Law nj rxpharmacy quesrions exam

Pataasin ang iyong marka sa homework at exams ngayon gamit ang Quizwiz!

Which of the following should be part of Drug Utilization Review? I. Drug-food interaction. II. Duplication of therapy. III. Direction for use. a. I only b. I and II only c. II and III only d. All

A Drug Utilization review may include: ________________________________ 1. known allergies. 2. rational therapy-contraindication. 3. reasonable dose, direction for use and route of administration. 4. duplication of therapy. 5. drug-drug, drug-food and drug-disease interactions. 6. adverse drug reactions. 7. overutilization or underutilization of prescribed drugs.

A prescription for Methadone for narcotic addiction treatment can be written by an authorized provider without being registered with the Drug Control Unit. a. True b. False

ANswer: (b) False, [New Jersey Controlled Dangerous Substances Act 13:45H-7.7]. A prescription for Methadone for narcotic addiction treatment cannot be written by an authorized provider without being registered with the Drug Control Unit. The dispensing pharmacy must also have a such registration. Nothing in this section shall prohibit a physician who is not specifically registered to conduct a narcotic treatment program from administering (but not prescribing) narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. Not more than one day's medication may be administered to the person or for the person's use at one time. Such emergency treatment may be carried out for not more than three days and may not be renewed or extended. This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.

A prescription for Cephalexin 500 mg has been presented by DS on January 20, 2017 with the direction: 1 cap po qid x 10 days. If the bulk bottle of Cephalexin has an expiration date of Jan/17, what would be the minimum quantity that should be dispensed by the pharmacist? a. 40 b. 0 c. 28 d. 14

Answer: (a) 40. The bulk bottle of Cephalexin has an expiration date of Jan/17, which indicates that the drug will be expiring on January 31, 2017. The prescription is presented on January 20 and is written for 10 days, therefore the pharmacist can fill the whole supply of the drug.

According to New Jersey State Pharmacy Law, if any Schedule V OTC substance is dispensed to one individual more than TEN times within any 12-month period, the pharmacist shall obtain oral or written confirmation from the purchaser's physician as to the continued need for the substance and shall document such confirmation in the Over-the-Counter Schedule V Record Book. TRUE FALSE

Answer: (b) False, [New Jersey Pharmacy Administrative Code 13:39-7.15(b)(8)]. If any Schedule V OTC substance is dispensed to one individual more than FIVE times within any 12-month period, the pharmacist shall obtain oral or written confirmation from the purchaser's physician as to the continued need for the substance and shall document such confirmation in the Over-the-Counter Schedule V Record Book.

A 45-year-old patient comes to the pharmacy and presents a prescription for Zolpidem written by his podiatrist. A pharmacist shall: a. not fill the prescription. b. fill the prescription. c. ask the patient to get a new prescription from an authorized prescriber. d. fill and dispense the prescription after filling out a DEA 222 order form.

Answer: (a) A pharmacist shall not fill the prescription, [New Jersey Controlled Dangerous Substances Act 13:45H-7.4(a) and New Jersey Administrative Code 13:39-7.13]. For a controlled substance prescription drug order to be legal, it must be issued for a legitimate medical purpose by an authorized individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing of controlled substances is upon the prescribing practitioner, but the pharmacist is responsible for the proper filling of the prescription drug order. A registered physician, dentist, veterinarian, or podiatrist authorized by this state to prescribe controlled substances can issue a prescription for controlled substances only in the usual course of his or her professional practice. Therefore, a pharmacist shall question the prescription for sleeping pill (Zolpidem) prescribed by a registered podiatrist.

Which of the following pharmacies may perform a prospective drug review in a Centralized Processing System? a. Central Processing Pharmacy b. Central Fill Pharmacy c. Dispensing Pharmacy d. Intake Pharmacy

Answer: (a) Central Processing Pharmacy, [New Jersey Administrative Code 13:39 4.19]. The four component functions of handling a prescription in centralized processing system are intake, processing, fulfillment and dispensing. Central prescription handling entails two or more licensed pharmacies sharing responsibility for performing the four component functions of handling a prescription. The following pharmacies may engage in central prescription handling: an intake or originating pharmacy; a central processing pharmacy; a central fill pharmacy; and a dispensing pharmacy. The four component functions of handling a prescription shall be performed by the following pharmacies: 1). An intake or originating pharmacy, which is a pharmacy that received the patient's or prescribing practitioner's request to fill or refill a prescription. 1A). A central processing pharmacy or a central fill pharmacy may be considered the intake or originating pharmacy if the prescription was transmitted by the prescribing practitioner directly to the centralized pharmacy or if the patient requested the refill from that pharmacy; 2). A central processing pharmacy, which is a pharmacy that engages in prescription review by performing functions that may include, but are not limited to, data entry, prospective drug review, refill authorizations, interventions, patient counseling, claims submission, claims resolution and adjudication; 3). A central fill pharmacy, which is a pharmacy engaging in central prescription handling by filling and/or refilling prescriptions, which includes the preparation and packaging of the medication; and 4). A dispensing pharmacy, which is a pharmacy that receives the processed prescription and/or the filled or refilled prescription for dispensing to the patient or to the patient's authorized representative and that offers patient counseling regarding the dispensed medication.

Checking for therapeutic duplication by pharmacists before dispensing a drug/device is generally classified as: I. Prospective DUR II. Retrospective DUR III. Triospective DUR a. I only b. II only c. III only d. II or III only

Answer: (a) DUR is normally defined as Drug Utilization Review, [OBRA-90, New Jersey Pharmacy Act 45:14-66(27)(a),(b),(c) and 42USC 1396r-8(g)(2)(B)]. A DUR which is done before dispensing medication to a patient is generally considered as a Prospective or Concurrent DUR. The advantage of such a DUR is that one has scope to eliminate error that can be harmful to patients. The type of study which occurs after dispensing of the medications is defined as Retrospective DUR. a. A pharmacist shall conduct a drug utilization review before each new medication is dispensed or delivered to a patient. b. A pharmacist shall conduct a prospective drug utilization review in accordance with the provisions of this section before refilling a prescription or medication order to the extent he deems appropriate in his professional judgment. c. A pharmacist shall exercise independent professional judgment as to whether or not to dispense or refill a prescription or medication order. In determining to dispense or refill a prescription or medication order, the decision of the pharmacist shall not be arbitrary but shall be based on professional experience, knowledge or available reference materials.

A pharmacist in charge shall check the accuracy of the data of a drug-dispensing device: a. Daily b. Weekly c. Biweekly d. Monthly

Answer: (a) Daily, [New Jersey Pharmacy Administrative Code 13:39-9.17(a)]. (a). Where the use of a drug-dispensing device is approved as an integral part of the drug distribution system by the facility, the registered pharmacist-in-charge and the Pharmacy and Therapeutics Committee, the device may be used when the pharmacist is not on duty (absent during either the day or night), provided that any absence of the pharmacist does not exceed 24 hours, or when the pharmacist is on duty, provided that proper review of the use of the drug-dispensing device can be ascertained. The supervision of any drug-dispensing device so utilized shall be the responsibility of the registered pharmacist-in-charge servicing the health care facility. The drug-dispensing device data shall be checked for accuracy every 24 hours by a pharmacist and so documented. (b). Packaging and labeling of medication for drug-dispensing devices, when done in the facility, shall be performed under the immediate personal supervision of a pharmacist in the employ of or under contract to the facility. (c). Stocking of the drug-dispensing devices with prepackaged medications shall be performed by or under the supervision of a pharmacist. (d). The cleanliness of the drug dispensing devices shall be maintained by a pharmacist or by a person under the supervision of a pharmacist. (e). Controlled substances and other medications to which, in the professional judgment of the registered pharmacist-in-charge, access should be limited, shall be secured within the drug dispensing device to limit access to single medications only and shall be checked and documented by the pharmacist or his or her designee who shall be a licensed professional, every 24 hours. Other than a pharmacist, only authorized registered nurses, licensed practical nurses, physicians, authorized prescribers or designated pharmacy technicians, interns and externs shall have access to the medication in each drug-dispensing device. The activity regarding all medication, including the identity of the person accessing the medication, shall be recorded and available to the pharmacist. (f). All medications withdrawn from a drug dispensing device require a medication order by an authorized prescriber. All such medication orders shall be checked by the pharmacist within 24 hours from the time of the original order and so noted on the pharmacy's patient medication profile. (g). When there is no licensed pharmacy on the premises and when the drug-dispensing devices are an integral part of the approved drug distribution system of the facility, the devices shall be controlled by the registered pharmacist-in-charge who is responsible for the pharmaceutical services of the institution. Under these circumstances, the time between medication order checks shall not exceed 24 hours.

In New Jersey, the prescription blanks shall be secured from a vendor approved by: a. Division of Consumer Affairs b. Office of Drug Control c. Drug Enforcement Administration d. Attorney General's Office

Answer: (a) Division of Consumer Affairs, [New Jersey Pharmacy Act 45:14-56(16)(a)]. A practitioner practicing in this State shall use non-reproducible, non-erasable safety paper New Jersey Prescription Blanks bearing that practitioner's license number whenever the practitioner issues prescriptions for controlled dangerous substances, prescription legend drugs or other prescription items. The prescription blanks shall be secured from a vendor approved by the Division of Consumer Affairs in the Department of Law and Public Safety.

Which of the following is/are NOT TRUE about dispensing Schedule V OTC controlled drugs? I. The purchaser should be at least 21 years of age. II. Dispensing should be done by a registered pharmacist. III. A record of dispensing must be entered in a Schedule V bound book. a. I only b. I and II only c. II and III only d. All

Answer: (a) I is not true, [New Jersey Controlled Dangerous Substances Act 13:45H-7.19(a)(1)-to-(5) and New Jersey Pharmacy Administrative Code 13:39-7.15(b)(8)]. The dispensing of Schedule V OTC controlled substances should be done only by registered pharmacist, and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a nonpharmacist). The purchaser should be at least 18 years of age. A record of dispensing must be entered in a Schedule V bound book. 1. No more than 240 cc or 48 dosage units of any controlled substance that contains opium, and no more than 120 cc or 24 dosage units of any other controlled substance, may be dispensed at retail to the same purchaser in any given 48-hour period. The pharmacist must maintain a bound record book with following information: 2. The name and address of purchaser 3. The name and quantity of the Schedule V substance sold 4. The date of the purchase 5. The name or initials of the pharmacist making the sale In addition to this, if any Schedule V substance is dispensed to one individual more than five times within any 12-month period,the pharmacist shall obtain oral or written confirmation from the purchaser's physician as to the continued need for the substance and shall document such confirmation in the Over-the-Counter Schedule V Record Book.

If a prescribing practitioner's authorized agent transmits the facsimile prescription, which of the following shall be required on the facsimile transmission of the prescription? I. The full name and title of the transmitting agent. II. Authorization or identification number provided by a prescribing practitioner's. III. The complete signature of the transmitting agent. a. I only b. I and II only c. II and III only d. All

Answer: (a) I only, [New Jersey Pharmacy Administrative Code 13:39-7.10(e)]. 1. A pharmacist shall not fill a facsimile prescription transmitted by anyone other than a practitioner authorized to prescribe medications or the prescribing practitioner's authorized agent. 2. The facsimile transmission of the prescription shall contain the following: a. The identification number of the facsimile machine which is used to transmit the prescription; b. The date and time of the prescription transmission; c. The name, address, telephone number and facsimile number of the pharmacy; and d. If an authorized agent transmits the facsimile prescription, the full name and title of the transmitting agent.

Which of the following is/are TRUE about prescription records under New Jersey State Pharmacy Law? I. All prescription records, including original and refilled prescription data, and the number of refills authorized by the prescriber shall be maintained for a period of not less than five years. II. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within a month. III. The most recent one year of a record's information shall be retrievable and readable within 72 hours upon request by the Board. a. I only b. I and II only c. II and III only d. All

Answer: (a) I only, [New Jersey Pharmacy Administrative Code 13:39-7.6(c),(d)]. All prescription records, including original and refilled prescription data, and the number of refills authorized by the prescriber, shall be maintained for a period of not less than five years. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of a record information shall be retrievable and readable within one business day.

Which of the following requires a DEA 222 form for purchase? a. Marijuana b. Pemoline c. Modafinil d. Clonazepam

Answer: (a) Marijuana is classified as Schedule I controlled drug, [New Jersey Controlled Dangerous Substances Act 13:45H-10.1 and 13:45H-6.3]. It requires a DEA 222 order form for purchase. Order forms (DEA 222) are required to be kept available for inspection for a period of two years or pursuant to the recordkeeping provisions of the State professional licensing board governing the registrant, whichever is longer. List of Schedule I controlled drugs: ____________________________ Difenoxin (Lyspafen) Dihydromorphine Heroin (Diacetylmorphine, diamorphine) Lysergic acid diethylamide (LSD, lysergide) Marijuana (Cannabis, marijuana) Mescaline Peyote

A licensed practitioner works from two different office locations; office A and office B. The practitioner usually prescribe, administer, dispense and stock controlled substances from office A regularly. From office B, he prescribes controlled substances but neither administers nor otherwise dispenses as a regular part of the professional practice. He, additionally, does not stock controlled substances at office B. Which of the following is TRUE? a. Only office A shall obtain a controlled substance registration. b. Only office B shall obtain a controlled substance registration. c. Neither office A nor office B requires controlled substance registration. d. A separate registration shall be required at each principal place of business; office A and office B.

Answer: (a) Only office A shall obtain the controlled substance registration, [New Jersey Controlled Dangerous Substances Act 13:45H-1.3(h)]. A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, prescribes, or dispenses controlled substances EXCEPT: h). For purposes of registration, the following activities by a registrant shall not be deemed to require an additional registration for a separate location: 1). An office used by a registered manufacturer, distributor or reverse distributor or his agents or employees to solicit or make sales of controlled dangerous substances, provided that no such substances are contained in or distributed from such office. 2). An office used by a registered dispenser where controlled dangerous substances are prescribed, provided that no such substances are administered, delivered, or otherwise dispensed, and no such substances are contained in such office.

Who shall be the responsible for the security of the keys and the security system access code to the pharmacy or pharmacy department? I. Pharmacist-in-charge II. Staff pharmacist III. Pharmacy owner a. I only b. I and II only c. II and III only d. All

Answer: (a) Pharmacist-in-charge, [New Jersey Administrative Code 13:39-4.15(b)(1)]. All entrances to the pharmacy or pharmacy department are capable of being locked and are connected to a monitored security system that transmits an audible, visual or electronic signal warning of intrusion. The security system shall be equipped with a back-up mechanism to ensure notification or continued operation if the security system is tampered with or is disabled. Only the pharmacist-in-charge shall be responsible for the security of the keys and the security system access code to the pharmacy or pharmacy department.

A pharmacist shall notify the Board in writing of any change in his or her address of record within 30 days. a. True b. False

Answer: (a) True, [N.J.A.C. 13:39-3.4]. A pharmacist shall notify the Board in writing of any change in his or her address of record within 30 days. Failure to notify the Board of any change in a pharmacist's address of record may result in disciplinary action and the imposition of penalties.

In New Jersey, closing of a pharmacy for more than 48 hours without a prior Board approval is NOT ALLOWED. a. True b. False

Answer: (a) True, [New Jersey Administrative Code 13:39-4.12(d)]. Any temporary closing of a pharmacy for more than 48 hours shall be reported to and approved by the Board. Notification to the Board shall include contingency plans for accessing patient records. Any temporary closing of more than 48 hours without prior Board approval shall result in the pharmacy being deemed a discontinued pharmacy.

If the immunization program is to take place somewhere other than the pharmacy practice site, the documentation pertaining to immunizations and a signed informed consent form from patient shall be maintained in the licensed pharmacist's possession at the immunization location, not in the pharmacy. a. True b. False

Answer: (a) True, [New Jersey Administrative Code 13:39-4.21(c),(g)(4)]. Documentation which establishes that a licensed pharmacist has satisfied the education and training requirements shall be maintained at the pharmacy practice site. If the immunization program is to take place somewhere other than the pharmacy practice site, the documentation and a signed informed consent form from a patient shall be maintained in the licensed pharmacist's possession at the immunization location. Such documentation shall be made available for inspection by the Board.

The prescription area of a retail pharmacy in New Jersey must be minimum of: a. 50 square feet. b. 150 square feet. c. 250 square feet. d. 500 square feet.

Answer: (b) 150 square feet, [New Jersey Administrative Code 13:39-5.4 (b) and 13:39-12.2(b)]. For pharmacies in operation prior to July 1, 1963, the space devoted to the prescription area and laboratory shall not be less than 10 percent of the main floor area of the pharmacy, and in no instance shall it be less than 50 square feet. If the main floor area of such pharmacy exceeds 1,200 square feet, the 10 percent requirement does not apply and the minimum requirement for the prescription area shall not be less than 120 square feet. For all other pharmacies including pharmacies subject to the provisions of (a) above which are moving to a new location, the prescription area must occupy exclusively a minimum of 150 square feet. A nuclear pharmacy dispensing radioactive drugs may be exempted from the general space requirements for pharmacies.

In the case of death of one of the partners, the permit issued to the partnership shall be terminated and a new pharmacy permit number shall be issued upon request. a. True b. False

Answer: (a) True, [New Jersey Administrative Code 13:39-4.5]. In the case of death of an individual owner or a partner, the permit issued to the deceased owner or to the partnership is terminated and shall be returned to the Board. If the operation of the pharmacy is to be continued, the estate or heirs of the deceased partner and/or the remaining partners shall comply with the requirements set forth in (c) a. When a complete change in ownership occurs and none of the current owners retains any ownership interest, the new owner(s) shall, prior to, or within 10 business days of, such change, submit to the Board a new permit application, the new permit application fee, and an inventory of the pharmacy's controlled substances. A new pharmacy permit number shall be issued upon request. b. When a reallocation of ownership interests occurs among existing owners, the owners shall, prior to, or within 10 business days of, such change, submit to the Board an affidavit explaining the asset reallocation. A new pharmacy permit number shall not be issued upon a reallocation of business assets among existing owners. c. When the existing ownership is changed through the addition of a new owner(s) or the subtraction of an existing owner, the owners shall, prior to, or within 10 business days of, the addition of the new owner(s), submit to the Board a new permit application and the new permit application fee. A new pharmacy permit number shall be issued upon request.

Whenever a pharmacist assumes or terminates the duties as a pharmacist-in-charge of a pharmacy, the pharmacist-in-charge and the permit holder shall so advise the Board in writing within 30 days by completing a form provided by the Board. a. True b. False

Answer: (a) True, [New Jersey Administrative Code 13:39-6.2(e)]. Whenever a pharmacist assumes or terminates the duties as a pharmacist-in-charge of a pharmacy, the pharmacist-in-charge and the permit holder shall so advise the Board in writing within 30 days by completing a form provided by the Board. A pharmacist-in-charge shall be a full-time employee, employed for a minimum of 35 hours per week and shall be physically present in the pharmacy or pharmacy department for that amount of time necessary to supervise.

