Law Exam #2
The PDUFA was quickly updated by the ________, mainly in response to the ________ epidemic.
FDAMA AIDS
Anabolic steroids are classified as: Schedule I Schedule II Schedule III Schedule IV Legend but not scheduled drugs
Schedule III
Under federal law, used CII order forms must be maintained for a period of at least: a) Two years b) Three years c) Five years d) Until the next controlled substance inventory e) For the business life of the pharmacy
a) Two years
Drug recalls applying to products likely to cause life-threatening effects are classified as: a) Class I b) Class III c) Class 0 d) Class X
a) Class I
The DEA registration number: a) Is a nine-character code consisting of two alphabetic letters followed by seven numeric digit b) Contains two letters, of which the second alphabetic letter represents the first letter of the registrant's first name c) Contains two letters, of which the first alphabetic letter represents the first letter of the registrant's last name d) All the above
a) Is a nine-character code consisting of two alphabetic letters followed by seven numeric digit
Who must be registered with the DEA in order for a pharmacy to dispense controlled substances? 1-The pharmacy 2-The pharmacist in charge 3-Every pharmacist who dispenses controlled substances on a routine basis a. 1 only b. 2 only c. 3 only d. 1 and 3 e. 1, 2, and 3
a. 1 only
In order to introduce a generic version of a brand name drug into the market, the generic drug manufacturer must submit a(n) _______ to the FDA: a. ANDA b. SNDA c. NDA d. IND e.GINA
a. ANDA
Products likely to cause injury or death would be recalled at level: a. Class I b. Class II c. Class III d. Market Withdrawal
a. Class I
The transferring of Controlled Substances in Schedule II requires: a. DEA Form 222 b. DEA Form 224 c. DEA Form 106 d .DEA Form 41
a. DEA Form 222
For drugs on the market between 1938 and 1962, the FDA provided the _____ which allowed manufacturers to show efficacy within a certain timeframe. a. DESI (Drug Efficacy Study Implementation) b. DEPR (Drug Efficacy Proof Report) c. DECR (Drug Efficacy Causes Reprot) d. DSSI (Drug Study Safety Implementation)
a. DESI (Drug Efficacy Study Implementation)
You are due for your biennial (every 2 years) Controlled Substances Inventory. You have recorded the inventory date, time, drug names, strengths, and forms, and are ready to count. You are not allowed by the DEA to: a. Estimate the quantity of CII medications, provided there are fewer than 1000 units. b. Estimate the quantity of CIII-V medications, provided there are fewer than 1000 units. c. Consider unopened bottles to contain the exact count listed on the bottle, for all controls. d. Count out all CII's in opened containers.
a. Estimate the quantity of CII medications, provided there are fewer than 1000 units.
Enforcement of the poison prevention packaging act is largely under the jurisdiction of the: a) FDA b) Federal trade commission c) Consumer product safety commission d) Drug enforcement agency e) Office of drug control and security
c) Consumer product safety commission
Orphan drugs are: a. Intended for the treatment of rare diseases b. Chemically dissimilar to any other marketed drugs c. Intended for use in children under the age of 16 d. Intended for use in children under the age of 5 e. Permitted to be administered to children without permission of their parents
a. Intended for the treatment of rare diseases
In which clinical trial phase is the manufacturer primarily studying the investigational drug in healthy volunteers for safety, toxicity, and PK purposes? a. Phase I b. Phase II c. Phase III d. Phase IV e. Pre-clinical trials
a. Phase I
Drugs prior to 1938 remained immune to the Kefvauer-Harris Amendment (aka Kefvauer-Harris was retroactive to 1938) as well as the FDCA. a. True b. False
a. True
The FDCA gave the FDA the powers (sanctions) of Criminal Prosecution, Seizure of Goods, and Injunction Relief, primarily based upon the areas of Misbranding and Adulteration. a. True b. False
a. True
The Robinson-Patman Act was amended by the Nonprofit Institution Act so that nonprofits can be exempt from "price fixing." a. True b. False
a. True
True or false? Federal law (controlled substances act) states that a schedule III controlled substances prescription shall not be refiled more than 5 times or more than six months after the date on which the prescription was written. a. True b. False
a. True
Which federal amendment/act was enacted to streamline the generic drug approval process, while giving patient extensions to innovator (brand name) drugs? a. Waxman-Hatch amendment b. Kefauver-Harris amendment c. Durham-Humphrey amendment d. Prescription drug marketing act e.None of the above
a. Waxman-Hatch amendment
The ANDA (Abreviated New Drug Application) applies to generic drugs, while the SNDA (Supplemental New Drug Application) is for: a. manufacturers interested in changing the process in their drug's synthesis, production procedure, packaging, labeling, etc. b. Drugs with major therapeutic gain (Type P for Priority), c. Drugs with similarities to drugs currently on the market (Type S for Similar) d. Orphan Drugs
a. manufacturers interested in changing the process in their drug's synthesis, production procedure, packaging, labeling, etc.
