Missed Federal Law Flashcards by Steven Tiner

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

A. Facts and Comparisons
B. Physician's Deck Reference
C. USP DI Volume I
D. USP DI Volume II
E. USP DI Volume III

E. USP DI Volume III

How well did you know this?

Not at all

Perfectly

When listing an ingredient on a product label, all of the following reference may be used by manufactures as primary sources for names EXCEPT

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

D. Facts and Comparisons

How well did you know this?

Not at all

Perfectly

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 Dictonary
B. Food Chemical Codex
C. USAN
D. USP Dictonary of Drug Names
E. USP/NF

E. USP/NF

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

In 2002, the FDA ruled that the noprescription 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

B. Misbranded

How well did you know this?

Not at all

Perfectly

HCFA is under the jurisdiction of the

A. Attorney General 
B. HHS
C. JCAHO
D. FDA
E. Dept. of Justice

B. HHS

How well did you know this?

Not at all

Perfectly

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
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

B. Dispense 30 tablets as requested by the patient

How well did you know this?

Not at all

Perfectly

Which of the following conditions must exist for the inspection of a pharmacy by an authorized inspector (Select all)

A. The inspector must have a search warrant
B. The owner of the pharmacy or the designated supervising pharmacist must be present
C. Inspection must be conducted during the regular business hours of the pharmacy.

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

How well did you know this?

Not at all

Perfectly

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. Adulteration
B. Misbranding
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.

B. Misbranding

How well did you know this?

Not at all

Perfectly

Under which of the following circumstances may Ipecac Syrup be sold without a prescription (select all)?

A. If the purchaser signs a pharmacy log book for sale
B. only if the household does not have small children
C. for future potential use during accidental poisoning

C. for future potential use during accidental poisoning

How well did you know this?

Not at all

Perfectly

Which of the following reference sources contain significant information concerning the bio equivalence of drug products

A. USP/NF
B. USP/DI
C. Electronic Orange Book

B. USP/DI

C. Electronic Orange Book

How well did you know this?

Not at all

Perfectly

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

A. Aspartame
B. Sulfites
C. methylparaben

A. Aspartame

B. Sulfites

How well did you know this?

Not at all

Perfectly

A physician telephones a pharmacy and prescribes 40 percodan tablets, 1 TID. which of the following is/are true

A. It may only be dispensed in an emergency
B. A written “cover” prescription must be received before the pharmacist may dispense the dedication
C. Not more than a 7 day supply may be prescribed orally

A. It may only be dispensed in an emergency

How well did you know this?

Not at all

Perfectly

A listed Chemical is defined by the Controlled substance 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

C. used in manufacturing a controlled substance

How well did you know this?

Not at all

Perfectly

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

B –> Would be correct if it was asking about Cosmetic product labels (Additives and active ingredients intermixed but ranked by decreasing concentrations)

How well did you know this?

Not at all

Perfectly

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

A. The date of birth of the patient
B. The date on which the prescription was signed
C. DEA number of the practitioner

A. The date of birth of the patient

How well did you know this?

Not at all

Perfectly

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

A. Physician offices
B. Pharmacies
C. Hospitals

C. Hospitals

How well did you know this?

Not at all

Perfectly

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

A. Aspirin
B. Acetaminophen
C. Potassium Chloride

How well did you know this?

Not at all

Perfectly

Which of the following is TRUE of C2 substances

A. They may only be dispensed by a community pharmacist pursuant to a written prescription signed by the practitioner
B. They may be administered or dispensed by a physician without a prescription to a patient with chronic pain
C. They may be administered by an institutional pharmacist pursuant to an order for immediate administration to the ultimate user.

How well did you know this?

Not at all

Perfectly

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

A. USP/NF
B. FTC
C. HCFA
D. CMS
E.  FDA

B. FTC

How well did you know this?

Not at all

Perfectly

Mr. D has not picked up a prescription that was filled last week. Which of the following actions is (are) legal for the pharmacist to take?

