Law quiz

Which of the following are mid-level practitioners? - Certified registered nurse anesthetists - Podiatrists - Optometrists - Nurse midwives - Dentists

- Certified registered nurse anesthetists - Optometrists - Nurse midwives

Which of the following is schedule III? (SATA) - Codeine 15mg tabs - Codeine 15mg with APAP 325mg tabs - Butalbital 50mg (a barbiturate) with APAP 325 tabs - Dronabinol 2.5mg caps - Modafinil 100mg tabs - Ezogabine - Dinabol 10mg

- Codeine 15mg with APAP 325mg tabs - Dronabinol 2.5mg caps - Dinabol 10mg

The public interest standard, as applied by the department of justice thorough the DEA: (SATA) - Is the lens for reviewing applications for registration - Is the lens used for reviewing the DEA-222 form - Would take into account the presence of a supporting state license - Would take into account the ability to participate in Medicaid and/or medicare - Would take into account any act that is inconsistent with the public interest

- Is the lens for reviewing applications for registration - Would take into account the presence of a supporting state license - Would take into account the ability to participate in Medicaid and/or medicare - Would take into account any act that is inconsistent with the public interest

You are presented with a prescription for 60 methadone 5mg tabs for a pt with chronic pain; directions to take "1 tab, orally, twice daily" delivered to you at your community pharmacy. You have 100 tabs in stock. She says she wants to try a 5 day supply (10 tabs) to see if it works, and if it does work will pick up the remainder. Without adding facts, please pick the single best answer. - You can give her the 5-day supply, but may not supply the remainder - You can give her only a 3-day supply, and must supply the remainder within 72 hours - You can give her the 5-day supply as requested, but must be able to supply the remainder within 72 hours - You are not permitted to dispense methadone to this pt since this is not an opioid tx program - You may dispense the 5-day supply and supply the remainder within 30 days of writing

- You may dispense the 5-day supply and supply the remainder within 30 days of writing

Choose each correct answer "Dispense" under the CSA includes which of the following: A: Administering a controlled substance (e.g., an injection) B: Prescribing a controlled substance C: Dispensing from a community pharmacy D: Distribution by a wholesaler E: Production by a manufacturer

A: Administering a controlled substance (e.g., an injection) B: Prescribing a controlled substance C: Dispensing from a community pharmacy

Concerning the 1500-hour experience component of pre-license training A: All of the experience may obtain through the Pharm. D. curriculum B: Some experience may obtain in the Pharm. D. curriculum, but some must be obtained outside academic program C: This must all obtain in Virginia, out-of-state experience does not count D: All of the experience must obtain outside of the academic training

A: All of the experience may obtain through the Pharm. D. curriculum

Which of the following is a schedule III? Please select each correct answer. A: Amobarbital suppository B: Codeine 15mg with acetaminophen 325mg tablets C: Butalbital 50mg with acetaminophen 325mg tablets D: Lorazepam 0.5mg E: Lyrica 25mg F: Paregoric tincture G: Methylphenidate 5mg

A: Amobarbital suppository B: Codeine 15mg with acetaminophen 325mg tablets F: Paregoric tincture

A physician who is out of town for 7 days would like to telephone a prescription to your pharmacy for oxycodone 15mg, 1 tab, po, q4h prn pain; nothing else works for this patient. Under federal law which of the following is/are true? (Choose each correct answer.) A: An emergency phone order is permissible under these circumstances B: A follow-up prescription must be delivered to the pharmacy within 72 hours C: Only a 5-day supply is permissible D: You are permitted to dispense a quantity sufficient to cover the emergency period (7 days)

A: An emergency phone order is permissible under these circumstances D: You are permitted to dispense a quantity sufficient to cover the emergency period (7 days)

With regard to inventories (select all that apply) A: An inventory of federal controlled substances (CII-CV) must be made at least every 2 years (within two years of the most recent inventory) B: An inventory of federal controlled substances (CII-CV) must be made at the start of business (opening day) C: An inventory of Virginia CVI controlled substances must be made at least every 2 years (within two years of the most recent inventory) D: An inventory must be made on the effective date of a newly scheduled controlled substance in CII-CV (e.g., tramadol on September 14, 2014) E: An inventory must be made on the effective date of any change in controlled substance schedule (e.g. from CIII to CII)

A: An inventory of federal controlled substances (CII-CV) must be made at least every 2 years (within two years of the most recent inventory) B: An inventory of federal controlled substances (CII-CV) must be made at the start of business (opening day) D: An inventory must be made on the effective date of a newly scheduled controlled substance in CII-CV (e.g., tramadol on September 14, 2014) E: An inventory must be made on the effective date of any change in controlled substance schedule (e.g. from CIII to CII)

"Prescription" under the CSA would include which of the following? A: An order for a controlled drug dispensed to a patient at a community pharmacy. B: An order for a controlled drug dispensed in a hospital for immediate administration to a patient C: A controlled drug administered directly by a physician to a patient D: A, B, and C E: A and C

A: An order for a controlled drug dispensed to a patient at a community pharmacy

"Prescription" under the CSA would include which of the following? A: An order for a controlled drug dispensed to a patient at a community pharmacy. B: An order for a controlled drug dispensed in a hospital for immediate administration to a patient C: A controlled drug administered directly by a physician to a patient D: An order for medical cannabis to be dispensed to a patient from a dispensary

A: An order for a controlled drug dispensed to a patient at a community pharmacy.

