MPJE: Federal Pharmacy Law Q&A - Controlled Substances and Labeling Regulations, Exams of Law

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MPJE: Federal Pharmacy Law (Q &A) 1) Which of the following reference sources include selected laws and regulations for controlled substances? a) facts and comparisons b) physician's desk reference c) USP DI Volume I d) USP DI Volume II e) USP DI Volume III - the answer is e) USP DI Volume III 2) The statement "Rx only" does NOT need to appear on the packing of a) orphan drugs b) controlled substances c) legend drugs d) OTC products e) injectable products - the answer is d) OTC products 3) Controlled substances prescriptions may be issued by prescribers I. to obtain controlled substances for dispensing in their office II. to prescribe drugs to be used by a patient for narcotic detoxification III. to prescribe controlled substance for a patient with chronic pain MPJE: Federal Pharmacy Law (Q &A) a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is b) III only 4) Which government body is responsible for funding and overseeing state Medicaid programs? a) DHHS b) CMS c) FDA d) NABP e) USP/NF- - the answer is b) CMS 5) A pt presents a prescription for 60 Empirin w/ codeine tables No. 4 to his local pharmacy and indicates that he would only like to get 30 of the tablets now and will return for the other 30 in a week. The pharmacist should: a) call the prescriber to get permission to dispense 30 b) dispense 30 as requested by the pt c) advise the pt that the full 60 tablets must be supplied at one time MPJE: Federal Pharmacy Law (Q &A) 10) In which of the following situations are child-resistant closure NOT required? I) when a community pharmacist dispenses fewer than 10 tablets of a drug product II) when a hospital pharmacy is filling a prescription for an outpatient III) when a hospital pharmacy fills a prescription for an inpatient a) I only b) III only c) I & II only d) II & III only e) I, II, & III- - the answer is b) III only 11) Under which one of the following circumstances may a pharmacist refuse to fill a prescription? a) the quantity of the controlled drug has been changed b) the pharmacists does not know the pt c) the pt is an alcoholic d) the prescription was written a week ago MPJE: Federal Pharmacy Law (Q &A) e) the prescriber is from another city- - the answer is a) the quantity of the controlled drug has been changed 12) What is the longest "beyond use" expiration date that a pharmacist may place on a prescription container if the original drug container label states "expiration date 1/2013"? Assume pharmacist fills the prescription on January 2, 2010 a) 7/2/10 b) 1/2/11 c) 7/2/11 d) 1/1/13 e) 1/31/13- - the answer is b) 1/2/11 13) The organization responsible for overseeing the selection of a non-propriety name for a new drug is the: a) FDA b) FTC c) APhA d) USF/NF e) USAN- - the answer is e) USAN MPJE: Federal Pharmacy Law (Q &A) 14) Which of the following entities must register in order to participate in the prescribing or dispensing of isotretinoin I. Prescribers II. Pharmacies III. Drug wholesalers a) I only b) III only c) I & II only d) II & III only e) I, II, & III- - the answer is e) I, II, & III 15) The use of an FDA approved drug for a use that is not approved for the drug is best described as being: a) Illegal b) terminal c) orphan d) off-label e) unprofessional- - the answer is d) off-label 16) Controlled substance prescriptions MPJE: Federal Pharmacy Law (Q &A) I. the prescription is valid not more than 60 days from the issue date II. the pharmacist must write "LTCF patient" on the prescription III. the total quantity dispensed cannot exceed 100 dosage units a) I only b) III only c) I & II only d) II & III only e) I, II, & III- - the answer is c) I & II only 20) The Marketing Act of 1987 guarantees a company that discovers, patents, and develops a new drug exclusive marking rights for up to: a) 50 years b) 10 years c) 17 years d) 20 years e)100 years- - the answer is d) 20 years 21) Which of the following products are Schedule III controlled substances? MPJE: Federal Pharmacy Law (Q &A) I. Percodan tablets II. Fiorinal Capsules III. Tylenol with Codeine #4 a) I only b) III only c) I & II only d) II & III only e) I, II, & III- - the answer is d) II & III only 22) Certain drug products are exempt from the requirement therapeutic equivalence because of: I. the grandfather clause II. their use in chemotherapy III. their high therapeutic index a) I only b) III only c) I & II only d) II & III only e) I, II, & III- - the answer is a) I only MPJE: Federal Pharmacy Law (Q &A) 23) The selling of drug samples in pharmacies is prohibited by which one of the following Federal acts? a) DSHEA b) Prescription drug marketing act c) Durham Humphrey Amendment d) Sherman Act E) Drug price competition act- - the answer is b) prescription drug marketing act 24) Which of the following actions is (are) NOT allowed in a community pharmacy with