A. Call the patient at home and leave a message with his son
B. Call the patient and leave a message on his home answering machine
C. Send an e-mail to the patient

A. Call the patient at home and leave a message with his son
B. Call the patient and leave a message on his home answering machine
C. Send an e-mail to the patient –???? seems wrong

How well did you know this?

Not at all

Perfectly

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

B. ASHP

How well did you know this?

Not at all

Perfectly

A physician wishes to prescribe a schedule II controlled substance for a patient residing in a hospice. How may the prescription be conveyed to a pharmacy

A. By e-mail
B. By fax
C. As a written prescription

B. By fax

C. As a written prescription

How well did you know this?

Not at all

Perfectly

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

A. For future possible use during accidental poisoning
B. Only if the house hold does not have small children
C. For limited use in a weight-loss program

A. For future possible use during accidental poisoning

How well did you know this?

Not at all

Perfectly

All of the following drugs falls into the category of "Grandfathered Drugs" EXCEPT ``` A. Thyroid B. Ampicillin C. Epinephrine D. Ephedrine E. Phenobarbital ```

B. Ampicillin

The original portion (Top part) of the form 222 is eventually kept on file by the ``` A. DEA B. Prescriber C. FDA D. Purchaser E. Supplier ```

E. Supplier

Which of the following are CS? A. Ergotamine tartrate B. Papaverine C. Levorphanol

C. Levorphanol

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 ```

B. at least every 30 days

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

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 ```

E. FDA and FTC

Under which of the following situations would a drug product be considered misbranded? A. An original bottle labeled 50 tablets contains 60 tablets B. The concentration of the tetracaine ointment 5% W/W is only 2% C. The manufacturer cannon prove the sterility of a solution labeled “Sterile Diphenhydramine Injection”

