PHA 310 Assignments for Exam2

Hatch-Waxman Amendment

required proof of bioequivalence to the innovator product

The beyond-use-date of a drug product is always the same as the manufacturer's expiration date. True or False

False

Original prescription information for Schedule III, IV or V controlled substances may be transferred ____ time(s) for the purpose(s) of refill dispensing between pharmacies who do not share a real-time online database. (Enter the alpha numeric character only)

1

Drug products with an "AB" rating in The Orange Book may not be substituted. Select one: True False

False

At a minimum a pharmacy is required to take an accurate and complete count of all controlled substance inventory at least once every ___ year(s). (Enter the alpha numeric character only)

2

Retail sales of pseudoephedrine (PSE) containing products may not exceed ____ grams of PSE per day per purchaser, regardless of the number of transactions. (Enter alpha numeric character only)

3.6

In the event a DEA Form 222 order cannot be completely filled, a partial fulfillment of the order may be made and the balance supplied by additional shipments within ____ days of the date on the order form. (Enter the alpha numeric character only)

60

published price paid by wholesalers to manufacturers

AMP

Abbreviated new drug application

ANDA

published wholesale price for a drug product

AWP

Mercer Hospital has a limited list of approved medications in each drug class from which its medical provider may choose from. This limited list of approved medications is known as an open or closed formulary?

Closed formulary

What is the acronym for the administration responsible for the federal Controlled Substances Act and is a part of the US Department of Justice?

DEA

Required the legend "Caution: Federal law prohibits dispensing without a prescription" on the manufacturer's label

Durham-Humphrey Amendment of 1951

Dr. Jones prescribed cefadroxil for his patient. Cefadroxil is not on Mercer Hospital's formulary. Using the principles of therapeutic substitution, the pharmacist must contact Dr. Jones to seek his approval of the use of the formulary medication cephalexin. Select one: True False

False

A Medicare Part D sponsor must include all anticonvulsant drug products in its formulary. True or False

False

Controlled substance inventory must be stored in a securely lock cabinet. Select one: True False

False

refers to a large number of relatively inert ingredients that are permitted to be used in drug and food products as excipients because of their relatively high degree of safety

Generally Recognized as Safe and Effective GRAS

standards in the manufacturing process for drug products in the US

Good Manufacturing Practice GMP

Health Insurance Portability and Accountability Act

HIPAA

Provided for regulation of prescription drug advertising by the FDA

Kefauver-Harris Amendment of 1962

responsible for administration of the NAPLEX and MPJE exams

National Association of Boards of Pharmacy NABP

numerical classification system for identifying specific drug products

National Drug Code NDC

refers to drugs which are available without a prescription

Over-the-Counter OTC

organization that manages pharmaceutical benefits for managed care organization or employers

Pharmacy Benefits Management PBM

The general recognized acronym for a skilled nursing facility is:

SNF

A pharmacist is the only person authorized to dispense a non-prescription Schedule V controlled substance. A non-pharmacist employee may complete the financial transaction. Select one: True False

True

The Code of Federal Regulations requires which dosage forms to be imprinted? (mark all that apply) Select one or more: a. Rx solid dosage forms Correct b. OTC solid oral dosage forms Correct c. the imprint to identify the manufacturer Correct d. the imprint to identify the specific drug product Correct

a. Rx solid dosage forms Correct b. OTC solid oral dosage forms Correct c. the imprint to identify the manufacturer Correct d. the imprint to identify the specific drug product Correct