Medications held for re-dispensing shall be used as soon as possible. Such medications, lacking original lot numbers and expiration dates, shall not be dispensed to patients beyond 12 months from the date the medications were originally prepared for dispensing. a. True b. False

Answer: (a) True, [New Jersey Administrative Code 13:39-7.16]. a). Prescription medication correctly dispensed to a patient may be accepted for return by the pharmacist but shall not be placed in stock for reuse or resale except as provided in N.J.A.C. 13:39-9.18(a)2. b). Prescription medication incorrectly dispensed to a patient shall be accepted for return by the pharmacist and shall not be placed back in stock for reuse or resale. c). Prescription medication that has been prepared for a patient, but which has not been dispensed to the patient, may be placed back in stock for reuse or resale provided that: 1). In the professional judgment of the pharmacist, the prescription medication is eligible for re-dispensing. 2). The prescription medication shall not be placed in manufacturers' stock containers of different lot numbers and/or with different expiration dates; 3). Manufacturers' stock containers shall not be overfilled; 4). In those circumstances in which prescription medications cannot be properly returned to the original manufacturers' stock containers, the medication shall be held in the pharmacy in the labeled container in which it has been repackaged. Prior to redispensing, such medications shall be placed in a new container with a new label or the original label shall be removed and the container shall be relabeled. 5). Medications held for re-dispensing shall be used as soon as possible. Such medications, lacking original lot numbers and expiration dates, shall not be dispensed to patients later than one year from the date the medications were originally prepared for dispensing. Re-dispensed medications shall be marked with the same use by date as the medication which was originally prepared for dispensing. Re-dispensed medications shall be marked with the same use by date as the medication which was originally prepared for dispensing.

The offer to counsel may be made by a pharmacy technician. a. True b. False

Answer: (a) True, [New Jersey Administrative Code 13:39-7.21(b)]. The offer to counsel may be MADE by pharmacy personnel. However, counseling shall be PERFORMED only by a pharmacist, or by a pharmacy intern or pharmacy extern under the immediate personal supervision of a pharmacist consistent with the requirements of N.J.A.C. 13:39-6.2(f)5.

A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation and such refusal is documented. a. True b. False

Answer: (a) True, [New Jersey Administrative Code 13:39-7.21(c)]. A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation and such refusal is documented. The absence of any record of a failure to accept the pharmacist's offer to counsel shall be presumed to signify that the offer was accepted and that the counseling was provided.

A pharmacy filling a prescription for human growth hormone in an outpatient setting, shall collect and electronically transmit to the Division's PMP (Prescription Monitoring Program) vendor on a DAILY BASIS information for each prescription, as specified in the New Jersey PMP Data Collection Manual. a. True b. False

Answer: (a) True, [New Jersey Controlled Dangerous Substances Act 13:45A-35.3]. A pharmacy filling a prescription for a Schedule II, III, IV, or V controlled dangerous substance or for human growth hormone, as defined in N.J.A.C. 13:45A-35.1, in an outpatient setting, shall collect and electronically transmit to the Division's PMP vendor on a daily basis information for each prescription, as specified in the New Jersey PMP Data Collection Manual. A pharmacy that does not dispense Schedule II, III, IV, or V controlled dangerous substances or human growth hormone, or that dispenses Schedule II, III, IV, or V controlled dangerous substances or human growth hormone only to inpatients in a hospital, long-term or other facility in which the residents are provided with 24-hour nursing care, shall apply to the Division for an exemption from the PMP on a form supplied by the Division and available at www.njconsumeraffairs.gov. A pharmacy shall transmit prescription information required by N.J.A.C. 13:45A-35.3 to the PMP vendor on a daily basis pursuant to the schedule established in the Data Collection Manual. Omissions and errors in the transmitted information shall be corrected and submitted as provided in the Data Collection Manual.

Pharmacies may disperse Schedules II, III, IV and V throughout the stock of noncontrolled substances. a. True b. False

Answer: (a) True, [New Jersey Controlled Dangerous Substances Act 13:45H-2.5(a),(b),(d) and (e)]. (a). Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet. (b). Controlled substances listed in Schedules II, III, IV and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances. (c). The registrant shall notify the Drug Control Unit of the theft or loss of any controlled substances upon discovery of such loss or theft. The registrant shall also complete DDC-52 form regarding such loss or theft. (d). Carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.

The hard-copy printout of each day's controlled substance prescription order refill data shall be maintained at that pharmacy for a period of five years from the dispensing date. a. True b. False

Answer: (a) True, [New Jersey Controlled Dangerous Substances Act 13:45H-7.14(f)(3)]. The hard-copy printout of each day's controlled substance prescription order refill data shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist must verify that the data indicated is correct and then sign this document in the same manner as he would sign a check or legal document (e.g., J.H. Smith, or John H. Smith). This document shall be maintained at that pharmacy for a period of five years from the dispensing date. This printout of the day's controlled substance prescription order refill data must be provided to each pharmacy using such a computerized system within 72 hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown. Such a book or file must be maintained at the pharmacy employing such a system for a period of five years after the date of dispensing the appropriately authorized refill. Any such computerized system shall have the capability of producing a printout of any refill data which the user pharmacy is responsible for maintaining under the Act, and its implementing regulations. For example, this would include a refill-by-refill audit trail for any specific strength and dosage form of any controlled substance (by either brand or generic name or both). Such a printout must indicate name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name and identification code of the dispensing pharmacist, and the number of the original prescription order. In any computerized system employed by a user pharmacy, the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours and if a representative of the Drug Control Unit request a copy of such printout from the user pharmacy, it must, if requested to do so by the representative of the Drug Control Unit verify the printout transmittal capability of its system by documentation (for example, postmark).

A registrant shall return for cancellation to the Drug Control Unit, within 10 days of the discontinuance or transfer of business activities, the State Certification of Registration. a. True b. False

Answer: (a) True, [New Jersey Controlled Dangerous Substances, Title 13, Chapter 45H, 13:45H(8.7)(b)]. A registrant shall notify the Drug Control Unit in writing no less than 14 days prior to the discontinuance or transfer of business activities with respect to controlled substances as set forth in (a) above, unless the Drug Control Unit waives this time limitation in individual instances, and shall return for cancellation to the Drug Control Unit, within 10 days of the discontinuance or transfer of business activities, the State Certification of Registration. Such notification shall include but not be limited to: 1). Name, address, State CDS and Federal DEA registration numbers of the registrant discontinuing or transferring his controlled substances activities; 2). Name, address, State CDS and Federal DEA registration numbers of the registrant, or proof of application for same, of registrant to whom the controlled substances are to be transferred; 3). Name, address, State CDS and Federal DEA registration numbers, or proof of application for same of the registrant receiving the records, which include prescription files, or patient orders of practitioners of the discontinued business; 4). Name, and address of the person or firm who will maintain records, such as invoices, purchase records and executed order forms of the discontinued or transferred business for a period of not less than two years; and 5). The date on which the discontinuance or transfer of the business activity will take place.

Any pharmacy located in Maryland which ships, mails, distributes or delivers in any manner, legend drugs or devices pursuant to a prescription into New Jersey, must obtain the registration as an out-of-State pharmacy from the New Jersey Pharmacy Board. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Act 45:14-73(34)]. Any pharmacy located in another state which ships, mails, distributes or delivers in any manner, legend drugs or devices pursuant to a prescription into this State, shall register with the board and provide the board with the following information: (1). The location, names and titles of all principal corporate officers of the pharmacy. A report containing this information shall be made on an annual basis and within 30 days after any change of office or corporate officer; and (2). That it complies with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is licensed as well as with all requests for information made by the board pursuant to this section. As a prerequisite to registering with the board, the pharmacy shall submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which it is located. The annual registration fee shall be established by the board and shall not exceed $500 annually. Any pharmacy subject to this section shall, during its regular hours of operation, but not less than six days per week, and for a minimum of 40 hours per week, provide a toll-free telephone service to facilitate communication between patients in this State and a pharmacists at a pharmacy who has access to the patient's records. This toll-free number shall be disclosed on a label affixed to each container of drugs dispensed to patients in this State.

A pharmacy may prepare compounded sterile preparations for a licensed prescriber for use in the prescriber's practice without a prescription pertinent to the prescriber's health care practice. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Administrative Code 13:39-11.18]: A pharmacy may prepare compounded sterile preparations for a licensed prescriber for use in the prescriber's practice without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice.

Under New Jersey State Pharmacy Law, radioactive drugs are to be dispensed only upon a non-refillable prescription order from a United States Nuclear Regulatory Commission licensed medical practitioner. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Administrative Code 13:39-12.2(j)]. Radioactive drugs are to be dispensed only upon a non-refillable prescription order from a United States Nuclear Regulatory Commission licensed medical practitioner (or the designated agent) authorized to possess, use and administer radiopharmaceuticals. General requirements for a nuclear pharmacist in New Jersey State: (a). A qualified nuclear pharmacist shall meet the following requirements, [New Jersey Pharmacy Administrative Code 13:39-12.3(a)(1),(2)]: 1. He or she is a pharmacist licensed to practice in the State of New Jersey; and 2. He or she meets minimal standards of training and experience in the handling of radioactive materials in accordance with the requirements of the United States Nuclear Regulatory Commission or its successor and the State of New Jersey Bureau of Radiation Protection.

If a pharmacist legally changes the name under which he or she engages in the practice of pharmacy, the pharmacist shall notify the Board within 10 days of such change. a. True b. False

Answer: (b) False, [New Jersey Pharmacy Administrative Code 13:39-3.3]. If a pharmacist legally changes the name under which he or she engages in the practice of pharmacy, the pharmacist shall notify the Board within 30 days of such change. The pharmacist shall submit original proof of the change of name or a certified copy of the court order or marriage certificate, which shall be retained by the Board. When a replacement license is issued, the initial license shall be returned for cancellation and the pharmacist shall remit the required fee as prescribed in N.J.A.C. 13:39-1.3.

The intern preceptor and the pharmacy intern shall notify the Board in writing within 10 days of a change in the pharmacy training site and/or the termination or resignation of the intern. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Administrative Code 13:39-2.7]. (a). No person shall be employed as a pharmacy intern until he or she has been registered with the Board pursuant to this section and his or her preceptor has been approved by the Board pursuant to N.J.A.C. 13:39-2.6(c). (b). An applicant for registration as a pharmacy intern shall submit a written application, on a form supplied by the Board, and shall submit: 1. His or her name, address and fingerprints for purposes of a criminal history background check to be conducted by the State of New Jersey pursuant to N.J.S.A. 45:1-28 et seq., (P.L. 2002, c. 104) to determine whether criminal history record information exists that may disqualify the applicant from being registered as a pharmacy intern by the Board; 2. A passport size photo of the applicant; 3. Evidence of good moral character, which shall be an ongoing requirement for registration. (c). A person who has been educated in a foreign country in a college or school of pharmacy that has not been approved by the American Council of Pharmaceutical Education (ACPE) or that has not been deemed ACPE-equivalent by ACPE, shall be certified by the Foreign Pharmacy Graduate Examination Committee (FPGEC) of the National Association of Boards of Pharmacy prior to applying to the Board for registration as a pharmacy intern. (d). A pharmacy intern registration obtained pursuant to this section shall be valid for a period of two years from the date of issuance. Upon application to the Board, an intern registration may be renewed one time only, on an individual basis, for reasons of military service, hardship, illness or disability. (e). A change in an intern preceptor shall require prior Board approval, consistent with the requirements of N.J.A.C. 13:39-2.6(d). The new intern preceptor shall be responsible for making application to the Board for approval. (f). The intern preceptor and the pharmacy intern shall notify the Board in writing within 10 days of a change in the pharmacy training site and/or the termination or resignation of the intern. (g). In addition to the notification requirements of (f) above, a pharmacy intern shall notify the Board in writing within 10 days of any change in his or her name or address of record, as defined in N.J.A.C. 13:39-1.2.

Prescription drug shall be accepted during the hours the pharmacy or pharmacy department is closed only if there is a secure assigned area for receiving such packages. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Administrative Code 13:39-4.15(b)(3)]. There is a secure area for receiving packages known to contain prescription legend drugs and devices and controlled substances. No prescription drug shall be accepted during the hours the pharmacy or pharmacy department is closed unless adequate security for the storage of such shipments has been provided.

According to New Jersey Pharmacy Law, whenever a pharmacy or licensed establishment changes location, the pharmacy or licensed establishment shall apply for a new permit on a form prescribed and furnished by the New Jersey Pharmacy Board. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Administrative Code 13:39-4.7(a)]. a). When a pharmacy permit holder intends to change the physical location and address of the permitted premises, the permit holder shall apply to the Board, at least 30 days prior to such change, for a new pharmacy permit. If the change in location and address will result in the temporary closing of the pharmacy, the permit holder shall comply with all requirements set forth at N.J.A.C. 13:39-4.10(c) and (d). The permit holder shall submit a new permit application pursuant to N.J.A.C. 13:39-4.1 and the new permit application fee set forth in N.J.A.C. 13:39-1.3. The Board shall issue an amended pharmacy permit reflecting the new location and address of the pharmacy. Before an amended permit may be issued to the permit holder for the new location, the Board shall inspect and approve the premises, fixtures, equipment and inventory of the new location to ensure compliance with this subchapter and all relevant statutes, regulations and ordinances. The permit holder shall ensure that the prescription and profile records from the pharmacy's previous location and address are maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the location and address change. b). Whenever there is a change in a pharmacy's address but no change in the physical location of the licensed premises, the permit holder shall, within 10 business days of the change in address, submit an affidavit to the Board explaining such change.

A registered pharmacy technician or a pharmacy technician applicant who is receiving in-service training which shall not exceed 210 days, shall be excluded from the 1 to 2 (pharmacist to technician) ratio during such training. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Administrative Code 13:39-6.15(e)(6)]. Under New Jersey State Pharmacy Law, a pharmacist shall not supervise more than two pharmacy technicians at any given time. The pharmacist shall provide immediate personal supervision, as defined in N.J.A.C. 13:39-1.2, of all pharmacy technicians he or she supervises. Those personnel who do computer processing of prescriptions are to be included in the 1 to 2 ratio. However, a registered pharmacy technician or a pharmacy technician applicant who is receiving in-service training, which shall not exceed 210 days, shall be excluded from the 1 to 2 ratio during such training. A pharmacist shall not supervise more than two persons receiving in-service training at the same time. A pharmacy that employs a registered pharmacist to pharmacy technician ratio greater than 1:2 shall: 1. Establish written job descriptions, task protocols, and policies and procedures that pertain to the duties performed by the pharmacy technicians; 2. Ensure and document that all pharmacy technicians who are working when the ratio exceeds 1:2 have: i. Passed the Pharmacy Technician Certification Board's Pharmacy Technician Certification Examination and have fulfilled the requirements to maintain this status; ii. Passed a Board-approved certification program and have fulfilled the requirements to maintain this status; or iii. Completed a program which includes a testing component which has been approved by the Board as satisfying the criteria set forth in (g) below. Completion of a program with a Board-approved testing component shall qualify the pharmacy technician to work only for the specific pharmacy and/or corporation for which the pharmacy technician was employed when the training was obtained. If the pharmacy technician becomes employed by another pharmacy and/or corporation, the pharmacy technician shall be required to complete the new employer's training program;

In New Jersey, no pharmacy shall operate without a registered pharmacist-in-charge for longer than 30 days. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Administrative Code 13:39-6.2(a),(b),(c)]. (a). Every pharmacy shall name a pharmacist licensed and in good standing in New Jersey as the registered pharmacist-charge of the pharmacy. No pharmacy shall operate without a registered pharmacist-in-charge for longer than 30 days. (b). Whenever the registered pharmacist-in-charge is absent from the pharmacy for more than 30 days, the registered pharmacist-in-charge and the permit holder shall notify the Board of the name of the registered pharmacist who shall act as the interim registered pharmacist-in-charge. (c). A registered pharmacist shall not assume the responsibilities of a registered pharmacist-in-charge of more than one pharmacy or pharmacy department simultaneously. A registered pharmacist-in-charge shall be a full-time employee, employed for a minimum of 35 hours per week and shall be physically present in the pharmacy or pharmacy department for that amount of time necessary to supervise and ensure that: 1. Adequate staffing is present to fulfill the needs of the pharmacy or pharmacy department; 2. Accurate records of all prescription medication received and dispensed are maintained; 3. Policies are in place regarding accurate dispensing and labeling of prescriptions and that such policies are followed; 4. Security of the prescription area and its contents are maintained at all times; 5. Only pharmacists and interns or externs under immediate personal supervision provide professional consultation with patients and physicians; 6. Only pharmacists, interns or externs accept telephone prescriptions and only pharmacists, interns or externs, or pharmacy technicians accept renewal authorizations;

A patient profile record shall be maintained for a period of not less than five years from the date of the last entry in the profile record. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Administrative Code 13:39-7.19(f) and 13:39-7.20]. A patient profile record shall be maintained for a period of not less than five years from the date of the last entry in the profile record. In using an electronic data processing system, the system shall have the capability of producing retrievable and readable documents of all original and refilled prescription data for a period of not less than five years, including the number of refills authorized by the prescriber. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of a information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but offsite facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations. Upon receipt of a new or refill prescription, a pharmacist shall examine the patient's profile record before dispensing the medication, to determine the possibility of a potentially significant drug interaction, reaction or misutilization of the prescription. Upon determining a potentially significant drug interaction, reaction or misutilization, the pharmacist shall take the appropriate action to avoid or minimize the problem, which shall, if necessary, include consultation with the patient and/or the practitioner.

The use of a patient's own medication during or after admittance to a hospital should be discouraged as a general or routine practice. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Administrative Code 13:39-9.16(a),(b)]. No drugs shall be administered to a patient except those provided through the pharmacy or as provided by written policies and procedures developed by the registered pharmacist-in-charge or, where applicable, the director of pharmaceutical services and approved by the Pharmacy and Therapeutics Committee. Although the use of a patient's own medications may be warranted in certain situations, it should be discouraged as a general or routine practice. If a patient's previously acquired medication is to be used, a written order to this effect shall be signed and dated by the patient's physician. Such medications shall be identified by the pharmacist as to contents and dispensing origin. Also, these medications shall be documented as part of the pharmacy's patient profile record system.

Under New Jersey State Pharmacy Law, a practitioner may write a prescription for a Schedule II controlled substance that exceeds 120 dosage units if the patient is suffering pain from cancer, intractable pain or terminal illness. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Administrative Code Title 13, Chapter 35, 13:35 - 7.6(c),(d)]. With respect to Schedule II controlled substances, a practitioner shall not authorize a quantity calculated to exceed 120 dosage units or a 30-day supply, whichever is less. (c). A practitioner may exceed the 120 dosage unit or 30-day supply limitations for Schedule II controlled substances in (b) above in the following circumstances: 1. For the 120 dosage unit limitation, the practitioner follows a treatment plan designed to achieve effective pain management which has been tailored to the needs of a patient who is suffering pain from cancer, intractable pain or terminal illness. The treatment plan shall state objectives by which treatment success is to be evaluated, such as pain relief and improved physical and psychological function, and shall indicate if any further diagnostic evaluations or other treatments are planned. The practitioner shall discuss the risks and benefits of the use of controlled substances with the patient, guardian or authorized representative; and 2. With regards to the 30-day supply limitation, a practitioner may prescribe the use of an implantable infusion pump which is utilized to achieve pain management for patients suffering from cancer, intractable pain or terminal illness. A prescription for such an implantable infusion pump may provide up to a 90-day supply as long as the physician evaluates and documents the patient's continued need at least every 30 days. (d). When controlled substances are continuously prescribed for management of pain for three months or more, the practitioner: 1. Shall review, at a minimum of every three months, the course of treatment, any new information about the etiology of the pain and the patient's progress toward treatment objectives; 2. Shall remain alert to problems associated with physical and psychological dependence; and 3. Shall periodically make reasonable efforts, unless clinically contraindicated, to either stop the use of the controlled substance, decrease the dosage, try other drugs such as nonsteroidal anti-inflammatories, or treatment modalities in an effort to reduce the potential for abuse or the development of physical or psychological dependence.