Controlled substance act inventory requirements state that if a CIII, IV, and V drug product container contains in excess of ____________ tablets or capsules, then an exact count is required. a) 500 b) 1000 c) 2500 d) 5000 e) 10000
b) 1000
Which of the following statement(s) on a cranberry extract label would be acceptable under DSHEA regulations? 1 - use: to reduce E. Coli during a UTI; 2 - use: to reduce the incidence and duration of UTIs; 3 - use: to help maintain a healthy urinary tract a) 1 only b) 3 only c) 1 & 2 only d) 1 & 3 only e) 1, 2, & 3
b) 3 only
A physician calls in a C-II script that meets the regulations for dispensing the C-II in an emergency situation, in what time frame must the physician provide the written version of the prescription to the dispensing pharmacy? a) 3 business days b) 7 calendar days c) 10 business days d) No written script is needed from the physician, as long as the pharmacist has transcribed all of the information into written format e) No written script is needed from the physician, as long as the pharmacist has transcribed all of the information into written format and the DEA has been informed in writing
b) 7 calendar days
Mrs. Schmidt calls your pharmacy to find out the price of Cephalexin 500 mg capsules. A pharmacist tells her it's against federal law to disclose the price of prescription drugs to a patient prior to receiving an order for the drug. a) True b) False
b) False
According to OBRA 90, a pharmacist is not required to offer to counsel a patient when the patient 1- appears to already understand the directions for use for the medication; 2 - is a health care professional; 3 - waives or refuses to accept the offer to counsel a) 1 only b) 2 only c) 3 only d) 1 & 2 only e) 2 & 3 only
c) 3 only
The address printed on the DEA 222 order form for your pharmacy is incorrect, therefore you: a) Must rewrite the correct address before order schedule II drugs b) Must promptly return forms to the DEA to correct the error c) Must correct the address when the current supply of forms is exhausted d) Must notify your drug supplier of the correct address by affidavit with the order form e) None of the above
b) Must promptly return forms to the DEA to correct the error
Cocaine powder, USP is an example of a drug in which schedule of controlled substances? a) Schedule I b) Schedule II c) Schedule III d) Schedule IV e) Cocaine is illegal, thus not within any DEA schedule
b) Schedule II
Which of the following restricts community/retail pharmacies from processing manufacturer prescription drug samples? a) The Durham-Humphrey Amendment b) The Prescription Drug Marketing Act c) The Waxman-health act d) The Robinson-Patman drug Distribution Act e) No restrictions exist for retail pharmacists
b) The Prescription Drug Marketing Act
You receive a recall notice from the FDA via your wholesaler that the product labeled as "warfarin 5 mg tabs USP" on your shelf mistakenly contains "warfarin USP and 0.1 mg of enoxaparin USP" in the tablets. Which of the following are true according to federal law? 1- The drug product is adulterated 2- The drug product is misbranded 3- This is a category IV recall situation a. 1 only b. 2 only c. 1 and 2 d. 2 and 3 e. 1, 2, and 3
b. 2 only
Controlled substance records must be retained by the registrant for how long? a. 1 year b. 2 years c. 5 years d. 10 years e. For the duration of the then current DEA registration period
b. 2 years
Medicare part D covers which of the following? 1- Outpatient hospital services 2- Outpatient physician services 3- Outpatient pharmacy services a. 1 only b. 3 only c. 1&3 only d. 2&3 only e.1, 2, & 3
b. 3 only
The DEA limits a pharmacy to this many Official DEA Order Forms (222), and requires them to be kept separately from all other pharmacy business materials: a. 49 (7 books of 7 forms) b. 42 (6 books of 7 forms) c. 36 (6 books of 6 forms) d. 42 (7 books of 6 forms)
b. 42 (6 books of 7 forms)