respect to prescription drug samples? I. Storing II. Ordering based upon a specific prescriber's request III. dispensing upon receipt of a prescription a) I only b) III only c) I & II only d) II & III only e) I, II, & III- - the answer is e) I, II, & III MPJE: Federal Pharmacy Law (Q &A) 29) The presence of which of the following drugs or adjuvants in a commercial drug product requires a special label warning? I. methylparaben II. sulfites III. aspartame a) I only b) III only c) I & II only d) II & III only e) I, II, & III- - the answer is d) II & III only 30) All of the following drugs fall into the category of "grandfathered drugs" EXCEPT a) thyroid b) ephedrine c) epinephrine d) phenobarbital e) ampicillin - the answer is e) ampicillin MPJE: Federal Pharmacy Law (Q &A) 31)The statement: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" is not required for I. controlled substances dispensed for use in "blinded" clinical investigations II. dispensing Schedule V drugs III. dispensing controlled substances to be administered to a pt in an institution a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is e) I, II, & III 32) The National Drug Code (NDC) consists of a series of a) letters only b) letters and numbers c) numbers only d) numbers and symbols e) symbols only - the answer is c) numbers only MPJE: Federal Pharmacy Law (Q &A) 33) Hospital inpatients receiving oral estrogen therapy must receive pt package inserts a) every day b) only with the first dose c) only at the first dose and when being discharged d) at least every 7 days e) at least every 30 days - the answer is e) at least every 30 days 34) Which of the following was the first to require that pharmaceutical manufacturers prove the safety of prescription drugs before marketing? a) Durham-Humphrey Amendment of 1951 b) Prescription Drug Marketing Act of 1987 c) Kefauver-Harris Amendment of 1962 d) F D & C of 1938 e) Pure food and drug act of 1906 - the answer is D) F D & C of 1938 35) To be admitted to a comprehensive maintenance program, narcotic-dependent individuals must have been physiologically dependent on narcotics for at least MPJE: Federal Pharmacy Law (Q &A) II. Only if the household does not have small children III. For limited use in a weight-loss program a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is A) I only 41) The original portion of the Form 222 is eventually kept on file by the A) DEA B) Supplier C) FDA D) Purchaser E) Prescriber - the answer is B) Supplier 42) Which of the following reference sources contain significant information concerning the bioequivalence of drug products? I Electronic Orange book II USP/DI III USP/NF MPJE: Federal Pharmacy Law (Q &A) a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is C) I & II only 43) Which one of the following reference sources is the first choice when a manufacturer is determining the preferred name of an additive for a product label? A) CTFA Cosmetic Ingredient Dictionary B) Food Chemical Codex C) USAN D) USP Dictionary of Drug Names E) USP/NF - the answer is E) USP/NF 44) According to federal law, a pharmacist must include which of the following on a prescription label? I Name of dispensing pharmacy II address of dispensing pharmacy III name of dispensing pharmacist a) I only b) III only c) I & II only MPJE: Federal Pharmacy Law (Q &A) d) II & III only e) I, II, & III - the answer is C) I & II 45) Under which of the following conditions may a pharmaceutical sales representative distribute samples of a prescription drug product? I Upon written request from a community pharmacy II Upon written request from a hospital pharmacy III Upon written request from a physician a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is B) III only 46) An orphan drug is one that has A) been removed from the market because of toxicity B) has been discontinued because of poor sales C) provided special economic incentives for the manufacturer D) has a low therapeutic index MPJE: Federal Pharmacy Law (Q &A) II. A US Public Health Service physician III. A foreign-trained physician a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is C) I & II only 52) Excipients included in pharmaceutical dosage forms are usually found on which of the following lists? A) DSHEA B) HPLC C) GRAS D) Top 200 E) USP - the answer is C) GRAS 53) The requirement for over-the-counter drugs to have "adequate directions for use" A) Means that the directions will be clear to a layperson for safe use of the product B) Applies only to products intended for oral consumption C) applies only to products for pediatric use MPJE: Federal Pharmacy Law (Q &A) D) includes the listing of potential side effects and toxicity E) includes the presence of bilingual directions - the answer is A) Means that the directions will be clear to a layperson for safe use of the product 54) Labels of OTC products that are for systemic use must include a warning specifically intended to protect: I pregnant women II