Pharmacy Law Practice Exam Answers

Pharmacy Law Practice Exam Answers

Which FDCA amendment exempted certain drugs from the “adequate directions for use” labeling requirement if they bear “Rx only” on their labels?

Durham Humphrey
b. Kefauver-Harris
c. Prescription Drug Marketing
d. Waxman-Hatch

The FDCA defines a “new drug” as a previously approved drug entity with a new:
a. route of administration.

indication for use.
c. combination of ingredients.
d. a and b
e. a, b and c.

route of administration, indication for use, combination of ingredients.

Which of the following circumstances would be considered “adulteration” under the FDCA?

A drug is prepared and packaged under unsanitary conditions.
b. The drug’s manufacturing procedures do not conform to GMP standards.
c. The drug is subject to the Poison Prevention Packaging Act and is not packaged accordingly.
d. a and b
e. a, b and c
A drug is prepared and packaged under unsanitary conditions, The drug’s manufacturing procedures do not conform to GMP standards.

Which of the following circumstances would be considered “misbranding” under the FDCA?

A drug’s label or labeling is false or misleading.
b. A prescription for a legend drug is refilled without the prescriber’s authorization.
c. A drug is subject to the Poison Prevention Packaging Act is not packaged accordingly.
d. a and b
e. a, b and c

A drug’s label or labeling is false or misleading, A prescription for a legend drug is refilled without the prescriber’s authorization, A drug is subject to the Poison Prevention Packaging Act is not packaged accordingly.

The purpose of DESI was to prove efficacy of prescription and OTC drugs that were marketed:

between 1938 and 1962.
b. before 1938.
c. after 1962.
d. none of the above.

The label on the container of an OTC drug intended for sale directly to a patient must include:

adequate directions for safe and effective use.
b. cautions and warnings needed for the protection of the user.
c. net contents of the package
d. name and address of the manufacturer, packer, or distributor
e. all of the above
f. only a, b and c

adequate directions for safe and effective use; cautions and warnings needed for the protection of the user; net contents of the package; name and address of the manufacturer, packer, or distributor

Which of the below is(are) officially recognized by the FDCA?

USP/DI
b. USP/NF
c. Homeopathic Pharmacopeia
d. a and b
e. b and c

USP/NF, Homeopathic Pharmacopeia

According to the Prescription Drug marketing Act of 1987, no person may sell, purchase, or trade:

prescription drug samples.
b. OTC drug samples.
c. starter packages of prescription drugs.
d. a and b
e. a, b, and c

When a pharmacy repackages a drug product in unit-dose packages, a record should be maintained which includes among other things the:

pharmacy’s identification number if different from the manufacturer’s lot number.
b. product’s manufacturer or supplier.
c. expiration date of the original container.
d. a and b
e. a, b, and c

pharmacy’s identification number if different from the manufacturer’s lot number, product’s manufacturer or supplier, expiration date of the original container.

Which of the following situations may require a pharmacy to register with the FDA, be subject to FDA inspections, and comply with CGMP?

Community pharmacist compounds large bulk quantities of inhaler solution and ships the product to
numerous out-of-state pharmacies for dispensing.
b. Hospital pharmacy repackages and relabels a drug product in unit-dose packaging for routine use for inpatients.
c. Community pharmacist compounds drugs in anticipation of prescription drug orders based on routine prescribing patterns.
d. a and b
e. a, b, and c

According to the Poison Prevention Packaging Act of 1970, a pharmacist may reuse:

a glass container on a prescription refill, provided a new child-resistant closure is used.
b. plastic non-child-resistant containers and lids on prescriptions for which the patient has requested waiver.
c. plastic child-resistant containers and lids on prescription refills.
d. a and b
e. a, b and c

It is not necessary to dispense an oral prescription drug for human use in a child-resistant container if the:

patient requests standard packaging.
II. prescriber requests standard packaging on the prescription for a specific patient.
III. prescriber requests a blanket waiver for child-resistant packaging for all of the prescriptions of one
patient.
IV. pharmacist, in his/her professional judgment, deems it is not necessary.
a. I
b. I and II
c. II and III
d. II, III and IV

While employed as a hospital pharmacy intern, you routinely repackage commercially available prescription drugs into USP-quality unit-dose containers. On January 1, 2011, you repackage Killacillin 200mg that carries an expiration date on the container of January 2, 2013. According to FDA recommendations, which expiration date should you place on the unit-dose packages?