On pharmacy permit renewal applications, it is mandatory that the pharmacy shall list the name and address of all pharmacy technicians which it currently employs. a. True b. False

Answer: (a) True, [New Jersey Pharmacy Practice Act 45:14-80(i)]. On pharmacy permit renewal applications, the pharmacy shall list the name and address of all pharmacy technicians which it currently employs.

According to New Jersey State Pharmacy Law, a pharmacy technician is allowed to stock legend drugs and controlled substances in an automated medication system. a. True b. False

Answer: (a) True, [Pharmacy practice Act 45:14-80(41)(a)(4) AND New Jersey Pharmacy Administrative Code 13:39-6.15(a)]. Pharmacy technicians may assist a licensed pharmacist in performing the following tasks: (1). Retrieval of prescription files, patient files and profiles and other records, as determined by the board, pertaining to the practice of pharmacy; (2). Data entry; (3). Label preparation; and (4). Counting, weighing, measuring, pouring and compounding of prescription medication or stock legend drugs and controlled substances, including the filling of an automated medication system. Pharmacy technicians may accept authorization from a patient for a prescription refill, or from a physician or the physician's agent for a prescription renewal, provided that the prescription remains unchanged.

A licensed prescriber affiliated with a licensed healthcare facility may use the New Jersey Prescription Blanks (NJPB) of the licensed facility. a. True b. False

Answer: (a) True, [Uniform Prescription Blanks 13:45A-27.3(b)]. A licensed prescriber affiliated with a licensed healthcare facility may use the NJPB of the licensed facility provided that: 1). The prescription is written for a patient treated at that healthcare facility; 2). The name and license number of the licensed prescriber, and the prescriber's National Provider Identifier (NPI) number, if the prescriber has obtained an NPI number, is legibly written, typed, stamped or otherwise affixed to the NJPB; 3). The prescription contains the signature of the licensed prescriber; and 4). If the prescription is for a controlled dangerous substance, the licensed prescriber's Federal Drug Enforcement Administration (DEA) registration number shall be pre‐printed, legibly written, typed, stamped, or otherwise affixed to the NJPB.

A New Jersey Prescription Blank (NJPB) that contains a prescription for Cephalexin and Alprazolam on the same prescription blank shall be considered valid. a. Yes b. No

Answer: (a) Yes, [New Jersey Administrative Code Title 13, Chapter 35, 13:35-7.2(h),(1),(2)]. Each prescription for a controlled substance shall be written on a separate NJPB. 1. An NJPB that contains prescriptions for two or more controlled substances shall be invalid. 2. An NJPB that contains a prescription for only one controlled substance and contains other prescription(s) other than another controlled substance shall be valid.

A patient brings a new prescription for Alprazolam with 5 eligible refills. The prescription is written on April 1, 2017. The prescription reads: Alprazolam 1 mg: 1 tablet by mouth at bed time x 30 days. Refills: 5 times A patient has requested medication to be partially filled. Below is the list of partially filled transactions: 1. 04/04/2017: 20 tablets 2. 05/05/2017: 40 tablets 3. 05/25/2017: 18 tablets 4. 06/09/2017: 23 tablets 5. 06/21/2017: 5 tablets 6. 08/11/2017: 35 tablets 7. 09/05/2017: 11 tablets 8. 10/11/2017: 36 tablets 9. 10/28/2017: 21 tablets 10. 11/05/2017: 6 tablets Based on above information what shall be the dispensed quantities (legally)? a. 180 tablets b. 152 tablets c. 150 tablets d. Cannot be partially filled.

Answer: (b) 152 tablets, [New Jersey Controlled Dangerous Substances Act 13:45H-7.15]. Partial refills of schedules III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after six months past the date of issue. In above example, the prescription expires on 10/01/2017 (six months from an issue date of 04/01/2017). Therefore, all partial filling before this date should be considered legal. The second thing the pharmacist has to observe that the total quantity dispensed in all partial fillings shall not exceed the total quantity prescribed. The prescription is written for 180 tablets, 1 tablet by mouth qd x 30 days with additional 5 refills. When adding all the partial filling starting from 04/04/2017 to 09/05/2017, the total quantities that the pharmacist can dispense legally come about 152 tablets.

How many pharmacy technicians shall a pharmacist supervise at any given time? a. 1 b. 2 c. 3 d. 4

Answer: (b) A ratio of registered pharmacists to pharmacy technicians should not exceed 1:2, [New Jersey Pharmacy Act 45:14-80(41)(d) and New Jersey Administrative Code 13:39-11.13]. Thus, normally a pharmacist can supervise two technicians at any given period of time. A pharmacy that wishes to employ a licensed pharmacist to pharmacy technician ratio greater than established in accordance with subsection (d). of this section, shall: (1). Establish written job descriptions, task protocols and policies and procedures that pertain to the duties performed by the pharmacy technician; (2). Ensure and document that each pharmacy technician pass the National Pharmacy Technician Certification Examination or a board approved certification program and fulfill the requirements to maintain this status, or complete a program which includes a testing component and which has been approved by the board as satisfying the criteria as set forth in subsection f. of this section; (3). Ensure that each pharmacy technician is knowledgeable in the established job descriptions, task protocols and policies and procedures in the pharmacy setting in which the technician is to perform his duties; (4). Ensure that the duties assigned to any pharmacy technician do not exceed the established job descriptions, task protocols and policies and procedures; (5). Ensure that each pharmacy technician receives in-service training before the pharmacy technician assumes his responsibilities and maintain documentation thereof; (6). Require and maintain on site a signed patient confidentiality statement from each technician; (7). Provide immediate personal supervision; and (8). Provide the board, upon request, with a copy of the established job descriptions, task protocols and policies and procedures for all pharmacy technician duties. Ratio for Sterile Compounding: a). Pharmacists shall provide immediate personal supervision to pharmacy technicians, pharmacy interns, or pharmacy externs who are performing STERILE COMPOUNDING. The ratio of pharmacists to pharmacy technicians shall not exceed 1:2 at any given time. 1). Supervision shall include, but is not limited to, the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, and the finished label. b). The pharmacist may delegate to pharmacy technicians, pharmacy interns, or pharmacy externs only the following tasks: recording of the prescription, selection of the drugs, container, and diluent, labeling, and compounding of preparations. The pharmacist shall ensure that each task has been performed correctly.

According to New Jersey State Pharmacy Law, the prescription record should be kept for: a. Two years from the date of dispensing. b. Five years from the date of dispensing. c. Three years from the date of dispensing. d. A year from the date of dispensing.

Answer: (b) According to New Jersey State Pharmacy Law, the prescription record should be kept on file for five years from the date of dispensing, [New Jersey Pharmacy Administrative Code 13:39-7.6(d)]. All audit trail and prescription information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of not less than five years. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of a record information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure.

A pharmacist receives a new prescription from a prescriber for compounding a cream that is commercially available. What shall pharmacist do? a. Fill the prescription. b. Do not fill the prescription.

Answer: (b) Do not fill the prescription, [New Jersey Administrative Code 13:39-11A.3 and 13:39-11A.4]. a. A pharmacist shall not compound preparations that contain drug products that appear on the Federal Food and Drug Administration's list of Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness. b. A pharmacist shall not compound any commercially available drug products unless: 1. The commercially available product is modified to produce a significant difference, in the professional judgment of the prescriber, between the compounded product for the patient and the comparable commercially available product; OR 2. The commercially available product is not available from normal distribution channels in a timely manner to meet the patient's needs, and the dispensing of the compounded product has been approved by the prescriber and the patient. c. A pharmacist who compounds a commercially available product consistent with the requirements of (a) above shall maintain documentation of the reason for such compounding.

How often shall a pharmacist renew his/her license? a. Every year b. Every 2 years c. Twice a year d. Every 3 years

Answer: (b) Every 2 years, [N.J.A.C. 13:39-3.7]. A pharmacist shall renew his or her license for a period of two years from the last expiration date. The pharmacist shall submit a renewal application to the Board, along with the renewal fee, prior to the date of license expiration. A pharmacist who fails to submit a renewal application within 30 days of license expiration shall have his or her license suspended without a hearing. Such suspension shall be deemed an administrative suspension. A pharmacist who continues to engage in the practice of pharmacy with a suspended license shall be deemed to be engaging in the unauthorized practice of pharmacy and shall be subject to the penalties set forth in N.J.S.A. 45:1-25 et seq. The Board shall send a notice of renewal to each pharmacist at least 60 days prior to the expiration of the license. If the notice to renew is not sent at least 60 days prior to the expiration date, no monetary penalties or fines shall be imposed upon the pharmacist for failure to renew.

In New Jersey, the inventory of controlled substances should be done every: a. Year b. Two years c. Three years d. Five years

Answer: (b) Every 2 years, [New Jersey Controlled Dangerous Substances Act 13:45H-5.5(d) and 13:45H-5.7]. A registrant may take an inventory on a date that is within four days of his biennial inventory date pursuant to N.J.A.C. 13:45H-5.7 if he notifies in advance the Special Agent in Charge of the Drug Enforcement Administration in his region and the Drug Control Unit of the date on which he will take the inventory. A registrant may take an inventory either as of the opening of business or as of the close of business on the inventory date. The registrant shall indicate on the inventory records whether the inventory is taken as of the opening or as of the close of business and the date the inventory was taken. The biennial inventory may be taken on the day of the year on which the initial inventory was taken or on the registrant's regular general physical inventory date, if any, which is nearest to and does not vary by more than six months from the biennial date that would otherwise apply.

A pharmacist granted authorization to engage in collaborative drug therapy management shall complete a minimum of 15 credits of continuing education every biennial renewal period in each disease(s) or condition(s) covered by the collaborative practice agreement(s) to which he or she is a party. a. True b. False

Answer: (b) False, [New Jersey Administrative Code 13:39-13.3 and 13.4(e)]. (a). In order to enter into an agreement to engage in the collaborative drug therapy management of a patient with a physician licensed in this State, a licensed pharmacist shall be pre-approved by the Board to engage in such activity. In order to obtain Board approval, a pharmacist shall submit a collaborative practice application and documentation that establishes that he or she has successfully completed one of the following: 1. A certificate training program offered by an American Council of Pharmaceutical Education-approved provider; 2. A post-graduate residency program accredited by the American Society of Health-System Pharmacists; or 3. A certification program from the Board of Pharmacy Specialties. (b). The Board shall issue an authorization to engage in collaborative drug therapy management to a pharmacist who, upon application to the Board, demonstrates satisfaction of the requirements of (a) above. (c). A pharmacist granted authorization to engage in collaborative drug therapy management pursuant to this section shall complete a minimum of 10 credits of continuing education every biennial renewal period in each disease(s) or condition(s) covered by the collaborative practice agreement(s) to which he or she is a party, consistent with the requirements of N.J.A.C. 13:39-3A. However, to the extent that a pharmacist may enter into collaborative practice agreements to treat patients with co-existing, interrelated conditions or diseases, a pharmacist need only complete a total of 10 credits in the interrelated conditions or diseases. All records relating to a collaborative practice agreement shall be maintained in either hard copy or electronic form for a period of not less than seven years from the date of termination of the agreement and shall be supplied to the Board upon request. All records shall be made available to persons authorized to inspect them under State and Federal statutes and regulations. The oldest six years of information shall be maintained in such a manner, so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but the storage facilities shall be secure. Patient records shall be kept confidential.

When a pharmacy permit holder intends to change the name of the pharmacy, the permit holder shall apply to the Board, at least 30 days prior to such change, for a new pharmacy permit. a. True b. False

Answer: (b) False, [New Jersey Administrative Code 13:39-4.9]. When a pharmacy permit holder intends to change the name of the pharmacy, the permit holder shall apply to the Board, at least 30 days prior to such change, for an AMENDED permit (a new permit number shall not be required). The permit holder shall submit a new permit application and the new permit application fee. The Board shall issue an amended pharmacy permit reflecting the new name of the pharmacy. The Board shall issue an amended permit bearing the new name upon return of the permit bearing the previous name to the Board for cancellation and payment of the permit fee. However, if a change in pharmacy name is associated with a change in ownership, the permit holder shall obtain a new pharmacy permit.

A pharmacist shall NOT fill an ELECTRONIC PRESCRIPTION if the prescription is transmitted by the prescribing practitioner's authorized agent. a. True b. False

Answer: (b) False, [New Jersey Administrative Code 13:39-7.11(b)]. A pharmacist shall not fill an electronic prescription transmitted by anyone other than a practitioner authorized to prescribe medications or the prescribing practitioner's authorized agent. If the electronic prescription is transmitted by the practitioner's authorized agent, the transmission shall include the full name and title of the agent. A pharmacist may fill a prescription for a Schedule II controlled substance transmitted electronically, provided that the original signed prescription is presented to the pharmacist prior to the dispensing of the controlled substance. If permitted by Federal law, and in accordance with Federal requirements, an electronic prescription shall serve as the original signed prescription. A pharmacist may fill a prescription for a Schedule III, IV or V controlled substance transmitted electronically, provided that the pharmacist has obtained the original signed prescription, an oral prescription, or a facsimile prescription from the prescribing practitioner or the prescribing practitioner's authorized agent prior to the dispensing. If permitted by Federal law, and in accordance with Federal requirements, an electronic prescription shall serve as the original signed prescription.

A prescription written for Ativan for "office stock" should only be filled by the pharmacist-in-charge. a. True b. False

Answer: (b) False, [New Jersey Administrative Code 13:45H-7.4(b)]. A prescription may not be issued in order for an individual practitioner to obtain a supply of controlled substances for the purpose of general dispensing to his/her patients. Therefore, a prescription written for office stock or "medical bag" use is not valid.

An intern preceptor shall not supervise the training of more than two pharmacy interns at a time. a. True b. False

Answer: (b) False, [New Jersey Administrative Code N.J.A.C. 13:39-2.6(d)]. The Board shall approve an intern preceptor selected by each pharmacy intern prior to the beginning of the internship. An intern preceptor shall not supervise the training of more than one pharmacy intern at a time. The intern preceptor in a pharmacy training site shall provide the Board with a detailed written report outlining the progress, aptitude and readiness to practice of any pharmacy intern under his or her supervision at the conclusion of the internship. The intern preceptor shall be responsible for supervising the activities of the pharmacy intern and providing the pharmacy intern with experience and knowledge related to the preceptor's area of practice.

A registrant who changes his place of business or professional practice from the location which is stated in the registration to a new location within the State of New Jersey, without any change in the ownership of the business or professional practice, shall still require to obtain New Registration reflecting new location. a. True b. False

Answer: (b) False, [New Jersey Controlled Dangerous Substances Act 13:45H-1.6]. b). A registrant who changes his place of business or professional practice from the location which is stated in the registration to a new location within the State of New Jersey, without any change in the ownership of the business or professional practice, may obtain an endorsement validating his registration for the remainder of the registration period at the new location by notifying the Director in writing, which notice shall set forth the name and registration number of the registrant, the address of the registered location, the address of the new location, and the effective date of the change of location. c). A registration shall terminate and become void if and when the registrant dies, ceases legal existence, or discontinues business or professional practice in the State of New Jersey. A registrant who ceases legal existence or discontinues business or professional practice shall notify the Director in writing and surrender his current registration. In the event that the business or professional practice will be continued or resumed after a change in ownership a new application for registration shall be made pursuant to N.J.A.C. 13:45H-1.1 and 1.2 of this Chapter.

The partial filling of Morphine sulfate for terminally ill patients must be done within 72 hours from the initial filling. a. True b. False

Answer: (b) False, [New Jersey Controlled Dangerous Substances Act 13:45H-7.10(d)]. Prescriptions for schedule II controlled substances written for patients in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist shall contact the practitioner prior to partially filling the prescription. Both the pharmacist and practitioner shall assure that a controlled substance is for a terminally ill patient. The pharmacist shall record on the prescription whether the patient is "terminally ill" or an "LTCF" patient. A prescription that is partially filled and does not contain the notation that the patient is "terminally ill" or a patient in a "LTCF" shall be deemed to have been filled in violation of N.J.S.A. 24:21. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed and the identification of the dispensing pharmacist. Prior to any subsequent partial filling, the pharmacist shall determine that the additional partial filling is necessary. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions, for patients in a LTCF, or patients with a medical diagnosis documenting a terminal illness, shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of the medication.

A registrant shall notify the Drug Control Unit in writing no less than 15 days prior to the discontinuance or transfer of business activities with respect to controlled substances. a. True b. False

Answer: (b) False, [New Jersey Controlled Dangerous Substances Act 13:45H-8.7(a,b)]. A registrant shall notify the Drug Control Unit in writing no less than 14 days (NOT 15 days) prior to the discontinuance or transfer of business activities with respect to controlled substances as set forth in (a) above, unless the Drug Control Unit waives this time limitation in individual instances, and shall return for cancellation to the Drug Control Unit, within 10 days of the discontinuance or transfer of business activities, the State Certification of Registration. Such notification shall include but not be limited to: 1). Name, address, State CDS and Federal DEA registration numbers of the registrant discontinuing or transferring his controlled substances activities; 2). Name, address, State CDS and Federal DEA registration numbers of the registrant, or proof of application for same, of registrant to whom the controlled substances are to be transferred; 3). Name, address, State CDS and Federal DEA registration numbers, or proof of application for same of the registrant receiving the records, which include prescription files, or patient orders of practitioners of the discontinued business; 4). Name, and address of the person or firm who will maintain records, such as invoices, purchase records and executed order forms of the discontinued or transferred business for a period of not less than two years; and 5). The date on which the discontinuance or transfer of the business activity will take place.

All licensed pharmacy practice sites shall report to the Board within 10 days of closing of the pharmacy practice site. a. True b. False

Answer: (b) False, [New Jersey Pharmacy Act 45:14-74 (35)(a)]. All licensed pharmacy practice sites shall report to the board the occurrences of any (No time limit; Shall report to the Board within reasonable time) of the following: (1). Closing of the pharmacy practice site; (2). Change of ownership, location, interior site design, permit classification or pharmacist-in-charge of the pharmacy practice site; (3). Any significant theft or loss of legend drugs or devices; (4). Disasters, accidents, any theft, destruction or loss of records required to be maintained by State or federal law; (5). Any pharmacy malpractice liability insurance claim settlement, judgment or arbitration award in excess of $10,000 to which an owner, an employee of, or the pharmacy practice site itself is a party; and (6). Any and all other matters and occurrences as the board may require by rule or regulation.