Emergency drug kits (in long-term care facilities) A: Are intended to intiate therapy to save the life of the patient B: Contents are approved by the Board of Pharmacy C: Are only used when delay in beginning treatment may be harmful D: Are intended to intiate therapy prior to receipt of ordered medication from pharmacy

A: Are intended to intiate therapy to save the life of the patient

Pharmacy services in long-term care facilities (select all that apply) A: Are permitted to have IV solutions in floor stock B: Are required to have automated dispensing cabinets C: Are permitted to destroy discontinued medication on premises D: Are permitted to have emergency drug kits for medication that is extremely urgent E: Are not permitted to have medication in Schedule II through V

A: Are permitted to have IV solutions in floor stock C: Are permitted to destroy discontinued medication on premises D: Are permitted to have emergency drug kits for medication that is extremely urgent

Under the Food, Drug, and Cosmetic Act, the definition of "drug" includes: (please select each correct answer) A: Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease B: Articles intended to affect the structure or any function of the body C: Products not intended to supplement the diet D: Articles that act through mechanical rather than chemical action

A: Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease B: Articles intended to affect the structure or any function of the body C: Products not intended to supplement the diet

Which of the following are necessary to maintain a malpractice case Select all that apply A: Causal connection B: Criminal intention C: Breach of duty D: Injury E: Statistical significance

A: Causal connection C: Breach of duty D: Injury

Which of the following is a schedule II? A: Codeine 15mg B: Hydrocodone 5mg with acetaminophen 325mg C: Human chorionic gonadotropin D: Lisdexfetamine 10mg caps E: Winstrol 2mg (an anabolic steroid) F: Secobarbital suppositories G: Tramadol 50mg

A: Codeine 15mg B: Hydrocodone 5mg with acetaminophen 325mg D: Lisdexfetamine 10mg caps

Which of the following is a schedule II? Please select each correct answer. A: Codeine 15mg tablet B: Clorpheniramine w/hydrocodone liquid (Tussionex) C: Cocaine ophthalmic drops D: Lacosamide oral E: Diazepam tabs F: Dexmethylphenidate 5mg XR capsules G: Carisoprodol 100mg tabs

A: Codeine 15mg tablet B: Clorpheniramine w/hydrocodone liquid (Tussionex) C: Cocaine ophthalmic drops F: Dexmethylphenidate 5mg XR capsules

Concerning the Drug Quality and Security Act of 2014 (Select all that apply) A: Congress explicitly gave FDA authority to regulate compounding in this law B: Congress explicitly gave FDA authority to regulate outsourcing facilities C: Congress explicitly gave FDA authority to regulate the supply chain of manufactured products D: Congress explicitly gave FDA authority to regulate biosimilars

A: Congress explicitly gave FDA authority to regulate compounding in this law B: Congress explicitly gave FDA authority to regulate outsourcing facilities C: Congress explicitly gave FDA authority to regulate the supply chain of manufactured products

The Western States case was about A: Contaminated doses of injectible medication causing fungal meningitis B: The Food and Drug Administration Modernization Act of 1997 C: FDA's "paper NDA" program D: The Orphan Drug Act of 1983

A: Contaminated doses of injectible medication causing fungal meningitis

(Choose each correct answer.) Administrative agencies such as the DEA: A: Enforce the law. B: Promulgate (write) regulations. C: Are part of the executive branch. D: Are part of the legislative branch.

A: Enforce the law. B: Promulgate (write) regulations. C: Are part of the executive branch.

The landmark case Gonzales v. Oregon (decided by the US Supreme Court) A: Established limits on the ability of the DEA, thru the Attorney General, to define legitimate medical purpose B: Established that FDA could not impose regulations, or its authority, over dietary supplement manufacturers C: Established that the FDAಬs unapproved "new drug" policy was inconsistent with the Drug Efficacy (Kefauver-Harris) amendments requiring proof of efficacy D: Established that restraint/prohibition of advertising by pharmacies violated First Amendment Free Speech rights

A: Established limits on the ability of the DEA, thru the Attorney General, to define legitimate medical purpose

Which of the following is/are C-V (select all correct answers) A: Ezogabine B: Lacosamide C: Camphorated tincture of opium (paregoric) D: Chloral hydrate E: Pregablin F: Lomotil G: Tramadol

A: Ezogabine B: Lacosamide E: Pregablin F: Lomotil

Which of the following must be reported to the prescription monitoring program (PMP) (select all correct answers) A: Gabapentin B: Guafenesin with codeine liquid C: Stanozolol tablets D: Pseudoephedrine tablets E: Meprobamate F: Cannabidiol (CBD)

A: Gabapentin C: Stanozolol tablets E: Meprobamate F: Cannabidiol (CBD)

Concerning Chapter 797 of USP, which of the following is not true: A: Includes reconstitution of powdered products B: Covers all places where sterile products are prepared C: Covers all persons who prepare sterile products D: Requires environmental monitoring and personnel testing

A: Includes reconstitution of powdered products

Please select each correct answer regarding internship. A: Interns may be counted toward the ratio of pharmacist-to-technician (on the technician side) when performing technician functions B: May complete "acts reserved to pharmacists" when under direct supervision of a pharmacist C: May retain intern status for three months after graduation D: Are not permitted to accumulate experience hours in another state (i.e., outside of Virginia) E: Are required to obtain experiential hours outside of the IPPE/APPE component of training

A: Interns may be counted toward the ratio of pharmacist-to-technician (on the technician side) when performing technician functions B: May complete "acts reserved to pharmacists" when under direct supervision of a pharmacist C: May retain intern status for three months after graduation

According to the regulatory scheme created by Congress, a compounded product that conformed to all of the requirements (Please select each correct choice) A: Is in a safe harbor B: Is "grandfathered" C: Is required to follow USP 795 or USP 797 guidelines D: Is adulterated