February 1, 2011
b. April 1, 2011
c. January 1, 2012
d. July 1, 2011
e. January 2, 2013

Which of the following statements is accurate concerning NDC numbers?

The FDA requires all commercial products to carry NDC numbers.
b. NDC number identifies the drug, strength, and size of package and is frequently used for third-party
claims submission.
c. An NDC indicates that the drug has received NDA approval.
d. a and b
e. a, b, and c

According to the FDA Compliance Policy Guide, which of the following pharmacy activities does the FDA consider to be traditional pharmacy activity that is NOT subject to FDA enforcement?

Extemporaneously compounding medication on receipt of a valid prescription from a licensed practitioner for an individual patient.
b. Compounding a medication from components that have not been determined to meet official compendial requirements.
c. Compounding drugs for third parties who resell the drugs to individual patients.
d. Compounding drugs that have been withdrawn from the market due to safety concerns

The FDA has notified Slipshod Pharmaceutical Manufacturer that several lots of their OTC analgesics have been found to be contaminated with digitoxin and present serious threat to patients’ safety. The FDA is likely to request that Slipshod announce which class of drug recall?

Class I
b. Class II
c. Class III
d. Class IV

Ipecac syrup, dispensed in a 4 ounce bottle to patient, is considered to be a(n):

prescription drug and dispensed only upon prescriptive authorization.
b. OTC drug and labeled accordingly.
c. OTC drug and labeled with specific FDA labeling requirements.

Ipecac syrup, dispensed in 15-30ml unit-dose containers and labeled according to FDA requirements, may be considered:

prescription only.
b. OTC.

It is within an opthalmologist’s scope of practice to prescribe:

Acetazolamide (Diamox)
II. Sodium Sulfacetamide solution 10%
III. Oxycodone 2.5mg/APAP 325mg
a. I only
b. III only
c. I and II only
d. II and III only
e. I, II and III

The expiration date on the manufacturer’s label of a prescription drug is July 2011. The pharmacist should consider the expiration of this drug to be:

July 1, 2011
b. July 15, 2011
c. July 31, 2011
d August 1, 2011

Which of the following has/have the authority to sign a triplicate DEA Form-222 in order to obtain CII drugs from another registrant?

a pharmacist or non-pharmacist, as designated in a current and properly executed power of attorney.
b. the pharmacist or non-pharmacist, who signed the most recent DEA application for a controlled substance registration.
c. a pharmacist who has received verbal authorization from the owner or manager of a pharmacy registrant.
d. a and b
e. a, b and c

A properly executed power of attorney:

automatically expires in three years with the registration.
b. authorizes an individual to sign any legal document on behalf of the person granting power of attorney.
c. must be notarized.
d. must be photocopied and the photocopy sent to the regional DEA office.
e. none of the above.

Annually, a pharmacy dispenses by prescription 100,000 dosage units of controlled substances. Without obtaining registration as a distributor, the pharmacy can distribute to other registrants a maximum of how many dosage units?

