 tablets

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 the patient's medical condition III. must tell the patient that the prescription may not be filled without the requested information

I only. Can fill the prescription at his/her discretion

Which of the following statements is (are) true? I. Commercial herbals are categorized as dietary supplements. II. Commercial herbals may be categorized as nonprescription drugs. III. None of the herbals used in the US are recognized in the USP/NF.

I only. Commercial herbals are categorized as dietary supplements.

Which of the following techniques would be classified as "high-risk, category II" for pharmacists to perform based upon USP guidelines for preparation of home-use sterile drug products? I. Compounding an injection solution using nonsterile drug powder and then passing the solution through a 0.22 micron filter. II. Mixing several sterile solutions together to make a batch of TPN injections. III. Pooling several vials of a chemotherapeutic drug injection for subsequent subdivision into individual minibags.

I only. Compounding an injection solution using nonsterile drug powder and then passing the solution through a 0.22 micron filter.

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.

I only. Dispense the prescription but note in the prescription files that counseling was refused.

Prescriptions for which of the following controlled substances may be partially filled upon request of the patient: I. Empirin with codeine #4 II. Ritalin III. Dilaudid

I only. Empirin with codeine #4

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

I only. FDA and state approved narcotic treatment programs

Upon formal request, to whom must the manufacturer of an herbal product submit data supporting the claims for the product? I. FDA or FTC II. pharmacists III. consumers

I only. FDA or FTC.

Under which of the following circumstances may Ipecac Syrup be sold without 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

I only. For future possible use during accidental poisoning.

A pharmacy has been compounding a psoriasis cream in 30-gram jars based upon prescriptions written by physicians in a local dermatology clinic. Under which of the following circumstances 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 provide a written purchase order.

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

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

I only. Form 224

Every new drug placed on the market will have a designated I. generic name II. trade name III. brand name

I only. Generic name

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.

I only. He may order it directly from a supplier using DEA Form 222.

Which of the following population(s) is (are) covered under the MMA? I. Medicare beneficiaries II. Medicaid beneficiaries III. nongovernmental employees

I. only (Medicare beneficiaries)

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.

I only. Honoring this request will represent a breach of privacy based upon the Federal HIPAA.

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 the designated supervising pharmacist must be present. III. The inspector must have a search warrant.

I only. Inspection must be conducted during the regular business hours of the pharmacy.

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 keep inventory records for at least 5 years from the date performed.

I only. Inventories for schedule II controlled substances must be kept separately from all other records of the pharmacy.

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 medication III. not more than a 7-day supply may be prescribed orally

I only. It may only be dispensed in an emergency.

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 injection

I only. Lortabs

Which of the following populations are covered under the Medicare Modernization Act of 2003? I. Medicare beneficiaries II. Medicaid beneficiaries III. Nongovernmental employees

I only. Medicare beneficiaries

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

I only. NDC numbers

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 he/she obtain a written prescription to cover the oral order

I only. Notify the regional DEA office

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

I only. Package the drug container in a plain paper outer wrapping

Which of the following barbiturates is classified in controlled substance category IV? I. Phenobarbital II. Pentobarbital III. Amobarbital

I only. Phenobarbital

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

I only. Potential for abuse and dependence

Pharmacists are required to periodically inventory supplies of which of the following drug products? I. Sonata capsules II. Entex liquid III. Sudafed plus liquid

I only. Sonata capsules

Which of the following are Schedule II controlled substances? I. sufentanyl II. psilocyn III. midazolam

I only. Sufentanyl

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 simply list "yellow dye"

I only. The concentration of tartrazine present may not be listed

Certain drug products are exempt from the requirements of therapeutic equivalence because of I. the grandfather clause II. their use in chemotherapy III. their high therapeutic index

I only. The grandfather clause

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.

I only. They must provide appropriate two-factor authentication credentialing.