A: Is in a safe harbor C: Is required to follow USP 795 or USP 797 guidelines

Medication assisted therapy (MAT) for opioid dependence Select each correct answer A: Maximum allowable dose of buprenorphine of 24 mg/day B: Buprenorphine/naloxone tablets be prescribed unless the patient requests plain buprenorphine C: Buprenorphine/naloxone tablets prescribed unless the patient is pregnant D: Prescription for buprenorphine may only be dispensed through an Opioid Treatment Program (OTP) E: Prescribers must have a waiver from SAMSHA and an "X" DEA number

A: Maximum allowable dose of buprenorphine of 24 mg/day C: Buprenorphine/naloxone tablets prescribed unless the patient is pregnant E: Prescribers must have a waiver from SAMSHA and an "X" DEA number

According to the regulatory scheme created by Congress, outsourcing facilities (Please select each correct choice) A: Must meet standards Current Good Manufacturing Practices B: Must be properly registered with FDA and comply with other regulations to enjoy a "safe harbor" C: May dispense products to hospitals, medical clinics, and other purchasers without a prescription D: May only produce sterile products E: Are permitted to dispense directly to patients under the "outsourcing facility" registration

A: Must meet standards Current Good Manufacturing Practices B: Must be properly registered with FDA and comply with other regulations to enjoy a "safe harbor" C: May dispense products to hospitals, medical clinics, and other purchasers without a prescription

Which of the following is/are "mid-level" practitioners for DEA purposes (assuming the state allows them to prescribe). Please choose each correct answer A: Nurse practitioners B: Pharmacists C: Optometrists D: Nurse midwives E: Dentists

A: Nurse practitioners B: Pharmacists C: Optometrists D: Nurse midwives

Patient package inserts ("PPI") are required for: A: Oral contraceptives B: Anti-depressants C: Fluoroquinolones D: NSAIDs

A: Oral contraceptives

Which of the following is/are C-II (select all correct answers) A: Pentobarbital capsules B: Phenobarbital tablets C: Pentobarbital suppositories D: Secobarital injection E: Butalbital with aspirin F: Butalbital with acetaminophen G: Amobarbital capsules

A: Pentobarbital capsules D: Secobarital injection G: Amobarbital capsules

Which of the following is/are C-IV? (select all correct answers) A: Phenteramine B: Phenobarbital C: Meprobamate D: Human chorionic gonadotropin E: Potiga F: Strattera

A: Phenteramine B: Phenobarbital C: Meprobamate

"Therapeutic equivalence" as defined by FDA requires all of the following (Select all that apply) A: Product has an approved NDA or ANDA B: Same active ingredients C: Bioequivalent to reference product D: Same dosage form E: Same inactive ingredients

A: Product has an approved NDA or ANDA B: Same active ingredients C: Bioequivalent to reference product D: Same dosage form

Fillomena T. Firefly "Fill" a pharmacist, receives a prescription for oxycodone 15mg, 100 tabs, but only has 10 in stock. She calls her colleague, Rufus Hammer, in the pharmacy across the street and Rufus tells her he can spare a bottle of 100 tablets. Fill says she will take them. In order to legally sell the oxycodone, Rufus must: A: Receive a 222 Order Form properly completed (copies 1 and 2), complete copy 1 and 2 (amount sold), send copy 2 to the DEA; copy 3 stays with Fill B: Execute a 222 Order Form by properly completing the form, keep copy 3 and send copies 1 and 2 to Fill's pharmacy C: Rufus may loan the oxycodone on the condition it is returned ASAP D: Sell the oxycodone pursuant to an invoice E: Rufus may not sell these under any circumstance

A: Receive a 222 Order Form properly completed (copies 1 and 2), complete copy 1 and 2 (amount sold), send copy 2 to the DEA; copy 3 stays with Fill

Which of the following are exempted from reporting to the prescription monitoring program A: Samples B: Schedule V prescription-requiring C: Methadone D: All prescriptions from veterinarians E: Naloxone

A: Samples

Select each correct answer. You discover that the physical inventory for diazepam 5mg tablets is five short of what you should have after subtracting records of dispensing from records of receipt. What factors are relevant to determine whether this is "significant". A: The volume of diazepam 5mg dispensed in your pharmacy B: Patterns associated with shortages of other controlled substances C: Strange behavior by co-workers D: Significance does not matter, you are required to report this

A: The volume of diazepam 5mg dispensed in your pharmacy B: Patterns associated with shortages of other controlled substances C: Strange behavior by co-workers

Which one of the following FDA programs are "compassionate use" providing patient access to medication outside of clinical trial (Select all that apply) A: Treatment IND B: Parallel track C: Expedited approval D: Paper NDA E: Prescription drug user fee

A: Treatment IND B: Parallel track

A patient approaches you to transfer a prescription for tramadol from another community pharmacy in the 'chain' that you work for. The chain has a centralized database of prescription drug information. Under federal law: A: Yes you may do this without contacting the other site if the database will automatically record the transaction and the refill B: Yes you may do this but you must contact the other site and complete the "transfer" procedure under federal law C: Yes you may do this, but it is a one-time transfer and all remaining refills are retained at the originating pharmacy D: No, this is a C-IV controlled substance and this is not permitted

A: Yes you may do this without contacting the other site if the database will automatically record the transaction and the refill

You receive a prescription for 180 oxycodone 5mg with instructions to take "1 tablet every 4 hours as needed for pain". It is issued by an oncologist, you have no reason to suspect forgery and you know that the patient is suffering from severe pain associated with metastasis to the bone. The patient's medical record indicates that has been treated for opiate addiction recently having received several weeks of Suboxone (buprenorphine) therapy. Can you fill this oxycodone prescription? A: Yes, there is a legitimate medical purpose B: Yes, it does not look like a forgery and this is your only concern C: No, this patient has been treated for opiate dependence and should not receive an opiate D: No, tolerance may develop