2500
b. 5000
c. 7500
d. 10,000

Controlled substance records that must be kept at the registration site include:

Invoices for controlled substance purchases.
II. Controlled substance prescriptions.
III. Controlled substance inventory records
IV. Executed DEA Form-222s
a. I and II
b. I, II, and III
c. II, III, and IV
d. I, II, III and IV

A pharmacist can fill a prescription for methadone for what medical reason?

maintenance of a patient’s addiction.
b. detoxification of an addicted patient.
c. analgesic purposes.
d. a and c

CIII and CIV controlled substance prescriptions may be partially filled, provided:

no dispensing occurs after 6 months from the date the prescription was issued.
b. the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
c. each partial filling is recorded in the same manner as a refilling.
d. a and b
e. a, b, and c

In general, CII controlled substance prescriptions may be partially filled provided:

no dispensing occurs after 72 hours from the date it was partially filled.
b. the pharmacist is unable to supply the full quantity.
c. the quantity dispensed in the partial fill is recorded on the face of the prescription or in the computer
record
d. a and b
e. a, b, and c

Which of the following are DEA-authorized methods that a pharmacist may use to file hardcopy controlled and noncontrolled substance prescriptions?

All prescriptions are filed together with CII prescriptions stamped with a red “C”.
II. CII prescriptions in one file; CIII, CIV, and CV prescriptions in another file; Non-controlled prescriptions in a third file.
III. CII prescriptions in one file; CIII, CIV and CV and non-controlled prescriptions together.
a. I only
b. III only
c. I & II
d. II and III
e. I, II, & III

After a pharmacy purchaser completes a DEA Form-222, which copy does the pharmacy retain?

Copy 1
b. Copy 2
c. Copy 3
d. Copies 1 and 2

Under which of the following circumstances does the pharmacist need to notify the DEA?

The pharmacy was robbed and CIIs and 222 forms were taken.
b. The pharmacy is planning to move to a new location.
c. The owner (sole proprietor) of a community pharmacy dies.
d. All of the above.

Which of the following statements is(are) accurate concerning the dispensing of OTC CV cough preparations?

The customer must be at least 18 years old.
b. The pharmacy technician may complete the entire transaction, including the dispensing, under the
supervision of a pharmacist.
c. The purchaser must present suitable identification to the pharmacist if he or she is unknown to the
pharmacist.
d. a and c

Who has primary authority on the federal level for the scheduling, rescheduling, or de-scheduling of controlled substances?

DEA
b. FDA
c. Attorney General
d. Attorney General in conjunction with the Secretary of Health and Human Services

If a pharmacist uses the 2-drawer manual filing system (not the computer) for storing controlled substance prescriptions as the primary method, which of the following schedules of medication should be marked with a red “C”?

All CIIs
b. CIII, CIV, and CVs
c. CIII and CIV only
d. All non-controlled prescriptions

On a controlled substance inventory, opened containers with which of the following drugs must be counted exactly?

CIIs
b. CII, CIII, and CIVs in any size of container
c. All controlled substances
d. Only CII, CIII, and CIVs in opened containers

When a DEA inspector conducts an audit of your controlled substances, what percent error are you allowed?

0%
b. 3%
c. 5%
d. 10%

Dispensing a C-V, OTC cough syrup containing codeine is limited to which of the following?

120 ml within 48 hours
b. 180 ml within 48 hours
c. 240 ml within 48 hours
d. No limitation if Barb Woods needs it!

A patient requests a refill of his prescription for diphenoxylate 2.5mg/Atropine sulfate 0.025mg. What are the limitations for refilling this prescription (with appropriate authorization) in Kansas?

no refills permitted
b. maximum of 5 refills
c. maximum of 5 refills or 6 months, whichever comes first
d. one year from the date of issuance

Which of the following prescription medications can be mailed by a community pharmacy through the US Postal Service to a patient?

meperidine 50 mg tablets
b. diazepam 10 mg injections
c. methylphenidate 5mg tablets
d. all of the above

A physician develops a product to relieve oral discomfort in cancer patients. He has a number of colleagues who are interested in using the product and asks you to compound it so that he may ship it to his colleagues in other states. He will supply you with a prescription marked “For Office Use” for a very large quantity of the preparation. The FDA
would likely:

view this a marketing a new drug without an approved NDA.
b. view you as a manufacturer.
c. consider your activities as being within the normal course of pharmacy practice.
d. Both a and b

Which statement is correct about dispensing a drug for a use that is unapproved by the FDA?