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 UTI's III. to reduce E. coli counts during a UTI

I only. To help maintain a healthy urinary tract in females

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 III. drug toxicity

I only. continued abuse of drugs

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

I only. incorporation into formulas for inpatient orders

Which of the following apply to prescriptions 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 three refills may be authorized on the original prescription

I only. not more than a one month supply may be dispensed

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 antibiotic II. sell a portion of the antibiotic to another area hospital III. sell a portion of the antibiotic to a community pharmacy

I only. purchase of that quantity of antibiotic

Certain drug products are exempt from the requirements of demonstrating therapeutic equivalence because of: I. the grandfather clause II. their narrow therapeutic index III. their high therapeutic index

I only. the grandfather clause

The Poison Prevention Packaging Act (PPPA) was intended to protect I. young children II. geriatric patients III. visually impaired patients

I only. young children

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 GMP.

I, II, and III

A customer enters your pharmacy and requests 25 x 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.

I, II, and III

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

I, II, and III

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

I, II, and III

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

I, II, and III

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 call in by a prescriber III. a written prescription signed by the prescriber

I, II, and III

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 patient in an institution

I, II, and III

Under which of the following situations would a drug product be considered adulterated? I. An herbal product that contains American ginseng rather than the Chinese ginseng listed on the label. II. A product on the shelf for sale is past its expiration date. III. A sterile parenteral solution contains a few microorganisms.

I, II, and III

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

I, II, and III

Which of the following are NOT true of electronic prescribing of controlled substances? I. Only PharmD 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

I, II, and III

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 pharmacist pursuant to an order for immediate administration to the ultimate user.

I, II, and III

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.

I, II, and III

Which of the following prescriptions for Accutane must bear the yellow sticker? I. Rx for an unmarried 16 year-old female II. Rx for a 60-year old female III. Rx for a 30-year old male

I, II, and III

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 a prescription II. Recalled prescription drugs among the drug stock III. Samples stored in the drug stock

I, II, and III.

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

I, II, and III.

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 with codeine capsules

I, II, and III.

When conducting a 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 opened container that originally held 500 tablets III. must make an exact count of all controlled substances in sealed, unopened containers

I, II, and III.

Which of the following might represent a breach of privacy based upon the federal Health Insurance Portability and Accountability Act (HIPAA)? I. Allowing a pharmaceutical sales representative to examine your prescription files to ascertain if a certain doctor is prescribing their company's new antidepressant. II. Sending a postcard reminding a patient that his Prozac prescription needs to be refilled. III. Providing a husband with a list of drug products and their therapeutic uses, received by his wife last year.

I, II, and III.

Which of the following techniques would be classified as "low-risk" for pharmacists to perform based upon USP guidelines for preparation of home-use sterile drug products? I. Placing 20 mEq of Potassium Chloride Injection into a one liter bag of Sterile D5W using a needle and syringe. II. Mixing 500 mL of a Sterile Amino Acids 5% Solution with 500 mL of D50W by gravity flow. III. Aseptically transferring 20 mL of Sterile Morphine Sulfate Injection into a 50 mL elastomere device.

I, II, and III.

Which of the following effervescent products are exempted from the Poison Prevention Packaging Act? I. aspirin II. acetaminophen III. potassium chloride

I, II, and III. Aspirin, acetaminophen, and potassium chloride

Which of the following are Schedule IV controlled substances? I. chlordiazepoxide II. halazepam III. zolpidem

I, II, and III. Chlordiazepoxide, halazepam, and zolpidem

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

I, II, and III. Lysergic acid diethylamide, mescaline, and peyote.

Which of the following hospital employees may be permitted to prescribe controlled substances even though they do not have a DEA registration number? I. Medical interns II. Medical residents III. Mid-level practitioners

I, II, and III. Medical interns, medical residents, and mid-level practitioners.

Which of the following products are approved for the treatment of narcotic dependence? I. methadone II. buprenorphine III. subutex

I, II, and III. Methadone, buprenorphine, and subutex

Which of the following drug products must be purchased using a DEA Form 222? I. methadone II. methlyphenidate III. fentanyl

I, II, and III. Methadone, methylphenidate, and fentanyl

Which of the following drug products must be ordered using DEA Form 222? I. Methadone II. Sufentanyl III. Percocet

I, II, and III. Methadone, sufentanyl, and percocet

Which of the following are Schedule II controlled substances? I. morphine tablets II. fentanyl injection III. secobarbital capsules

I, II, and III. Morphine tablets, fentanyl injection, and secobarbital capsules.