A: Yes, there is a legitimate medical purpose

You receive a faxed order for a 30-day supply of Oxycontin 80mg "1 tablet 2x daily" for a patient at a long-term care facility. A: You may fill this prescription as is B: You may fill this but only if it is an emergency, and then only enough for the emergency period C: You may fill this only if it is an emergency, and then only up to a maximum 5-day supply D: You may not fill this without a written prescription E: You may only fill this if it is delivered electronically

A: You may fill this prescription as is

You receive a faxed order for a 30-day supply of lorazepam 1mg, "take 1 tablet 2x daily" for a patient at a long- term care facility. A: You may fill this prescription as is B: You may fill this but only if it is an emergency, and then only enough for the emergency period C: You may fill this, and a follow-up "Authorization for Emergency Dispensing" is required within 7 days D: You may not fill this without a written prescription E: You may only fill this if it is delivered electronically

A: You may fill this prescription as is

To obtain approval for a therapeutically equivalent generic mediation, which of the following is required A: New drug application B: Abbreviated new drug application C: Supplemental new drug application D: IND (investigational new drug) application

B: Abbreviated new drug application

Which of the following is/are C-III (select all correct answers) A: Human Chorionic Gonadotropin (HCG) B: Anabolic steroids C: Butalbital with acetaminophen D: Acetaminophen 325mg with codeine 15mg E: Dronabinol capsules F: Butalbital with aspirin G: Paregoric (camphorated tincture of opium)

B: Anabolic steroids D: Acetaminophen 325mg with codeine 15mg E: Dronabinol capsules F: Butalbital with aspirin G: Paregoric (camphorated tincture of opium)

Concerning the Drug Quality and Security Act of 2013 A: Congress explicitly gave FDA authority to regulate samples in this law B: Congress explicitly gave FDA authority to regulate outsourcing facilities C: Congress explicitly gave FDA authority to require a Risk Evaluation and Mitigation Strategy when safety is a concern D: Congress explicitly gave FDA authority to regulate biosimilars

B: Congress explicitly gave FDA authority to regulate outsourcing facilities

An "authorized generic" Select all that apply A: May not be substituted in Virginia because there is no NDA or ANDA to support "therapeutic equivalence" B: Does not require an NDA or an ANDA to get on the market C: Has been placed on the market by the NDA holder D: Requires a 505(b)2 application to get on the market E: Requires an NDA to get on the market

B: Does not require an NDA or an ANDA to get on the market C: Has been placed on the market by the NDA holder

Fillomena T. Firefly ("Fill"), a pharmacist, receives a prescription for oxycodone 15mg, 100 tabs, but only has 10 in stock. She calls her colleague, Haywood Jabuzzoff, in the pharmacy across the street and Haywood tells her he can spare a bottle of 100 tablets. Fill says she will take them. In order to legally obtain the oxycodone, Fill must: A: Receive a 222 Order Form properly completed, complete copy 1 and 2 (amount sold), send copy 2 to the DEA, with copy 3 retained by Haywood's pharmacy B: Execute a 222 Order Form by properly completing the form, keep copy 3 and send copies 1 and 2 to Haywood's pharmacy C: Have Haywood loan the oxycodone on the condition it is returned ASAP D: Purchase the oxycodone pursuant to an invoice E: Haywood may not sell these under any circumstance

B: Execute a 222 Order Form by properly completing the form, keep copy 3 and send copies 1 and 2 to Haywood's pharmacy

Which of the following is/are C-V (select each correct answer) A: Meprobamate (Miltown) B: Lacosamide (Vimpat) C: Buprenorphine sublingual tablets (Subutex) D: Promethazine with codeine (10mg/5ml) liquid E: Tapentadol F: Paregoric (camphorated tincture of opium) G: Loperamide

B: Lacosamide (Vimpat) D: Promethazine with codeine (10mg/5ml) liquid

According to the regulatory scheme created by Congress, outsourcing facilities (Please select each correct choice) A: Must meet standards of USP 797 (sterile products) and USP 795 (non-sterile) B: Must be properly registered with FDA and comply with other regulations to enjoy a "safe harbor" C: May dispense products to hospitals, medical clinics, and other purchasers without a prescription D: Are primarily established for sterile products, but may also produce non-sterile products E: Are permitted to dispense directly to patients under the "outsourcing facility" registration

B: Must be properly registered with FDA and comply with other regulations to enjoy a "safe harbor" C: May dispense products to hospitals, medical clinics, and other purchasers without a prescription D: Are primarily established for sterile products, but may also produce non-sterile products

Which of the following is the beyond use date for a non-sterile, non-aqueous compounded product A: Not later than 30 days, or the expiration date of any API B: Not later than 6 months, or the expiration date of any API C: Not later than 14 days when stored at controlled cold temperatures D: Thirty (30) hours at controlled room temperature, or 9-days in the refrigerator, or 45 days in the freezer

B: Not later than 6 months, or the expiration date of any API

You have repackaged 100 doses of clonidine 0.1mg from the bulk bottle into individual unit doses on November 1, 2018. The original expiration date was January 1, 2021. What is the expiration date of the repackaged unit doses? A: January 1, 2021 B: November 1, 2019 C: December 1, 2019 D: August 1, 2019

B: November 1, 2019

When dispensing a 72-hour supply of cephalexin 500mg to be administered at one capsule every six hours, how many "back-up" doses are permissible? A: Zero B: One C: Two D: Four

B: One

Which of the following is both adulterated and misbranded A: Medication dispensed in the absence of proper CRP (child-resistant packaging) B: Oral, solid medication dispensed without an identifying code on each tablet/capsule C: Medication that is filthy, putrid or decomposed D: Prescription-requiring medication dispensed without required Medication Guide