Drug Efficacy Amendment

adopted as a result of public concern about thalidomide

OBRA '90 is federal legislation that required pharmacist-offered patient counseling to which patient population(s)? Select one: a. Medicare patients b. Medicaid patients c. HMO patients d. All patients

b. Medicaid patients

Which of the following encourages the develop of drugs for the treatment of "rare diseases"? Select one: a. Durham-Humphrey Amendment b. Orphan Drug Act c. Medicare Modernization Act d. Kefauver-Harris Amendment

b. Orphan Drug Act Correct

OBRA '90 requires which of the following actions be performed? Select one or more: a. Pharmacist conduct retrospective DUR at the time of dispensing b. Pharmacist conduct prospective DUR at the time of dispensing c. Verbal offer for patient counseling by the dispensing pharmacist d. Verbal offer for patient counseling by the pharmacy clerk

b. Pharmacist conduct prospective DUR at the time of dispensing c. Verbal offer for patient counseling by the dispensing pharmacist

The first phase of a clinical trial that evaluates drug efficacy in treating a specific disease is: Select one: a. Phase 1 b. Phase 2 c. Phase 3 d. Phase 4

b. Phase 2 Correct

What is the name of and the correct acronym for the agency responsible for administering Medicare and overseeing states' administration of Medicaid? Select one: a. Centers for Medical Services (CMS) b. Centers for Medicare and Medicaid Services (CMMS) c. Centers for Medicare and Medicaid Services (CMS) d. Centers for Healthcare Services (CHS)

c. Centers for Medicare and Medicaid Services (CMS) Correct

Manufacturers are required to provide prescription drug package inserts that are approved by the FDA. Prescription drug package inserts include all of the following types of information EXCEPT: Select one: a. Dosage and administration b. Indications and usage c. Manufacturers suggested retail price d. Clinical pharmacology

c. Manufacturers suggested retail price Correct

At what interval may patients enrolled with medicare advantage plan change providers: Select one: a. Every month b. Every 6 months c. Once a year d. Never

c. Once a year Correct

All of the following drugs or adjuvants require special label warnings except for: Select one: a. Tartrazine b. Aspartame c. Sodium benzoate d. Aspirin

c. Sodium benzoate Correct

Hydroxyzine pamoate and hydroxyzine hydrochloride are considered: Select one: a. pharmaceutical equivalents b. therapeutic equivalents c. pharmaceutical alternatives d. suitable for substituion

c. pharmaceutical alternatives

Causation

connection between behavior and damages

One wrongful act by a pharmacist may lead which of the following type(s) of action(s): Select one: a. Administrative action b. Civil action c. Criminal action d. All of the above e. None of the above

d. All of the above Correct

Which of the following activities does not represent a potential breach of privacy based on HIPAA? Select one: a. Allowing a pharmaceutical representative to examine your prescription files to ascertain if a certain doctor is prescribing their company's new antidpressant b. Sending a postcard reminding a patient that her Zoloft prescription need to be refilled c. Providing an adult man with a list of drug products and their therapeutic uses received by his mother during the last year d. All of the above are potential breaches of privacy

d. All of the above are potential breaches of privacy

Enforcement of the Poison Prevention Protection Act of 1970 falls under the jurisdiction of the: Select one: a. Federal Trade Commission b. Centers for Medicare and Medicaid Services c. Food and Drug Administration d. Consumer Product Safety Commission

d. Consumer Product Safety Commission Correct

Which of the following activities are not acceptable for a patient receiving a mailed prescription product from a Canadian pharmacy? Select one: a. Having the drug mailed directly to the patient home b. Having the drug mailed directly to the patient's physician c. Having the drug mailed directly to the patient's pharmacy d. Having a 6 month supply of the drug mailed to either the patient's home, practitioner or pharmacy

d. Having a 6 month supply of the drug mailed to either the patient's home, practitioner or pharmacy

The compounding technique that employs an "open-system" for home-use sterile drug products is classified as: Select one: a. Low risk Category I b. Low risk Category II c. High risk Category I d. High risk Category II

d. High risk Category II Correct

Since 2008 the cost of vaccines and their administration are covered by which Medicare program? Select one: a. Medicare Part A b. Medicare Part B c. Medicare Part C d. Medicare Part D

d. Medicare Part D Correct

The general recognized acronym for National Provider Identifier is: Select one: a. NABP b. PI c. NPA d. NPI

d. NPI Correct

What clinical trial phase consists of the post-marketing surveillance of a drug that was recently introduced onto the market? Select one: a. Phase 1 b. Phase 2 c. Phase 3 d. Phase 4

d. Phase 4

Breach of duty

departure from a required obligation

Medicare Modernization Act

encompasses four programs: Medicare Part A, B, C, and D

FDA Modernization Act of 1997

encouraged manufacturers to conduct research for uses of currently approved drugs