Which of the following is (are) used in the treatment of narcotic dependence? I. Naltrexone II. Methadone III. Buprenorphine

I, II, and III. Naltrexone, methadone, and buprenorphine

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

I, II, and III. Nitroglycerin, nitrostat, and isordil

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

I, II, and III. Nonprescription tablets, prescription tablets, and prescription capsules

A pharmacist telephones a patient's home to advise him of the upcoming need to refill one of his prescriptions. With which of the following parties may the message be left? I. patient's wife II. patient's mother III. patient's brother-in-law

I, II, and III. Patient's wife, mother, and brother-in-law.

Which of the following types of products in a hospital pharmacy must be barcoded? I. prescription drugs II. biologicals III. nonprescription drugs

I, II, and III. Prescription drugs, biologicals, and nonprescription drugs.

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's and V's

I, II, and III. Schedule II's, III's, IV's, and V's.

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

I, II, and III. Schedule II's, III's, and IV's.

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

I, II, and III. Schedule II, III, and IV.

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"

I, II, and III. The original annual deductible, the monthly premium, and the "donut hole".

Manufacturers will place an NDC on package labels for which of the following dosage forms? I. capsules II. oral suspensions III. vials of a parenteral solution

I, II, and III. capsules, oral suspensions, and vials of parenteral solution

An institutional pharmacy employer may NOT prevent pharmacists with which of the following conditions from working in a parenteral admixture room? I. chronic alcoholism II. HIV infection III. epilepsy

I, II, and III. chronic alcoholism, HIV infection, and epilepsy

Which of the following commercial products intended for oral intake must have identification codes on individual dosage units? I. nonprescription tablet products II. prescription tablet products III. prescription capsule dosage forms

I, II, and III. nonprescription tablet products, prescription tablet products, and prescription capsule dosage forms

Drug products with which of the following codes may be substituted for one another? I. B II. AB III. A

II and III only. AB and A

A police officer visits a pharmacy and informs the pharmacist that he has arrested an individual suspected of writing a fictitious prescription that was filled in the pharmacy. The officer requests the original prescription as evidence. Which of the following would be appropriate action(s) for the pharmacist to take? I. The pharmacist should give the officer the prescription as long as the officer provides the pharmacist with a written receipt. II. As described, the prescription is not legally considered to be a forged prescription. III. The pharmacist is not obligated to give the officer the prescription.

II and III only. As described, the prescription is not legally considered to be a forged prescription and the pharmacist is not obligated to give the officer the prescription.

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

II and III only. Coloring agents and antimicrobial preservatives

Which of the following products are exempt from the FDA regulations concerning expiration dating? I. USP/NF drug products II. dietary supplements III. vitamins

II and III only. Dietary supplements and vitamins

Controlled substances may be stored in a pharmacy I. on a controlled substance shelf in the pharmacy department II. dispersed through the pharmacy department with noncontrolled drug products III. in a securely locked cabinet

II and III only. Dispersed through the pharmacy department with noncontrolled drug products and in a securely locked cabinet.

Which of the following products are Schedule III controlled substances? I. Percodan tablets II. Fiorinal capsules III. Tylenol with Codeine #4

II and III only. Fiorinal capsules and Tylenol with Codeine #4.

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

II and III only. Homeopathic Pharmacopeia of the US and USP/NF.

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 DEA.

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

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 the patient is a resident of a LTCF III. if the patient is a hospice patient

II and III only. If the patient is a resident of a LTCF and if the patient is a hospice patient

Which dosage forms of secobarbital must be ordered using a DEA Form 222? I. Suppository II. Injectable III. Capsule

II and III only. Injectable and capsule.

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 substances.

II and III only. It may be partially filled by the supplier, and a physician may use it to order Schedule II controlled substances.