B: Oral, solid medication dispensed without an identifying code on each tablet/capsule

Which of the following is, or may be, both adulterated and misbranded (please select each correct answer) A: Medication dispensed in the absence of proper CRP (child-resistant packaging) B: Oral, solid medication dispensed without an identifying code on each tablet/capsule C: Medication whose tamper-resistant elements are not present D: Prescription-requiring medication dispensed without "adequate directions for use"

B: Oral, solid medication dispensed without an identifying code on each tablet/capsule C: Medication whose tamper-resistant elements are not present

The "corresponding responsibility" of pharmacists (Please select each correct answer.) A: Relates to the requirement that an offer to counsel the patient is made B: Permits only prescriptions that are issued in the usual course of professional practice C: Requires pharmacists to be satisfied that a controlled substance prescription is for a legitimate medical purpose D: Requires pharmacists to fill controlled substance prescriptions precisely as written, without question

B: Permits only prescriptions that are issued in the usual course of professional practice C: Requires pharmacists to be satisfied that a controlled substance prescription is for a legitimate medical purpose

Which of the following insulins do not require a prescription (Select each correct answer) A: Glargine B: Regular C: Aspart D: Neutral protamine Hagedorn E: Glulisine F: Detemir G: NPH-regular 70/30

B: Regular D: Neutral protamine Hagedorn G: NPH-regular 70/30

Which one of the following is not required to obtain a license to practice pharmacy in Virginia A: Pass NAPLEX and MPJE B: Status as United States citizen, or permanent resident C: Good moral character D: Graduate of an accredited school of pharmacy E: At least 18 years-of-age

B: Status as United States citizen, or permanent resident

Please select each correct answer regarding generic substitution in Virginia. A: To permit substitution the prescriber must check the box "substitution permitted" on the prescription B: To prohibit generic substitution the prescriber must write "brand medically necessary" C: The lot number of the product dispensed must be recorded on the prescription D: The name of the manufacturer is recorded on the prescription and the label of the finished prescription dispensed to the patient E: The label of the finished product, dispensed to the patient, must contain "generic for _brand__".

B: To prohibit generic substitution the prescriber must write "brand medically necessary" D: The name of the manufacturer is recorded on the prescription and the label of the finished prescription dispensed to the patient E: The label of the finished product, dispensed to the patient, must contain "generic for _brand__".

Which amendment to the Food, Drug, and Cosmetic Act required proof of bioequivalence compared to the "pioneer" or brand-name drug A: Kefauver-Harris (the Efficacy Amendment) 1962 B: Waxman Hatch (Drug Price Competition and Patent Term Restoration Act) 1984 C: Food and Drug Administration Modernization Act (FDAMA) 1997 D: The Durham-Humphrey Amendments (Prescription Drug Act) 1952

B: Waxman Hatch (Drug Price Competition and Patent Term Restoration Act) 1984

Which amendment to the Food, Drug, and Cosmetic Act required proof of bioequivalence compared to the "pioneer" or brand-name drug A: Kefauver-Harris (the Efficacy Amendment) 1962 B: Waxman Hatch (Drug Price Competition and Patent Term Restoration Act) 1984 C: Food and Drug Administration Modernization Act (FDAMA) 1997 D: The Durham-Humphrey Amendments (Prescription Drug Act) 1952

B: Waxman Hatch (drug price competition and patent term restoration act) 1984

A prescription for buprenorphine without naloxone may be prescribed: A: Only by a physician B: When the formulation is other than tablet C: When converting from methadone D: When there is a demostrated intolerance to naloxone E: Through the state health department X F: When hospitalized for an acute illness

B: When the formulation is other than tablet C: When converting from methadone D: When there is a demostrated intolerance to naloxone

Which of the following must register with DEA as a "distributer"? (Select all that apply) A: Physician assistants B: Wholesalers C: Community pharmacies D: Opioid treatment programs E: Pharmacies when they exceed 5% of total dosage units by "non-prescription" sales

B: Wholesalers E: Pharmacies when they exceed 5% of total dosage units by "non-prescription" sales

A hospice patient presents a prescription for 60 morphine 60mg sustained-release, take 1 tab 2x daily. She requests a 14 days supply today to find out how well it works for her and asks if she could get 28 tabs today and the remainder in a week. You have 300 in stock. Can you grant this request? A: Yes, she has up to 30 days to get the remainder B: Yes, she has up to 60 days to get the remainder C: Yes, she has up to 72 hours to get the remainder D: Yes, but she can not get the remainder

B: Yes, she has up to 60 days to get the remainder

You receive a telephone order for a 30-day supply of Oxycontin 80mg "1 tablet 2x daily" from the physician next door for a patient residing in a nursing home; a written prescription could be delivered by office staff, but it is not not convenient. A: You may fill this prescription as is B: You may fill not fill this without a written prescription, this is not an emergency C: You may fill this but only for a maximum 5-day supply D: You may fill this as ordered, but an Authorization for Emergency Dispensing (follow-up) is required

B: You may fill not fill this without a written prescription, this is not an emergency

Which of the following is/are C-IV (select all correct answers) A: Pregabalin (Lyrica) B: diazepam (Valium) C: Tramadol (Ultram) D: Carisoprodol (Soma) E: Butalbital with aspirin F: Butalbital with acetaminophen G: Phenobarbital

B: diazepam (Valium) C: Tramadol (Ultram) D: Carisoprodol (Soma) G: Phenobarbital

Technicians may do all except which one of the following: A: Enter medication history and Rx information B: Prepare/repackage medication for dispensing C: Accept telephone orders for new prescriptions from prescribers D: Load automated dispensing cabinets and devices E: Prepare labels