If a drug manufactured under conditions that do not meet the requirements of the GMP, the product is considered by the FDA to be: a. A generic substitute b. Adulterated c. Contaminated d. Misbranded e. Non-prescription
b. Adulterated
A complete controlled substances inventory is required how often under federal law: a. Annually b. Biennially c. Trienially d. Within 30 days of each DEA registration renewal date e. Only when the controlled substance inventory of DEA registration is transferred
b. Biennially
Pharmacies register every 3 years with the DEA to dispense controlled substances using: a. DEA Form 222 b. DEA Form 224 c. DEA Form 106 d .DEA Form 41
b. DEA Form 224
A Therapeutic Substitution is when drugs have equal bio-equivalence, including the same peak, same AUC. An example would be: substituting acetaminophen for Tylenol. a .True b. False
b. False
A sales rep is recommending the off label use of Warfarin for ear-aches. Presuming there is some scientific evidence, and you deem it reliable, this is kosher with the law. a. True b. False
b. False
Misbranding occurs when a drug is listed in the USP, but did not meet USP specifications (unless variations from the USP were clearly labeled) a. True b. False
b. False
Samuel Hopkins Adams wrote for Collier's Weekly about contaminated smallpox vaccines, which led to the Pure Food and Drug Act. a. True b. False
b. False
The Kefvauer-Harris Amendment quickened the drug approval process. a. True b. False
b. False
The Medical Device Amendment classifies artificial hearts, pacemakers, stents, and catheters as Class II. a. True b. False
b. False
The Pure Food and Drug Act adequately addressed regulation of drugs with emphasis on drug safety. a. True b. False
b. False
The pharmacist notifies the DEA, using the proper form, when an in-transit loss of controlled substances has occurred and it was discovered before the pharmacist signed for or took possession of the controlled substances a. True b. False
b. False
True or false? A drugs manufacturer may not, under any circumstances, distribute scientific literature or medical journals regarding off label uses regarding one of its drug products a. True b. False
b. False
Which of the following could be a valid DEA registration number for John Nash, a physician assistant? a. AN7854222 b. MN8812960 c. JN46221151M d. PA5549615 e. A and D could both be correct
b. MN8812960
Prior to the first dose, and every 30 days, patients must receive patient package inserts for all of the following except: a. Accutane b. Warfarin c. Progesterone/Estrogen d. Statins
b. Warfarin
Misbranding is a drug containing any of several potentially dangerous or addictive drugs, and a. its label indicates all addictive ingredients b. its label failed to indicate the accurate quantity or proportion of such drugs c. its label indicates all dangerous ingredients d. its label failed to indicate the consequences of all ingredients
b. its label failed to indicate the accurate quantity or proportion of such drugs
Amphetamine (Adderall) falls into: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
b.Schedule II
Hydromorphone falls into: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
b.Schedule II
Which of the following drug products must be purchased using a DEA form 222? 1 - Percodan (oxycodone/APAP); 2- Dilaudid (hydromorphone); 3 - Meridia (sibutramine) a) 1 only b) 3 only c) 1 & 2 only d) 1 & 3 only e) 1, 2, & 3
c) 1 & 2 only
Who can request that a specific prescription be dispersed in non-child resistant packaging? 1 - patient; 2 - prescriber; 3 - pharmacist a) 1 only b) 3 only c) 1 and 2 only d) 1 and 3 only e) 1, 2, and 3
c) 1 and 2 only
According to the DSHEA, a product such as Saw Palmetto may be labeled to state that it: a) Cures prostatitis b) Helps treat prostatitis c) Supports a healthy prostate d) Prevents prostate cancer e) Will return the prostate to normal size and function
c) Supports a healthy prostate