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

II and III only. MS Contin and Concerta

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

II and III only. May be partially filled under certain conditions and written for a hospice patient may be faxed to a pharmacy

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

II and III only. Not more that for a 6 month period and only if authorized by the prescriber

Which of the following are mid-level practitioners? I. Podiatrists II. Nurse Midwives III. Nurse Practitioners

II and III only. Nurse midwives and nurse practitioners

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

II and III only. Only one product may be ordered on each line of the form, and It is used to order Schedule II controlled substances.

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

II and III only. Plastic container and plastic closure.

Permission to not use a child-resistant closure on a prescription may be granted by the I. pharmacist II. prescriber III. patient

II and III only. Prescriber and patient.

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

III only. in an emergency situation

According to FDA guidelines, which of the following activities are NOT acceptable for an individual receiving mailed prescription drug products from a Canadian pharmacy? I. Having the drug mailed directly to his home rather than to his physician. II. Receiving a six months supply of the drug. III. Splitting the drug supply with his neighbor, who has a prescription for the same product.

II and III only. Receiving a six months supply of the drug and splitting the drug supply with his neighbor, who has a prescription for the same product.

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

II and III only. Schedule II, III, and IV controlled drugs

Which of the following actions is (are) permissible under the FDA rules for prescription compounding by pharmacies? I. Informing an allergy specialist that the pharmacy can economically compound 50 mg diphenhydramine capsules. II. Sending brochures to nurse practitioners that indicate that the pharmacy compounds topical ointments for the treatment of skin rashes. III. Advertising to opthalmologists that the pharmacy can compound sterile, isotonic ophthalmic solutions.

II and III only. Sending brochures to nurse practitioners that indicate that the pharmacy compounds topical ointments for the treatment of skin rashes and advertising to opthalmologists that the pharmacy can compound sterile, isotonic opthalmic solutions.

Which of the drug products used to treat narcotic dependence is (are) administered sublingually? I. Methadone II. Subutex III. Suboxone

II and III only. Subutex and Suboxone

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

II and III only. Sulfites and aspartame

Which of the following protocols must a hospital pharmacy follow in order to process 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.

II and III only. The hospital must store the samples separate from the regular stock, and a licensed practitioner must have requested the samples from the company.

What constitutes appropriate action for a pharmacist when an uncooperative patient refuses to provide information for his patient prescription profile? I. The pharmacist should explain that it is illegal for the patient to refuse to provide the requested information. II. The pharmacist may fill the prescription without a medication history. III. The pharmacist may refuse to fill the prescription.

II and III only. The pharmacist may fill the prescription without a medication history and the pharmacist may refuse to fill the prescription.

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 product's expiration date may be included in the bar code III. Labels of vaccine products must be bar coded

II and III only. The product's expiration date may be included in the bar code, and labels of vaccine products must be bar coded.

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.

II and III only. They may be ordered by the FDA, and they may be voluntary actions by the pharmaceutical manufacturer.

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

II and III only. invoices for controlled substances and prescription files

A community pharmacy may fill prescriptions received from a licensed practitioner utilizing a manufacturer's I. drug samples II. voucher or coupon III. starter pack

II and III only. voucher or coupon and starter pack

A prescriber requests information concerning the "off-label" therapeutic use of a drug. In which of the following sources may a pharmacist find such information? I. TV advertisement sponsored by the drug manufacturer II. product insert III. AHFS

III only. AHFS

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

III only. All prescription drug products marketed in the US must have NDC's.

Under which of the following situations would a drug product be considered misbranded? I. The manufacturer cannot prove the sterility of a solution labeled "Sterile Folic Acid Injection". II. The concentration of a benzocaine ointment is 2% but is labeled as 5% w/w. III. An original bottle labeled 50 tablets contains 30 tablets.

III only. An original bottle labeled 50 tablets contains 30 tablets.