nursing women III geriatric women a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is C) I & II only 55) Which of the following is/are true regarding the sale of codeine-containing schedule V cough medicine without a prescription I only a pharmacist may dispense the product to the consumer II a non-pharmacist may "ring up" the sale and collect payment for the product MPJE: Federal Pharmacy Law (Q &A) III Not more than 120mL or 24 dosage units of this product may be sold to the same purchaser in any 7 day period a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is C) I & II only 56) Which of the following controlled drugs may a pharmacist mail through the US postal service I. Schedule II's II. Schedule III's III. Schedule IV's a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is E) I, II, & III MPJE: Federal Pharmacy Law (Q &A) 62) which of the following types of products in a hospital pharmacy must be barcoded? I prescription drugs II biological III nonprescription drugs a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is E) I, II, & III 63) the expiration on a commercial pharmaceutical product is July 2013. The actual date that this product will be considered expired will be after: A) June 30th B) July 1st C) July 15th D) July 31st E) August 1st - the answer is D) July 31st 64) Controlled substance inventories I. may be done at any time during the workday II must be taken at least once each year MPJE: Federal Pharmacy Law (Q &A) III must be made for each registered location a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is B) III only NOTE: But, if you also figure in the state requirements, the correct answer would be D) II & III only 65) Which of the following statements concerning Medicare Plan D is/are correct? I The plan is voluntary for persons on Medicare II Insurance companies may limit prescription drug quantities to 30 day supplies for some drugs III Insurance companies may require participants to receive prescriptions from mail order pharmacies a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is C) I & II only MPJE: Federal Pharmacy Law (Q &A) 66) The primary objective or charge for individual state boards of pharmacy is the A) protection of the general public B) protection of the profession C) protection of individual pharmacists D) enforcement of federal laws E) serving as an intermediary between chain, independent and institutional pharmacies - the answer is A) Protection of the general public 67) Two generic companies manufacture a specific drug in several dosage forms. Which one of the dosage forms is MOST likely to present problems with bioequivalence? A) tablet B) capsule C) oral solution D) parenteral solution E) Aerosol - the answer is E) Aerosol 68) Hospitals that plan on using large quantities of tax- free grain alcohol should obtain which of the following forms? A) ATF 11 B) ATF 222 C) DEA 222 MPJE: Federal Pharmacy Law (Q &A) a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is A) I only NOTE: If he does not specify federal law only, the correct answer should actually be c) I & II only 73) According to federal law, a pharmacist must include which of the following on a prescription label? I A prescription serial number II The name of the manufacturer III Expiration date from the manufacturer's label a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is A) I only 74) When refilling a prescription that requires a child- resistant container, the pharmacist must always replace which of the following I the glass container MPJE: Federal Pharmacy Law (Q &A) II the plastic container III The plastic closure a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is D) II & III only 75) HCFA is under the jurisdiction of the A) Attorney General B) HHS C) JCAHO D) FDA E) Dept. of Justice - the answer is B) HHS 76) A pharmacy that compounds many prescriptions may be cited by the FDA of the volume of its prescriptions being sent out-of-state is in excess of ______% A) 2 B) 5 C) 10 D) 20 MPJE: Federal Pharmacy Law (Q &A) E) 50 - the answer is B) 5 % 77) the advertising to the general public of OTC drugs is basically under the regulatory responsibilities of the: A) FTC only B) FDA and FTC C) FDA only D) DEA E) HCFA - the answer is A) FTC only 78) A pharmacy has been compounding a psoriasis cream in 30 gram jars based upon prescriptions written by physicians at a local dermatology clinic. Under which of the following circumstance could the pharmacy also dispense the jars? I For patients of other prescribers based upon written prescriptions II To the original dermatology clinic for dispensing by the dermatologists III To other pharmacies provided they provided a written purchase order a) I only b) III only c) I & II only MPJE: Federal Pharmacy Law (Q &A) C) Schedule IV D) Schedule V E) Noncontrolled - the answer is B) Schedule III 84) A pharmacist who does not receive a registration renewal form from DEA within 45 days before the expiration of his/her