The orange book is used to identify: a) Chemical generic names of all drugs b) Average wholesale pricing for the drug c) Therapeutically equivalent drug products d) Adverse effects of all FDA-approved drugs e) Drugs available in foreign countries
c) Therapeutically equivalent drug products
The first segment (five or six numbers) of the NDA identifies the: a) drug NDA file number b) drug product c) manufacturer d) FDA's prescription monograph code e) package size
c) manufacturer
Cough preparations like Robitussin AC that have < ______mg of codeine per 100mL are Schedule 5. a. 100mg/100ml b. 150mg/100ml c. 200mg/100ml d. 300mg/100ml
c. 200mg/100ml
According to the IND process, the FDA has _______ to respond to a company with whether they think the drug is suitable for testing or not. a. 3 years b. 3 months c. 30 days d. 1 year
c. 30 days
In the Orange book, A therapeutic equivalence rated _____ means products have an actual or potential equivalency problems. a. A b. B c. AB d. ANDA
c. AB
Labels for OTC drugs include: a. Manufacturer's lot number b. intended route of administration, if not oral c. Active ingredients and quantity of certain other ingredients d. The Federal Legend
c. Active ingredients and quantity of certain other ingredients
The Durham-Humphrey Amendment (Prescription Drug Act) determined a properly labeled prescription must include the patient's name, date filled, directions from prescriber, and all of the following except: a. Address and Name of the pharmacy b. Name and dosage of the drug c. Address of the patient d. Physician's name e. prescription number
c. Address of the patient
The FDCA was not retroactive for drugs created before 1938. Which of the following is not among significant pre-1938 drugs? a. Thyroxine b. Digoxin c. Aspirin d. Nitroglycerin e. Phenobarbital
c. Aspirin
Which of the following has the authority to change the schedule of controlled drugs? a. Secretary of drug enforcement agency b. Office of inspector general c. Attorney general of U.S. d. Secretary of FDA e.President of U.S. via executive order
c. Attorney general of U.S.
You work in a methadone clinic. A glass bottle full of methadone has just fallen to the floor and shattered, spilling the contents everywhere. You should: a. Clean it up, carefully separate the methadone from glass, and send it to a "reverse distributor" using form 222. b. Clean it up, dispose of the medication, and record it as a loss on DEA Form 106. c. Clean it up, dispose of the medication, and record it as destroyed on DEA Form 41. d. Clean it up, dispose of the medication. No DEA Form is necessary.
c. Clean it up, dispose of the medication, and record it as destroyed on DEA Form 41.
Dr. Davis created his own IUD known as the ______________, which resulted in many cases of ______________ due largely to the ________ of the product. a. Dalkon Shield, PCOS, medication concentration b. Davis Shield, Pelvic Inflammatory Disease, medication concentration c. Dalkon Shield, Pelvic Inflammatory Disease, design d. Dalkon Shield, PCOS, research flaws
c. Dalkon Shield, Pelvic Inflammatory Disease, design
The Nutrition and Labeling Education Act was influenced most by: a. Food Manufacturers/Producers b. Drug Wholesalers c. Fad diets of the 1980s d. Drug Manufacturers
c. Fad diets of the 1980s
The primary basis for determining whether a marketed product will be considered a "drug" according to the FDCA is... a. It's chemical structure/nature b. It's safety and efficacy profile c. It's intended use d. It's DSM-IV classification e.It's ICD-10 classification
c. It's intended use
The clinical trial phase including the largest, pre-market human testing phase and all emphasis on efficiency as a diverse population of subjects with the intended indication/disease state is: a. Phase I b. Phase II c. Phase III d. Phase IV e.Phase V
c. Phase III
Anabolic steroids were put into this schedule to give the DEA better control over them: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
c. Schedule III
If a hypothetical dosage form contained 35mg Codeine per tablet, this would be: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