Medicare Prescription Drug Improvement and Modernization Act of 2003

established formal medication therapy management programs

Durham-Humphrey Amendment of 1951

established two classes of drugs (Rx and OTC)

Statutory law is enacted by whom?

federal and state legislature

Duty to care

legal obligation to care

Actual damage

may include physical, emotional, and financial hardship

Procedures

methods employed that result in action in day-to-day operations

Policies

principles adopted to reach long-term goals

Pure Food and Drug Act of 1906

prohibited foods and drugs distributed through interstate commerce from being adulterated or misbranded

FDA Modernization Act of 1997

provided a fast-track review to expedite approval of drugs used to treat life-threatening conditions

Orphan Drug Act of 1983

provided tax incentives to manufactures to develop drugs to treat disease that are considered rare

Medicare Part A

provides hospitalization insurance

Medicare Part B

provides medical insurance for physician services

Medicare Part C

provides medicare managed care

Medicare Part D

provides prescription drug programs

FDA Modernization Act of 1997

replaced the prescription drug "legend" with "Rx only"

Hatch-Waxman Amendment

streamlined the drug approval process for generic products

Drug Price Competition and Patent-Term Restoration Act

was also know as the Hatch-Waxman Amendment

Food, Drug, and Cosmetic Act of 1938

was the first law applied to cosmetics and medical device

Regulations

"laws" made by administrative agencies which have the legal force of statute

Rules

"laws" made by administrative agencies which have the legal force of statute

The maximum volume of Ipecac Syrup that can be sold without a prescription is ___ mL.

30

How many elements of negligence must be present in order for a plaintiff to recover damages?

4

A pharmacy must register as a wholesaler if greater than ____ percent of controlled substance doses dispensed each year are transferred to another pharmacy. (Enter the alpha numeric character only)

5

You are a pharmacist at Smith's Pharmacy. You receive a prescription for 30 tablets of methylphenidate ER 20mg. The pharmacy only has 10 tablets in stock. You tell the patient that you will place an order for another stock bottle and supply the remainder of the prescription. The pharmacy has ___ hours to fulfill the remainder of this prescription to the patient. (Enter alpha-numeric character only)

72

equipment that can stand repeated use, is for a medical purpose and is appropriate for use at home

DME

review of prescription use, prescribing patters or drug utilization by patients

DUR

A non-pharmacist employee may dispense a non-prescription Schedule V controlled substance to a patient. Select one: True False

False

Additives and therapeutically active ingredients should be listed together on drug products in alphabetical order. True or False

False

Drug recalls are always initiated by the FDA. True or False

False

Medication Therapy Services is a term that describes a broad range of services provided by pharmacies. Medicare Part D sponsors may elect to auto-enroll qualified beneficiaries. True or False

False

Orphan drugs are markets for the treatment of disease that affect a small patient population. A rare disease is classified as a disease that affects <500,000 persons. True or False

False

Pharmacists cannot dispense medications to patients when it is known that the patient is using a drug product for an "off-label" use? True or False

False

Prescription drug products are required to have adequate directions for use placed on the container label by the manufacturer. True or False

False

The Federal Anti-Tampering Act requires all OTC drug products to be sold in tamper-resistant packaging. Select one: True False

False

The responsibility for proper prescribing and dispensing of controlled substances relies solely upon the prescribing practitioner. The pharmacist carries no responsibility. Select one: True False

False

When refilling a prescription, a pharmacist may reuse the patient's plastic prescription vial and closure? Select one: True False