registration must notify I his/her state's board of pharmacy II the regional FDA III the DEA in writing and request renewal forms a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is B) III only 85) The maximum volume of Ipecac Syrup that may be sold without a prescription is A) 15 mL B) 120 mL C) 60 mL D) 30 mL E) 240 mL - the answer is D) 30 mL MPJE: Federal Pharmacy Law (Q &A) 86) Patients treated in an ambulatory care comprehensive narcotic treatment program may receive methadone doses by which of the following routes? I IV II IM III oral a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is B) III only 87) The total number of digits in the NDC number present on a pharmaceutical package may be: A) 2 or 3 B) 5 or 6 C) 8 or 9 D) 10 or 11 E) 15 or 16 - the answer is D) 10 or 11 MPJE: Federal Pharmacy Law (Q &A) 88) Which of the following protocols must a hospital pharmacy follow in order to possess pharmaceutical manufacturer's drug samples? I The hospital must be registered as a drug wholesaler II The hospital must store the samples separate from the regular stock III A licensed practitioner must have requested the samples from the company a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is d) II & III only 89) Which of the following actions by a company offering Medicare Plan D coverage is(are) NOT permitted? I charging a $250 deductible II eliminating an deductible charge to the patient III limiting the choice of pharmacies to only one community chain a) I only b) III only c) I & II only MPJE: Federal Pharmacy Law (Q &A) B) Durham-Humphrey Amendment of 1951 C) FD and C act of 1938 D) Kefauver-Harris Amendment of 1962 E) Poison Prevention Act - the answer is C) FD & C Act of 1938 95) Under which of the following conditions may practitioners of "Traditional Chinese Medicine" sell ephedra-containing products? A)The level of ephedra is less than 1 mg/dose B) Only a 10 day supply of product is sold C) The label does not indicate that the product is a dietary supplement D) A prescription is issued for the product E) Sales are not legal - the answer is C) The label does not indicate that the product is a dietary supplement 96) Which of the following must be present on the labels of nonprescription drug products intended for oral use? A) Sodium content of active ingredients B) total sodium content of both active and inactive ingredients C) Sodium chloride content of active ingredients D) Total sodium chloride content of both active and inactive ingredients MPJE: Federal Pharmacy Law (Q &A) E) no requirements have been established - the answer is B) total sodium content of both active and inactive ingredients 97) After dispensing prescriptions for several months for a schedule II analgesic, the pharmacist realizes that a patient with severe pain from bone cancer is addicted to the drug. Which one for the following actions is the most appropriate for the pharmacist? A) Report the situation to the state board of pharmacy B) Report the situation to the state medical board C) Report the situation to the DEA D) Refuse to fill an further prescriptions E) Continue to fill the prescriptions - the answer is E) Continue to fill the prescriptions 98) When conducting controlled substance inventory, the registrant I. must make an exact count of open containers of schedule II substances II. may estimate the count of a schedule IV substance in an open container that originally held 500 tablets III. must make an exact count of all controlled substances in sealed, unopened containers a) I only b) III only MPJE: Federal Pharmacy Law (Q &A) c) I & II only d) II & III only e) I, II, & III - the answer is E) I, II, & III 99) Which of the following statements concerning drug recalls is (are) accurate? I They occur only after fatalities have occurred II they may be ordered by the FDA III They may be voluntary actions by the pharmaceutical manufacturer a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is D) II & III only 100) Which of the following is true about DEA form 222? I If it contains incorrect information the supplier may correct it and initial the correction II If an order cannot be filled by a supplier the form must be returned to the purchaser III If any forms are lost, the loss must be reported to the DEA MPJE: Federal Pharmacy Law (Q &A) E) never - the answer is D) Once a year 105) A DEA form 222a is used A) to order Schedule II controlled substances B) to order all controlled substances C) to return unused controlled substances D) as a requisition form for Form 222 E) to register a practitioner with DEA - the answer is D) as a requisition form for Form 222 106) The label of a parenteral product is not required to list the presence of a(an): A) inert gas B) buffer system C) antimicrobial preservative D) antioxidant E)) chelating agent - the answer is A) inert gas 107) A pharmacist may fill prescriptions for and mail which of the following drugs through the US Postal Service? I Schedule