c. Schedule III
The NDA is submitted to the FDA: a. before Phase 1 trials b. after Phase 2 trials c. after Phase 3 trials d. after Phase 1 trials
c. after Phase 3 trials
According to federal law, schedule II drugs may be stocked/stored only in the following ways: 1) in locked vaults, safes, or cabinets; 2) in any areas if there are cameras or surveillance systems in place; 3) dispersed amongst the regular (non-controlled) inventory/stock a) 1 only b) 3 only c) 1 & 2 d) 1 & 3 e) 1, 2, & 3
d) 1 & 3
Which of the following is/are true about theft of significant loss of controlled substances: 1- A report must be made on a DEA 106 form 2- The pharmacy most notify the nearest DEA office 3-The pharmacy should notify local police a. 1 only b. 3 only c. 1 and 2 d. 2 and 3 e. 1, 2, and 3
e. 1, 2, and 3
Which of the following systems are permissible for filling prescriptions (assume all scripts are properly marked and/or readily retrievable in each filling system)? 1- One file: all prescriptions in a single file (with all controlled substances marked with a red "C" or easily retrievable) 2 - Two files: CII prescriptions in one file and all other prescriptions in a 2nd file (with all controlled substances marked "C" or easily retrievable) 3 - three files: CII in one file, CIII-V in a 2nd file, and non-controlled substance prescriptions in a 3rd file a) 1 only b) 3 only c) 1 and 2 only d) 2 and 3 only e) 1, 2, and 3
d) 2 and 3 only
The term drug from Food Drug and Cosmetics act means: a) Articles recognized in the US Pharmacopeia or national formulary b) Articles (other than food) intended to affect the structure or any function of the body c) Articles intended to diagnose, treat, cure, mitigate, or prevent a disease d) All of the above e) None of the above
d) All of the above
Which of the following DEA forms is required to destroy controlled substances? a) DEA 106 b) DEA 222 c) DEA 442 d) DEA 41 e) DEA 363
d) DEA 41
How often must a DEA-registrant re-register with the DEA a) Annually- at the time the registrants state license is renewed b) Annually - on or before June 30 c) Every 2 years d) Every 3 years e) Only when the registrant moves the physical location or there is a change of ownership
d) Every 3 years
According to federal law, zolpidem is an example of a drug product in which controlled substance schedule: a) I b) II c) III d) IV e) V
d) IV
A(n) _________________ must be substituted by manufacturers to the FDA in order to market a new drug. a) NDC b) FDA-C c) FDC d) NDA e) Form 222
d) NDA
NEED ANSWER Pharmacies are allowed 3 ways to file prescription records. Which of the following is not one of those ways? a. 3 separate files; one for CII, one for CIII-V, and one for non-control prescriptions b. 2 separate files; one for CII, one for CIII-V along with non-control prescriptions but with a 1 inch red "C" marked on CIII-V's. c. 2 separate files; one for non-control prescriptions, one for CII-V with CIII-V marked with a 1 inch red "C". d. 2 separate files; one for non-control prescriptions, one for CII-V with CII's marked with a 1 inch red "C."
d. 2 separate files; one for non-control prescriptions, one for CII-V with CII's marked with a 1 inch red "C."
A physician has called in an emergency prescription for a fentanyl patch. You determine this is an emergency situation, and will dispense the fentanyl and require the physician to send you a written prescription within ______. You also see that you have 4 patches left in an open box. The prescription is for 8 patches. You know the shipment comes in tomorrow morning, and the patient agrees to come back. If the patient comes back within ______, you can fill the rest of the prescription, as long as it was documented on the script. If this were to occur in a LTCF, the prescription would be good for ______. a. 24 hours, 24 hours, 1 week. b. 48 hours, 72 hours, 6 months. c. 72 hours, 72 hours, 30 days. d. 7 days, 72 hours, 60 days.
d. 7 days, 72 hours, 60 days.