False

responsible for investigating unfair business practices including misleading advertising

Federal Trade Commission FTC

Did not require manufacturers to list ingredients of directed for use

Pure Food and Drug Act of 1906

What is the maximum number of refills a prescriber may authorize on a prescription for Adderall XR 10mg? Select one: a. 0 b. 1 c. 5 d. 6

a. 0

A drug manufactured under conditions that do not meet the standards of GMP is considered: Select one: a. Adulterated b. Misbranded c. Expired

a. Adulterated Correct

This agency is responsible for investigating unfair business practices including misleading advertising: Select one: a. FTC b. CDC c. HCFA d. CMS

a. FTC Correct

The Waxman-Hatch Amendment did which of the following (select all that apply)? Select one or more: a. Granted extended patent protection for innovator drug products b. Required generic manufacturers to prove safety and efficacy c. Required generic manufacturers to prove bioequivalence d. Required generic manufacturers to wait until the innovator patent expires to begin research

a. Granted extended patent protection for innovator drug products Correct c. Required generic manufacturers to prove bioequivalence Correct

Which of the following is true for selling Ipecac Syrup without a prescription? Select one: a. It may be sold for future use during an accidental poisoning b. It may not be sold to households that have small children c. It may be sold only if the purchaser signed the pharmacy log book d. It may not be sold without a prescription under any circumstances

a. It may be sold for future use during an accidental poisoning Correct

Mr. Smith presents to the pharmacy with a prescription for "Econosource". The community pharmacist may fill Ms. Smith's prescription utilizing all of the following EXCEPT: Select one: a. Manufacturer drug samples b. Manufacturer voucher c. Manufacturer starter pack d. Manufacturer coupon

a. Manufacturer drug samples Correct

Which of the following populations are covered under the Medicare Modernization Act of 2003? Select one: a. Medicare beneficiaries b. Medicaid beneficiaries c. Non-governmental employees d. Governmental employees

a. Medicare beneficiaries Correct

Which of the following OTC products must be packaged in tamper-evident packaging? Select one or more: a. Mouthwash b. Moisturizing lotion c. Eye drops d. Insulin

a. Moutwash c. Eye drops d. Insulin

Which of the following statement(s) about a prescription is/are true? Select one or more: a. Once filled, a prescription is the legal property of the pharmacy b. The original prescription is the legal property of the patient c. Medicare Modernization Act requires prescription records be kept for 10 years d. FDA requires drug distribution records be kept for 5 years

a. Once filled, a prescription is the legal property of the pharmacy Correct c. Medicare Modernization Act requires prescription records be kept for 10 years Correct d. FDA requires drug distribution records be kept for 5 years Correct

A prescription label in the outpatient/retail setting is required to contain which of the following: (mark all that apply) Select one or more: a. Patient's name b. Drug name c. Directions for use d. Practitioner's DEA

a. Patient's name b. Drug name c. Directions for use

Products with an "A" rating in The Orange Book are considered: Select one or more: a. Pharmaceutical equivalents b. Therapeutic equivalents c. Not substitutable d. Substitutable

a. Pharmaceutical equivalents b. Therapeutic equivalents d. Substitutable

Which of the following clinical trial stages is conducted exclusively in health human subjects? Select one: a. Phase 1 b. Phase 2 c. Phase 3 d. Phase 4

a. Phase 1 Correct

The general recognized acronym for Supplemental New Drug Application is: Select one: a. SNDA b. SDA c. NDA d. ADA

a. SNDA Correct

A DEA Form 222 must be used when purchasing which of the following classes of controlled substances? Select one: a. Schedule II b. Schedule III c. Schedule IV d. Schedule V

a. Schedule II

Who is authorized to grant final approval of a drug name? Select one: a. Secretary of HHS b. Executive Director of APhA c. Director of the FDA d. Director of CMS

a. Secretary of HHS Correct

Who may grant "blanket" permission to not use a poison prevention closure on a prescription medication when dispensed to the patient? Select one: a. The patient b. The Pharmacist c. The Prescriber d. All of the above

a. The patient

Which of the following are considered examples of an adulterated drug product? Select one or more: a. a drug product that contains an unapproved color additive b. a drug product is lower in strength than official standards c. a drug product that displays decomposition based on color change d. a drug product does not have each active ingredient identified

a. a drug product that contains an unapproved color additive Correct b. a drug product is lower in strength than official standards Correct c. a drug product that displays decomposition based on color change Correct