C: Accept telephone orders for new prescriptions from prescribers

Automated dispensing cabinets (e.g., "Pyxis") A: Require a separate DEA registration in hospitals B: Are used exclusively for "floor stock" medications C: Are capable of a "running inventory" D: Must be audited at least quarterly

C: Are capable of a "running inventory"

According to the regulations of the Virginia Board of Pharmacy with regard to continuous hours and breaks, which one of the following is incorrect: A: The pharmacist may voluntarily waive any workplace hour limits and break standards B: May be required to work more than 12 hours in an emergency C: Are required to close the pharmacy during the 30-minute break D: May not be compelled to work more than six consecutive hours without a 30-minute break E: May not be compelled to work more than 12 hours in any work-day

C: Are required to close the pharmacy during the 30-minute break

Elements to assure safe use ("ETASU") (choose each correct statement) A: Are included in the 1984 Waxman Hatch amendments (also known as the Drug Price Competition and Patent Term Restoration Act) B: May incude a Medguide or Patient Package Insert C: May include prescribing restrictions D: May be part of a REMS E: May include a restricted distribution program

C: May include prescribing restrictions D: May be part of a REMS E: May include a restricted distribution program

Among other things OBRA 90 A: Created a universal health program for all residents of the United States B: Sought to regulate advertising and promotion of compounded products C: Provided at least one condition of participation in Medicaid D: Was determined to be unconstitutional by the Supreme Court of the United States (SCOTUS) E: Was a direct mandate from Congress for pharmacists to counsel patients

C: Provided at least one condition of participation in Medicaid

The Orphan Drug Act: A: Is widely thought to have resulted from a tragedy involving thalidomide B: Was validated by the case US v. Generix C: Provided, among other things, tax incentives for the manufacturer D: Is a compassionate use program providing access to medication in clinical trials used for life-threatening diseases

C: Provided, among other things, tax incentives for the manufacturer

To prescribe controlled substances in Virginia, "individual practitioners" must be: A: Registered with the Department of Agriculture B: Registered with th FDA C: Registered with the DEA D: Registered with the Department of Internal Revenue

C: Registered with the DEA

For the purposes of receiving telephone orders, an "emergency situation": A: Is required to dispense from a telephone order for CIII-V medications B: Is required to dispense from a fax for CII for a nursing home resident C: Requires no alternative medication is available D: Telephone orders are no longer permitted with the availability of e-prescribing

C: Requires no alternative medication is available

The Virginia Board of pharmacy (Select all that apply) A: Consists of 10 pharmacists and 2 citizen-members B: Are appointed by the Virginia Pharmacy Association on recommendation of the Board of Pharmacy C: Serve four-year terms D: Are lead by an Executive Director who serves as Chair E: Elects a Chair who provides leadership for the Board

C: Serve four-year terms E: Elects a Chair who provides leadership for the Board

Under which circumstances may dispensed medication, that has left the premises, be returned for redispensing (Please select each correct choice) A: When the patient gets their money back B: When it is originally dispensed by mail order C: When the medication is dispensed and returned within a hospital D: Where compendial storage requirements are assured, and it in the original sealed container E: When it is out for delivery and has not left the possession of the delivery agent

C: When the medication is dispensed and returned within a hospital D: Where compendial storage requirements are assured, and it in the original sealed container E: When it is out for delivery and has not left the possession of the delivery agent

You receive a fax order for a 30-day supply of lorazepam 1mg "1 tablet 2x daily" for a patient enrolled in the hospice program. A: You may fill this but only if it is an emergency, and then only enough for the emergency period B: You may fill this but only for a 5-day supply, and a follow-up prescription is required C: You may fill this; no follow-up prescription is required D: You may only fill this if it is delivered electronically

C: You may fill this; no follow-up prescription is required

Chapter 800 of USP A: Creates a quality control process for sterile compounding B: Creates a quality control process for non-sterile compounding C: Creates a quality control process for hazardous medication D: Creates a quality control process for outsourcing facilities

C: creates a quality control process for hazardous medication

Concerning pseudoephedrine regulation: A: It may be sold only in pharmacies B: Sales are restricted to 3.6 grams/day and 9 grams/month by mail order C: It must be sold in "blister packs" or pouches in units of 2 D: The restrictions relate only to liquid forms of the medication

C: it must be sold in "blister packs: or pouches in units of 2

The investigational new drug exemption is an exemption from: A: Income taxes B: Clinical trials C: Pharmaceutical equivalence D: "New drug" liability

D: "New drug" liability

Concerning naloxone dispensing by pharmacies A: Naloxone dispensing requires a prescription B: Naloxone may only be dispensed to patients who have completed the REVIVE! training C: When dispensing naloxone an offer to counsel is sufficient D: A prescription for naloxone is required for patients receiving an opioid and a benzodiazepine E: Is required any time the patient has concomitant opioid and carisoprodol therapy

D: A prescription for naloxone is required for patients receiving an opioid and a benzodiazepine

Which of the following is adulterated Select all that apply A: A producted that is filthy, putrid, or decomposed B: A product that is packaged in clear glass, but should be in light-resistant container C: A product that has been stored at over 90 degrees for two months, and should be stored at room temp D: A product that, when opened, contains a feather

D: A product that, when opened, contains a feather

When completing an inventory of controlled substances: A: You may make an estimate of partial (open) packages of CII when the initial package quantity is 1000 units or greater B: An exact count of all controlled substances is required C: You may estimate partial (open) packages of CIII when the initial package quantity is 1000 units or greater D: An exact count of all CII medication is required

D: An exact count of all CII medication is required

The Drug Efficacy Study implementation ("DESI") A: Was required by the Food, Drug, and Cosmetic Act B: Concerned medication that had never been approved by FDA C: Is ongoing today D: Concerned medication approved by FDA between 1938 and 1962