The FDCA defined Adulteration as: a. drugs not stored under USP standards. b. drugs which failed to conform to USP/NF standards for purity, quality, strength, and appropriate assays. c. A drug listed in the USP, but which did not meet USP specifications, unless variations from the USP were clearly labeled. d. A and B e. All of the Above
d. A and B
The FDCA defined Misbranding: a. in such a way as to regulate "incomplete labeling" b. as a drug containing any of several potentially dangerous or addictive drugs, and its label failed to indicate the accurate quantity or proportion of such drugs c. in such a way as to regulate "misleading labeling" d. A and C e. All of the above
d. A and C
A Medicare Patient who has elected to pay for Part D coverage can expect all of the following except: a. Premiums of about 35$ per month b. 250$ deductible c. 25% copay up to 2250$ d. A donut hole between 2250$ up to 5100$. e. all of the above f. none of the above
d. A donut hole between 2250$ up to 5100$.
OBRA 90 concerns Medicaid and requires states to participate in: a. Mandatory Rebates (Best price, average manufacturer's price) b. Demonstration Projects (CQI, determines benefit for patients) c. Drug Utilization Review (Retrospective, Educational, Prospective) d. All of the above e. None of the above
d. All of the above
The Pure Food and Drug Act of 1906: a. was focused on accurate labeling of medications b. was able to be enforced upon the basis of adulteration c. was able to be enforced upon the basis of misbranding d. All of the above
d. All of the above
The Prescription Drug Marketing Act did all of the following except: a. Required state registration of all drug wholesalers, secondary distributers, repackagers, etc. b. Prohibited non-profits from re-selling drugs, with the exception of their own employees c. Strict record keeping of all "samples" of drugs d. Allows retail pharmacies to receive drug "samples" only upon written request.
d. Allows retail pharmacies to receive drug "samples" only upon written request.
All of the following are true of CRC's except: a. At least 90% of adults, having been shown how, can open within 5 minutes b. Not more than 20% of children < 5, having been shown how, can open within 5 minutes c. Must meet USP standards for tightness, light resistance d. Are more properly termed "child-proof" e. May not be reused
d. Are more properly termed "child-proof"
The FDCA defines Drug as: a. articles used for food or drink for man or other animals b. Intended for cleansing, beautifying, promoting attractiveness, or altering appearance c. An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article intended for diagnosis, cure, mitigation, treatment, or prevention of disease or other medical conditions; AND Does not achieve its effect by chemical action or by being metabolized. d. Articles (other than Food) intended: For diagnosis, cure, mitigation, treatment, or prevention of disease, which affect the structure or function of body
d. Articles (other than Food) intended: For diagnosis, cure, mitigation, treatment, or prevention of disease, which affect the structure or function of body
Which of the following persons does the controlled substances act empower to execute a form 222 on behalf of a retail pharmacy? a. Any licensed pharmacist employed by the pharmacy b. Any person who is authorized to sign the initial DEA registration or renewal application c. Any person granted power of attorney by the person who signed the most recent DEA registration or renewal application d. B and C e. All of the above
d. B and C
Which form should be used to notify the DEA of a significant loss of controlled substances due to a burglary, a gap in inventory (meaning possible diversion or dispensing mistakes), or in-transit loss discovered after the pharmacist has signed for or taken custody of controlled substances shipped to the pharmacy. a. DEA Form 222 b. DEA Form 224a c. DEA Form 41 d. DEA Form 106
d. DEA Form 106
The Food and Drug Administration Modernization Act (FDAMA) did all of the following except: a. permitted manufacturers to provide information about "off-label" use. b. enlisted States to enforce limits on compounding pharmacies in order to reduce bulk-compounding. c. Allow only "anticipatory compounding" in compounding pharmacies d. Developed a fast track approval system for drugs for rare diseases (found in populations < 200,000).
d. Developed a fast track approval system for drugs for rare diseases (found in populations < 200,000).