The registered pharmacist in charge shall ensure that medications in the automated medication system are inspected, at least monthly, for expiration or use by date, misbranding and physical integrity. a. True b. False

Answer: (b) False, [New Jersey Pharmacy Administrative Code 13:39-10.3(b)]. The registered pharmacist in charge or the registered pharmacist under contract with a healthcare facility responsible for the dispensing of medications shall be responsible for the following: 1. Reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality and prevention of unauthorized access and malfunction; 2. Ensuring that medications in the automated medication system are inspected, at least once every two months, for expiration or use by date, misbranding and physical integrity, and ensuring that the automated medication system is inspected, at least once every two months, for security and accountability; 3. Assigning, discontinuing or changing personnel access to the automated medication system; 4. Ensuring that the automated medication system is stocked accurately and an accountability record is maintained in accordance with the written policies and procedures of operation.

A licensee shall maintain all documentation concerning the completion of continuing education requirements for a period of two years from the completion of the credit hours and shall submit such documentation to the Board upon request. a. True b. False

Answer: (b) False, [New Jersey Pharmacy Administrative Code 13:39-3A.4(a),(b)]. A licensee shall maintain all documentation concerning the completion of continuing education requirements for a period of five years (NOT two years) from the completion of the credit hours and shall submit such documentation to the Board upon request. Such documentation shall consist of: 1. For programs offered by American Council of Pharmaceutical Education approved providers, a certificate of completion from the course or program; 2. For programs and courses approved by the Board, the sponsors' written verification of attendance; 3. For teaching or research appointments in an academic setting, a statement from the chairperson of the department verifying completion of the assignment; 4. For research appointments in an industrial setting, a statement from the project coordinator verifying completion of the assignment; 5. For participation as a preceptor in an externship program, a certificate from the college of pharmacy; 6. For participation as a preceptor in an internship program, a certificate from the Board; and 7. For publications in a peer-reviewed professional journal, submission of the published article.

A permit holder shall submit to the Board, on an annual basis, within 60 days after the permit expiration, a renewal application and the renewal fee set forth in N.J.A.C. a. True b. False

Answer: (b) False, [New Jersey Pharmacy Administrative Code 13:39-4.2(a)(b)(c)]. A permit holder shall submit to the Board, on an annual basis, within 30 days after the permit expiration, a renewal application and the renewal fee set forth in N.J.A.C. A permit holder that fails to submit the renewal application within 30 days after the permit expiration shall submit the late renewal fee set forth in N.J.A.C. In addition to the renewal fee. A permit holder that continues to engage in the practice of pharmacy with an expired permit shall be deemed to be engaging in the unauthorized practice of pharmacy and shall be subject to the penalties. The Board shall send a notice of renewal to each permit holder, at least 60 days prior to the expiration of the permit. If the notice to renew is not sent 60 days prior to the expiration date, no monetary penalty or fines shall apply to the permit holder for any unauthorized practice during the period following the permit expiration, not to exceed the number of days short of 60 before the renewal was issued.

RJ owns the Goodneighborlife Pharmacy. He has recently sold his pharmacy to TN. According to New Jersey state pharmacy law, RJ can transfer his pharmacy permit to TN. a. True b. False

Answer: (b) False, [New Jersey Pharmacy Administrative Code 13:39-4.5(a) and 4.6]. According to New Jersey pharmacy law, a pharmacy permit is nontransferable. (a). When there is a change in the ownership of the business entity holding a permit to operate a pharmacy, the following requirements shall be satisfied, as applicable: 1. When a complete change in ownership occurs and none of the current owners retains any ownership interest, the new owner(s) shall, prior to, or within 10 business days of, such change, submit to the Board a new permit application pursuant to N.J.A.C. 13:39-4.1, the new permit application fee set forth in N.J.A.C. 13:39-1.3, and an inventory of the pharmacy's controlled substances. A new pharmacy permit number shall be issued upon request; 2. When a reallocation of ownership interests occurs among existing owners, the owners shall, prior to, or within 10 business days of, such change, submit to the Board an affidavit explaining the asset reallocation. A new pharmacy permit number shall not be issued upon a reallocation of business assets among existing owners; or 3. When the existing ownership is changed through the addition of a new owner(s) or the subtraction of an existing owner, the owners shall, prior to, or within 10 business days of, the addition of the new owner(s), submit to the Board a new permit application pursuant to N.J.A.C. 13:39-4.1 and the new permit application fee set forth in N.J.A.C. 13:39-1.3. A new pharmacy permit number shall be issued upon request. (b). Upon a change in ownership pursuant to (a) above, the new ownership of such entity shall take custodial ownership of the previous five years of prescription and profile records of the previous pharmacy and shall ensure that the prescription and profile records are maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the date of acquisition. (c). Upon the sale, transfer or acquisition of the business assets of a pharmacy, the person or entity acquiring such assets shall take custodial ownership of the pharmacy's previous five years of prescription and profile records and shall ensure that the prescription and profile records are maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the date of acquisition. (d). If there is a change of registered agents or officers or a change of stock ownership involving 10 percent or more of the outstanding stock of a publicly traded corporation, the corporation shall file an affidavit with the Board within 30 days indicating the changes that have taken place and any other information requested by the Board.

A prescription for non-controlled medication or devices which pursuant to New Jersey State Pharmacy Law may be sold, dispensed or furnished only upon prescription, shall not be renewed without specific authorization of the prescriber, and the prescription may not be refilled after two years from the date of original prescription. a. True b. False

Answer: (b) False, [New Jersey Pharmacy Administrative Code 13:39-7.3(a)]. A prescription for non-controlled medication or devices which pursuant to New Jersey State Pharmacy Law may be sold, dispensed or furnished only upon prescription, shall not be renewed without specific authorization of the prescriber, and the prescription may not be refilled after ONE year from the date of original prescription. Prescriptions marked "PRN" or other letters or words meaning refill as needed shall not be renewed beyond one year past the date of original prescription.

Under New Jersey State Pharmacy Law, a prescription written by authorized prescriber living in Canada can be filled by a pharmacist in New Jersey without any hesitation. a. True b. False

Answer: (b) False, [New Jersey Pharmacy Administrative Code 13:39-9.26(a),(b)]. (a). Only medication orders issued by an authorized prescriber licensed to write medication orders in the United States or any territory of the United States shall be considered valid medication orders and such medication orders shall be filled pursuant to New Jersey law. Medication orders, other than those listed in (a) above, shall not be filled by a pharmacy in New Jersey.

A prescriber may post-date controlled dangerous substance prescriptions. a. True b. False

Answer: (b) False, [New Jersey Pharmacy Administrative Code 13:45H-7.5(a),(b) and http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm]. All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the full name, address, proper academic degree or other definitive identification of the professional practice for which he or she is licensed and registration number of the practitioner. Where a prescription contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date. All prescriptions for controlled substances, regardless of schedules, shall be presented to the pharmacist for filling within 30 days after the date when issued. A practitioner may sign a prescription in the same manner as he would sign a check or legal document (for example, J.H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written in ink or indelible pencil or typewriter and shall be manually signed by the practitioner. The prescription may be prepared by a secretary or agent of the practitioner for the signature of the practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law or rules. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by these rules. An intern, resident, or foreign-trained physician, or physician on the staff of a Veteran's Administration facility, exempted from registration under the Code of Federal Regulations, Title 21, part 1301.24(c) shall include on all prescriptions issued by him the registration number of the hospital or other institution and the special internal code number assigned to him by the hospital or other institution as provided in the Code of Federal Regulations, Title 21, part 1301.24(c), in lieu of the registration number of the practitioner required by this section. Each written prescription shall have the name of the physician stamped, typed, or handprinted on it, as well as the signature of the physician.

A written prescription that contains the photocopy of the prescriber's signature is considered a valid prescription. a. True b. False

Answer: (b) False. Carbon or duplicate written prescriptions are not valid prescriptions. A written prescription must bear the original signature of the prescriber, not a copy or photo copy or stamp of the signature of the prescriber.

An audit trail record of all pharmacists, pharmacy technicians, interns and externs employed by the pharmacy shall be maintained by the pharmacy for a period of not less than two years after the last date of employment. a. True b. False

Answer: (b) False. [New Jersey Administrative code 13:39-7.6(c)]. 1. On or after April 5, 2011, a pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s) or extern(s) performing the component functions of each step of prescription handling which are required to be performed by a pharmacist, pharmacy technician, intern or extern. 2. All steps performed by a pharmacy technician, intern or extern shall be documented in the audit trail. All entries to the audit trail made by a pharmacy technician, intern or extern shall be reviewed and approved by the pharmacist. 3. Appropriate documentation identifying the unique and secure user identifier of all pharmacists, pharmacy technicians, interns and externs employed by the pharmacy shall be maintained by the pharmacy for a period of not less than five years after the last date of employment. 4. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of a record information shall be retrievable and readable within one business day. 5. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure.

Which of the following drugs is classified as a Schedule controlled III drug? a. Fioricet b. Fiorinal c. Codeine d. Lorazepam

Answer: (b) Fiorinal (Butalbital with Aspirin) is classified as a Schedule III drug, [Section 811(g) (3) (A) of the Controlled Substances Act]. Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine. Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine. The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet. Interesting to note that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital. The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophenn) is added. The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg. The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from scheduling. In Fiorinal the aspirin to butalbital ratio is approximately 97 mg to 15 mg, which is less than the 188mg:15mg ratio, so it is classified as a Schedule III substance.

Which of the following is/are TRUE ABOUT pharmacy internship under the New Jersey State Pharmacy Law? I. The 1,440 hours of practical experience shall be completed in no less than 34 weeks and no more than 104 weeks, under the supervision of an intern preceptor. II. Each week of practical experience shall consist of no less than 15 hours and no more than 45 hours of actual service per week. III. An intern preceptor shall not supervise the training of more than two pharmacy interns at a time. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true, [New Jersey Administrative Code 13:39-2.6(b),(d)]. (a). "Pharmacy internship or externship" means the program in which practical experience is acquired by a pharmacy intern or extern. b). The 1,440 hours of practical experience required for the successful completion of a pharmacy internship shall be obtained consistent with the following: 1). The 1,440 hours of practical experience shall be completed in no less than 34 weeks and no more than 104 weeks, under the supervision of an intern preceptor. Each week of practical experience shall consist of no less than 15 hours and no more than 45 hours of actual service per week; 2). The intern preceptor and the pharmacy intern shall keep accurate records of the time spent by the pharmacy intern for credit toward the requirements of (b)1 above. The Board shall provide appropriate forms to be submitted to the Board for approval of internship experience; and 3). No credit shall be given for hours served as a pharmacy intern prior to the applicant's registration with the Board and approval of the intern preceptor by the Board. d). The Board shall approve an intern preceptor selected by each pharmacy intern prior to the beginning of the internship. An intern preceptor shall not supervise the training of more than one pharmacy intern (Not two pharmacy-interns) at a time.

Which of the following information about Plan-B One Step is/are TRUE? I. It is intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. II. With Plan B One-Step, a patient has up to 72 hours to prevent a pregnancy. III. If a patient is 15 or older, Plan B One-Step is available ONLY through a prescription. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II are true. Plan B One-Step is a backup plan that helps prevent pregnancy after birth control failure. The sooner a patient takes an emergency contraception, the better it works. Plan B One-Step requires just one pill. Other emergency contraception requires two pills, 12 hours apart. With Plan B One-Step, a patient has up to 72 hours (3 days) to prevent a pregnancy. It is not the abortion pill and it isn't a substitute for routine birth control. Plan B is available to all Over-The-Counter without the prescription or presenting an id. A patient is required to take a single pill, as soon as possible within 72 hours, after an unprotected intercourse or a contraceptive failure.

Which of the following activities are allowed when a pharmacist is taking a restroom or 30-minute meal breaks while working in a pharmacy? I. The receipt of new written prescriptions. II. The dispensing of prescription medications which have been checked by the pharmacist. III. The accepting of refill authorization from a prescriber on telephone. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [NEW JERSEY ADMINISTRATIVE CODE, Title 13, Chapter 39, 13:39-6.4(2)]. A sole pharmacist on duty may take restroom breaks and 30-minute meal breaks while working in a pharmacy consistent with the following requirements: 1. The pharmacist shall remain in the pharmacy or, in the case of a pharmacy department, in the pharmacy department building, and shall be accessible for emergencies or for counseling, if requested; 2. The pharmacy shall remain open during the restroom or meal breaks, provided a pharmacy employee remains present in the pharmacy, for patient related services, which include, but are not limited to, the following: i. The receipt of new written prescriptions; and ii. The dispensing of prescription medications which have been checked by the pharmacist; and 3. A sign shall be posted in the prescription dispensing area stating "Pharmacist on break, but available for emergencies and counseling."

Which of the following emergency medications may a pharmacist allow to administer to an adult patient under the current New Jersey State Pharmacy Law? I. Epinephrine II. Diphenhydramine III. Acetylcysteine a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [New Jersey Administer Code 13:39-4.21(a)]. The provisions of this section set forth the requirements for licensed pharmacists authorized to administer vaccines and related emergency medications, which shall be limited to diphenhydramine and epinephrine, to eligible patients who are 18 years of age and older, under the following circumstances: 1). Pursuant to a prescription by a New Jersey licensed physician for a vaccine, related emergency medications, and pharmacist administration of the vaccine that is patient specific; 2). In immunization programs implemented pursuant to a New Jersey licensed physician's standing order for the vaccine, related emergency medications, and administration instructions that are not patient specific; and/or 3). In immunization programs sponsored by government agencies that are not patient specific.

Which of the following is/are (an) approved continuing education provider(s)? I. Courses offered by ACPE II. Courses approved by New Jersey Pharmacy Board III. Courses offered by CME-1 a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [New Jersey Administrative Code 13:39-3A.2(a)]. A licensee may obtain continuing education credit from the following categories: 1). Programs or courses offered by American Council of Pharmaceutical Education approved providers; 2). Programs and courses that have received prior Board approval pursuant to N.J.A.C. 13:39-3 A.6; 3). Graduate course work relevant to the practice of pharmacy, taken at an accredited college or university, beyond that required for professional licensure; 4). Participation in teaching and/or research appointments; 5). Participation as a preceptor in externship programs; 6). Participation as a preceptor in internship programs; and 7). Publication of an article related to the practice of pharmacy in a peer-reviewed professional journal.

Which of the following shall NOT be required on an electronic prescription for a controlled substance? I. Prescriber's handwritten original signature II. an NJPB III. Prescriber's DEA Number a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [New Jersey Administrative Code 13:39-7.11(e)]. An electronic prescription shall contain all information required to be included on a written prescription pursuant to New Jersey State Board of Medical Examiners rule except that a 1. handwritten original signature and 2. an NJPB (New Jersey prescription Blank) Shall NOT be required for the prescription. The practitioner's electronic signature or other secure method of validation shall be provided with the electronic prescription unless the prescription is transmitted by the practitioner's authorized agent. If transmitted by an authorized agent, the full name and title of the agent shall be included on the transmission and the agent shall not sign the prescription.

Prescriptions shall not be required to be issued on a New Jersey Uniform Prescription Blank if such prescriptions issued at facilities within or outside of New Jersey that are regulated by the: I. United States Department of Veterans Affairs II. United States Department of Defense III. United States Department of Justice a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [New Jersey Administrative Code 13:39-7.1]. a. A pharmacist shall only fill a prescription issued by a practitioner licensed to issue prescriptions in New Jersey and practicing in New Jersey if the prescription is on a New Jersey Uniform Prescription Blank. b. A pharmacist shall fill a prescription issued by a practitioner authorized to issue prescriptions in another state, territory or possession of the United States, including prescriptions issued at facilities within or outside of New Jersey that are regulated by the United States Department of Veterans Affairs and/or the Department of Defense. Such prescriptions shall be filled pursuant to New Jersey law. Such prescriptions shall not be required to be issued on a New Jersey Uniform Prescription Blank. c. Prescriptions, other than those listed in (a) and (b) above, shall not be filled by a pharmacy in New Jersey.

Which of the following is/are correct filing method(s) for controlled substances? I. One file for CII, second file for III, IV and V and a third file for non-controlled substances. II. One file for CII and a second file for III, IV, V and non-controlled substances. III. One file for controlled and a second file for non-controlled substances. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [New Jersey Administrative Code 13:39-7.9(a) and (b) and New Jersey Controlled Dangerous Substances Act 13:45H-5.4(d)]. (a). Prescriptions for all controlled substances listed in Schedule II shall be maintained in a separate prescription file. (b). Prescriptions for all controlled substances listed in Schedules III, IV and V shall be maintained in a separate prescription file for such controlled substances only or in such form that they are readily retrievable from other prescription records of the pharmacy. (c). Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than one-inch high and filed either in the prescription file for controlled substances listed in Schedule II or in the prescription file for non-controlled substances. (d). If a pharmacy employs an electronic recordkeeping system for prescriptions that permits identification by prescription number and retrieval of original documents by the practitioner's name, patient's name, drug dispensed and date filled, then the requirement to mark the hard copy prescription with a red "C" shall be waived.

Which of the following should NOT be done by a pharmacy technician? Label preparation. Authorization acceptance from a physician for a prescription renewal. Dosage and directions verification. Data entry.

Answer: (c) Dosage and directions verification, [New Jersey Pharmacy Act 45:14-80(41) AND New Jersey Pharmacy Administrative Code 13:39-6.15(b)]: Pharmacy technicians shall not: ____________________________ (1). Receive new verbal prescriptions; (2). Interpret a prescription or medication order for therapeutic acceptability and appropriateness; (3). Verify dosage and directions; (4). Engage in prospective drug review; (5). Provide patient counseling; (6). Monitor prescription usage; (7). Override computer alerts without first notifying the pharmacist; (8). Transfer prescriptions from one pharmacy to another pharmacy. (9). Violate patient confidentiality.

After dispensing an emergency Schedule II drug, the pharmacist shall contact which of the following upon not receiving a written prescription from the prescriber within 7 days? I. The DEA Office II. The Drug Control Unit III. The State Board of Pharmacy a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [New Jersey Controlled Dangerous Substances Act 13:45H-7.8(d)(1-to-4). Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed (not to exceed the amount for a 72 hour period) to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of N.J.A.C. 13:45H-7.4, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the Drug Control Unit and the nearest office of the DEA in his district if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense with a written prescription of a prescribing individual practitioner.

Which of the following may be manufactured by a pharmacist without being registered as manufacturer? I. A final preparation contains 10 mg Codeine + 90 mg non-active ingredients. II. A final preparation contains 20 mg Codeine + 80 mg non-active ingredients. III. A final preparation contains 30 mg Codeine + 70 mg non-active ingredients. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [New Jersey Controlled Dangerous Substances Act 13:45H-8.5]. A pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding 20 percent of the completed solution, compound or mixture. Therefore; 1. A final preparation contains 10 mg Codeine + 90 mg non-active ingredients (10 % Codeine) 2. A final preparation contains 20 mg Codeine + 80 mg non-active ingredients (20 % Codeine)

Which of the following is/are TRUE about continuing education credit hour requirement(s) under New Jersey State Pharmacy Law? I. Each applicant for biennial license renewal shall complete a minimum of 30 credits of continuing education during the preceding biennial period. II. At least three continuing education credits shall be obtained in pharmacy law applicable to the practice of pharmacy in New Jersey. III. At least 15 of the 30 continuing education credits shall be obtained through didactic instruction. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [New Jersey Pharmacy Administrative Code 13:39-3A.l(a),(b)]. (a). Each applicant for biennial license renewal shall complete a minimum of 30 credits of continuing education during the preceding biennial period, except that the Board shall not require completion of continuing education credits for an applicant's initial license renewal. At least 10 (NOT 15) of the continuing education credits shall be obtained through didactic instruction. For purposes of this paragraph, "didactic instructions' means in-person instruction and may include telephonic or electronic instruction that is interactive, but shall not include videotaped instruction. At least three continuing education credits shall be obtained in pharmacy law applicable to the practice of pharmacy in New Jersey. (b). Ten credits of continuing education may be carried over into a succeeding biennial period only if such credits were earned during the last six months of the preceding biennial period and were not previously reported.

