Guide to Federal Pharmacy Law 9th Edition

In which of the following situations are child-resistant closure required?

I. When a community pharmacist dispenses fewer than 10 tablets of a drug product

II. When a hospital pharmacy fills a prescription for an outpatient

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

When a community pharmacist dispenses fewer than 10 tablets of a drug product

When a hospital pharmacy fills a prescription for an outpatient

Permission to omit the use of a child-resistant closure when filling a prescription may be granted by the:

I. patient

II. prescriber

III. pharmacist

Patient and Prescriber

The Marketing Act of 1987 guarantees a company that discovers, patents, and develops a new drug exclusive marketing rights for up to how many years?

A. 50 years

B. 20 ears

C. 17 years

D. 10 years

E. 100 years

20 years

Auto injectors are commercially available for the administration of:

A. naloxone

B. HCTZ

C. amlodipine

D. sertraline

E. gabapentin

naloxone

Which of the following reference sources include selected laws and regulations for controlled substances?

A. Facts and Comparisons

B. Physician's Des Reference

C. USP DI Volume I

D. USP DI Volume II

E. USP DI Volume III

USP DI Volume III

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. USAN

C. Food Chemicals Codex

D. Facts and Comparisons

E. USP Dictionary of Drug Names

Facts and Comparisons

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

A. extension of patent protection

B. tax credits for subsequent years

C. refunds of income tax

D. grants of money from the FDA

E. fewer visits from the FDA

extension of patent protection

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

A. The prescriber is from another city

B. The pharmacist does not know the patient

C. The patient is an alcoholic

D. The prescription was written a week ago

E. The quantity of the controlled drug has been changed

The quantity of the controlled drug has been changed

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. ANDA

B. Investigational new drug application

C. New drug application

D. Generic drug application

E. Supplemental new drug application

ANDA

The term "donut hole" refers to a component of which one of the following?

A. Medicare Part B

B. National Drug Code

C. Medicare Part D

D. Poison Prevention Act

E. Prescription Drug Marketing Act of 1987

Medicare Part D

Into how many segments is the NDC number on a pharmaceutical package divided?

A. 5

B. 2

C. 4

D. 3

E. 7

3

Which of the following barbiturates are classified as Schedule II controlled substances?

I. butalbital

II. pentobartal

III. amobarbital

pentobartal

amobarbital

Which one of the following reference sources is the most appropriate choice when a manufacturer is determining the preferred name of an additive for a product label?

A. CTFA Cosmetic Ingredient Dictionary

B. Food Chemicals Codex

C. USAN

D. USP Dictionary of Drug Names

E. USP/NF

USP/NF

Which of the following drug products must be ordered using DEA Form 222?

I. Fentanyl

II. Vicodin

III. Pentobarbital

I. Fentanyl

II. Vicodin

III. Pentobarbital

Which government body is responsible for funding and overseeing state Medicaid programs?

A. DHHS

B. CMS

C. FDA

D. NABP

E. USP/NF

CMS

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

phase I

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

Phase II

Under which of the following conditions may a pharmaceutical sales representative distribute samples of a prescription drug product?

I. Upon written request from a physician

II. Upon written request from a hospital pharmacy

III. Upon written request from a community pharmacy

Upon written request from a physician

Which of the following may a nurse in a doctor's office perform, with the prescriber's permission, with regard to a Schedule III prescription?

I. write the prescription and sign prescriber's name

II. write the prescription except for the drug name, strength, quantity and prescriber's name

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

write the entire prescription except for signing the prescriber's name

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.

Continue to fill the prescriptions.

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

once a year

A pharmacist may fill prescriptions in pharmacies is prohibited by which one of the following Federal acts?

A. DSHEA

B. Durham Humphrey Amendment

C. Prescription Drug Marketing Act

D. Sherman Act

E. Drug Price Competition Act

Drug Price Competition Act

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

Durham Humphrey Amendment

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. misbranded

C. safe and effective

D. potentially toxic

E. expired

misbranded

Who is responsible for the retrospective drug utilization reviews established by OBRA 90?