It is illegal for a pharmacist to dispense a prescription for an unapproved use.
b. It is illegal only if the pharmacist is aware that it is for an unapproved use.
c. It is illegal if the use varies significantly from the regular usage (in terms of dose, etc.)
d. It is legal to dispense a medication for an unapproved use.

The advertising of OTC products is regulated primarily by:

FDA
b. HHS
c. FTC
d. DEA

In order to serve on the Kansas State Board of Pharmacy, you must:

be a resident of Kansas.
b. have been actively engaged in the practice of pharmacy in Kansas for 5 years prior to appointment.
c. have had your name submitted to the governor by the Kansas Pharmacist Association.
d. a and b only
e. a, b, and c

The authority to grant practitioners a license to prescribe drugs resides with:

the federal government
b. the state government
c. the local district court
d. none of the above

The statement: “Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed.” Must appear on prescription medication containers which contain controlled substances in the following schedules EXCEPT:

CIII
b. CV
c. CII
d. CIV
e. It must be on containers of all of the above schedules.

When a manufacturer refuses to recall its violative drug product at the request of the FDA, which of the following legal remedies is available to the FDA?

Publicity
b. Injunction
c. FDA-initiated recall
d. Seizure of the product

Pharmacist Van received a methylphenidate prescription that was dated March 1, 2011. On what date is this prescription no longer valid in Kansas?

March 8, 2011
b. April 15, 2011
c. June 2, 2011
d. September 2, 2011

The minimum necessary requirement for disclosing PHI does NOT apply to:

Payment for services
b. Marketing activities
c. Treatment activities
d. a and c

Dr. Johns, a DEA-registered internist, calls on Friday evening requesting that you dispense #15 Levo-Dromoran tablets to Susan Folkes. You are satisfied that the situation is an emergency. Dr. Johns must supply you with a signed prescription within how much time?

72 hours
b. 96 hours
c. 5 days
d. 7 days

Dr. Johns would also like to continue Susan on this medication for two more weeks. Which of the following is true?

He may write on the prescription he sends to you for the emergency period for a total of 45 doses.
b. He may authorize and you may fill 2 refills on the emergency prescription you wrote.
c. He must give you two prescriptions: one covering #15 doses for the emergency time and one for the
additional doses.
d. You may alter the emergency prescription to reflect the additional doses and have him sign his name on
it.

Which items is(are) included in the definition of “unprofessional conduct” stated in the Kansas Pharmacy Practice Act?

Fraud when applying for registration or a permit.
b. Intentionally falsifying or altering prescriptions.
c. Unlawful diversion of drugs to others.
d. Intentionally adulterating any drug.
e. All of the above.

Which of the following are true concerning pharmacists’ continuing education requirements in Kansas?

One CEU is equal to one contact hour.
II. Thirty contact hours are required biennially for re-licensure.
III. Failure to supply the Board of Pharmacy evidence of adequate CE will cause one’s license to become
inactive.
a. I only
b. III only
c. I & II only
d. II & III only
e. I, II, & III

According to DEA regulations, all of the following information is required for recording an OTC CV sale, EXCEPT:

name and address of purchaser
b. name and quantity of drug
c. intended use of the drug
d. date of sale of the drug
e. name or initials of dispensing pharmacist

As the pharmacist-in-charge of a retail pharmacy that is owned by a non-pharmacist, you are responsible for notifying the Board in writing within what period of time if you decide to quit as the pharmacist-in-charge?

5 days
b. 10 days
c. 14 days
d. None of the above

When a pharmacist leaves the premises of a community pharmacy, a pharmacy intern may:

continue to fill prescriptions as long as none are dispensed.
b. take prescription transfers from other pharmacies.
c. hand prescriptions to patients as long as they are refills and were filled by the pharmacist.
d. a and c
e. do none of the above.

Which of the following statements is (are) accurate concerning the transferring of prescriptions?