Which of the following information is/are TRUE about the New Jersey Prescription Blanks (NJPB)? I. A separate NJPB shall be utilized for each prescription written for a controlled dangerous substance. II. If a licensed prescriber utilizes an NJPB pre‐printed with multiple drugs, the prescriber shall obliterate, by a cross‐off procedure, any drug that is not being prescribed. III. No more than two medications shall appear on the prescription. a. I only b. I and II only c. II and III only d. All

Answer: (b) I and II only, [Uniform Prescription Blanks 13:45A-27.3(c)to(f)]. c). A separate NJPB shall be utilized for each prescription written for a controlled dangerous substance. The licensed prescriber's Federal DEA registration number shall be pre‐printed, legibly written, typed, stamped, or otherwise affixed to the NJPB. No other medication shall appear on the prescription. d). If a licensed prescriber utilizes an NJPB pre‐printed with multiple drugs, the prescriber shall obliterate, by a cross‐off procedure, any drug that is not being prescribed. e). A prescription transmitted verbally or transmitted electronically by telephone, facsimile, modem or other means to a pharmacy by a licensed prescriber shall be exempt from the requirement of utilizing an NJPB if the licensed prescriber provides the pharmacist with his or her license number, DEA number, as appropriate to the particular prescription and NPI number. f) A licensed prescriber writing a prescription for a Schedule II narcotic substance to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion, or a prescription for a Schedule II narcotic substance for a hospice patient, OR a prescription for any Schedule II substance for a long‐term care facility resident, Shall be exempt from the requirement of utilizing an NJPB.

MJ comes to a pharmacy and requests a transfer of a prescription for Alprazolam from another pharmacy. His patient profile shows that three eligible refills have been left on the prescription. If both pharmacies, transferring and receiving, electronically sharing a real-time, on-line database, how many times may the original prescription be transferred between pharmacies? a. One-time only b. Maximum three times c. As many times as needed until prescription expires d. Cannot be transferred

Answer: (b) Maximum three times, [New Jersey Administrative Code 13:39-7.8(d) and New Jersey Controlled Dangerous Substances Act 13:45H-7.18(a)]. The one-time transfer of the original prescription information for a controlled substance listed in Schedules III, IV, or V, if any authorized refills remain, for the purpose of dispensing is permissible between pharmacies within six (6) months from the date the prescription was issued. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization.

What is the maximum amount of Robitussin A/C that can be dispensed to a given purchaser within a 48-hour period? a. 240 cc b. 120 cc c. 60 cc d. 480 cc

Answer: (b) Not more than a 4 ounce (120 cc) over-the-counter preparation containing Codeine can be dispensed to a given purchaser within a 48-hour period, [New Jersey Controlled Dangerous Substances Act 13:45H-7.19(a)(2)].

A pharmacist is adding 1000 mg of pure codeine powder to 100 cc of Tylenol with codeine Elixir (120 mg/12 mg/5 cc). The resultant mixture should be classified as: a. Schedule II b. Schedule III c. Schedule IV d. Schedule V

Answer: (b) The compounded mixture should be classified as a Schedule III controlled drug. The amount of Codeine present in the final mixture is 1.24 gms (1000 mg plus 240 mg). It has been stated under CSA that if a mixture contains less than 1.8 gms of Codeine per 100 cc, it should be classified as a Schedule III controlled substance, [New Jersey Controlled Dangerous Substances Act 13:45H-10.1]. List of Schedule III controlled drugs: ______________________________ Amobarbital and noncontrolled active ingredients Amobarbital suppository dosage form Anabolic steroids Barbituric acid derivative Benzphetamine (Didrex, Inapetyl) Buprenorphine (Buprenex, Temgesic) Butabarbital (Butisol, Butibel) Butalbital (Fiorinal, Butalbital with aspirin) Codeine and isoquinoline alkaloid (Codeine with papaverine or noscapine) Codeine combination product (Empirin, Fiorinal, Tylenol, ASA or APAP w/codeine) Dronabinol in sesame oil in soft gelatin capsule (Marinol) Gamma-hydroxybutyric acid Ketamine Lysergic acid Lysergic acid amide Methyltestosterone (Android, Oreton, Testred, Virilon) Nalorphine (Nalline) Nandrolone (Deca-Durabolin, Durabolin, Durabolin-50) Norethandrolone(Nilevar, Solevar) Opium combination product (Paregoric) Pentobarbital and noncontrolled active ingredients Pentobarbital suppository dosage form Phendimetrazine (Bontril) Secobarbital and noncontrolled active ingredients Secobarbital suppository dosage form Testosterone (Android-T, Androlan, Depotest, Delatestryl) Thiopental (Pentothal)

MJ has brought a prescription for Amoxicillin 500 mg 1 po tid to a pharmacy. The pharmacy only has an Amoxicillin Suspension 250 mg/5cc in a stock. The pharmacist has tried to contact the prescriber, but he has been out of town for the weekend. Under these circumstances, the pharmacist may: a. not fill the prescription. b. dispense a suspension but shall notify the prescriber within 48 hours of dispensing. c. ask the patient to go to another pharmacy. d. contact another prescriber to get a new prescription for suspension.

Answer: (b) Under New Jersey State Pharmacy Law, a pharmacist may dispense a prescription in a different dosage form than originally prescribed if the pharmacist notifies the prescriber no later than 48 hours following the dispensing of the prescription, provided the dosage form dispensed has the appropriate drug release rate, [New Jersey Pharmacy Act 45:14-60(21)].

How many members does the New Jersey State Pharmacy Board consist of? a. 7 b. 9 c. 11 d. 3

Answer: (c) 11 members, [New Jersey Pharmacy Act 45:14-43]. 1. The board shall consist of eleven members, two of whom shall be public members and one of whom shall be a state executive department member. 2. Each of the remaining eight members shall be pharmacists. 3. Each pharmacist member shall have at least five years of experience in the practice of pharmacy in this State after licensure, and shall at the time of appointment and throughout their tenure: be currently licensed and in good standing to engage in the practice of pharmacy in this State, and be actively engaged in the practice of pharmacy in this State. 4. The Governor shall appoint the members of the board.

In which of the following instances, a dispensing of a drug shall be classified as misbranded? a. A tablet falls on a floor dispensed by a pharmacist. b. A spider is found in an original manufacturer container. c. A returned drug is mixed with the drug containing a different lot number. d. A drug is compounded without properly sanitizing the compounding area.

Answer: (c) A returned drug is mixed with the drug containing a different lot number, [Food, Drugs And Cosmetics 53-1-109]. The choices a, b and d are considered to be adulterated. A drug shall be classified as misbranded if: (a). Its labeling is false or misleading in any particular way. (b). It is in a package form, unless it bears a label containing: (1). the name and place of business of the manufacturer, packer, or distributor; and (2). an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. (c). Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d). It is a drug and its container is so made, formed, or filled as to be misleading; or (e). It is an imitation of another drug; or (f). It is offered for sale under the name of another drug. (g). It is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. (h). It is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive. (i). It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 510 of FDCA.

The compounding of Cisplatin shall be performed under: I. Compounding aseptic containment isolator II. Class II biological safety cabinet III. Class III biological safety cabinet a. I only b. II only c. All d. None of the above

Answer: (c) All, [New Jersey Administrative Code 13:39-11.9(c)]. c). Pharmacies shall compound antineoplastic agents and other hazardous substances only in: 1. A compounding aseptic containment isolator or a Class II or Class III biological safety cabinet in a negative pressure cleanroom. When handling volatile hazardous drugs, such devices shall be vented to the outside air; or 2. A compounding aseptic containment isolator located outside of a negative pressure cleanroom, consistent with N.J.A.C. 13:39-11.8. When handling volatile hazardous drugs, such devices shall be vented to the outside air.

Which of the following forms is required to destroy controlled substances? a. DEA 106 b. DEA 222 c. DEA 41 d. DEA 82

Answer: (c) Any person in possession of any controlled substance and desiring or required to dispose of such substance may request the Special Agent in Charge, U.S. Department of Justice, Drug Enforcement Administration, 80 Mulberry St., 2nd Floor, Newark, N.J. 07102 for authority and instructions to dispose of such substance. The person may also contact the Drug Control Unit for such authority and instruction, [New Jersey Controlled Dangerous Substances Act 13:45H-8.10(a),(b)]. The request shall be made in the following manner: 1. If the person is a registrant required to make reports pursuant to Part 304 of the Act, he shall list the controlled substances or substance which he desires to dispose of on the "b" subpart of the report normally filed by him, and submit three copies of that report to the Special Agent in Charge, U.S. Department of Justice, Drug Enforcement Administration, 80 Mulberry St., 2nd Floor, Newark, N.J. 07102. 2. If the person is a registrant not required to make reports pursuant to Part 304 of the Act, he shall list the controlled substance or substances which he wishes to dispose of on DEA-41 form or Form DDC-51 of the Drug Control Unit. If he elects to use the DEA-41 form, he must submit three copies of that form to the Special Agent in Charge, U.S. Department of Justice, Drug Enforcement Administration, 80 Mulberry St., 2nd Floor, Newark, N.J. 07102. If the person elects to use the DDC-51 form, he must submit three copies of that form to the Drug Control Unit or may telephone that agency. 3. If the person is not a registrant he shall submit to the Special Agent in Charge a letter stating: i. The name and address of the person; ii. The name and quantity of each controlled substance to be disposed of; iii. How the applicant obtained the substance, if known; and iv. The name, address and registration number, if known, of the person who possessed the controlled substance prior to the applicant, if known. (b). The Special Agent in Charge or the Drug Control Unit shall authorize and instruct the applicant to dispose of the controlled substances in one of the following manners: 1. By transfer to the District Office of the Special Agent in Charge; 2. By transfer to a person registered under the act and authorized to possess such substance or substances; 3. By destruction in the presence of an agent of the District Office of the Special Agent in Charge or an agent of the Drug Control Unit; or 4. By such other means as the Special Agent in Charge or the Drug Control Unit may determine to assure that the substance or substances does not become available to unauthorized persons.

Which of the following requires a tamper-evident packaging? a. Cold EZ lozenges b. Tolnaftate cream c. Prilosec capsules d. Sensodyne fluoride tooth paste

Answer: (c) Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). A tamper-evident package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-evident feature shall be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and retail display.

Which of the following is/are TRUE regarding New Jersey Prescription Blanks? I. A practitioner practicing in this State shall use non-reproducible, non-erasable safety paper New Jersey Prescription Blanks bearing that practitioner's license number whenever the practitioner issues prescriptions for controlled dangerous substances, prescription legend drugs or other prescription items. II. The prescription blanks shall be secured from a vendor approved by the Division of Consumer Affairs in the Department of Law and Public Safety. III. The practitioner shall notify the Office of Drug Control in the Division of Consumer Affairs as soon as possible but no later than 7 days after being made aware that any New Jersey Prescription Blank in the practitioner's possession has been stolen. I only III only I and II only All

Answer: (c) I and II only, [New Jersey Pharmacy Act 45:14-55(a),(b)]. A practitioner practicing in this State shall use non-reproducible, non-erasable safety paper New Jersey Prescription Blanks bearing that practitioner's license number whenever the practitioner issues prescriptions for controlled dangerous substances, prescription legend drugs or other prescription items. The prescription blanks shall be secured from a vendor approved by the Division of Consumer Affairs in the Department of Law and Public Safety. A licensed practitioner practicing in this State shall maintain a record of the receipt of New Jersey Prescription Blanks. The practitioner shall notify the Office of Drug Control in the Division of Consumer Affairs as soon as possible but no later than 72 hours after being made aware that any New Jersey Prescription Blank in the practitioner's possession has been stolen. Upon receipt of notification, the Office of Drug Control shall take appropriate action, including notification to the Department of Human Services and the Attorney General.

A practitioner shall not issue a prescription for a narcotic drug listed in any schedule which drug is intended for the purpose of "detoxification" or "maintenance treatment." However, this section of the law is exempted when a practitioner dispense or administer narcotic drugs to relieve acute withdrawal symptoms provided that: I. Such treatment shall not exceed 7 days. II. No more than one day's supply of the drug is provided to the patient at a time. III. Arrangements are made for referring the patient to an addiction specialist or a drug treatment program for the treatment. a. I only b. I and II only c. II and III only d. All

Answer: (c) II and III are correct, [New Jersey Controlled Dangerous Substances Act 13:45H-7.7(a)(b)(c)]. A practitioner shall not issue a prescription for a narcotic drug listed in any schedule which drug is intended for the purpose of "detoxification" or "maintenance treatment." However, this section of the law is exempted when a practitioner dispense or administer narcotic drugs to relieve acute withdrawal symptoms provided that: a. Such treatment shall not exceed 72 hours, and cannot be renewed or extended. b. No more than one day's supply of the drug is provided to the patient at a time. c. Arrangements are made for referring the patient to an addiction specialist or a drug treatment program for the treatment. This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.

A person wishing to be registered with the Board as a pharmacy technician shall: I. Be 17 years of age or older. II. Possess a high school diploma or its equivalent. III. Submit a certification attesting to the fact that he or she is proficient in written and spoken English. a. I only b. I and II only c. II and III only d. All

Answer: (c) II and III only, [NEW JERSEY ADMINISTRATIVE CODE, Title 13, Chapter 39, 13:39-6.6(a)]. (a). A person wishing to be registered with the Board as a pharmacy technician shall: 1. Be 18 years (NOT 17 years) of age or older; 2. Possess a high school diploma or its equivalent; 3. Submit a certification attesting to the fact that he or she is proficient in written and spoken English; 4. Apply to the Board for registration and submit the application fee set forth in N.J.A.C. 13:39-1.3; 5. Submit his or her name, address and fingerprints for purposes of a criminal history background check pursuant to N.J.S.A. 45:1-28 et seq., (P.L. 2002, c. 104) to determine whether criminal history record information exists which may disqualify the applicant from being registered by the Board; and 6. Submit, as part of the application for registration, evidence of good moral character which is an ongoing requirement for registration, and evidence that he or she: i. Is not presently engaged in drug or alcohol use that is likely to impair the ability to practice as a pharmacy technician with reasonable skill and safety. For purposes of this section, the term "presently" means at the time of application or any time within the previous 365 days; ii. Has not been convicted of violating any law of this State or any other state of the United States relating to controlled dangerous substances or other habit-forming drugs; iii. Has not been convicted of violating any law relating to the practice of pharmacy; iv. Has not been convicted of a crime involving moral turpitude; and v. Has not had his or her authority to engage in the activity regulated by the Board suspended or revoked as a result of any administrative or disciplinary proceedings in this or any other jurisdiction which determined the applicant to be in violation of any laws, rules or regulations pertaining to the practice of pharmacy, and that the applicant is not currently under suspension or revocation. A pharmacy shall not employ as a pharmacy technician applicant any person who was previously employed as a pharmacy technician applicant at a pharmacy in the State and who failed to complete the pharmacy technician registration process or any person who has been the subject of disciplinary action by the Board.

If the prescriber fails to include on the original prescription directions to the patient for use of the medication, the registered pharmacist shall: I. not fill the prescription. II. make a documented attempt to contact the prescriber to obtain such directions. III. dispense the prescription and indicate on the label the words ''use as directed'' or ''as ordered by the physician'' if the prescriber cannot be contacted. a. I only b. II only c. II and III only d. III only

Answer: (c) II and III only, [New Jersey Pharmacy Administrative Code 13:39-7.2]. If the prescriber fails to include on the original prescription directions to the patient for use of the medication, the registered pharmacist shall make a documented attempt to contact the prescriber to obtain such directions. In cases where the prescriber cannot be contacted, the registered pharmacist shall indicate on the label the words ''use as directed'' or ''as ordered by the physician''.

If the prescription is written for an animal, which of the following shall be required on the prescription? I. Name of an animal II. The species of animal III. The full name and address of the owner of the animal a. I only b. I and II only c. II and III only d. All

Answer: (c) II and III only. If the prescription is for an animal, the prescription shall state the species of animal for which the drug is prescribed and the full name and address of the owner of the animal.

Which of the following is/are NOT TRUE regarding electronically transmitted prescriptions under New Jersey Pharmacy Law? I. A pharmacist may fill a prescription for a Schedule II controlled substance transmitted electronically. II. A pharmacist may fill a prescription for a Schedule III, IV or V controlled substance transmitted electronically. III. A pharmacist may use a technological device in order to circumvent his or her responsibilities with regard to verifying the validity of electronic transmitted prescriptions. a. I only b. I and II only c. III only d. All

Answer: (c) III is NOT TRUE, [New Jersey Administrative Code Title 13, Chapter 39, 13:39-7.11(h),(i),(m)]. 1). A pharmacist may fill a prescription for a Schedule II controlled substance transmitted electronically, provided that the original signed prescription is presented to the pharmacist prior to the dispensing of the controlled substance. If permitted by Federal law, and in accordance with Federal requirements, an electronic prescription shall serve as the original signed prescription. 2). A pharmacist may fill a prescription for a Schedule III, IV or V controlled substance transmitted electronically, provided that the pharmacist has obtained the original signed prescription, an oral prescription, or a facsimile prescription from the prescribing practitioner or the prescribing practitioner's authorized agent prior to the dispensing. If permitted by Federal law, and in accordance with Federal requirements, an electronic prescription shall serve as the original signed prescription. 3). A pharmacist shall not use a technological device in order to circumvent his or her responsibilities with regard to verifying the validity of prescriptions or in order to circumvent other standards of pharmacy practice.

If a schedule V Over The Counter drug is dispensed pursuant to the prescription order of a practitioner, the dispensing container shall be labeled according to: a. OTC labeling requirement b. Non-controlled rx requirement c. Controlled rx requirement d. Does not require labeling

Answer: (c) If a schedule V drug is dispensed pursuant to the prescription order of a practitioner, the prescription shall be labeled according to controlled substances prescription labeling requirement, and the order shall be filed in accordance with the requirements for schedule III and IV orders, [New Jersey Controlled Dangerous Substances, Title 13, Chapter 45H, 13:45H 7.18(a)]. If a schedule V drug is dispensed other than pursuant to a prescription order, the dispenser shall make the record required by the law, in a bound controlled substance V register at the time of the transaction.

In New Jersey, a pharmacist should not dispense any non-controlled drug or device if the prescription is presented: a. More than 180 days after the date of issuance. b. More than 90 days after the date of issuance. c. More than 365 days after the date of issuance. d. More than 30 days after the date of issuance.