A. each state

B. consultant pharmacists

C individual community pharmacies

D. hospital pharmacies

E. all dispensing pharmacits

each state

HCFA is under the jurisdiction of the

A. Attorney General

B. HHS

C. JCAHO

D. FDA

E. Department of Justice

HHS

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

notify the regional DEA office

A patient presents a prescription for 60 Tylenol w/ 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 tabs of Tylenol w/codeine No. 2

dispense 30 tablets as requested by the patient

Which of the following reference book(s) are legal documents recognized by the federal government?

I. USP/NF

II. Homeopathic Pharmacopeia of the US

III. Remington's Pharmaceutical Sciences

USP/NF

Homeopathic Pharmacopeia of the US

Which of the following conditions must exist for the inspection of a pharmacy by an authorized inspector?

I. The inspector must have a search warrant

II. The owner of the pharmacy or the designated supervising pharmacist must be present

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

Inspection must be conducted during the regular business hours of the 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. not more than for a 6 month period

III. only if authorized by the prescriber

Which of the following are mid-level practitioners?

I. Dermatologist

II. Nurse Midwives

III. Nurse Practitioners

II. Nurse Midwives

III. Nurse Practitioners

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. the DEA in writing and request renewal forms

II. the regional FDA office

III. his/her state's board of pharmacy

the DEA in writing and request renewal forms

A pharmacist telephones a patient's home to remind her of an upcoming refill. With which of the following parties may the message be left?

I. patient's husband

II. patient's mother

III. patient's brother-in-law

I. patient's husband

II. patient's mother

III. patient's brother-in-law

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

adulteration

When a Schedule II prescription is partially filled for a LTCF patient

I. the total quantity dispensed cannot exceed 100 dosage units

II. the pharmacist must write "LTCF patient" on the prescription

III. 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 prescription is valid not more than 60 days from the issue date

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. invoices for controlled substances

III. prescription files

Certain drug products are exempt from the requirements of therapeutic equivalence because of:

I. their high therapeutic index

II. their use in chemotherapy

III. the grandfather clause

the grandfather clause

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

numbers only

A pharmacist confides in his hospital's chief pharmacist that he has tested positive for HIV. Which of the following statement is(are) true?

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

II. The pharmacist's access to the preparation of parenteral admixtures may be limited

III. The pharmacist may be terminated due to a potentially contagious condition

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

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

I. if the purchaser signs a pharmacy log book for the sale

II. only if the household does not have small children

III. for future potential use during accidental poisoning

for future potential use during accidental poisoning

Which of the following reference sources contain significant information concerning the bioequivalence of drug products?

I. USP/NF

II. USP/DI

III. Electronic Orange Book

II. USP/DI

III. Electronic Orange Book

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 permissible

B. Limiting your sale to not more than one pint

C. By making a simple loan of the alcohol

D. By charging the pharmacy the purchase price plus the alcohol tax

E. It is never permissible

It is never permissible

Which of the following items provided by pharmaceutical companies are legal for community pharmacies to possess for the dispensing of prescription drugs?

I. Drug samples are properly labeled

II. Vouchers intended for filing from the pharmacy's stock

III. Starter packs

I. Drug samples are properly labeled

II. Vouchers intended for filing from the pharmacy's stock

III. Starter packs

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

I. aspartame

II. sulfites

III. methylparaben

I. aspartame

II. sulfites

A physician telephones a pharmacy and prescribes 40 Percodan tablets, I 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

It may only be dispensed in an emergency

Which of the following drug products must be purchased by a pharmcy with the use of a DEA Form 222?

I. OxyContin

II. Dilaudid

III. Marinol Capsules

. OxyContin

Dilaudid

A pharmacy providing services under the Medicare Modernization Act of 2003, which uses the program's discount cards, may establish a formulary limiting the drugs to which of the following?