II non-narcotics II Benzodiazepines III Schedule II narcotics MPJE: Federal Pharmacy Law (Q &A) a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is E) I, II, & III 108) Which of the following drug products must be purchased by pharmacies using DEA Form 222? I Strattera II MS Contin III Concerta a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is D) II & III 109) Which one of the following types of information is useful but not mandatory on the labels of OTC products? A) name of manufacturer B) address of manufacturer C) net contents MPJE: Federal Pharmacy Law (Q &A) D) adequate directions for use E) NDC number - the answer is E) NDC number 110) Dronabinol is a Schedule III controlled substance that is related most closely to A) cocaine B)marijuana C) LSD D) morphine E) methylphenidate - the answer is B) marijuana 111) Which of the following is true of DEA Form 222? I May be used to transfer Schedule II drugs from one pharmacy to another II May be used to return Schedule II drugs to the supplier III It must contain the name and address of the supplier from whom schedule II controlled substances are being ordered a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is E) I, II, & III MPJE: Federal Pharmacy Law (Q &A) a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is C) I & II only 117) A pharmaceutical manufacturer has withdrawn a drug from the market since it was deemed by the FDA to be ineffective. Under which one of the following conditions may a pharmacy volunteer to compound capsules of the drug for patients? A) only if 14 day supplies of the capsules are dispensed B) If a physician writes the prescription specifying "medically necessary" C) If the capsule strength is one-half or less than the original commercial capsule D)Only specific physicians write for the prescriptions E) If the pharmacy is willing to be cited for violations of FDA guidelines for compounding - the answer is E) If the pharmacy is willing to be cited for violations of FDA guidelines for compounding 118) When a pharmacist conducts a controlled substance inventory, which of the following must be included MPJE: Federal Pharmacy Law (Q &A) I Drugs stored in a warehouse for the registrant at a different location II Drugs ordered by a customer but not yet paid for III All controlled substances dispensed over the past 30 days a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is C) I & II only 119) Which of the following is NOT required on the label of unit dose packages prepared in a hospital? A) name of the drug B) beyond-use expiration dating C) control number D) strength of drug E) manufacturer's expiration date - the answer is E) manufacturer's expiration date 120) "Grandfathered" drugs are A) often not listed in the Orange Book B) found in the Orange Book as Code B only MPJE: Federal Pharmacy Law (Q &A) C) found in the Orange Book as Code AB only D) to be prescribed only by generic name E) found in the Orange Book as Code A only - the answer is A) often not listed in the Orange Book 121) What is the time interval during which newly eligible individuals may enroll in Medicare Plan D without a penalty? A) 3 months B) 6 months C) 7 months D) 9 months E) 1 year - the answer is C) 7 months 122) The USP/NF is best described as a publication that is published by: A) the HHS B) the FDA C) the Pharmaceutical Manufacturer's Association D) an independent organization E) a coalition of US pharmaceutical companies - the answer is D) an independent organization MPJE: Federal Pharmacy Law (Q &A) d) II & III only e) I, II, & III - the answer is b) III only 127) Which of the following volumes of the USP DI contains significant information concerning the bioequivalence of drug products? I. Volume I II. Volume II III. Volume III a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is b) III only 128) A drug that is marketed for the treatment of a relatively rare disease is referred to as a(n): A) orphan drug B) me-too drug C) prodrug D) USAN drug E) first pass effect drug - the answer is A) orphan drug MPJE: Federal Pharmacy Law (Q &A) 129) What acronym is used by the USP to designate sterile products that are prepared in a home infusion pharmacy for delivery to a patient's home residence? A) SP B) LVP C) PPI D) HSD E) TRP - the answer is D) HSD 130) With respect to pregnancy warnings, category D indicates that the drug A) is safe for 98% of all females during pregnancy B) should not be used during the first trimester C) should be administered only if the potential benefits are acceptable despite the potential risks D) should not be used during pregnancy E) does not pose any danger to either the mother or fetus - the answer is C) should be administered only if the potential benefits are acceptable despite the potential risks 131) A hospital that has two 55-gallon drums of tax-free grain alcohol must: A) report the amount remaining to the ATF every six months MPJE: Federal Pharmacy Law (Q &A) B) inventory the stock