In order for two products to be considered therapeutically equivalent, they must: Select one or more: a. contain the same active ingredient b. have the same route of administration c. have the same strength/ concentration d. be bioequivalent e. have the same dosage form

a. contain the same active ingredient b. have the same route of administration c. have the same strength/ concentration d. be bioequivalent e. have the same dosage form

Misbranding includes which of the following? (mark all that apply) Select one or more: a. dispensing a prescription-only drug product without an authorized prescription b. dispensing a refill for a prescription without authorization from the prescriber c. dispensing diclofenac gel 2% that is labeled as 10% d. dispensing a drug product that shows evidence of decomposition based on color change

a. dispensing a prescription-only drug product without an authorized prescription Correct b. dispensing a refill for a prescription without authorization from the prescriber Correct c. dispensing diclofenac gel 2% that is labeled as 10% Correct

Private health information may be provided to: Select one or more: a. health care providers directly involved in the patient's treatment b. law enforcement officials with a legal warrant c. family members without the patient's consent d. family members with the patient's consent

a. health care providers directly involved in the patient's treatment b. law enforcement officials with a legal warrant c. family members without the patient's consent

The requirement that over-the-counter products have "adequate directions of use" _____. Select one: a. means the package directions should 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 intended for pediatric use d. includes a listing of potential toxicities and antidotes, if applicable

a. means the package directions should be clear to a layperson for safe use of the product Correct

Schedule III and IV controlled substances may be refilled ____. Select one: a. not more than 5 times in a 6-month period if authorized by the physician at the time of issuance b. not more than 12 times in a 12-month period if authorized by the physician at the time of issuance c. never; refills are not allowed for Schedule III and IV controlled substances d. one time in a 6-month period if authorized by the prescriber at the time of issuance

a. not more than 5 times in a 6-month period if authorized by the physician at the time of issuance

Copy 3 of the DEA Form 222 ultimately ends up with the: Select one: a. purchaser b. supplier c. DEA d. state board of pharmacy

a. purchaser

Good Manufacturing Practice (GMP) is designed to assure which of the following: Select one or more: a. safety b. quality c. efficacy d. stability

a. safety Correct b. quality Correct

Administrative action against a pharmacist may occur when? Select one or more: a. the pharmacist has violated a statute b. the Agency believes an act has been committed that warrants an investigation c. one party brings a lawsuit against another party claiming injury d. when there is a breach of contract

a. the pharmacist has violated a statute Correct b. the Agency believes an act has been committed that warrants an investigation Correct

Compounded aqueous solutions made from manufactured solid dosage forms expires in ____ days when stored at a cold temperature. Select one: a. 7 b. 14 c. 21 d. 30

b. 14 Correct

The national drug code number is divided into how many segments? Select one: a. 2 b. 3 c. 4 d. 5

b. 3 Correct

Partial filling of a Schedule II controlled substance prescription for a patient in a Long Term Care Facility may not exceed ___ days from the date of issuance. Select one: a. 30 b. 60 c. 90 d. 180

b. 60

Which of the following methods may a pharmacy employ to store prescription records? Select one or more: a. A two-file system. One file consists of Schedule II, III, IV, and V prescriptions dispensed. Schedule II prescriptions are stamped with a 1" red "C". One file consists of non-controlled prescriptions dispensed. b. A two-file system. One file consists of Schedule II, III, IV and V prescriptions dispensed. Schedule III, IV and V prescriptions are stamped with a 1" red "C". One file consists of non-controlled prescriptions dispensed. c. A two-file system. One file consists of Schedule II prescriptions dispensed. One file consists Schedule III, IV and V and non-controlled substance prescriptions dispensed. Schedule III, IV and V controlled prescriptions are stamped with a 1" red "C". d. A three-file system. One file consists of Schedule II prescriptions dispensed. One file for Schedule III, IV and V prescriptions dispensed. One file consists of non-controlled prescriptions dispensed.