Answer: (c) In New Jersey, a pharmacist should not dispense any non controlled drug or device if the prescription is presented more than 365 days or 1 year after the date of issuance. However, all prescriptions for controlled substances, regardless of schedules, shall be presented to the pharmacist for filling within 30 days after the date when issued. [New Jersey Pharmacy Administrative Code 13:39-7.3(a)(1) and New Jersey Controlled Dangerous Substances Act 13:45H-7.5(a)]. All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the full name, address, proper academic degree or other definitive identification of the professional practice for which he or she is licensed and registration number of the practitioner. A practitioner may sign a prescription in the same manner as he would sign a check or legal document (for example, J.H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written in ink or indelible pencil or typewriter and shall be manually signed by the practitioner. The prescription may be prepared by a secretary or agent of the practitioner for the signature of the practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law or rules. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by these rules. An intern, resident, or foreign-trained physician, or physician on the staff of a Veteran's Administration facility, exempted from registration under the Code of Federal Regulations, Title 21, part 1301.24(c) shall include on all prescriptions issued by him the registration number of the hospital or other institution and the special internal code number assigned to him by the hospital or other institution as provided in the Code of Federal Regulations, Title 21, part 1301.24(c), in lieu of the registration number of the practitioner required by this section. Each written prescription shall have the name of the physician stamped, typed, or handprinted on it, as well as the signature of the physician.

Which of the following drug(s) is classified as a controlled substance? a. Cipro b. Vibramycin c. Lyrica d. Antara

Answer: (c) Lyrica (Pregabalin) is classified as a Schedule V controlled substance, [New Jersey Controlled Dangerous Substances Act 13:45H-10.1].

All of the following are Schedule I controlled drugs EXCEPT: Heroin LSD Methylphenidate Marijuana

Answer: (c) Methylphenidate(Ritalin) is a Schedule II controlled drug, [New Jersey Controlled Dangerous Substances Act 13:45H-10.1]. List of Schedule I controlled drugs: _____________________________ Difenoxin (Lyspafen) Dihydromorphine Heroin (Diacetylmorphine, diamorphine) Lysergic acid diethylamide (LSD, lysergide) Marijuana (Cannabis, marijuana) Mescaline Peyote

If a prescriptions issued by a health care facility, the New Jersey Prescription Blanks shall bear which of the following on prescription blanks? a. Nine-digit internal control number b. X-DEA number c. Unique provider number d. Office of Drug Control 12 digit number

Answer: (c) Unique Provider Number, [New Jersey Pharmacy Act 45:14-56(17)(a)]. Prescriptions issued by a health care facility shall be written on non-reproducible, non-erasable safety paper New Jersey Prescription Blanks. The prescription blanks shall be secured from a vendor approved by the Division of Consumer Affairs in the Department of Law and Public Safety. The New Jersey Prescription Blanks shall bear the Unique Provider Number assigned to that health care facility for the issuing of prescriptions for controlled dangerous substances, prescription legend drugs or other prescription items.

A pharmacist has substituted generic Metoprolol (Mfg: Mylan) for the prescribed brand name Lopressor (Mfg: Pfizer). Which of the following shall be placed on dispensing label? a. Metoprolol, (Mylan) b. Metoprolol (Mylan), Lopressor c. Metoprolol, (a generic for Lopressor) d. Lopressor (Pfizer), Metoprolol

Answer: (c) Metoprolol, (a generic for Lopressor), [New Jersey Administrative Code 13:39-7.12(a)(3)]. a). The dispensed container for any product shall bear a permanently affixed label with at least the following information: 1). The pharmacy name and address; 2). The pharmacy telephone number; 3). The brand name, or if a generic, the brand name and the name of the generic in the following form, with the generic name and brand name inserted as appropriate: "------ Generic for-------"; 4). The strength of medication, where applicable; 5). The quantity dispensed; 6). The date upon which prescription medication is dispensed; 7). A CDS cautionary label, where applicable; 8). The patient name; 9). The practitioner's name; 10). The prescription number; 11). Directions for use; and 12). The phrase "use by" followed by the product's use by date, if dispensed in any packaging other than the manufacturer's original packaging.

Which of the following is/are classified as Schedule II controlled drug(s)? I. Heroin II. Morphine III. Pentobarbital a. I only b. I and II only c. II and III only d. All

Answer: (c) Morphine sulfate and Pentobarbital are classified as Schedule II controlled drugs, [New Jersey Controlled Dangerous Substances Act 13:45H-10.1]. Heroin is classified as a Schedule I controlled drug. List of Schedule II controlled drugs: _____________________________ Alfentanil (Alfenta) Amobarbital (Amytal, Tuinal) Amphetamine (Dexedrine, Biphetamine) Lisdexamfetamine (Vyvanse) Coca Leaves Cocaine Codeine Dextropropoxyphene, bulk (non-dosage forms) Dihydrocodeine (Didrate, Parzone) Diphenoxylate Diprenorphine Ecgonine (Cocaine precursor, in Coca leaves) Ethylmorphine (Dionin) Fentanyl (Innovar, Sublimaze, Duragesic) Glutethimide (Doriden, Dorimide) Hydrocodone (dihydrocodeinone) Hydrocodone and isoquinoline alkaloid Hydrocodone combination product (Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia) Hydromorphone (Dilaudid, dihydromorphinone) Levo-alphacetylmethadol (LAAM, long acting methadone, levomethadyl acetate) Meperidine (Demerol, Mepergan, pethidine) Methadone (Dolophine, Methadose, Amidone) Methamphetamine (Desoxyn, D-desoxyephedrine, ICE, Crank, Speed) Methylphenidate (Ritalin) Morphine (MS Contin, Roxanol, Duramorph, RMS, MSIR) Opium poppy Opium tincture Opium, granulated Opium, powdered Opium, raw Oxycodone (OxyContin, Percocet, Tylox, Roxicodone, Roxicet) Oxymorphone (Numorphan) Pentobarbital (Nembutal) Poppy Straw Concentrate Remifentanil (Ultiva) Secobarbital (Seconal, Tuinal) Sufentanil (Sufenta) Tapentadol (Nucynta)

A patient comes to a pharmacy with a prescription for Oxycontin. After processing the claim, the pharmacist finds out that he does not have enough quantity to dispense the full supply. Under this circumstance, the pharmacist may: a. Tell the patient to pick up partial quantities within a week. b. Call another pharmacy and borrow a bottle of Oxycontin. c. Reverse the claim and return the prescription back to the patient. d. Call the physician and change the quantity.

Answer: (c) Oxycontin is a schedule II controlled substance, [New Jersey Controlled Dangerous Substances Act 13:45H-7.10(b),(c) and 13:45H-10.1]. When dealing with schedule II controlled substances, it is better to reverse the claim and return the prescription to the patient. The another option would be to dispense the partial quantity within 72 hours of initial dispensing of the drug.

All of the following can be present on the label of Unit Dose Packaging EXCEPT: a. Lot number b. Expiration date c. Serial number d. Manufacturer

Answer: (c) The serial number is usually present on the label of the prescription container, [New Jersey Pharmacy Administrative Code 13:39-9.2-Unit Use Packaging]. "Unit use packaging'' means a single unit use medication provided in sealed packaging, which contains the following information for each unit in the package: 1. Product name 2. Strength and/or quantity and/or volume, where appropriate 3. Lot number 4. Use by date 5. Manufacturer or repackager 6. If there is more than one product in the single unit, a physical description of each medication in the single unit.

When a pharmacy department is closed, the wholesale supplier shall: a. drop the shipment in the store department in the presence of a store manager. b. take the whole shipment back if the pharmacy department is closed. c. unload the shipment in a secured area provided by the pharmacy. d. only unload the shipment in the presence of the pharmacist in charge.

Answer: (c) The supplier can unload the shipment in a secured area provided by the pharmacy, [New Jersey Pharmacy Administrative Code 13:39-4.15(b)(1)-to-(4)]. No prescription drug shall be accepted from any supplier during the hours the pharmacy department is closed unless adequate security for the storage of department shipments has been provided. The holder of a pharmacy or pharmacy department permit and the registered pharmacist-in-charge of the pharmacy or pharmacy department shall ensure that: 1. All entrances to the pharmacy or pharmacy department are capable of being locked and are connected to a monitored security system that transmits an audible, visual or electronic signal warning of intrusion. The security system shall be equipped with a back-up mechanism to ensure notification or continued operation if the security system is tampered with or is disabled. Only the registered pharmacist-in-charge of the permitted premises or the pharmacy department shall be responsible for the security of the keys and the security system access code to the pharmacy or pharmacy department; 2. If a theft or diversion of prescription legend drugs or devices or controlled substances, or a significant loss of prescription legend drugs or devices or controlled substances, as delineated in (a) above, is reported to the registered pharmacist-in-charge, the registered pharmacist-in-charge shall notify the holder of the pharmacy or pharmacy department permit of such report. The registered pharmacist-in-charge and the holder of the pharmacy or pharmacy department permit shall ensure that: i. A written report is filed with the Board upon discovery of the theft or diversion or the significant loss of prescription legend drugs or devices; and ii. A written report is filed with the Federal Drug Enforcement Administration upon discovery of the theft or diversion or any significant loss of controlled substances, consistent with Federal requirements. A copy of such report shall be filed with the Office of Drug Control, consistent with State requirements and with the Board; 3. There is a secure area for receiving packages known to contain prescription legend drugs and devices and controlled substances. No prescription drug shall be accepted during the hours the pharmacy or pharmacy department is closed unless adequate security for the storage of such shipments has been provided; and 4. If a drop-off device is utilized for prescriptions, it is of a one-way, irretrievable and secure design.

In the case of unauthorized refills, the dispensed quantity of the refilled drug should be limited to a: One-day supply. Seven-day supply. Three-day supply Thirty-day supply.

Answer: (c) Three-day supply, [New Jersey Pharmacy Administrative Code 13:39-7.4(a)]. In the absence of a current, valid prescription, a pharmacist may dispense an emergency supply (no more than a 72-hour quantity) of a chronic maintenance drug or device if, in his or her professional judgment, refusal would endanger the health or welfare of the patient, provided the following conditions are satisfied. 1. The pharmacist first ascertains to the best of his or her ability, by direct communication with the patient or caregiver, that such a medication or device was prescribed for that patient by order of a practitioner. The pharmacist shall require the patient or caregiver to provide suitable identification. Such communication shall be documented in the patient profile record system maintained pursuant to N.J.A.C. 13:39-7.19 or in the pharmacy's other manual or electronic files; and 2. The pharmacist documents the dispensing of the emergency supply in the prescription record system.

When up to three separate prescriptions for a total of up to a 90-day supply of a Schedule II controlled substance are presented by a patient, the pharmacist shall: a. accept and fill all three prescriptions at one time. b. fill the first prescription and reject the other two prescriptions. c. fill the first prescription no later than 30 days after the date of issuance. d. not fill any prescription.

Answer: (c) fill the first prescription no later than 30 days after the date of issuance, [New Jersey Controlled Dangerous Substances Act 13:45H-7.5(a)]. When up to three separate prescriptions for a total of up to a 90-day supply of a Schedule II controlled substance are issued to a patient by a physician, a pharmacist shall fill such prescriptions. i. All three prescriptions may be accepted at one time and held pending filling as indicated below: (1). The first prescription shall be filled no later than 30 days after the date of issuance; and (2). The second and third prescriptions shall be filled no later than 30 days after the date indicated on the prescription as the earliest date on which the prescription may be filled. ii. Prescriptions presented individually shall be filled as indicated below: (1). The first prescription shall be filled no later than 30 days after the date of issuance; (2). The second and third prescriptions shall be presented to the pharmacy and filled no later than 30 days after the date indicated on the prescription as the earliest date on which the prescription may be filled. iii. A patient shall not be provided with more than a 30-day supply of a Schedule II medication at one time.

All documentation and records pertaining to immunizations shall be maintained in either hard copy or electronic form for a period of not less than: a. 5 years from the date of most recent entry. b. 3 years from the date of most recent entry. c. 2 years from the date of most recent entry. d. 7 years from the date of most recent entry.

Answer: (d) 7 years from the date of most recent entry, [New Jersey Administrative Code 13:39-4.21(l)]. All documentation and records pertaining to immunizations shall be maintained in either hard copy or electronic form for a period of not less than 7 years from the date of most recent entry and shall be supplied to any physician or health care provider upon receipt of a signed patient release of health information form. All records shall be made available to persons authorized to inspect them under State and Federal statutes and regulations. The oldest six years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but the storage facilities shall be secure. Patient records shall be kept confidential.

A pharmacist may release a confidential report only to: I. A patient's agent. II. The State Pharmacy Board. III. An insurance carrier. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [42C.F.R. Part 3 and Public Law 104-191]. A confidential record is privileged and a pharmacist may release a confidential record only to: (1). The patient or the patient's agent; (2). A practitioner or another pharmacist if, in the pharmacist's professional judgment, the release is necessary to protect the patient's health and well-being; (3). The board or to a person or another state or federal agency authorized by law to receive the confidential record; (4). A law enforcement agency engaged in investigation of a suspected violation; (5). A person employed by a state agency that licenses a practitioner, if the person is performing the person's official duties; or (6). An insurance carrier or other third party payor authorized by the patient to receive the information.

Who may access the automated medication system for stocking and retrieval of medications? I. Licensed Pharmacist II. Registered Pharmacy-Intern III. Qualified pharmacy technician a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code 13:39-10.4(7)]. Access to the automated medication system for stocking and retrieval of medications is limited to licensed practitioners or qualified pharmacy technicians, interns and externs under the supervision of a pharmacist. An accountability record, which documents all transactions relative to stocking and removing medications from the automated medication system shall be maintained.

Pharmacists may compound sterile preparations in a quantity that is supported by prior valid prescriptions or medication orders before receiving a valid written prescription or medication order, provided the pharmacist: I. Documents a history of valid prescriptions or medication orders subsequently received, within the beyond-use dating time of each product, which have been generated solely within an established professional prescriber-patient-pharmacist relationship. II. Documents the batch preparation process, including selection of the drugs, containers, and diluents, lot numbers and expiration dates of the drugs, containers and diluents, if any, and verification that the compounded sterile preparation has been visually inspected to ensure the absence of particulate matter in solutions. III. Each batch shall be given a unique batch number to identify the specific batch. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code 13:39-11.17 and New Jersey Administrative Code 13:39-11.18]. Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs may compound sterile preparations in a quantity that is supported by prior valid prescriptions or medication orders before receiving a valid written prescription or medication order, provided the pharmacist: 1. Documents a history of valid prescriptions or medication orders subsequently received, within the beyond-use dating time of each product, which have been generated solely within an established professional prescriber-patient-pharmacist relationship; 2. Maintains the prescription or medication order on file for all such products dispensed at the pharmacy; 3. Documents the batch preparation process, including selection of the drugs, containers, and diluents, lot numbers and expiration dates of the drugs, containers and diluents, if any, and verification that the compounded sterile preparation has been visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness of labeling. Each batch shall be given a unique batch number to identify the specific batch; and 4. Ensures that the labeling requirements set forth at N.J.A.C. 13:39-11.21(a)1, 5, 7, 9, and 10 are satisfied. (b). Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs, consistent with N.J.A.C. 13:39-11.13, may batch prepare compounded sterile preparations for use by a licensed prescriber in his or her practice without a prescription, pursuant to N.J.A.C. 13:39-11.18, provided the pharmacist: 1. Complies with all requirements of N.J.A.C. 13:39-11.18; and 2. Documents the batch preparation process in accordance with N.J.A.C. 13:39-11.20(c). A pharmacy may prepare compounded sterile preparations for a licensed prescriber for use in the prescriber's practice without a prescription consistent with State and Federal laws pertinent to the prescriber's health care practice.

The dispensed container for any compounded sterile preparation shall bear a permanently affixed label with at least: I. The date and the time prepared. II. The name and strength or quantity of all active ingredients. III. The phrase "use by" followed by the preparation's use by date and time. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code 13:39-11.21]. a). The dispensed container for any compounded sterile preparation shall bear a permanently affixed label with at least the following information: 1). The date and the time prepared; 2). In the retail pharmacy only, the name of the prescriber; 3). The name of the patient; 4). Directions for use; 5). The name and strength or quantity of all active ingredients, and the name and volume of the diluent, vehicle, and base solution(s), if applicable; 6). The name, address, and telephone number of the pharmacy; 7). The phrase "use by" followed by the preparation's use by date and time (if no time is stated, it is presumed to be 11:59 P.M. of the stated use by date). 8). Any ancillary and cautionary instructions as needed; 9). As pertinent, a warning consistent with applicable Federal and State law, that antineoplastic agents and other hazardous substances products are biohazardous; 10). As pertinent, the requirements for proper storage; and 11). In a retail pharmacy, for those medications not dispensed pursuant to the requirements of N.J.A.C. 13:39-9, the prescription number. b). For immediate use compounded sterile preparations, when the preparation is not administered by the person who prepared it, or its administration is not witnessed by the person who prepared it, the compounded sterile preparation shall be labeled consistent with the requirements of (a) above and shall also include the name or identifier of the person who prepared the compounded sterile preparation.

Which of the following information is/are TRUE about Beyond Use Date (BUD)? I. Where the manufactured drug product is the source of the active ingredient, the beyond-use date shall not be later than 25 percent of the time remaining until the product's expiration date or six months, whichever is earlier. II. Where a United States Pharmacopeia-National Formulary (USP-NF) substance is the source of the active ingredient, the beyond-use date shall not be later than six months or the expiration date of the ingredient, whichever is earlier. III. For water-containing formulations (prepared from ingredients in solid form), the beyond-use date shall not be later than 14 days for liquid preparations when stored at cold temperatures between 2 degrees and 8 degrees Celsius. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code 13:39-11A.11]. a). The beyond-use date is the date after which a compounded non-sterile preparation shall not be used. The beyond-use date shall be determined from the date the preparation is compounded. Because compounded preparations are intended for administration immediately or following short-term storage, beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products. b). In the absence of stability information that is applicable to a specific drug product and preparation, the following are the maximum beyond-use dates for non-sterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature unless otherwise indicated: 1. For nonaqueous liquids and solid formulations: i. Where the manufactured drug product is the source of the active ingredient, the beyond-use date shall not be later than 25 percent of the time remaining until the product's expiration date or six months, whichever is earlier; ii. Where a United States Pharmacopeia-National Formulary (USP-NF), analytical reagent (AR), certified American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substance is the source of the active ingredient, the beyond-use date shall not be later than six months or the expiration date of the ingredient, whichever is earlier; and iii. Where there is more than one ingredient, the beyond-use date shall be no longer than six months or the expiration date of the first ingredient to expire, whichever is earlier; 2. For water-containing formulations (prepared from ingredients in solid form), the beyond-use date shall not be later than 14 days for liquid preparations when stored at cold temperatures between two degrees and eight degrees Celsius (36 degrees and 46 degrees Fahrenheit); and 3. For all other formulations, the beyond-use date shall not be later than the intended duration of therapy or 30 days, whichever is earlier.