every month C) inventory the stock every 6 months D) maintain a running inventory of the volume E) take a year-end inventory - the answer is D) maintain a running inventory of the volume 132) the names of which of the following ingredients are required to be included on the labels of pharmaceutical products I. flavoring oils II coloring agents III antimicrobial preservatives a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is d) II & III only 133) If a specific lot of a pharmaceutical company's tablets fails to meet the expected expiration dating, the lot may be considered to be: A) adulterated B) unstable MPJE: Federal Pharmacy Law (Q &A) C) FTC only D) DEA E) HCFA - the answer is B) FDA and FTC 138) Which of the following conditions must exist for the inspection of a pharmacy by an authorized inspector? I. inspection must be conducted during the regular business hours of the pharmacy II. The owner of the pharmacy or a designated supervising pharmacist must be present III. The inspector must have a search warrant a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is a) I only 139) Samples of prescription drugs received from the pharmaceutical companies may be A) given to patients by the prescriber B) dispensed from a hospital pharmacy for inpatients C) dispensed from a hospital to outpatients D) sold through community pharmacies MPJE: Federal Pharmacy Law (Q &A) E) traded to another pharmacy for other drugs - the answer is A) given to patients by the prescriber 140) Which of the following items must be ordered from a wholesaler on DEA order form 222? I Morphine HCL injection 10 mL vials (10mg/mL) II Meperidine HCL tablets 50 mg III diazepam tablets 10 mg a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is c) I & II only 141) Ephedra may no longer be present in which of the following products in a community pharmacy? I) nonprescription drug products II) Herbal teas III) Dietary supplements a) I only b) III only c) I & II only MPJE: Federal Pharmacy Law (Q &A) d) II & III only e) I, II, & III - the answer is b) III only 142) Eszopiclone is an example of a drug product in controlled substance schedule A) I B) II C) III D) IV E) V - the answer is D) IV 143) The label of a bottle of Ipecac Syrup sold OTC for accidental poisoning must: I. have its warnings printed in red ink II. contain the telephone number of the regional poison control center III. state that the appropriate dose is the entire bottle followed by a full glass of water a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is a) I only MPJE: Federal Pharmacy Law (Q &A) I. not more than 6 times II. not more than for a 6 month period III. only if authorized by the prescriber a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is d) II & III only 149) Phenobarbital is a drug that is classified as a(n) A) Schedule III drug B) OTC drug C) Schedule V drug D) non-controlled drug E) schedule IV drug - the answer is E) schedule IV drug 150) The federal act that specifically limits the reimportation of drug products that were previously exported by a pharmaceutical manufacturer is the: A) Prescription Drug Marketing Act of 1987 B) Durham-Humphrey Amendment 1951 C) FD & C Act of 1938 MPJE: Federal Pharmacy Law (Q &A) D) DSHEA E) Kefauver-Harris Amendment of 1962 - the answer is A) Prescription Drug Marketing Act of 1987 151) Which of the following may a nurse in a doctor's office perform, with the prescriber's permission, with regard to a Schedule II prescription? I. write the prescription and sign prescriber's name II. write the prescription except for the drug name, strength, quantity and prescriber's name III write the entire prescription except for signing the prescriber's name a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is b) III only 152) A pharmaceutical company requests the names and addresses of patients who have received a certain antidepressant drug during the past month I. Honoring this request will represent a breach of privacy based upon the Federal Health Insurance Portability and Accountability Act MPJE: Federal Pharmacy Law (Q &A) II. The request is appropriate if the company only wishes to send the patients information concerning depression III. The request may be honored if the company gives the pharmacist an affidavit that a list of the patients' names and addresses will not leave the company a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is a) I only 153) Which of the following are mid-level practitioners? I. Podiatrists II. Nurse Midwives III. Nurse Practitioners a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is d) II & III only MPJE: Federal Pharmacy Law (Q &A) 158) Under which of the following situations would a drug product be considered misbranded? I. An original bottle labeled 50 tablets contains 60 tablets II. The concentration of tetracaine ointment 5% W/W is only 2% III. The manufacturer can not prove the sterility of a labeled "sterile Diphenhydramine Injection