D: Concerned medication approved by FDA between 1938 and 1962

Which of the following is accurate A: Congress explicitly gave FDA authority to regulate compounding in the Food Drug and Cosmetic Act of 1938 B: Congress explicitly gave FDA authority to regulate compounding in the Prescription Drug User fee Act 1997 C: Congress explicitly gave FDA authority to regulate compounding in Orphan Drug Act of 1983 D: Congress explicitly gave FDA authority to regulate compounding in the Drug Quality and Security Act of 2014

D: Congress explicitly gave FDA authority to regulate compounding in the Drug Quality and Security act of 2014

The policy of the federal government with regard to medical cannabis A: Was explicitly ruled unconstitutional in the case Gonzales v. Raich B: Continues to be "zero tolerance" with regard to state medical cannabis programs C: Has resulted in changing cannabis from Schedule I to Schedule II D: Has become more flexible in recent years with regard to state-regulated programs

D: Has become more flexible in recent years with regard to state-regulated programs

Which one of the following is not a form of medical error A: Omission B: Commission C: Intellectual D: Intentional

D: Intentional

Criminal liability flowing from the practice of pharmacy A: Happens more frequently than administrative liability B: Happens more frequently than civil/malpractice liability C: No pharmacist has ever been charged with a crime following a dispensing error D: Is exceedingly rare

D: Is exceedingly rare

The three-pronged approach of the Commonwealth for promoting competence in professional pharmacy practice includes which one of the following: A: Pharmacy school - APPEs - Post graduate CE B: Pre-clinical - Clinical - Post-clinical C: Constitution - Statute - Regulation D: Licensing - Professional conduct - Continuing education

D: Licensing - Professional conduct - Continuing education

You receive a prescription at your community pharmacy for methadone and the patient informs you that it is to prevent immediate withdrawal from addiction to heroin. There are no other indications. Can you legally fill this prescription? A: Yes, methadone is approved for this purpose. B: Yes, there are no legal restrictions regarding methadone. C: No, methadone is a C-I controlled substance and is only permitted to be used in research. D: No, methadone may be dispensed from the pharmacy for analgesic purposes, but not to prevent immediate withdrawal.

D: No, methadone may be dispensed from the pharmacy for analgesic purposes, but not to prevent immediate withdrawal.

The Secure and Responsible Disposal Act of 2010 A: Addressed the compounding problem highlighted by the New England Compounding Center B: Requires FDA to make regulations about disposal of unwanted/unused medication C: Requires the Federal Trade Commission to make regulations about removing inappropriate direct to consumer advertising of medication D: Requires DEA to make regulations that will create a process for disposal of unused/unwanted controlled substances

D: Requires DEA to make regulations that will create a process for disposal of unused/unwanted controlled substances

The Secure and Responsible Disposal Act of 2010 A: Addressed the compounding problem highlighted by the New England Compounding Center B: Requires FDA to make regulations that will create a process for disposal of unwanted/unused controlled substances C: Requires the Federal Trade Commission to make regulations about removing inappropriate direct to consumer advertising of medication D: Requires DEA to make regulations that will create a process for disposal of unused/unwanted controlled substances

D: Requires DEA to make regulations that will create a process for disposal of unused/unwanted controlled substances

Which amendment to the Food, Drug, and Cosmetic Act gave FDA authority to determine whether a medication is OTC or will require a prescription. A: Kefauver-Harris (the Efficacy Amendment) 1962 B: Waxman Hatch (Drug Price Competition and Patent Term Restoration Act) 1984 C: Food and Drug Administration Modernization Act (FDAMA) 1997 D: The Durham-Humphrey Amendments (Prescription Drug Act) 1952

D: The Durham-Humphrey Amendments (Prescription Drug Act) 1952

Co-prescribing naloxone with opioids is required A: With any prescription for chronic pain B: When the prescription for acute pain exceeds a 7-day supply C: When the daily morphine milligram equivalent (MME) exceeds 100mg D: When there is concomitant prescription for lorazepam E: When there is concomitant prescription for gabapentin

D: When there is concomitant prescription for lorazepam

Vandazole (metronidazole 0.75% vaginal gel) is an example of: A: Unapproved new drug B: Authorized generic C: Therapeutic equivalent D: Improved generic

D: improved generic

"Therapeutic equivalence" as defined by FDA requires all of the following EXCEPT (i.e., which one is not required): A: Product has an approved NDA or ANDA B: Same active ingredients C: Bioequivalent to reference product D: Same dosage form E: Same inactive ingredients

E: Same inactive ingredients

You have received a prescription for a controlled substance from Lucretia P. Driftwood, a (female) Nurse Practitioner. Her DEA number is MH7251376. Which of the following are true? I. The DEA number is invalid because the check digit does not match the 7th digit II. The DEA number is invalid because the second letter does not match the first letter of her last name III. The DEA number is invalid because the first letter is incorrect.

I only

Prescriptions may be filed as follows: I. Three separate files: CII's, CIII-V's, and non-controls II. Two separate files: CII's, and CIII-VI III. Two separate files: CII-V's and CVI's

