Pharmacy Law Midterm
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
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)
"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 to obtain inventory in a medical office (i.e., for "office use")
A: An order for a controlled drug dispensed to a patient at a community pharmacy.
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: Articles 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
Which of the following is/are "mid-level" practitioners? Please choose each correct answer A: Certified registered nurse anesthetists B: Podiatrists C: Optometrists D: Nurse midwives E: Dentists
A: Certified registered nurse anesthetists C: Optometrists D: Nurse midwives
Which of the following is a schedule II? Please select each correct answer. 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 2013 (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
(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.
Which of the following is/are C-V (select all correct answers) A: Ezogabine B: Lacosamide C: Camphorated tincture of opium (paregoric) D: Gabapentin E: Lyrica F: Lomotil G: Epidiolex
A: Ezogabine B: Lacosamide D: Gabapentin E: Lyrica F: Lomotil G: Epidiolex
You have received a prescription for a controlled substance from Lucretia P. Driftwood, a (female) Nurse Practitioner. Her DEA number is MH7251376: 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. A: I only B: III only C: I & II D: II &III only E: I, II, &III
A: I only The DEA number is invalid because the check digit does not match the 7th digit
According to the regulatory scheme created by Congress, a compounded product that conformed to all of the requirements established in the DQSA (Please select each correct choice) A: Is in a "safe harbor" B: Is "adulterated" C: Is required to follow USP 795 or USP 797 guidelines D: Is an "authorized generic"
A: Is in a "safe harbor" C: Is required to follow USP 795 or USP 797 guidelines
The "public interest" standard, as applied by the Department of Justice through the DEA (select each correct answer) A: Is the lens used for reviewing applications for registration B: Is the lens used for reviewing the DEA-222 form C: Would take into account the presence of a 'supporting' state license D: Would take into account the ability to participate in Medicaid and/or Medicare E: Would take into account any act that is inconsistent with the public interest
A: Is the lens used for reviewing applications for registration C: Would take into account the presence of a 'supporting' state license D: Would take into account the ability to participate in Medicaid and/or Medicare E: Would take into account any act that is inconsistent with the public interest
The "public interest" standard, as applied by the Department of Justice through the DEA (select each correct answer) A: Is the lens used for reviewing applications for registration B: Is the lens used for reviewing the DEA-222 form C: Would take into account the presence of a 'supporting' state license D: Would take into account the ability to participate in Medicaid and/or Medicare E: Would take into account any act that is inconsistent with the public interest
A: Is the lens used for reviewing applications for registration C: Would take into account the presence of a 'supporting' state license D: Would take into account the ability to participate in Medicaid and/or Medicare E: Would take into account any act that is inconsistent with the public interest
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: Physician assistants E: Dentists
A: Nurse practitioners B: Pharmacists C: Optometrists D: Physician assistants
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
(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
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' where you work. 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 at your community pharmacy for suboxone and the patient informs you that it is to prevent immediate withdrawal from addiction to heroin. There is no evidence of chronic pain, and the prescription is correct in all other ways. Can you legally fill this prescription? A: Yes, suboxone has an FDA-approved indication for this purpose. B: Yes, there are no legal restrictions regarding suboxone. C: No, suboxone is a C-II controlled substance and is only permitted to be used in research. D: No, suboxone may be dispensed from the pharmacy for analgesic purposes, but not to prevent immediate withdrawal.
A: Yes, suboxone has an FDA-approved indication for this purpose.
You receive a prescription at your community pharmacy for suboxone and the patient informs you that it is to prevent immediate withdrawal from addiction to heroin. There is no evidence of chronic pain, and the prescription is correct in all other ways. Can you legally fill this prescription? A: Yes, suboxone is approved for this purpose. B: Yes, there are no legal restrictions regarding suboxone. C: No, suboxone is a C-II controlled substance and is only permitted to be used in research. D: No, suboxone may be dispensed from the pharmacy for analgesic purposes, but not to prevent immediate withdrawal.
A: Yes, suboxone is approved for this purpose.