a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is a) I only 159) Which of the following is (are) true of practitioners who prescribe controlled substances electronically? I. They must provide appropriate two-factor authentication credentialing II. They may issue prescriptions for up to 3 patients simultaneously with a single signature III. They may only prescribe Schedule III, IV, and V drugs electronically a) I only MPJE: Federal Pharmacy Law (Q &A) b) III only c) I & II only d) II & III only e) I, II, & III - the answer is a) I only 160) Which of the following employees may administer or dispense drugs to patients as part of a narcotic treatment program? I. Pharmacists II. Registered Nurses III. Licensed practical nurses a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is e) I, II, & III 161) Who must be registered with the DEA in order for a hospital pharmacy to dispense controlled substances? I. Every pharmacist who dispenses on a regular basis II. The chief pharmacist III. The hospital pharmacy MPJE: Federal Pharmacy Law (Q &A) a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is b) III only 162) While presenting a talk on drug abuse, a pharmacist is asked for information concerning the "date-rape drug". Her response may include which of the following? I. The drug is a schedule II substance II. The generic name for the drug is gamma- hydroxybutyric acid III. The therapeutic classification of the drug is as a behavioral depressant and hypnotic a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is b) III only 163) Which of the following drug products are controlled substances? I. Lyrica MPJE: Federal Pharmacy Law (Q &A) I. at any time as long as it is followed by a written "cover" prescription II. If a patient is a resident of a LTCF III. If the patient is a hospice patient a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is d) II & III only 168) All of the following would be considered as incidences of misbranding EXCEPT A) one of the active drug in a product is not identified on the label B) the original bottle of 60 contains only 50 tablets C) the names of inactive ingredients are not on the label D) the level of alcohol in the product is 5% V/V but the label states 15% V/V E) the pharmacist dispenses a drug product without the required prescription authorization - the answer is D) the level of alcohol in the product is 5% V/V but the label states 15% V/V MPJE: Federal Pharmacy Law (Q &A) 169) Which of the following drug products is/are NOT classified as a controlled substance? I. Toviaz II. Ramelteon III. Actiq a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is c) I & II only 170) A pharmacist may refuse to accept or fill a prescription under all of the following circumstances EXCEPT when: A) the prescription is suspected to be either forged or fictitiously written B) the pharmacist believes that the drug product may be harmful to the patient C) the pharmacist believes that he will be violating the law by filling the prescription D) the drug or drug product is not in stock E) the patient is known to be HIV positive - the answer is E) the patient is known to be HIV positive MPJE: Federal Pharmacy Law (Q &A) 171) A product that contains not more than 1.8 g of codeine per 100 mL is considered to be in Schedule A) I B) II C) III D) IV E) V - the answer is C) III 172) A pharmacist may issue a Power of Attorney to an individual in order to permit the individual to I. fill controlled substance prescriptions II. conduct a narcotic treatment facility III. complete DEA Form 222 orders a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is b) III only 173) Which of the following apply to prescription for Accutane? I . not more than a one month supply may be dispensed II. The prescription must be filled within 30 days of issue MPJE: Federal Pharmacy Law (Q &A) E) Anti-terrorist protection - the answer is A) de- indentification 178) A pharmacist may partially fill a Schedule II prescription I. and the remaining portion of the prescription may be filled within 72 hr of the partial fill II. if the pharmacist does not have enough medication in stock to completely fill the prescription III. If the patient only wants some of the medication prescribed. a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is c) I & II only 179) A statement that a specific OTC product has a tamper evident feature may be placed in any of the following locations EXCEPT on the: A) closure B) front of the package C) back of the package D) under the product name MPJE: Federal Pharmacy Law (Q &A) E) on the tamper evident device - the answer is E) on the tamper evident device 180) A pharmacy that compounds large numbers of prescriptions may be cited by the FDA if its volume of prescriptions being sent out-of-state is in excess of ___% A) 25 B) 75 C) 40 D) 10 E) 5 - the answer is E) 5 181) Pharmacists are required to periodically inventory supplies of which of the following drug products? I. Sonata capsules