In order to administer vaccines and related emergency medications, a licensed pharmacist shall satisfy which of the following education and training requirements? I. Completion of an academic and practical curriculum that includes instruction in CDC guidelines for vaccine administrations. II. Current certification in the American Heart Association Basic Life Support. III. At least two hours of continuing education in immunizations in each biennial renewal period. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code 13:39-4.21(b)]. In order to administer vaccines and related emergency medications pursuant to this section, a licensed pharmacist shall be pre-approved by the Board to perform such functions. In order to obtain such prior Board approval, a pharmacist shall submit documentation to the Board which establishes that he or she has satisfied the following education and training requirements: 1. Completion of an academic and practical curriculum that includes instruction in Centers for Disease Control and Prevention (CDC) guidelines for vaccine administrations; 2. ACPE approved curriculum on the following subjects: a. The Occupational Exposure to Bloodborne Pathogens standard of the Occupational Health and Safety Administration (OSHA); b. CDC Guideline for Infection Control in Health Care Personnel; c. Basic immunology; d. Communicable or vaccine preventable disease epidemiology; e. Vaccine characteristics, contraindications, monitoring, proper storage and proper handling; f. Informed consent; g. Pre-and post-vaccine assessment and counseling; h. Immunization record management; i. Injection techniques; j. Emergency responses to adverse events; k. Medical waste disposal; and l. Reporting adverse events; m. Current certification in the American Heart Association Basic Life Support (BLS) and the Red Cross Adult Cardiac Pulmonary Resuscitation (CPR); n. At least two hours of continuing education in immunizations in each biennial renewal period.

All prescription areas where non-sterile compounding is performed shall contain which of the following minimum equipment and supplies? I. Glass funnels. II. Suppository mold. III. Class A prescription balance. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code 13:39-5.8(b) and 13:39-5.9]. b). All prescription areas where non-sterile compounding is performed shall contain the following minimum equipment and supplies, which shall be stored, so as to be readily accessible: 1). Class A prescription balance with a complete set of metric weights or equivalent electronic weighing device; 2). A glass mortar and pestle; 3). Glass funnels; 4). Stirring rods; 5). Ointment tile or parchment paper; and 6). Suppository mold. All pharmacies shall have all balances, scales, weights and automatic counting devices inspected every 12 months by the Department of Weights and Measures of the municipality or county in which the pharmacy is located, and such balances, scales, weights and automatic counting devices shall be properly sealed by the applicable authority.

Who may accept verbal new prescription on telephone from registered prescriber? I. Pharmacist II. Pharmacy-Intern III. Pharmacy-Extern a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code 13:39-6.2(f)(5),(6) and 13:39-7.8(e)]. 5). Only pharmacists and interns or externs under immediate personal supervision provide professional consultation with patients and physicians; 6). Only pharmacists, interns or externs accept telephone prescriptions and only pharmacists, interns or externs, or pharmacy technicians consistent with the requirements of N.J.A.C. 13:39-6.6(b), accept renewal authorizations. 7). Only pharmacists and interns or externs under immediate personal supervision transferred the prescription between pharmacies for the purpose of refill dispensing.

Pharmacy interns and pharmacy externs may assist the pharmacist in performing which of the following tasks? I. Retrieval of prescription files, patient files, and profiles and other such records pertaining to the practice of pharmacy. II. The filling of an automated medication system. III. Transcription of scanned prescription or medication order information into the patient record. I only I and II only II and III only All

Answer: (d) All, [New Jersey Administrative Code 13:39-6.5(b),(c)]. b). Pharmacy interns and pharmacy externs may assist the pharmacist in performing the following tasks: 1. Retrieval of prescription files, patient files, and profiles and other such records pertaining to the practice of pharmacy; 2. Data entry of prescription medication information, including the original or refill date of the prescription, the number or designation identifying the prescription, the practitioner's information, and the name, strength, and quantity of the prescribed medication; 3. The collection of the following demographic information for the patient profile: the name, address, and telephone number of the patient; the patient's age, date of birth; or age group (infant, child, adult); gender; any allergies and idiosyncrasies of the patient; and any medical conditions that may relate to drug utilization; 4. Transcription of scanned prescription or medication order information into the patient record; 5. Label preparation; 6. The counting, weighing, measuring, pouring, and compounding of prescription medication or stock legend drugs and controlled substances, including the filling of an automated medication system; and 7. Accepting authorization from a patient for a prescription refill, or from a practitioner or his or her agent for a prescription renewal, provided that the prescription remains unchanged. c). The collection of the demographic information under (b)3 above may be performed by unlicensed or unregistered personnel.

I. All audit trail and prescription information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of not less than five years. II. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. III. The most recent one year of a record information shall be retrievable and readable within one business day. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code 13:39-7.6(d)]. All audit trail and prescription information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of not less than five years. The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of a record information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.

Who may have access to the Institutional Pharmacy during "After Hours"? I. Staff Pharmacist II. Pharmacist-in-charge III. Designated registered nurse a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code 13:39-9.21]. a). Only a pharmacist shall have access to the pharmacy stock of controlled dangerous substances in Schedules II through V. b). Only a pharmacist shall have access to the institutional pharmacy except that in a pharmacist's absence from an institution, a registered nurse designated by the registered pharmacist-in-charge may obtain medication from the hospital pharmacy as needed in an emergency and not available as floor stock. c). A designated registered nurse shall remove only those medication doses which shall be administered prior to the opening of the pharmacy. The designated registered nurse may remove the following from the pharmacy stock of drugs or automated dispensing device: 1). A drug in its original container or a drug prepackaged by the pharmacy for use in the institution; 2). The required dose(s) of a drug from the original container for a specific patient. d). The pharmacist-in-charge shall obtain from the registered nurse on a suitable form a record of any drugs removed showing the following: 1). The name of the drug; 2). The dosage size; 3). The amount taken; 4). The date; 5). The patient's name and location; and 6). The signature of the nurse. e). The pharmacist-in-charge shall obtain with the record in (d) above the container from which the required dose(s) was taken for drug administration purposes in order that it may be properly checked by a pharmacist.

What are requirement(s) to become a licensed preceptor? I. Has been licensed and employed on a full-time basis as a pharmacist in the area of practice in which he or she is to be engaged as a preceptor for at least two years immediately preceding the date of application. II. An applicant is currently engaged in the practice of pharmacy in the State of New Jersey. III. Has not been convicted of a crime or offense relating adversely to the practice of pharmacy. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code N.J.A.C. 13:39-2.6(c)]. A pharmacist who wishes to be an intern preceptor shall apply to the Board and shall furnish evidence that he or she: 1. Has been licensed and employed on a full-time basis as a pharmacist in the area of practice in which he or she is to be engaged as a preceptor for at least two years immediately preceding the date of application and is currently engaged in the practice of pharmacy in the State of New Jersey; and 2. Has not been convicted of a crime or offense relating adversely to the practice of pharmacy consistent with N.J.S.A. 45:1-21(f) or a crime of moral turpitude and has not been the subject of disciplinary action taken by a professional board resulting in the suspension, revocation or surrender of a license or the placement of significant limitations on such license.

Who may transmit an electronic prescription? I. A licensed physician II. A licensed podiatrist III. The practitioner's authorized agent a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Administrative Code, Title 13, Chapter 39, 13:39-7.11]. (a). A pharmacist may accept for dispensing an electronic prescription, consistent with the requirements of this section. For purposes of this section, "electronic prescription" means a prescription which is transmitted by a computer device in a secure manner, including computer to computer and computer to facsimile transmissions. (b). A pharmacist shall not fill an electronic prescription transmitted by anyone other than a practitioner authorized to prescribe medications pursuant to N.J.S.A. 45:14-40, or the prescribing practitioner's authorized agent. If the electronic prescription is transmitted by the practitioner's authorized agent, the transmission shall include the full name and title of the agent.

Which of the following is/are TRUE about a pharmacy generated products or briefly called PGPS? I. A pharmacist may prepare a pharmacy generated product to be sold over-the-counter without a prescription or medication order. II. A pharmacy generated product shall be stored in such a manner as to be inaccessible to the public. III. A pharmacy generated product shall be sold directly to the consumer only after professional interaction or consultation between a pharmacist and the consumer. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Controlled Administrative Code 13:39-11A.7 ]. a). A pharmacist may prepare a pharmacy generated product to be sold over-the-counter without a prescription or medication order provided that: 1. The product does not contain an ingredient that exceeds allowable strengths and doses for over-the-counter drugs; and 2. The finished product is not one for which a prescription or medication order is required. b). A finished product that is prepared pursuant to (a) above shall be properly labeled with the following: 1. The product name; 2. The name of all ingredients; 3. The strength or quantity of all active ingredients; 4. The package size; 5. Directions for use; 6. The use by date, consistent with the requirements of N.J.A.C 13:39-11A.11; 7. The name, address, and telephone number of the pharmacy; 8. Any ancillary and cautionary instructions, as needed; and 9. As pertinent, the requirements for proper storage. c). A pharmacy generated product shall be sold directly to the consumer only after professional interaction or consultation between a pharmacist and the consumer. d). A pharmacy generated product shall be stored in such a manner as to be inaccessible to the public. e). A pharmacy generated product shall not be sold to any entity for resale purposes.

Which of the following is/are classified as Schedule IV controlled drug(s)? I. Oxazepam II. Zaleplon III. Butorphanol a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Controlled Dangerous Substances Act 13:45H-10.1]. List of Schedule IV controlled drugs: ______________________________ Tramadol (Ultram) Alprazolam (Xanax) Barbital(Barbitone) Butorphanol (Stadol, Stadol NS, Torbugesic, Torbutrol) Carisoprodol (Soma) Chloral hydrate (Noctec) Chlordiazepoxide (Librium, Libritabs, Limbitrol, SK-Lygen) Clonazepam (Klonopin, Clonopin) Clorazepate(Tranxene) Dexfenfluramine (Redux) Propoxyphene dosage forms with other ingredients Diazepam (Valium, Valrelease) Dichloralphenazone (Midrin) Difenoxin 1 mg/ Atropine 25 mcg (Motofen) Estazolam (ProSom, Domnamid, Eurodin, Nuctalon) Ethchlorvynol (Placidyl) Fenfluramine (Pondimin, Ponderal) Flurazepam (Dalmane) Lorazepam (Ativan) Mazindol (Sanorex, Mazanor) Meprobamate (Miltown, Equanil, Deprol, Equagesic, Meprospan) Midazolam (Versed) Modafinil (Provigil) Oxazepam (Serax, Serenid-D) Pemoline (Cylert) Pentazocine (Talwin, Talwin NX, Talacen, Talwin Compound) Phenobarbital (Luminal, Donnatal, Bellergal-S) Phentermine (Ionamin, Fastin, Adipex-P, Obe-Nix, Zantryl) Prazepam (Centrax) Quazepam (Doral, Dormalin) Sibutramine (Meridia) Temazepam (Restoril) Triazolam (Halcion) Zaleplon (Sonata) Zolpidem (Ambien) Zopiclone (Imovane) Eszopiclone (Lunesta)

Which of the following drugs can be dispersed throughout the stock of noncontrolled substances in community pharmacies? I. Hydrocodone II. Lorazepam III. Morphine a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Controlled Dangerous Substances Act 13:45H-2.5(a)(b)]. Normally, Controlled substances listed in Schedules II, III, IV and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances. Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet. Carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.

The Board of Pharmacy may refuse to issue or renew a pharmacist license if the applicant('s): I. fails to repay a student loan issued or guaranteed by the state or the Federal Government. II. license has been revoked or suspended by any other state. III. has permitted an unlicensed person or entity to perform an act for which a license or certificate of registration or certification is required by the board. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Enforcement Act 45:1-21]. A board may refuse to admit a person to an examination or may refuse to issue or may suspend or revoke any certificate, registration or license issued by the board upon proof that the applicant or holder of such certificate, registration or license: a. Has obtained a certificate, registration, license or authorization to sit for an examination, as the case may be, through fraud, deception, or misrepresentation; b. Has engaged in the use or employment of dishonesty, fraud, deception, misrepresentation, false promise or false pretense; c. Has engaged in gross negligence, gross malpractice or gross incompetence which damaged or endangered the life, health, welfare, safety or property of any person; d. Has engaged in repeated acts of negligence, malpractice or incompetence; e. Has engaged in professional or occupational misconduct as may be determined by the board; f. Has been convicted of, or engaged in acts constituting, any crime or offense involving moral turpitude or relating adversely to the activity regulated by the board; g. Has had his authority to engage in the activity regulated by the board revoked or suspended by any other state, agency or authority for reasons consistent with this section; h. Has violated or failed to comply with the provisions of any act or regulation administered by the board; i. Is incapable, for medical or any other good cause, of discharging the functions of a licensee in a manner consistent with the public's health, safety and welfare; j. Has repeatedly failed to submit completed applications, or parts of, or documentation submitted in conjunction with, such applications, required to be filed with the Department of Environmental Protection; k. Has violated any provision of P.L.1983, c.320 (C.17:33A‐1 et seq.) or any insurance fraud prevention law or act of another jurisdiction or has been adjudicated, in civil or administrative proceedings, of a violation of P.L.1983, c.320 (C.17:33A‐1 et seq.) or has been subject to a final order, entered in civil or administrative proceedings, that imposed civilpenalties under that act against the applicant or holder; l. Is presently engaged in drug or alcohol use that is likely to impair the ability to practice the profession or occupation with reasonable skill and safety. For purposes of this subsection, the term "presently" means at this time or any time within the previous 365 days; m. Has prescribed or dispensed controlled dangerous substances indiscriminately or without good cause, or where the applicant or holder knew or should have known that the substances were to be used for unauthorized consumption or distribution; n. Failing to perform any statutory or legal obligation placed upon a licensee. For purposes of this section, failing to repay a student loan issued or guaranteed by the state or the Federal Government in accordance with the terms of the loan or failing to comply with service scholarship obligations shall be considered a failure to perform a statutory or legal obligation, and the minimum disciplinary action imposed shall be a suspension of the license until new payment terms are agreed upon OR the scholarship obligation is resumed, followed by probation for the duration of the student loan or remaining scholarship obligation period, and a fine equal to 10 % of the defaulted loan amount. Fines collected shall be deposited into the Medical Quality Assurance Trust Fund.

To obtain a license to engage in the practice of pharmacy, the applicant shall: I. Have attained the age of 18 years. II. Be of good moral character. III. Have graduated and received a professional degree from an approved college or school of pharmacy. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Pharmacy Act 45:14-50 And New Jersey Administrative Code 13-39-2.1(d)(4)]. To obtain a license to engage in the practice of pharmacy, the applicant shall: a. Have submitted a written application in the form prescribed by the board; b. Have attained the age of 18 years; c. Be of good moral character; d. Have graduated and received a professional degree from a college or school of pharmacy that has been approved by the board; e. Have completed an internship or other program that has been approved by the board, or demonstrated to the board's satisfaction experience in the practice of pharmacy which meets or exceeds the minimum internship requirements of the board; f. Have successfully passed an examination or examinations as determined by the board; and g. Have paid the fees specified by the board for the examination and any related materials, and have paid for the issuance of the license. h. If the applicant is applying for initial licensure more than two years following his or her graduation from pharmacy school, the applicant shall complete 1,440 hours of practical experience in a Board-approved internship. The applicant shall register with the Board as an intern and shall satisfy all internship requirements set forth in N.J.A.C. 13:39-2.6 within the two-year period immediately preceding the date of application.

Which of the following must be TRUE regarding reciprocating a license from another state to New Jersey? I. The applicant is of good moral character and satisfies the requirements of the N.J.A.C. II. The applicant has engaged in the practice of pharmacy for a period of at least 1,000 hours within the last two years or has met the internship requirements set forth by the N.J.A.C. III. Any other license granted to the applicant by any other state has not been suspended, revoked or otherwise restricted for any reason. I only I and II only II and III only All

Answer: (d) All, [New Jersey Pharmacy Act 45:14-53(14)]. In order for a pharmacist currently licensed in another jurisdiction to obtain a license by reciprocity in this State, an applicant shall submit a completed application and the licensure fee set forth by the N.J.A.C. The completed application shall include evidence that: 1. The applicant has attained the age of 18. 2. The applicant is of good moral character and satisfies the requirements of the N.J.A.C. 3. The applicant has engaged in the practice of pharmacy for a period of at least 1,000 hours within the last two years or has met the internship requirements set forth by the N.J.A.C. within the one-year period immediately preceding the date of application. **Please Note Under N.J.A.C Section 13:39-2A.1: The applicant shall have engaged in the practice of pharmacy for a period of at least 1,500 hours within the two-year period immediately preceding the date of application...** 4. The applicant obtained initial licensure by examination and that the license is in good standing. 5. Any other license granted to the applicant by any other state has not been suspended, revoked or otherwise restricted for any reason except the failure to renew or for the failure to obtain the required continuing education credits in any state where the applicant is currently licensed but not engaged in the practice of pharmacy; and 6. The applicant has graduated and received a professional degree from a college or school of pharmacy that has been approved by the Board. **Please Note Under N.J.A.C Section 13:39-2A.5: If the applicant for reciprocal licensure fails the MPJE examination three times, the Board may direct the applicant to take remedial courses at an accredited school or college of pharmacy prior to retaking the law examination.**

Which of the following information about New Jersey Prescription Blanks is/are TRUE? I. New Jersey Prescription Blanks shall be uniform, non-reproducible, non-erasable safety paper prescription blanks. II. New Jersey Prescription Blanks shall include an identifiable logo or symbol that will appear on all prescription blanks. III. If the prescriber has a National Provider Identifier, the prescription blank shall include the National Provider Identifier. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Pharmacy Act 45:14-59]. The Division of Consumer Affairs in the Department of Law and Public Safety shall establish the format for uniform, non-reproducible, non-erasable safety paper prescription blanks, to be known as New Jersey Prescription Blanks, which format shall include an identifiable logo or symbol that will appear on all prescription blanks. The prescription blanks for each prescriber or health care facility shall be numbered consecutively and if the prescriber or health care facility has a National Provider Identifier, the prescription blank shall include the National Provider Identifier. The division shall approve a sufficient number of vendors to ensure production of an adequate supply of New Jersey Prescription Blanks for practitioners and health care facilities Statewide.

Which of the following is/are TRUE ABOUT administration of vaccine by a pharmacist under the New Jersey State Pharmacy Law? I. A pharmacist may administer an influenza vaccine to a patient who is seven years of age or older. II. For a patient who is under 18 years of age, a pharmacist shall not administer a vaccine except with the permission of the patient's parent or legal guardian. III. For a patient who is under 12 years of age, a pharmacist shall not administer a vaccine unless pursuant to a prescription by an authorized prescriber. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Pharmacy Act 45:14-63]. (1) Notwithstanding any law, rule, or regulation to the contrary, a pharmacist may administer drugs to a patient 18 years of age or older, provided the pharmacist is appropriately educated and qualified, as determined by the board in accordance with the requirements set forth in the rules jointly promulgated by the board and the State Board of Medical Examiners, and provided the drugs are administered under any one of the following conditions: (a). pursuant to a prescription by an authorized prescriber for a vaccine and related emergency medications; (b). in immunization programs implemented pursuant to an authorized prescriber's standing order for the vaccine and related emergency medications; or (c). in immunization programs and programs sponsored by governmental agencies that are not patient specific. (2). A pharmacist may administer an influenza vaccine to a patient who is seven years of age or older. For a patient who is under 18 years of age, a pharmacist shall not administer a vaccine except with the permission of the patient's parent or legal guardian. For a patient who is under 12 years of age, a pharmacist shall not administer a vaccine unless pursuant to a prescription by an authorized prescriber. Nothing in this subsection shall be construed to require a patient 12 years of age or older to obtain a prescription for an influenza vaccine.