A. An original bottle labeled 50 tablets contains 60 tablets

``` To be admitted to a comprehensive maintenance program narcotic-dependent individuals must have been physiologically depended on narcotics for at least? A. 30 days B. 90 days C. 180 days D. 12 months E. 18 months ```

D. 12 months

Which of the following drug products must be purchased by pharmacies using DEA form 222? A. Concerta B. MS Contin C. Strattera

A. Concerta | B. MS Contin

Which fo the following sublingual tablets do NOT have to be dispensed in child resistant containers? A. Isordil B. Nitrostat C. Nitroglycerin

A. Isordil B. Nitrostat C. Nitroglycerin

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

A. A herbal product that contains American ginseng rather than the chiness ginseng listed on the label B. A product on the shelf for sale is past its expiration date C. A sterile parenteral solution contains a few microorganisms

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

E. Secretary of HHS

The Component of marijuana that is believed to have the most activity to alleviate neuropathic pain, glaucoma and nausea is ``` A. LLB B. SLM C. CBD D. MLS E. THC ```

C. CBD

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 level of alcohol in the product is 5% V/V but the label states 15% V/V C. the names of inactive ingredients are not on the label D. the original bottle of 60 contains only 50 tables E. a pharmacist dispenses a drug product without the required prescription authorization

B. the level of alcohol in the product is 5% V/V but the label states 15% V/V

Which of the following statements concerning Medicare Plan D is (are) correct? A. The plan is voluntary for persons on Medicare B. Insurance companies may limit prescription drug quantities to 30 day supplies for some drugs C. Insurance companies may require participants to receive prescription from mail order pharmacies.

A. The plan is voluntary for persons on Medicare | B. Insurance companies may limit prescription drug quantities to 30 day supplies for some drugs

A product that contains not more than 1.8g of codeine per 100ml is considered to be in schedule? ``` A. I B. II C. III D. IV E. V ```

C. III

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

A. ATF 1447

Dronabinol is a schedule III CS that is related most closely to ``` A. Cocaine B. LSD C. Marijuana D. nabumetone E. Methylphenidate ```

C. Marijuana

Excipients included in pharmaceutical dosage forms are usually listed on which of the following ``` A. DSHEA B. HPLC C. GRAS D. Top 200 E. USP ```

C. GRAS

When conducting a controlled substance inventory, the registratnt A. Must make an exact count of open containers of C2 substances B. may estimate the count of a C-IV substance in an opened container that originally held 500 tablets C. must make an exact count of all controlled substance in sealed, unopened containers

A. Must make an exact count of open containers of C2 substances B. may estimate the count of a C-IV substance in an opened container that originally held 500 tablets C. must make an exact count of all controlled substance in sealed, unopened containers

A patient who is being treated with methadone in a narcotic treatment program is admitted to a hospital for the treatment of his pneumonia. How can the client receive his methadone while he is in the hospital? A. The patient can be given enough doses at the narcotic treatment program to carry him over his hospital stay. B. Authorized nurses can administer methadone to the patient in the hospital in order to maintain or detoxify the patient C. Authorized nurses can administer methadone to the patient in the hospital in order to maintain or detoxify the patient

B. Authorized nurses can administer methadone to the patient in the hospital in order to maintain or detoxify the patient C. Authorized nurses can administer methadone to the patient in the hospital in order to maintain or detoxify the patient

For which one of the following drugs must a patient sign an informed consent before receiving the original prescription ``` A. olanzapine B. morphine sulfate, sustained release C. hydrochlorothiazide D. almotriptan E. tetracycline ```

A. olanzapine

A statement that a specific OTC product has a tamper evident feature may be placed in any of the following locations EXCEPT on the ``` A. Closure B. tamper evident device C. back of the package D. under the product name E. front of the package ```

B. tamper evident device

A pharmacist observes a misleading prescription drug product advertisement on television. To which one of the following would be a complaint be most effective? ``` A. APhA B. The local chamber of Commerce C. AMA D. OPDP E. VIPPS ```

D. OPDP

A pharmacist counsels a customer about 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: A. The concentration of tartrazine present may not be listed B. the ingredients, including tartrazine, will be listed alphabetically C. Rather than list each individual coloring agent, the manufacturer may simply list :yellow dye"

A. The concentration of tartrazine present may not be listed

Which of the following are permissible when taking a controlled substance inventory? A. assistance of a technician to count tablets B. use of a recording device C. Maintaining inventory records on a recording device

A. assistance of a technician to count tablets | B. use of a recording device

Under which one of the following Acts are biological products classified as "biosimilars"? ``` A. Durham-Humphrey Amendment B. Health Care Act C. FDA Modernization Act D. Prescription Drug Marketing E. Orphan Drug ```