Non-controlled prescriptions may be transferred as many times as there are authorized refills on the
prescription.
II. CII prescriptions may be transferred only one time.
III. Pharmacy technicians may process the prescription transfer in Kansas.
a. I only
b. III only
c. I & II only
d. II & III only
e. I, II, & III

During a routine DEA inspection, the pharmacist is required to allow the inspector to examine:

personnel files of current employees.
b. controlled substances destruction records.
c. controlled substances pricing data.
d. controlled substances sales revenue data.
e. a and b

Identify which of the following functions can be performed by a Kansas pharmacy technician.

Read and interpret the prescription
II. Personally offer to counsel each patient with each new prescription
III. Affix the prescription label to the drug container
a. I only
b. III only
c. I & II only
d. II & III only
e. I, II, & III

Pharmacist Erickson is the pharmacist in charge of a community pharmacy that offers on-premises pharmacist services for 55 hours per week. The local county hospital has requested that Jones also become the PIC for the county hospital pharmacy that has on-premises pharmacist services for 20 hours per week. May pharmacist Erickson
legally be PIC at both registered sites?

yes
b. no

A physician’s assistant may legally perform which of the following activities under written protocol with a responsible physician?

May directly administer a prescription drug.
II. May prescribe a CII drug by oral or telephonic communication in an emergency.
III. May prescribe a CIII, CIV, or CV drug in writing.
a. I only
b. III only
c. I & II only
d. II & III only
e. I, II, & III

The reference library of a community pharmacy is required to include all of the following items EXCEPT:

Medical dictionary
b. Recognized reference in drug interactions
c. Recognized reference on compounding and manufacturing
d. Copy of the Kansas Controlled Substance Act and regulations

What is the maximum number of pseudoephedrine HCl 60mg tablets a pharmacist may legally sell to one purchaser in one day if he/she presents the required identification?

36
b. 60
c. 73
d. 146

Which of the below practitioners may apply for and receive a DEA registration number in Kansas?

Dentists
b. Surgeons
c. Optometrists
d. a and b only
e. a, b and c

A pharmacist must send a copy of each of the following documents to the regional DEA office EXCEPT:

Power of Attorney
II. Most recent controlled substance inventory
III. State pharmacy registration
a. I only
b. III only
c. I and II only
d. II and III only
e. I, II and III

All of the following practice activities must be performed by a licensed pharmacist EXCEPT:

Performing drug regimen reviews.
b. Interpreting and verifying patient medication records.
c. Prepackaging medications in unit-dose containers.
d. Ensuring the proper selection of prescription drugs, devices or suppliers.

In Kansas, a patient’s medication profile record in a community pharmacy is required to contain all of the following information EXCEPT:

Name and address of the patient
b. Patient’s age
c. Initial date of dispensing and prescription number
d. Name of the dispensing pharmacist
e. Drug allergies and sensitivities

Which of the following individuals are required to be identified by nametags if performing pharmacy-related duties?

Pharmacist
b. Pharmacy Technician
c. Pharmacy student and intern
d. All of the above

What is the maximum number of different OTC drugs that may be offered for sale through one vending machine?

5
b. 12
c. 20
d. 25

A “brick and mortar” pharmacy operates an Internet site that provides advertising for pharmacy services, provides some patient educational material, and accepts non-controlled prescription and OTC orders. Orders received from the Internet site are dispensed from inventory located in the physical pharmacy. Which of the entities must be registered
with the DEA?

The “brick and mortar” pharmacy
b. The Internet site
c. a and b
d. Neither a nor b

Which of the following activities is (are) the responsibility of a pharmacist-in-charge of a community pharmacy?

Develop or approve written policies and procedures for the pharmacy.
II. Maintain records in the pharmacy describing the training and education regarding work functions
performed by all pharmacy personnel.
III. Inventory all controlled substances in the pharmacy within 72 hours after beginning to function as the PIC.
a. I only
b. III only
c. I & II only
d. II & III only
e. I, II, & III

Which of the following might represent a breach of privacy based on federal HIPAA?