Drug advertising is regulated through all of the following except: a. FDA via FDCA b. FTC via FTC Act c. Lanham Act (Trademark Act) d. Durham-Humphrey
d. Durham-Humphrey
The Waxman-Hatch Amendment (Drug Price and Patent Term Act) resulted in: a. Abbreviated New Drug Application for brand name drugs (show bio-equivalence) b. Patent Term Extensions to generic drugs (capped at 5 years) c. Applies to US drugs only d. Resulted in requirement of the FDA to publish the Orange Book, a book showing bio-equivalency of "brand" and "generics."
d. Resulted in requirement of the FDA to publish the Orange Book, a book showing bio-equivalency of "brand" and "generics."
Butorphanol and propoxyphene are narcotics belonging to: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
d. Schedule IV
Lorazepam is: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
d. Schedule IV
Which of the following requires all drug products to be proven both safe and effective before they could be marketed? a. The food drug and cosmetic act of 1938 b. The Durham-Humphrey amendment of 1951 c. The FDA modernization act of 1953 d. The Kefauver-Harris amendment of 1962 e. None of the above
d. The Kefauver-Harris amendment of 1962
A physician that prescribes a FDA approved prescription drug product for a non-labeled indication is... a. Negligent under a strict liability standard b. Setting up the pharmacy/pharmacist for a misbranding claim c. Practicing outside his/her scope of authority d. Within his/her rights under federal law e. Required to demonstrate the merits of the intended use if the FDA requests writing
d. Within his/her rights under federal law
A drug is misbranded if it: a. has a false or misleading label b. has a label missing required information c. required information is not easily read d. all of the above e. none of the above
d. all of the above
NEED ANSWER The DEA must investigate pharmaceutical thefts if: a. Replacement cost of controlled substances exceeds $500 b. Someone was killed or suffered significant bodily injury during the theft c. Those involved in planning or executing the theft crossed interstate or international lines. d. all of the above
d. all of the above
The FDAMA established a new drug development process including: a. Pre-Clinical Testing (in-vivo & in-vitro animal testing) b. Filing an IND (Investigational New Drug) form with the FDA c. Clinical Trials (Phase I, II, III, IV) d. all of the above
d. all of the above
The Harrison Narcotics Act of 1914: a. taxed the production, sale, and use of opium b. required prescriptions for products exceeding the allowable limit of narcotics c. mandated increased record keeping for doctors and pharmacists dispensing narcotics d. all of the above e. none of the above
d. all of the above
Under the Kefvauer-Harris Amendment, drugs may only be marketed if: a. proven safe & effective for intended use. b. proven safe & effective with adequate labeling . c. proven safe & effective with adequate labeling and good manufacturing practices. d. prove safe & effective with adequate labeling and good manufacturing practices, and the manufacturer is registered.
d. prove safe & effective with adequate labeling and good manufacturing practices, and the manufacturer is registered.
According to the federal controlled substance act, which of the following drugs is/are controlled substances? 1. Meperidine injectable solution; 2. Leaf/marijuana for medicinal use; 3. Fentanyl transdermal patch a) 1 only b) 3 only c) 1 & 2 only d) 1 &3 e) 1, 2, & 3
e) 1, 2, & 3
FDA-approved drug products that are considered therapeutically equivalent to a brand name drug under FDA regulations/guidance would be rated as a) TE b) BA c) RBQ d) EQ e) AB
e) AB
Which could be the correct DEA number for Dr. Robert Bridge, MD? a) MD3254769 b) AB1244696 c) AR1354783 d) RB2489436 e) BB7263546
e) BB7263546
Controlled substances are classified into schedules based upon: a) ARNQ chemical classification b) FDA indication for use c) DEA indication for use d) ARNQ narcotic classification e) DEA determined abuse and dependency potential
e) DEA determined abuse and dependency potential
Whenever one DEA registrant distributes a schedule II drug to another DEA registrant: a) A DEA from 224a must be used b) A DEA form 42 must be used c) The drug must be sold "at cost" d) An invoice must be delivered along with the drug e) No invoice is needed, but a DEA form 222 is required
e) No invoice is needed, but a DEA form 222 is required
DEA forms 222a is used: a) To order schedule II controlled substances b) To order controlled substances in schedules III, IV, and V c) To register a practitioner with the DEA d) To return unused controlled substances e) To requisition a supply of DEA-222 forms