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

III only. Chain or community pharmacy

Which of the following conditions may preclude a pharmacist from working in a hospital pharmacy? I. alcoholism II. HIV infection III. Cocaine addiction

III only. Cocaine addiction

Which of the following OTC products must be in tamper-resistant packaging? I. topical lotion II. hair shampoo III. contact lens solution

III only. Contact lens solution

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

III only. Dietary supplements

The minimum requirements that a community pharmacist must follow when filling a controlled substance prescription written for an outpatient by a hospital resident that is the I. drug belongs to either Schedule III or IV II. resident must have a DEA number III. hospital must have a DEA number

III only. Hospital must have a DEA number

Which of the following practice settings must include bar coding on pharmaceutical products? I. Physician offices II. Pharmacies III. Hospitals

III only. Hospitals

Which of the following actions by a company offering Medicare Plan D coverage is (are) NOT permitted? I. charging a $250 deductible II. eliminating any deductible charge to the patient III. limiting the choice of pharmacies to only one community chain

III only. Limiting the choice of pharmacies to only one community chain

The major objective of the Electronic Orange Book is to compare drug products that are I. different dosage forms II. most economical III. multisourced

III only. Multisourced

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

III only. Must be made for each registered location

Which of the following agents is an anabolic steroid? I. hydrocortisone II. fluticasone III. nandrolone

III only. Nandrolone

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

III only. Number of dosage units dispensed

Which of the following is TRUE? I. Original schedule III, IV, or V prescriptions may be transferred from 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 another as long as the number of refills transferred does not exceed those authorized by the prescriber or the law.

III only. Pharmacies electronically sharing a real-time, online database may transfer refills to another as long as the number of refills transferred does not exceed those authorized by the prescriber or the law.

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.

III only. Some states may permit sale of these products without a prescription

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

III only. Supplier for 2 years

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 office III. the DEA in writing and request renewal forms

III only. The DEA in writing and request renewal forms.

Which of the following statements concerning the National Drug Code (NDC) is (are) true? I. The NDC must be imprinted on all commercial capsules and tablets. II. Only drugs that have an approved new drug application on file may have an NDC. III. The NDC may be used for reimbursement purposes.

III only. The NDC may be used for reimbursement purposes.

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

III only. The date of birth of the patient

A partial filling of a Schedule II prescription is permissible under which of the following circumstances? I. The patient is over 65 and only wants half the number of doses prescribed by the physician because he cannot afford the full amount. II. The prescriber indicates that she would like the patient to get half the prescription today and the rest in a week if the medication agrees with him. III. The pharmacist is out of stock and will provide the balance of the prescription to the patient in two days.

III only. The pharmacist is out of stoke and will provide the balance of the prescription to the patient in two days.

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 admixture may be limited. III. The pharmacist may be considered disabled under the Americans with Disabilities Act.

III only. The pharmacist may be considered disabled under the Americans with Disabilities Act.

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-hydroxybutryric acid III. The therapeutic classification of the drug is as a behavioral depressant and hypnotic

III only. The therapeutic classification of the drug is as a behavioral depressant and hypnotic.

A pharmacist may sell herbals provided that: I. the patient is properly counseled with respect to their use. II. the consumer is cautioned to use the product for not more than two weeks. III. there are adequate directions on the package for patient use.

III only. There are adequate directions on the package for patient use.

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.

III only. Upon written request from a physician.

In which of the following situations are child-resistant closures 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.

III only. When a hospital pharmacy fills a prescription for an inpatient.

In which of the following situations are child-resistant closures not required? I. When a prescriber dispenses a prescription drug directly from his/her office. II. When a hospital pharmacy fills a prescription for an outpatient. III. When a hospital pharmacy fills a prescription for an inpatient.

III only. When a hospital pharmacy fills a prescription for an inpatient.

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

III only. complete DEA Form 222 orders

A prescription for methadone is issued for the purpose of managing a patient's narcotic addiction 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

III only. may not be filled

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

III only. must have its warnings printed in red ink.

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

III only. oral

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

III only. retrospective review

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

III only. the hospital pharmacy

Colonial Labs is the first company to develop and market a particular product as a transdermal patch. This product would probably be described in the Orange Book as: I. NTI II. A rated III. the reference drug product

III only. the reference drug product

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 substances for a patient with chronic pain

III only. to prescribe controlled substances for a patient with chronic pain