I, II and III

Buprenorphine mono-product (Subutex) i. Shall not exceed 3% of prescription for buprenorphine by any prescriber ii. May be prescribed for patients with a genuine intolerance iii. May be prescribed at the preference of the patient

i and ii

To prescribe controlled substances in Virginia, "individual practitioners" must be: i. Permitted by state law ii. Registered with the DEA iii. Registered with the Board of Pharmacy

i and ii

In Virginia technician competence i. Is established by completing training and passing an exam ii. Is established by the pharmacist in charge iii. Is maintained by obtaining minimum 5 hours of continuing education each year

i and iii

In Virginia, outsourcing facilities i. Must maintain all required records for at least two (2) years ii. Are in business to compete with traditional pharmaceutical manufacturers iii. Must be registered/permitted with both FDA and VBoP, regardless of physical location

i and iii

MedGuides are required for: i. NSAIDS ii. Anti-depressants iii. Oral contraceptives

i and iii

Pursuant to the FDA's Orange Book which of the following would be correct? i. FDA-approved drugs that are bioequivalent and pharmaceutically equivalent to the reference product are presumed to be therapeutically equivalent ii. A-rated drugs are not bioequivalent iii. Most state generic substitution laws prohibit pharmacists from substituting products not rated as bioequivalent

i and iii

The landmark case US v. Sullivan (decided by the US Supreme Court) i. Established that Congress 'interstate commerce' power extends to dispensing by a pharmacist even though it is completely 'intra-state' in nature ii. Determined that the FDA's paper new drug application policy ("Paper NDA") is inconsistent with the Drug Efficacy (Kefauver-Harris) amendments to the Food, Drug, and Cosmetic Act iii. Established that pharmacy practice could be regulated by federal law

i and iii

The Drug Price Competition and Patent Term Restoration Act (also known as Waxman-Hatch) i. Enacted the Abbreviated New Drug Application process ii. Established a regulatory process for samples iii. Established informed consent as a requirement to admitting patients into clinical trials

i only

You receive an emergency telephoned prescription for hydrocone 5mg/acetaminophen 325mg. The pharmacist immediately reduces the order to writing and properly prepares and dispenses the prescription. i. Follow-up prescription (Authorization For Emergency Dispensing) within 7 days ii. Maximum 5-day supply iii. Follow-up prescription (Authorization For Emergency Dispensing) within 72 hours

i only

Prior to closing for greater than one week, a pharmacy shall i. Post a notice at least 30-days in advance ii. Mail notice to any patient with refills at least 14 days in advance iii. Notify the Board of Pharmacy at least 14 days in advance

i, ii and iii

"Dispense" under the CSA includes which of the following: i. Administering a controlled substance (e.g., an injection) ii. Prescribing a controlled substance iii. Dispensing a controlled substance by a community pharmacy

i, ii, and iii

Among other things the "Prescription Monitoring Program" database i. Requires the prescriber's ID# ii. The dispenser's ID# iii. The method of payment

i, ii, and iii

Which of the following conditions must be met for a controlled substance prescription to be issued? i. the prescriber must be an "individual practitioner" ii. the prescriber must be authorized by state law to prescribe controlled substances iii. the prescriber must be registered with DEA, or qualify under an exception

i, ii, and iii

Grounds for an action against your license (e.g., probation, suspension, fine, etc.) include i. negligence ii. practice beyond the scope of the profession iii. practice constituting danger to public health

i, ii, iii

Among other things OBRA 90: i. created an individual mandate to purchase health insurance ii. required states to make medication counseling by pharmacists a condition of participation in Medicaid iii. was originally targeting only Medicaid patients, but has been broadened by every state to all patients

ii and iii

An "authorized generic" i. May not be substituted in Virginia because there is no NDA or ANDA to support "therapeutic equivalence" ii. Does not require an NDA or an ANDA to get on the market iii. Has been placed on the market by the NDA holder

ii and iii

Pursuant to the FDA's Orange Book which of the following would be correct? i. FDA-approved drugs that are bioequivalent and pharmaceutically equivalent to the reference product are presumed to be therapeutically equivalent ii. A-rated drugs are not bioequivalent iii. Most state generic substitution laws prohibit pharmacists from substituting products not rated as bioequivalent

ii and iii

To formally add a new clinical indication to a drug with an approved NDA (or ANDA) the proponent must i. File a New Drug Application (NDA) ii. File an Supplemental NDA iii. Complete additional clinical trials

ii and iii

Which of the following agencies regulate controlled substances? i. The federal agency is called the Federal Trade Commission ("FTC") ii. The Virginia state agency is called the Board of Pharmacy iii. The federal agency is called the Drug Enforcement Administration ("DEA")

ii and iii

Which of the following would be correct regarding records of receipt by a pharmacy for controlled substances i. Invoices are acceptable records for all schedules of drugs ii. DEA Form 222 or CSOS is required for Schedule II medication iii. An invoice is required for Schedules III-V

ii and iii

An "authorized" generic: i. Is approved under a "505(b)2" NDA ii. Must demonstrate therapeutic equivalence to the brand name product iii. Does not require an Abbreviated New Drug Application (ANDA)

iii only

CV controlled substances: i. Are limited to 5 refills within 6 months ii. Must contain the following on the prescription label dispensed to the patient "Caution: Federal law prohibits transfer of this drug to any person other than the patient for whom it is intended" iii. Under federal law may be dispensed without a prescription if the statement "Rx-only" is not present (i.e., "non-legend" drug)

iii only

Concerning a unit-dose distribution system i. There may be up to a 72-hour supply when administered by licensed personnel ii. This may only be operated through an automated dispensing cabinet iii. The medication must be securely stored ("locked") at the nursing units

iii only

The "corresponding responsibility" rule: i. relates to the requirement that patients are equally responsible for success in medication therapy ii. relates to the rule that counseling may not be delegated iii. requires pharmacists to be satisfied that a controlled substance prescription is for a legitimate medical purpose

iii only

The landmark case United States v. Generix Drug Corp. (decided by the US Supreme Court) i. Established that pharmacy practice could be regulated by federal law ii. Established that Congress 'interstate commerce' power extends to dispensing by a pharmacist though it is completely 'intra-state' in nature iii. Determined that the FDA's paper NDA (generic drug application) policy was inconsistent with the Drug Efficacy (Kefauver-Harris) amendments requiring proof of efficacy

iii only