A. the top 200 frequently dispensed drugs

B. at least one drug from each of the 208 therapeutic categories

C. only brand-name drugs

D. 100 brand-name drugs plus their equivalent generic products

E. only drugs available generically

at least one drug from each of the 208 therapeutic categories

Proposed regulations from the FDA are first published in the:

A. Federal Register

B. Congressional Record

C. The Drug Times

D. USP/NF

E. Supplements of the USP/NF

Federal Register

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. begin monthly urine analysis

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

inform his/her employer within 5 days of the conviction

Prescription drug package inserts include all of the following types of information EXCEPT:

A. adverse reactions

B. contraindications

C. symptoms and treatment of overdosing

D. AWPs

E. date of most recent revision of the labeling

AWPs

When filling a controlled substance prescription written for an outpatient by a hospital resident, it is essential that the

I. prescribed drug is in either Schedule III or IV

II. resident must have a DEA number

III. hospital must have a DEA number

hospital must have a DEA number

Which of the following is true of controlled substance inventories?

I. The registrant must keep inventory records for at least 5 years from the date performed

II. Controlled substance inventories must be performed annually

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

Inventories for schedule II controlled substances must be kept separately from all other records of the pharmac

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. used in manufacturing a controlled substance

D. listed in the USP DI

E. listed in the Electronic Orange Book

used in manufacturing a controlled substance

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

Additives and active ingredients intermixed but ranked by increasing concentrations

Which of the following is/are NOT required to be on a prescription for a controlled substance?

I. The date of birth of the patient

II. The date on which the prescription was signed

III. DEA number of the practitioner

The date of birth of the patient

Which of the following practice setting must include bar coding on pharmaceutical products?

I. Physician offices

II. Phrmacies

III. Hospitals

Hospitals

The authority for determining in which controlled substances schedule a new drug will be assigned is the

A. Director of the FDA

B. President of the US

C. Director of the DEA

D. Attorney General of the United States

E. Director of HHS

Attorney General of the United States

Which of the following agents is an anabolic steroid?

I. nandrolone

II. betamethasone

III. mometasone

nandrolone

Which of the following effervescent products are exempted from the Poison Prevent Packaging Act?

I. aspirin

II. acetaminophen

III. potassium chloride

I. aspirin

II. acetaminophen

III. potassium chloride

Which of the following is TRUE of Schedule II controlled substances?

I. They may only be dispensed by a community pharmacist 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. They may only be dispensed by a community pharmacist 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

The main responsibility for oversight of OTC drug advertising rests with the

A. USP/NF

B. FTC

C. HCFA

D. CMS

E.FDA

FTC

Which of the following actions are appropriate when mailing a narcotic drug filled pursuant to 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 fictitious return address on the outer wrapping

Package the drug container in a plain paper outer wrapping

Which of the following is (are) a guideline for determining the expiration date for repackaging of a drug product by a pharmacy?

I. Use one-half of the time remaining on the original package

II. Do not exceed one year from the date of packaging

III. Do not exceed the expiration date on the original package

Do not exceed one year from the date of packaging

III. Do not exceed the expiration date on the original package

Controlled substances prescriptions may be issued by prescribers

I. to prescribe controlled substances for a patient with chronic pain

II. to prescribe drugs to be used by a patient for narcotic detoxification

III. to obtain controlled substances for dispensing in their office

to prescribe controlled substances for a patient with chronic pain

The CAN-SPAM Act deals with which of the following issues?