II. Entex Liquid III. Sudafed Plus Liquid a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is A) I only MPJE: Federal Pharmacy Law (Q &A) 182) Which of the following categories of drugs require the legend "Rx only" to be on the manufacturer's package I. Schedule V controlled drugs II. Schedule II controlled drugs III Schedule III and IV controlled drugs a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is d) II & III only 183) The iPLEDGE program is intended to assure appropriate and safe dispensing of which one of the following drugs A) pravastatin B) isotretinoin C) neviraprine D) sildenafil E) thalidomide - the answer is B) isotretinoin 184) A pharmacist confides in his hospital's chief pharmacist that he has tested positive for HIV. Which of the following statements is(are) true? MPJE: Federal Pharmacy Law (Q &A) II A product on the shelf for sale past its expiration date III A sterile parenteral solution contains a few microorganisms a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is e) I, II, & III 189) Proposed regulations from the FDA are first published in the: A) Federal Register B) Congressional Record C) New York Times and Wall Street Journal D) USP/NF E) Supplements of the USP/NF - the answer is A) Federal Register 190) Which of the drug products used to treat narcotic dependence is (are) administered sublingually? I. Methadone II. Subutex III Suboxone MPJE: Federal Pharmacy Law (Q &A) a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is b) III only the correct answer would probably actually have to be D) II & III only as both of those are delivered sublingually to treat narcotic dependence (reference: Lexi-Comp) 191) Under which of the following circumstances may Ipecac Syrup be sold without a prescription I. If the purchaser signs a pharmacy log book for the sale II. only if the household does not have small children III. for future potential use during accidental poisoning a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is b) III only 192) A pharmaceutical manufacturer requests from a community pharmacy the names and addresses of patients receiving the company's antidepressant so that a MPJE: Federal Pharmacy Law (Q &A) special discount coupons may be provided for future prescriptions. The scenario is probably in violation of which of the following laws A) DSHEA B) FDA Modernization Act 1997 C) OBRA 90 D) HIPAA E) Sherman Antitrust Act - the answer is D) HIPAA 193) Which of the following drug products may be purchased by a pharmacy WITHOUT the use of a DEA Form 222? I. Lortabs II. Marinol Capsules III. Stadol Injections a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is a) I only MPJE: Federal Pharmacy Law (Q &A) d) II & III only e) I, II, & III - the answer is e) I, II, & III 198) A hospital pharmacy director is informed that an employee has been convicted of selling cocaine on the street. Which of the following actions may the director take based upon the Federal Anti-drug Abuse Act of 1988? I. warn the employee not to possess or sell illegal drugs in the future II. place a letter of reprimand in the employee's personnel file III. terminate the employment of the individual a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is e) I, II, & III 199) Which of the following is TRUE of Schedule II controlled substances? I. They may be dispensed by a community pharmacist only pursuant to a written prescription signed by the practitioner MPJE: Federal Pharmacy Law (Q &A) II. They may be administered or dispensed by a physician without a prescription to a patient with chronic pain III. They may be administered by an institutional pharmacists pursuant to an order for immediate administration to the ultimate user a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is e) I, II, & III 200) A patient presents a prescription for MS Contin 30 mg tablets #60 to his local pharmacy and indicates that he would only like to get 30 of the tablets now and will return for the other 30 in a week if the medication agrees with him. The pharmacist should A) call the prescriber to get permission to dispense 30 B) dispense 30 tablet as requested by the patient C) advise the patient that the full 60 tablets must be supplied at one time D) fill the prescription as requested by the patient but advise the patient that the balance must be picked up within 72 hours MPJE: Federal Pharmacy Law (Q &A) E) dispense 30 tablets of the 60 mg strength of MS Contin - the answer is C) advise the patient that the full 60 tablets must be supplied at one time 201) Major objectives for developing a formulary include: I. give prescribers a greater latitude of drug seletion II. Allow therapeutic substitution III. reduce drug inventory a) I only b) III only c) I & II only d) II & III only e) I, II, & III - the answer is d) II & III only 202) Which of the following are Schedule IV controlled substances? I. zolpidem II. buprenorphine III. methylphenidate a) I only b) III only c) I & II only