b. A two-file system. One file consists of Schedule II, III, IV and V prescriptions dispensed. Schedule III, IV and V prescriptions are stamped with a 1" red "C". One file consists of non-controlled prescriptions dispensed. c. A two-file system. One file consists of Schedule II prescriptions dispensed. One file consists Schedule III, IV and V and non-controlled substance prescriptions dispensed. Schedule III, IV and V controlled prescriptions are stamped with a 1" red "C". d. A three-file system. One file consists of Schedule II prescriptions dispensed. One file for Schedule III, IV and V prescriptions dispensed. One file consists of non-controlled prescriptions dispensed.

The patent of a innovator drug has expired. Which of the following must a second manufacturer submit to place a generic form of the drug product on the market? Select one: a. Investigational new drug application b. Abbreviated new drug application c. Generic drug application d. Supplemental new drug application

b. Abbreviated new drug application Correct

According to the federal Controlled Substance Act, drug products containing pseudoephedrine must be kept where in the pharmacy? Select one: a. Dispersed throughout the cough and cold aisle b. Behind a counter inaccessible to the general public c. In the prescription department d. In a securely locked cabinet

b. Behind a counter inaccessible to the general public

Which of the following organizations is directly responsible for the administration of Medicare programs? Select one: a. JACHO b. CMS c. FDA d. AARP

b. CMS Correct

Agents classified as "Fast Track" drugs will receive what type of review by the FDA? Select one: a. Standard review b. Priority review c. Immediate review d. Rolling review

b. Priority review Correct

Pre-clinical trials involve subjects that are: Select one: a. healthy humans without disease b. animals c. humans with disease d. humans who are in a state of disease remission

b. animals Correct

The Office of Prescription Drug Promotion's purpose is: (mark all that apply) Select one or more: a. educate the public about misleading advertising of prescription drug products b. educate health care providers about misleading advertising of prescription drug products c. solicit the public to report misleading advertisement of prescription drug products d. solicit health care providers to report misleading advertisement of prescription drug products

b. educate health care providers about misleading advertising of prescription drug products Correct d. solicit health care providers to report misleading advertisement of prescription drug products Correct

Which of the following is/are true about negligence? Select one or more: a. is a tort, civil, or criminal wrong b. is caused by a deviation from the standard of care c. is an intended act d. is a tort, civil, or personal wrong

b. is caused by a deviation from the standard of care Correct d. is a tort, civil, or personal wrong Correct

Which of the following is applicable to "case" law? Select all that apply Select one or more: a. written law enacted by federal and state legislature b. is dynamic and constantly changing c. is affected by the decisions of appellate and other courts d. can be cited as a precedent

b. is dynamic and constantly changing CORRECT

Copy 1 of the DEA Form 222 ultimately ends up with the: Select one: a. purchaser b. supplier c. DEA d. state board of pharmacy

b. supplier

A dispensing pharmacy may use a fax of a Schedule II prescription as the original written prescription when which of the following is/are true? Select one or more: a. the fax is received by a home infusion pharmacy and the drug product prescribed is intended for parenteral administration b. the patient is a resident of a Long Term Care Facility c. the patient is enrolled in hospice care d. faxed prescriptions for Schedule II controlled substances are never permitted

b. the patient is a resident of a Long Term Care Facility c. the patient is enrolled in hospice care d. faxed prescriptions for Schedule II controlled substances are never permitted