A. Receipt of excessive advertising through the US mail

B. Patients who cross the border to purchase Canadian drug products

C. Receiving unsolicited phone calls from Canadian pharmacies

D. Improper e-mail use

E. Phamacists who provide excessive counseling to patients

Improper e-mail use

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

. name of the dispensing pharmacy

II. address of the dispensing pharmacy

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. 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

Labels of OTC products that are for systemic use must include a warning specifically intended to protect:

I. geriatric women

II. nursing women

III. pregnant women

II. nursing women

III. pregnant women

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. does not indicate number of tablets present

C. contains an unapproved color additive

D. inactive ingredient has undergone partial decomposition

E. manufactured in a plant that fails to meet GMPs

does not indicate number of tablets present

The organization responsible for the accreditation of many health institutions such as hospitals is the:

A. APhA

B. ASHP

C. HHS

D. FTC

E. JCAHO

JCAHO

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

tartrazine

Which of the following OTC products must be in a tamper-resistant package?

I. contact lens solution

II. hair shampoo

III. topical lotion

contact lens solution

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. by email

II. by fax

III. as a written prescription

by email

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

For future possible use during accidental poisoning

All of the following drugs fall into the category of Grand-fathered Drugs" EXCEPT

A. thyroid

B. ephedrine

C. ampicillin

D. phenobarbital

E. epinephrine

ampicillin

The original portion of the Form 222 is eventually kept on file by the

A. DEA

B. prescriber

C. FDA

D. purchaser

E. supplier

supplier

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

Schedule III

Which of the following are controlled substances?

I. ergotamine tartrate

II. papaverine

III. levorphanol

levorphanol

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

Form 224

Which of the following products are Schedule III controlled substances?

I. Tylenol with Codeine #4

II. Fiorinal Capsules

III. Percodan tablets

Tylenol with Codeine #4

II. Fiorinal Capsules

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

oral

A new drug product is given the name "felorazepam". It is likely to be classified as

A. Schedule II

B. Schedule III

C. Noncontrolled

D. Schedule V

E. Schedule IV

E. Schedule IV

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.

special economical incentives for the manufacturer

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 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

means that the directions will be clear to a layperson for safe use of the product

Hospital inpatients receiving oral estrogen therapy must receive patient package inserts:

A. every day

B. at least every 30 days

C. only at the first dose and when being discharged

D. at least every 7 days

E. only with the first dose

at least every 30 days

Which of the following are Schedule II controlled substances?

I. morphine tablets

II. fentanyl injection

III. tramadol

I. morphine tablets

II. fentanyl injection

What permanent identification must a pharmacy possess if it plans to electronically bill Medicare or Medicaid for prescriptions?

A. DEA number

B. NDC

C. FDA registration number

D. AWP

E. NPI

E. NPI

The expiration date on a commercial pharmaceutical products is July 2020. 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

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

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

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. HCFA

C. FTC only

D. DEA

E. FDA and FTC

FDA and FTC

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. to order DEA 222 forms

E. to register a practitioner with DEA

to order DEA 222 forms

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. sustained release tablet

E sustained release tablet

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 cannot provide the sterility of a solution labeled "Sterile Diphenhydramine Injection".

An original bottle labeled 50 tablets contains 60 tablets

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

12 months

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. Advise the purchase of the drug off the shelves since it is an OTC drug

E. Suggest that the patient purchase an herbal product for sleep

. Advise the purchase of the drug off the shelves since it is an OTC drug

Which of the following drug products must be purchased by pharmacies using DEA Form 222?

I. Concerta

II. MS Contin

III. Strattera

I. Concerta

II. MS Contin

Which of the following sublingual tablets do NOT have to be dispensed in child-resistant containers?

I. Isordil

II. Nitrostat

III. Nitroglycerin

I. Isordil

II. Nitrostat

III. Nitroglycerin

The acronym, DUR, is most closely associated with which of the following?

A. Drug clinical trials

B. Medicare reimbursement

C. Patient counseling

D. Drug nomenclature

E. MedWatch

Patient counseling

Pharmacists are required to periodically inventory supplies of which of the following drug products?

I. Sonata capsules

II. Entex liquid

III. Sudafed plus liquid

Sonata capsules