B. Health Care Act

What is the time interval during which newly eligble individuals may enroll in Medicare Plan D without penalty? ``` A. 3 months B. 6 months C. 7 months D. 9 months E. 1 year ```

C. 7 months

Which of the following volumes of the USP DI contains significant information concerning the bio equivalence of drug products? A. Volume I B. Volume II C. Volume III

C. Volume III

Which of the following categories of drugs require the legend "Rx only" to be on the manufacturer's package? A, Schedule V CS B, Schedule II CS C, Schedule III and IV CS

B, Schedule II | C, Schedule III and IV

In order to be considered bioequivalent warfarin sodium tablets must have about the same A. color B. excipients C. AUC

C. AUC

Ephedra may no longer be present in which of the following products in a community pharmacy? A. Nonprescription drug products B. Herbal teas C. Dietary Supplements

C. Dietary Supplements

Schedule II prescriptions A. may only be refilled once B. may be partially filled under certain conditions C. written for a hospice patient may be faxed to a pharmacy

B. may be partially filled under certain conditions | C. written for a hospice patient may be faxed to a pharmacy

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

The federal act that specifically limits the re-importation 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. FD & C Act of 1938 D. DSHEA E. Kefauver-Harris Amendment of 1962 ```

A. Prescription Drug Marketing Act of 1987

Which of the following drug products is/are NOT classified as a controlled substance? A. Tovaiz B. Ramelteon C. Actiq

A. Tovaiz | B. Ramelteon

Which of the following are schedule II controlled substances? A. Sufentanil B. propofol C. midazolam

A. Sufentanil

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. USP Pharmacopoeial Convention E. a coalition of US pharmaceutical companies

D. USP Pharmacopoeial Convention

Which of the following is MOST important to consider in determining whether a community pharmacy is required to meet HIPAA regulations? A. The prescription volume is greater than 20000 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

Which of the following is true? A. Prescribers must keep records of a ll controlled substances that they dispense directly to the patient B. Prescribers must keep records of all controlled substances administered in the course of narcotic detoxification treatment C. Precribers must keep record of all controlled substances that they receive as samples

A. Prescribers must keep records of a ll controlled substances that they dispense directly to the patient B. Prescribers must keep records of all controlled substances administered in the course of narcotic detoxification treatment

Narcotic drugs may be dispensed to treat narcotic dependence in which of the following facilities? A. Any institutional pharmacy B. Any facility with a DEA certified narcotic treatment counselor C. FDA and State approved treatment programs

C. FDA and State approved treatment programs

The label of a bottle of Ipecac Syrup sold OTC for accidental poisoning must: A. have its warning printed in red ink B. contain the telephone number of the regional poison control center C. state that the appropriate dose is the entire bottle followed by a full glass of water.

A. have its warning printed in red ink

The Code, shape and color that is imprinted on each commercial oral tablet must provide which of the following information A. manufacturer or distributor B. name and strength of the drug C. date of manufacturing

A. manufacturer or distributor | B. name and strength of the drug

Which of the following apply to prescriptions for isotretinoin? A. Not more than a 1 month supply may be dispensed B. The prescription must be filled within 30 days of issue C. Not more than 3 refills may authorized on the original prescription

A. Not more than a 1 month supply may be dispensed

Which of the following employees may administer or dispense drugs to patients as part of a narcotic treatment program? A. Pharmacist B. Registered nurses C. Licensed Practical nurses

A. Pharmacist B. Registered nurses C. Licensed Practical nurses

A community pharmacy develops and prepares batches of 5000 sustained release capsules similar to a commercially available product but at a lower price. The pharmacy may be cited for this activity based upon: A. The formula may be considered a new drug B. The failure to follow GMPs. C. The preparation of 5000 capsules may be considered manufacturing

A. The formula may be considered a new drug B. The failure to follow GMPs. C. The preparation of 5000 capsules may be considered manufacturing

Which of the products listed below would be considered to be Schedule III controlled substance? A. A product that contains 90 mg of codeine per dose B. A product that contains 15 mg of hydrocodone per dose C. A product that contains 2.5mg of diphenoxylate and 25 mcg of atropine sulfate per dose.

A. A product that contains 90 mg of codeine per dose | B. A product that contains 15 mg of hydrocodone per dose

If a specific lot of a pharmaceutical company's tablets fails to meet 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 classification of drugs into controlled substances schedules by the federal government is based upon the drug's A. Potential for abuse and dependence B. therapeutic index C. toxicity

A. Potential for abuse and dependence