A pharmacist may dispense a Schedule II controlled substance upon the receipt of oral authorization by a prescriber provided: Select one: a. the quantity prescribed and dispensed does not exceed a one month supply b. the pharmacist immediately reduces the prescription in writing c. the pharmacist notifies the DEA within 7 days that an emergency dispensing has occurred d. the pharmacist receives a written "cover" prescription from the prescriber within 3 days of the oral authorization

b. the pharmacist immediately reduces the prescription in writing

The term "label" refers to: Select one: a. information printed on the outside package of a drug product b. written material appearing on the immediate container of a drug product c. written material accompanying a drug product d. labels are not utilized when dispensing a drug product

b. written material appearing on the immediate container of a drug product Correct

Prescription Drug Marketing Act of 1987

banned re-importation of prescription drugs produced into the US

Prescription Drug Marketing Act of 1987

banned the sale, trade or purchase of prescription drug samples

The total number of digits in a NDC number present on a drug package may be: Select one: a. 2 or 3 b. 6 or 7 c. 10 or 11 d. 14 or 15

c. 10 or 11 Correct

The first applicant to demonstrate its "generic" product is equivalent to the innovator product is granted ___ months of exclusivity in the generic market. Select one: a. 1 month b. 3 months c. 6 months d. 9 months e. 12 months

c. 6 months Correct

The general recognized acronym for an Abbreviated new Drug Application is: Select one: a. NDA b. SNDA c. ANDA d. ADA

c. ANDA Correct

The statement "The safety of a drug during human pregnancy has not been determined. Animal studies are either positive for fetal risk or animal studies have not been conducted" describes which pregnancy category? Select one: a. Category A b. Category B c. Category C d. Category D

c. Category C Correct

A drug application that is granted "Type P" status by the FDA implies which of the following? Select one: a. the drug is for parenteral use only b. the drug will receive a low priority (passive) review c. the drug will receive high priority review d. the drug is similar to other drug products on the market

c. the drug will receive high priority review Correct

A pharmacist may refuse to fill a prescription for a patient for all of the following reasons EXCEPT Select one: a. when filling the prescription would cause the pharmacist to violate law b. when the pharmacist does not have the drug in stock c. when the patient is rude to the pharmacy technician at drop off d. when the pharmacist has reason to believe the prescription is fictious

c. when the patient is rude to the pharmacy technician at drop off

Kefauver-Harris Amendment

created Good Manufacturing Practice (GMP) requirements

Damon was seen by the Dr. Khan, a podiatrist and a "golfing buddy", for treatment of an ingrown toenail. During the visit Damon asked Dr. Khan to prescribe cephalexin for a sinus infection. Dr. Khan obliges and provides Damon with the requested prescription. Dr. Khan has: Select one: a. Acted within his scope of practice of full prescribing authority b. Acted within his scope of practice of narrow prescribing authority c. Acted outside of his scope of practice of full prescribing authority d. Acted outside of his scope of practice of narrow prescribing authority

d. Acted outside of his scope of practice of narrow prescribing authority

Which of the following defines "administrative" law? Select one: a. is a body of principles that has evolved and ended over time from judicial decisions b. is a reported decision of another court which is considered a new interpretation of the law c. is written law enacted by federal and state legislature d. is issued to direct the enacted laws of federal and state governments

d. is issued to direct the enacted laws of federal and state governments Correct

Contract law

duties assumed because of an agreement between parties

Tort law

duties created by law not by the parties involved

Durham-Humphrey Amendment of 1951

required adequate directions for use on the manufacturer's label of nonprescription products

Kefauver-Harris Amendment of 1962

required all new drugs to be shown as safe and effective

Food, Drug, and Cosmetic Act of 1938

required any new drug to be proven safe when used according to label directinons

Medical Device Amendment of 1976

required devices to be manufactured in accordance with GMP

Patient Protection and Affordable Care Act of 2010

requires all individuals to have health insurance