Allowing a pharmaceutical sales representative to peruse your prescription files to ascertain of a certain doctor is prescribing a new antidepressant.
II. Providing a husband with a list of drug products and their therapeutic uses that his wife received last year.
III. Allowing a pharmacy clerk to call out the names of waiting patients to pick up their prescriptions.
a. I only
b. III only
c. I & II only
d. II & III only
e. I, II, & III

The term “preceptor” in Kansas is defined as a licensed pharmacist who possesses at least ___ years of experience as a registered pharmacist and who supervises students obtaining their required pharmaceutical experience.

2 Years

Prescriptions in Kansas must be kept on file for __ years.

5 Years

The total number of dosage units of all controlled substances distributed to DEA registrants by a practitioner during the twelve-month calendar year in which the practitioner is registered to dispense cannot exceed ___ percent of the total number of dosage units of all controlled substances distributed and dispensed during this time period.

A Kansas-licensed pharmacist who changes his/her residential address must notify the Board of Pharmacy within what period of time?

30 Days

A pharmacist in charge in Kansas must successfully pass the PIC exam with a score of at least ____% within ___ days of the change in the pharmacy registration at the location.

85% ; 30 days

Incident reports must be kept on file for __ years in Kansas.

5 years

Each registrant shall notify the executive secretary of the Board in writing of any change in majority ownership of the operation for which the registration was issued within ___ days after the date the change in ownership becomes effective.

5 Years

A treating physician shall not prescribe dispense or prescribe more than a ___ – day supply of controlled substances to treat obesity for a patient at one time.

30 day supply

A vaccination protocol that establishes what vaccines a pharmacist may administer, procedures for record keeping, and emergency response is considered valid for what period of time?

2 Years

The emergency room of a hospital may provide an interim supply of prepackaged drugs to an outpatient on order of a physician when a pharmacist is not on the premises. The interim supply is limited to what quantity?

Ans: Sufficient supply until a prescription can be filled

Dolittle Pharmacy needs to order the following medications from their drug wholesaler.

diazepam 10mg tablets 2 bottles of 100
codeine sulfate 30mg tabs 4 bottles of 100
Fioricet tabs 1 bottle of 100
Fiorinal tabs 2 bottles of 100
Dilaudid 2mg/ml inj. 5 boxes of 25 amps
methadone 5mg tabs 2 bottles of 100
Tylox caps. 1 bottle of 100
Lomotil liquid 2.5mg/5ml 1 bottle of 60ml

Which of the above drugs must be ordered from the wholesaler using a DEA-222 form?

codeine sulfate tabs
Dilaudid inj.
methadone tabs
Tylox

In Kansas, a preceptor may supervise not more than ___ (how many) pharmacy students or interns at any time?

A pharmacy must limit the OTC sales of pseudoephedrine tablets to no more than ____ grams (of base) per purchaser per 30 days.

9 Gram

The ratio of pharmacy technicians to pharmacists must not exceed ___ unless two of the
technicians hold certification approved by the board, in which case the ratio of technicians to pharmacists may be ___.

2:1; 3:1

A prescriber may issue multiple prescriptions authorizing a patient to receive a total of up to a ___-day supply of CII medication providing the prescriber writes specific directions on each prescription indicating the earliest date it may be filled and no pharmacist fills it before that date.

90 days

In Kansas, revocation of one’s pharmacist license is for all time, except that any time after ___(amount of time) the licensee may reapply to the Executive Secretary of the Board of Pharmacy for reinstatement.

1 Year

According to Kansas law, syringes may be sold OTC but are considered to be ____ [(see definition 21-36a01(f)(11) and 21-36a10(b)]

Drug paraphernalia

The Kansas Board of Pharmacy consists of ___ members who are eligible to serve for a maximum of ___ terms of ___ years each (see 74-1603 & 74-1604).

7; 2 terms; 4 years each

To comply with minimum CQI requirements in Kansas, a community pharmacy must meet at least ____ (how many times) each quarter of each calendar year to review all incident reports generated for each reportable event that occurred in that pharmacy since the last meeting.

One time