e) To requisition a supply of DEA-222 forms
The NDC code must a. be assigned by the FDA for every OTC and Prescription drug b. must be present on all drug packaging c. must be present on all dosage units d. is currently a 10 digit code, the first five digits identifying the manufacturer, the last five digits identifying the drug and package size. e. A and D f. All of the above
e. A and D
The Food Drug and Cosmetic Act of 1938: a. was a direct result of "the sulfanilamide scare" in which 107 people died. b. gave the FDA broader power to regulate the safety of medications c. gave the FDA broader power to regulate medications prior to marketing d. A and B e. A, B, and C
e. A, B, and C
A drug product is adulterated within the meaning of the food drug and cosmetic act if: a. It consists in whole or in part of any filthy, putrid, or decomposed substance b. It has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health c. The methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices d. B and C are correct e. All of the above are correct
e. All of the above are correct
Under federal law, which of the following is not required on the prescription label of a dispensed legend drug? a. Directions for use b. Name of patient c. A serial or unique identifying number d. Quantity dispensed e. All of the above are required
e. All of the above are required
The Orphan Drug Act and the Waxman-Hatch Amendment were developed to a. speed up the process of FDA drug approval for non-generics b. speed up the process of manufacturing c. rectify the long drug approval process with tax benefits and patent period d. rewards for manufacturers who create drugs for rare diseases (<200,000 people with disease). e. C and D f. All of the above
e. C and D
When pharmacies get together (illegally) to boycott a company, say Pfizer, this is known as: a. Price Fixing b. Monopolies c. Restraint of Trade d. Market Power e. Collusion
e. Collusion
All of the following are correct descriptions of the Clinical Trials Phases except: a. Phase 1: small group of healthy individuals. Purpose: to evaluate toxicity, pharmacokinetics, and safety. b. Phase 2: 100 + patients who have the disease/symptoms. Purpose: to evaluate, preliminarily, the drug's effectiveness and dosage. c. Phase 3: 1,000's in RCT's to compare effectiveness of the new drug versus standard therapy. d. Phase 4: Post Marketing Studies e. Phase 5: Voluntary reporting of ADRs through FDA Medwatch program
e. Phase 5: Voluntary reporting of ADRs through FDA Medwatch program
Generally, drugs for antitussive, antidiarrheal and analgesic purposes are: a. Schedule I b.Schedule II c. Schedule III d. Schedule IV e. Schedule V
e. Schedule V
A pharmacy must register as a distributor, if it transfer to other DEA registrants, more than: a. 2 percent of all controlled substances in 1 year b. 5 percent of all controlled substances over the 3 year registration period c. 3 percent of all controlled substances in 2 years d. 4 percent of all controlled substances over the 3 year registration period e.5 percent of all controlled substances in 1 year
e.5 percent of all controlled substances in 1 year
Which of the following, if done by a pharmacist, would likely violate the FDCA? a. Place a book describing scurvy and the role of vitamin C in the disease immediately next to the vitamin C on her shelf b. Recommend a book on the use of roots, leaves and extracts in Chinese medicine c. Place a book on the shelf next to the ginkgo biloba tablets that describes the virtues and uses for ginkgo biloba d. Recommend and sell a bottle of vitamin C for promoting a healthy immune system e.Recommend and sell a bottle of gingko biloba tablets for use in preventingAlzheimer's
e.Recommend and sell a bottle of gingko biloba tablets for use in preventingAlzheimer's
Medicaid covers medically and financially indigent persons for: a. Hospital and physician services b. Diagnostics (lab, x-ray, etc) c. Skilled nursing and home health d. Dental and Optomatry e. Outpatient medications f. All of the above g. none of the above
f. All of the above
The Kefvauer-Harris Amendment (Drug Efficacy Act) was passed into law mainly due to a severe adverse drug reaction (birth defect, 7,000 children in Europe) known as ______________, caused by the drug named _____________.
phocomelia thalidomide
The Federal Anti-Tampering Act of 1982 was brought about because of tampering of ____________ in Chicago and ___________and ___________ in Washington, resulting in deaths.
tylenol excedrin sudafed