Which of the following laws first required the statement Caution: Federal law prohibits dispensing without a prescription ``` A. FD & C Act of 1938 B. Durham-Humphrey Amendment of 1951 C. Kefauver-Harris Amendment D. Prescription Drug Marketing Act E. Pure Food and Drug Act of 1906 ```

B. Durham-Humphrey Amendment of 1951

Which of the following commercial drug products intended for oral administration must have an identifying imprint on each individual dosage unit? A. Nonprescription tablets B. Prescription Tablets C. Prescription capsules

A. Nonprescription tablets B. Prescription Tablets C. Prescription capsules

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. Dispensing to inpatients in the form of a tonic D. sell pint quantities to community pharmacies E. loan pint quantities to other hospitals

C. Dispensing to inpatients in the form of a tonic

Which of the following are Schedule IV controlled substances? A. Zaleplon B. buprenorphine C. methylphenidate

A. Zaleplon

Which one of the following dosage forms is LEAST likely to present bioequivalence problems ``` A. Capsule B. tablet C. IV solution D. Transdermal patch E. suspension ```

C. IV solution

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

B. DRG

Blood and/or urine tests are frequently performed on participants in comprehensive narcotic maintenance treatment programs in order to detect A. continued abuse of drugs B. hepatotoxicity C. drug toxicity

A. continued abuse of drugs

The Consumer product safety commission is responsible for which of the following ``` A. Federal food, Drug and Cosmetic Act B. Poison prevention packaging Act C. Prescription drug to OTC status D. Good Manufacturing Practice program E. DSHEA ```

B. Poison prevention packaging Act

A customer enters your pharmacy and request 25 quinine 260mg tablets. Which of the following responses by the pharmacist would be appropriate? A. Quinine tablets can no longer be sold OTC B. OTC quinine is considered to be unsafe for the prevention of malaria C. OTC quinine is considered ineffective for the treatment of nocturnal leg cramps

A. Quinine tablets can no longer be sold OTC B. OTC quinine is considered to be unsafe for the prevention of malaria C. OTC quinine is considered ineffective for the treatment of nocturnal leg cramps

According to Federal regulations, a color additive may not be added to which one of the following dosage forms? ``` A. Tablets B. Capsules C. Syrups D. Parenteral Solutions E. Topical lotions ```

D. Parenteral Solutions

All of the following acronyms are related to prescription drug pricing EXCEPT ``` A. DME B. AWP C. AAC D. EAC E. MAC ```

A. DME

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

A. FDA

Which of the following entities must be registered in order to participate in the prescribing or dispensing of isotretinoin? A. Prescribers B. Pharmacies C. Drug wholesalers

A. Prescribers B. Pharmacies C. Drug wholesalers

Controlled substance prescriptions A. may be written by typewriter (except for the prescriber's signature) B. Must have the name of the physician printed, or stamped, or typed, or hand-printed on it. C. May be prepared by an agent of the prescriber for the prescriber's signature

A. may be written by typewriter (except for the prescriber's signature) B. Must have the name of the physician printed, or stamped, or typed, or hand-printed on it. C. May be prepared by an agent of the prescriber for the prescriber's signature

A physician share with your pharmacy a topical moistureiziing formula which contains a prescription drug. Which of the following would be appropriate actions for your pharmacy to take? A. Fill prescriptions written by the physician for 120 grams of this formual B. Prepare a pound of the formula in anticipation of additional prescriptions or refills C. Prepare 50 x 120g of the formula for sale from the physician's office

A. Fill prescriptions written by the physician for 120 grams of this formual B. Prepare a pound of the formula in anticipation of additional prescriptions or refills

Which of the following is required to be on the labeling of the prescription container when the pharmacist fills a C-III CS prescription? A. Date of initial filling B. Federal "Caution" warning C. Number of dosage units dispensed

A. Date of initial filling | B. Federal "Caution" warning

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. FD & C Act of 1938 C. Omnibus Reconciliation Act of 1990 D. Prescription Drug Marketing Act of 1987 E. Kefauver-Harris Amendment of 1962 ```

C. Omnibus Reconciliation Act of 1990

When Explaining the Medicare Plan D program to a married couple, the pharmacist should emphasize that which of the following applies to each individual? A. The original annual deductible B. The monthly premium C. The "donut hole"

A. The original annual deductible B. The monthly premium C. The "donut hole"

A customer had a prescription originally filled on December 1, 2015 and at that time acknowledged receiving the pharmacy's notice of privacy rights under HIPAA. She also receives a refill dispensed on January 2, 2016. What is the earliest date that the pharmacy may discard the patient's acknowledgment? ``` A. 12/1/2016 B. 1/2/2016 C. 12/1/2021 D. 1/2/2020 E. never ```

C. 12/1/2021

Labels of commercial drug products that are intended for electrolyte replacement must state the concentration expressed in terms of A. weight or concentration B. milliequivalents C. millimoles

B. milliequivalents | C. millimoles