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
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 A: i, ii, and iii B: iii only C: i only D: i and ii only E: ii and iii only
A: i, ii, and iii i. Administering a controlled substance (e.g., an injection) ii. Prescribing a controlled substance iii. Dispensing a controlled substance by a community pharmacy
The beyond use date (BUD) for a sterile product containing two reconstituted components in a 100ml solution (medium risk) stored in the refrigerator is: A: 14 days B: 9 days C: 7 days D: 3 days
B: 9 days
To obtain approval for a therapeutically equivalent generic medication, 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)
Which of the following is a schedule III? Please select each correct answer. A: Codeine 15mg tablets B: Codeine 15mg with acetaminophen 325mg tablets C: Butalbital 50mg (a barbiturate) with acetaminophen 325mg tablets D: Dronabinol 2.5mg capsules E: Modafinil 100mg tablets F: Ezogabine 100mg G: Dianabol 10mg
B: Codeine 15mg with acetaminophen 325mg tablets D: Dronabinol 2.5mg capsules G: Dianabol 10mg
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 X E: Tapentadol F: Lomotil (diphenoxylate with atropine) G: Loperamide
B: Lacosamide (Vimpat) D: Promethazine with codeine (10mg/5ml) liquid F: Lomotil (diphenoxylate with atropine)
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 active pharmaceutical ingredient (API) B: Not later than 6 months, or the expiration date of any active pharmaceutical ingredient (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 active pharmaceutical ingredient (API)
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-evident 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-evident 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
The Thompson v. Western States Medical Center case was a reaction by pharmacists to 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
B: The Food and Drug Administration Modernization Act of 1997
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 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: Meprobamate (Miltown) F: Secobarbital suppositories G: Modafinil (Provigil)
B: diazepam (Valium) C: Tramadol (Ultram) D: Carisoprodol (Soma) E: Meprobamate (Miltown) G: Modafinil (Provigil)
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 Food and Drug Administration (FDA) A: I only B: ii only C: i and iii D: ii and iii E: I, ii, and iii
B: ii only The Virginia state agency is called the Board of Pharmacy
According to federal law, 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. May be dispensed without a prescription if the statement "Rx-only" is not present in labeling (i.e., "non- legend" drug) A: i only B: iii only C: i and ii D: ii and iii E: i ii and iii
B: iii only May be dispensed without a prescription if the statement "Rx-only" is not present in labeling (i.e., "non- legend" drug)
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) A: i only B: iii only C: i and ii D: ii and iii E: i ii and iii
B: iii only Under federal law may be dispensed without a prescription if the statement "Rx-only" is not present (i.e., "non-legend" drug)
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 FDAs paper NDA (generic drug application) policy was inconsistent with the Drug Efficacy (Kefauver-Harris) amendments requiring proof of efficacy A: i only B: iii only C: i & iii only D: ii &iii only E: i, ii, &iii
B: iii only iii. Determined that the FDAs paper NDA (generic drug application) policy was inconsistent with the Drug Efficacy (Kefauver-Harris) amendments requiring proof of efficacy
An "authorized" generic: i. Is approved under a "505(b)2" NDA ii. Must prove safety and efficacy through clinical trials iii. Does not require an Abbreviated New Drug Application (ANDA) A: i only B: iii only C: i and iii D: ii and iii only E: i, ii, & iii
B: iii only iii. Does not require an Abbreviated New Drug Application (ANDA)
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 A: i only B: iii only C: i and ii only D: ii and iii only E: i, ii, and iii
B: iii only requires pharmacists to be satisfied that a controlled substance prescription is for a legitimate medical purpose
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
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 A: I only B: III only C: I & II D: II &III only E: I, II, &III
C: I & II (UNDER VA LAW) I. Three separate files: CII's, CIII-V's, and non-controls II. Two separate files: CII's, and CIII-VI OR E: I, II, & III (UNDER FEDERAL LAW) 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
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
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
The Orphan Drug Act: A: Is widely thought to have resulted from a tragedy involving thalidomide B: Was validated by the case Thompson v. Western States Medical Center C: Provided incentives for the manufacturer to develop products with limited market potential D: Is a compassionate use program providing access to medication in clinical trials used for life-threatening diseases
C: Provided incentives for the manufacturer to develop products with limited market potential
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 incentives for the manufacturer to develop products with limited market potential D: Is a compassionate use program providing access to medication in clinical trials used for life-threatening diseases
C: Provided incentives for the manufacturer to develop products with limited market potential
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 that no alternative medication is available D: Telephone orders are no longer permitted with the availability of e-prescribing
C: Requires that no alternative medication is available
You receive a fax order for a 30-day supply of methylphenidate 10mg "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
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 FDAs 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 A: i only B: iii only C: i & iii D: ii & iii E: i, ii, &iii
C: i & iii i. Established that Congress interstate commerce power extends to dispensing by a pharmacist even though it is completely 'intra-state' in nature iii. Established that pharmacy practice could be regulated by federal law
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 A: i only B: iii only C: i and ii D: ii and iii E: i ii and iii
C: i and ii i. Permitted by state law ii. Registered with the DEA
The Drug Price Competition and Patent Term Restoration Act (also known as Waxman-Hatch) i. Enacted the Abbreviated New Drug Application process ii. Required generic drug companies to pay a "user fee" to enter the market iii. Required generic drug companies to prove bioequivalence to the brand name product A: i only B: iii only C: i and iii D: ii and iii E: i, ii, and iii
C: i and iii i. Enacted the Abbreviated New Drug Application process iii. Required generic drug companies to prove bioequivalence to the brand name product
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. Sufficient supply to cover the emergency period A: i, ii, and iii B: i only C: i and iii D: ii and iii E: iii only
C: i and iii i. Follow-up prescription (Authorization For Emergency Dispensing) within 7 days iii. Sufficient supply to cover the emergency period
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 A: i only B: iii only C: ii and iii D: i and iii E: i, ii & iii
C: ii and iii ii. File an Supplemental NDA iii. Complete additional clinical trials
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
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
Which of the following is accurate A: Congress explicitly gave FDA authority to regulate compounding in the Food Drug and Cosmetic Act B: Congress explicitly gave FDA authority to regulate compounding in the Prescription Drug User fee Act C: Congress explicitly gave FDA authority to regulate compounding in Orphan Drug Act D: Congress explicitly gave FDA authority to regulate compounding in the Drug Quality and Security Act
D: Congress explicitly gave FDA authority to regulate compounding in the Drug Quality and Security Act
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
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
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
Pursuant to the FDAs 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. The FDA requires pharmacists only dispense products that are rated "therapeutically equivalent" to the reference product iii. Most state generic substitution laws prohibit pharmacists from substituting products not rated as bioequivalent A: i only B: iii only C: ii and iii D: i & iii E: i, ii, & iii
D: i & iii i. FDA-approved drugs that are bioequivalent and pharmaceutically equivalent to the reference product are presumed to be therapeutically equivalent iii. Most state generic substitution laws prohibit pharmacists from substituting products not rated as bioequivalent
MedGuides are required for: i. Proton pump inhibitors ii. Fluoroquinolones iii. Anti-depressants A: i only B: iii only C: i and ii D: ii and iii E: i, ii, and iii
D: ii and iii ii. Fluoroquinolones iii. Anti-depressants
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 A: i only B: iii only C: i and ii D: ii and iii E: i, ii, and iii
D: ii and iii 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
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 drug ii. DEA Form 222 or CSOS is required for Schedule II medication iii. An invoice is required for Schedules III-V A: i only B: iii only C: i and iii D: ii and iii E: i, ii, & iii
D: ii and iii ii. DEA Form 222 or CSOS is required for Schedule II medication iii. An invoice is required for Schedules III-V
You are presented with a prescription for 60 methadone 5mg tablets for a patient with chronic pain; directions to take "1 tab, orally, twice daily" delivered to you at your community pharmacy. You have 100 tablets in stock. She says she wants try a 5-day supply (10 tablets) it to see if it works, and if it does work will pick up the remainder. Without adding facts, please select the single best answer. A: You can give her the 5-day supply, but may not supply the remainder B: You can give her only a 3-day supply, and must supply the remainder within 72 hours C: She can give her the 5-day supply requested, but must be able to supply the remainder within 72 hours D: You are not permitted to dispense methadone to this patient since this is not an opioid treatment program E: You may dispense the 5-day supply, and supply the remainder within 30 days of writing
E: You may dispense the 5-day supply, and supply the remainder within 30 days of writing
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 A: i only B: iii only C: ii and iii D: ii and iii E: i, ii, & iii
E: i, ii, & iii 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
According to federal law, prescriptions may be filed as follows: i. Three separate files: CII's, CIII-V's, and non-controls ii. Two separate files: CII's in one, and CIII-V's plus non-controls in another (as long as controls are readily retrievable) iii. Two separate files: one for controls and another for non-controls (i.e., Virginia C-VI) A: i only B: iii only C: i and ii only D: ii and iii only E: i, ii, and iii
E: i, ii, and iii i. Three separate files: CII's, CIII-V's, and non-controls ii. Two separate files: CII's in one, and CIII-V's plus non-controls in another (as long as controls are readily retrievable) iii. Two separate files: one for controls and another for non-controls (i.e., Virginia C-VI)