Which of the following should be part of a patient's counseling? I. The name and description of the drug. II. Techniques for self-monitoring of therapy. III. Action to be taken in the event of a missed dose. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Pharmacy Act 45:14-67(28) and 13:39-7.21]. To optimize drug therapy, a pharmacist shall counsel the patient or patient's agent regarding: 1. the name and description of the drug or device. 2. dosage form, dosage, route of administration, and duration of drug therapy. 3. special direction and precautions for preparation, administration, and use by the patient. 4. common severe side or adverse effects or interactions and therapeutic contraindications that may occur with the therapy. 5. techniques for self-monitoring of drug therapy. 6. proper storage of medication. 7. refill information. 8. action to be taken in the event of a missed dose.

When should a pharmacist offer patient counseling? I. Upon a new prescription drug order. II. Upon refill of a prescription drug order. III. Once yearly on maintenance drugs. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Pharmacy Act 45:14-67(28)]. A pharmacist should offer patient counseling on new prescription drug orders, refill orders and once yearly on maintenance drugs (maintenance medications are defined as any medication the patient has taken for one year or longer).

Which of the following must be done by the pharmacy permit holder before closing or ceasing pharmacy's operation at a specific place? I. A permit holder shall write the Board of Pharmacy at least 15 days in advance to anticipate date of ceasing operation as a licensed pharmacy. II. A permit holder shall also inform the Office of Drug Control and the Drug Enforcement Administration at least 15 days prior to the anticipated closing date. III. A permit holder shall return the permit to the Board for cancellation within 30 days of the closing. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Pharmacy Administrative Code 13:39-4.10(a),(b)]. 1. Whenever a pharmacy is to be discontinued and closed for any reason, including suspension or retirement of the permit holder, sale or insolvency, the permit holder shall immediately send written notification of the anticipated closing to the State Board of Pharmacy, the Office of Drug Control and the Drug Enforcement Administration at least 15 days prior to the anticipated closing date. 2. Whenever a pharmacy is to be discontinued and closed as a result of an unanticipated occurrence, such as the death of the permit holder, the permit holder's representative shall send written notification to the Board, the Office of Drug Control and the Drug Enforcement Administration, as soon as possible prior to the actual closing date. 3. All medications, including prescription legend and controlled drugs, should be transferred to the holder of a current pharmacy permit; a wholesaler; a reverse distributor; and/or a manufacturer. 4. Within 30 days of closing a pharmacy pursuant to the permit holder or his or her representative shall remove all drug signs from both the inside and outside of the discontinued pharmacy and shall notify the Board in writing of the location of the previous five years of prescription and patient profile records. 5. The permit holder or his or her representative shall return the permit to the Board for cancellation within 30 days of the closing.

Faxing a prescription for Schedule II controlled drugs may serve as the original prescription only if: I. A prescription for a Schedule II narcotic substance prescribed for pain management to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion. II. A prescription for a Schedule II substance prescribed for pain management for a resident of a long-term care facility. III. A prescription for a Schedule II narcotic substance prescribed for pain management for a patient receiving services from a hospice certified by Medicare. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Pharmacy Administrative Code 13:39-7.10(h)(1),(2),(3)]. A pharmacist may fill a prescription for a Schedule II controlled substance transmitted by facsimile provided that the original signed prescription is presented to the pharmacist prior to the dispensing of the controlled substance, EXCEPT: 1. A prescription for a Schedule II narcotic substance prescribed for pain management to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile shall serve as the original written prescription. 2. A prescription for a Schedule II substance prescribed for pain management for a resident of a long-term care facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile shall serve as the original written prescription. 3. A prescription for a Schedule II narcotic substance prescribed for pain management for a patient receiving services from a hospice certified by Medicare under Title XVIII or licensed by the State may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent shall note on the facsimile prescription that the patient is a hospice patient. The facsimile shall serve as the original written prescription.

The pharmacist may release to the patient at discharge any remaining medication in a multiple dose container provided that the pharmacist: I. counsels the patient prior to discharge from the hospital or medical facility. II. labels the medications for outpatient use. III. ensures that discharge orders contain the attending physician's authorizations to release the remaining doses of the prescription to the patient or guardian. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Pharmacy Administrative Code 13:39-9.12(e)]. The pharmacist may release to the patient at discharge any remaining medication in a multiple dose container (for example, inhalers, multiple dose injectable medications such as insulin, topical preparation, drops, ointments, and topical irrigation solutions), provided that the pharmacist: 1. Labels the medications for outpatient use pursuant to labeling requirements. 2. Counsels the patient prior to discharge from the hospital or medical facility. 3. Ensures that discharge orders contain the attending physician's authorizations to release the remaining doses of the prescription to the patient or guardian.

Which of the following is/are TRUE about decentralized pharmacies? I. When the decentralized pharmacy is closed, a licensed nurse may dispense medication in accordance with the written policies and procedures of the institution. II. Institutions operating decentralized pharmacies shall notify the Board, in writing, of the existence of, and the discontinuation of, each decentralized pharmacy location. III. Institutional decentralized pharmacies shall be subject to normal Board inspections. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Pharmacy Administrative Code 13:39-9.25(a-to-f)]. An institutional decentralized pharmacy or a ''satellite pharmacy'' means an area within a health care system that has been issued an institutional permit and is in a location other than the original permitted location, where the preparation, dispensing or compounding of medications is performed. Medication shall not be dispensed from a decentralized pharmacy without a pharmacist present, except that, when the decentralized pharmacy is closed, a licensed nurse may dispense medication in accordance with the written policies and procedures of the institution. Institutions operating decentralized pharmacies shall notify the Board, in writing, of the existence of, and the discontinuation of, each decentralized pharmacy location. Institutional decentralized pharmacies shall be subject to normal Board inspections.

Which of the following is/are TRUE about issuing a schedule II controlled substance under normal circumstances under New Jersey Pharmacy Law? I. A pharmacist may only fill a written prescription for a schedule II controlled drug issued in New Jersey if the prescription is on a New Jersey Uniform Prescription Blank. II. With respect to a schedule II controlled substance, a practitioner shall not authorize a quantity calculated to exceed 120 dosage units or a 30-day supply, whichever is less under New Jersey Pharmacy Law. III. A practitioner may exceed the 120 dosage unit limitation for Schedule II controlled substances when a patient is suffering from cancer, intractable pain or terminal illness. a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [New Jersey Pharmacy Administrative Code 13:45H-7.8(e),13:45H-7.10(d), 13:35-7.6(b),(c) and New Jersey Pharmacy Act 45:14-55]. A pharmacist may only fill a written prescription for a schedule II controlled drug issued in New Jersey if the prescription is on a New Jersey Uniform Prescription Blank. With respect to a schedule II controlled substance, a practitioner shall not authorize a quantity calculated to exceed 120 dosage units or a 30-day supply, whichever is less under New Jersey Pharmacy Law. However in certain medical conditions, a practitioner may exceed the 120 dosage unit limitation for Schedule II controlled substances, if the practitioner follows a treatment plan designed to achieve effective pain management which has been tailored to the needs of a patient who is suffering pain from cancer, intractable pain or terminal illness.

According to New Jersey State Pharmacy Law, which of the following mid-level practitioners may prescribe and/or dispense a Schedule II controlled substances in the course of their professional practices? I. Physicians assistant II. Nurse practitioner III. Optometrists a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf]. Pursuant to Title 21, Code of Federal Regulations, Section 1300.01(b28), the term mid-level practitioner means an individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the state in which they practice. 1. AMB (Ambulance Service) 2. AS (Animal Shelters) 3. DOM (Doctors of Oriental Medicine) 4. ET (Euthanasia Technicians) 5. HMD (Homeopathic Physician) 6. MP (Medical Psychologists) 7. ND (Naturopathic Physician) 8. NP (Nurse Practitioners) 9. NH (Nursing Homes) 10. OD (Optometrists) 11. PA (Physician Assistants) 12. RPH (Registered Pharmacists) For the State of New Jersey, only following mid level practitioners can either prescribe or administer or both, schedule controlled substances. 1. AS (Animal Shelters): Schedule II administer, dispense and procure for sodium pentobarbital. 2. NP (Nurse Practitioner): Can prescribe (only) Schedule II to V controlled substances. 3. PA (Physician assistants): Can prescribe (only) Schedule II to V controlled substances. 4. OD (Optometrists): Can prescribe (only) Schedule III to V controlled substances and Schedule II Hydrocodone products.

Under Controlled Substances Act (CSA), what changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V? I. The dosage form of the prescribed controlled substance II. The strength of the prescribed controlled substance III. The quantity of the prescribed controlled substance a. I only b. I and II only c. II and III only d. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/faq/general.htm]. The pharmacist may add or change the patient's address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions. The pharmacist is never permitted to make changes to the patient's name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber's signature.

The Board may suspend or revoke the license of a pharmacist for: I. Paying rebates or entering into an agreement for payment of rebates to any physician, dentist or other person for the recommending of the services of any person. II. Providing or causing to be provided to a physician, dentist, veterinarian or other person authorized to prescribe, prescription blanks or forms bearing the pharmacist's or pharmacy's name, address or other means of identification. III. Claiming professional superiority in the compounding or filling of prescriptions. I only I and II only II and III only All

Answer: (d) All. The Board may suspend or revoke the license of a pharmacist for, [New Jersey Pharmacy Act 45:14-65(26)]: a. Paying rebates or entering into an agreement for payment of rebates to any physician, dentist or other person for the recommending of the services of any person. b. Providing or causing to be provided to a physician, dentist, veterinarian or other person authorized to prescribe, prescription blanks or forms bearing the pharmacist's or pharmacy's name, address or other means of identification. c. Claiming professional superiority in the compounding or filling of prescriptions or in any manner implying professional superiority which may reduce public confidence in the ability, character or integrity of other pharmacists. d. Fostering the interest of one group of patients at the expense of another which compromises the quality or extent of professional services or facilities made available. e. Distribution of premiums or rebates of any kind whatsoever in connection with the sale of drugs and medications provided, however, that trading stamps and similar devices shall not be considered to be rebates for the purposes of this act and provided further that discounts, premiums and rebates may be provided in connection with the sale of drugs and medications to any person who is 60 years of age or older. f. Advertising of prescription drug prices in a manner inconsistent with rules and regulations promulgated by the Director of the Division of Consumer Affairs, except that no advertising of any drug or substance shall be authorized unless the Commissioner of Health and Senior Services shall have determined that the advertising is not harmful to public health, safety and welfare. g. Engaging in activities beyond the scope of a collaborative drug therapy management agreement. Before a certificate shall be refused, suspended or revoked, the accused person shall be furnished with a copy of the complaint and given a hearing before the board. Any person whose certificate is so suspended or revoked shall be deemed an unlicensed person during the period of such suspension or revocation, and as those shall be subject to the penalties prescribed in this act, but that person may, at the discretion of the board, have his certificate reinstated at any time without an examination, upon application to the board. Any person to whom a certificate shall be denied by the board or whose certificate shall be suspended or revoked by the board shall have the right to review that action by appeal to the Appellate Division of the Superior Court in lieu of prerogative writ.

Under New Jersey State Pharmacy Law, the laminar flow hood shall be certified every: a. Week b. Quarter c. Month d. Six months

Answer: (d) Every six months, [New Jersey Pharmacy Administrative Code 13:39-11.24(8),(9)]. Laminar airflow workbenches, compounding aseptic isolators, compounding aseptic containment isolators, and biological safety cabinets shall be certified every six months, and every time they are moved, by an independent certification company to ensure that these primary engineering controls meet appropriate ISO classifications. A cleanroom shall be certified by an independent certification company every six months and whenever the room or a primary engineering control in the room is relocated or altered, or whenever major service to the facility is performed, to ensure that the cleanroom meets appropriate ISO classifications.

VJ came to the pharmacy and said that he could only pay for 30 tablets of Ritalin. The remaining he would collect next week. The pharmacist may tell him: a. Okay, but call us before you come. b. We cannot dispense this prescription. c. You have to pay us in advance for the whole supply. d. No, you cannot do that.

Answer: (d) No, you cannot do that, [New Jersey Controlled Dangerous Substances Act 13:45H-7.10(a),(b),(c)]. Under no circumstances, the partial filling of Schedule II controlled drugs (Ritalin) should be done after 72 hours from its initial filling based on a patient's request. (a). The partial filling of a prescription for a controlled substance listed in schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). (b). The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner. (c). No further quantity may be supplied beyond 72 hours without a new prescription.

What changes may a pharmacist make to a prescription written for a controlled substance in schedule II after verbally consulting with a practitioner? I. Patient's name II. Controlled substance prescribed III. Prescriber's signature a. I only b. II only c. III only d. None of the above

Answer: (d) None of the above, [http://njpublicsafety.com/ca/pharm/Board%20of%20Pharmacy%20Schedule%20II%20Guidance.pdf]. The Board has received many inquiries from pharmacists asking what types of changes, if any, can be made to hardcopy prescriptions written for Schedule II medications. The Board has compiled the below list of changes, with appropriate protocols to be followed, in order to provide direction for pharmacists when confronted with the following scenarios. It should be noted that this document has been reviewed and approved, to be released as guidance, by the New Jersey Board of Pharmacy, the New Jersey Drug Control Unit, and the Director's office of the Division of Consumer Affairs. The Drug Enforcement Administration has had an opportunity to review this Guidance Document, however the Board has not received any formal comment from that agency. 1). The following items may be changed upon consultation with the prescriber: a. Patient's address b. Drug strength c. Drug quantity (both numeric and alpha representations) d. Drug dosage form e. Directions for use f. Date issued g. DEA number (if omitted) 2). The following items may be added without consultation with the prescriber: a. Patient's address b. Date of birth c. A notation to correct a misspelled name 3). The following items are NEVER permitted to be changed: a. Patient's name (other than as noted above) b. Controlled substance prescribed (except to substitute a generic) c. Prescriber's signature

Phenergan with Codeine syrup is classified as: a. Schedule II b. Schedule III c. Schedule IV d. Schedule V

Answer: (d) Phenergan with Codeine syrup is classified as a Schedule V controlled drug, [New Jersey Controlled Dangerous Substances Act 13:45H-10.1]. List of Schedule V controlled drugs: ______________________________ Codeine preparations - 200 mg per 100 ml or 100 gm (Robitussin AC, Phenergan with Codeine) Difenoxin preparations - 0.5 mg Difenoxin + 25mcg Atropine sulfate (Motofen) Dihydrocodeine preparations 100 mg per 100 ml or 100 gm Diphenoxylate preparations- 2.5 mg Diphenoxylate + 25mcg Atropine sulfate (Lomotil, Logen) Ethylmorphine preparations 100 mg per 100 ml or 100 gm Opium preparations - 100 mg per 100 ml or gm (Parepectolin, Kapectolin PG, Kaolin Pectin P.G.) Lyrica - Pregabalin Vimpat - Lacosamide Potiga- Ezogabine

In which of the following situations is a PDR not required? I. A patient visits a physician in the physician's office and receives a prescription. The patient has the prescription filled in a retail pharmacy. II. A pharmacist in a hospital pharmacy fills an outpatient prescription for a hospital employee. III. A pharmacist fills a prescription for a patient who lives in a personal care home. IV. A pharmacist fills a prescription for a patient in a nursing home.

Answer: (d) The PDR is required for retail or outpatient prescriptions, [OBRA-90, 42USC 1396r-8(g)(2)(B)]. The PDR does not extend to the following: ____________________________________ (1) An order for a drug for an inpatient of an institution. (2) A drug dispensed in an emergency room. (3) A drug dispensed by a medical practitioner. (4) A drug dispensed by a pharmacist to a medical practitioner who will administer it to a patient. The following are examples of situations in which a PDR is required: _________________________________________________________ (1) A patient visits a physician in the physician's office and receives a prescription. The patient has the prescription filled in a retail pharmacy. (2) A pharmacist fills a prescription for a patient who lives in a personal care home. (3) A pharmacist in a hospital pharmacy fills an outpatient prescription for a hospital employee. (4) A patient is treated on a non-emergency basis in an outpatient clinic of a hospital and is given a prescription. (5) The patient has the prescription filled either in the hospital pharmacy or in a retail pharmacy. The following are examples of situations in which a PDR is not required: ____________________________________________________________ (1) A pharmacist fills a prescription for a patient in a nursing home. (2) A pharmacist in a hospital dispenses a drug that will be administered to a patient in the hospital. (3) A physician dispenses a drug to a patient being treated in the emergency room. (4) A pharmacist dispenses a radiopharmaceutical to a physician who will administer it to a patient.

All of the following are required on an OTC medication label EXCEPT: a. Inactive ingredients b. Directions c. Expiration date d. NDC number

Answer: (d) The following information is required on any OTC medication label, [21CFR201.2, 21CFR207.35, 21CFR201.6-201.63 and 21CFR201.1-201.55]: 1. Drug Facts - title 2. Active ingredient(s)-including amount in each dosage unit 3. Purpose - pharmacologic class 4. Use(s) - indications 5. Warnings 6. Do not use - absolute contraindications, when the product should not be used under any circumstances 7. Ask a doctor before use if you have - warnings for persons with certain preexisting conditions and for persons experiencing certain symptoms 8. Ask a doctor or pharmacist before use if you are - drug/drug and drug/food interactions 9. When using this product - side effects that could occur and substances or activities to avoid 10. Stop use and ask a doctor if - signs of toxicity and other serious reactions that would require consumers to stop using the product immediately 11. Pregnancy/breast-feeding warning 12. Keep out of reach of children/Accidental overdose warnings 13. Direction - dosage and when, how, or how often to take 14. Other information 15. Inactive ingredients 16. Questions? (Optional) - followed by telephone number 17. Lot number 18. Expiration date 19. Name and addresses of manufacturer or distributor The National Drug Code (NDC) number is requested but NOT required to appear on all drug labels (prescription as well as OTC) and in all drug labeling, including the label of any prescription drug container furnished to a consumer. If the NDC number is shown on a drug label, it shall be displayed as required in [21CFR207.35(b)(3)].

The records in a Schedule V (OTC) bound book should be maintained for at least: a. 3 years from the date of last transaction. b. 5 years from the date of last transaction. c. 1 years from the date of last transaction. d. 2 years from the date of last transaction.

Answer: (d) The records in Schedule V (OTC) bound book should be maintained for at least 2 years from the date of the last transactions, [New Jersey Controlled Dangerous Substances Act 13:45H-5.4(a) and 13:45H-7.19(a)(5)] New Jersey Controlled Dangerous Substances Act 13:45H-5.4(a): (a). Every inventory and other record required to be kept under this subchapter shall be kept by the registrant and be available, for at least two years from the date of such inventory of records, for inspecting and copying by authorized employees of the Drug Enforcement Administration and the Drug Control Unit, except that financial and shipping records (such as invoices and packing slips but not executed order forms subject to N.J.A.C. 13:45H-6.13) may be kept at a central location, rather than at the registered location, if the registrant has notified the Drug Enforcement Administration and the Drug Control Unit of his intentions to keep central records. Written notification must be submitted by registered or certified mail, return receipt requested to the Special Agent in Charge in the region in which the registrant is located and the Drug Control Unit. Unless the registrant is informed by the Special Agent in Charge or the Drug Control Unit that permission to keep central records is denied, the registrant may maintain central records commencing 14 days after receipt of his notification by the Special Agent in Charge and the Drug Control Unit. Registrants who desire to continue maintaining central recordkeeping will make notification to the local Special Agent in Charge and the Drug Control Unit as provided in this section.

A pharmacy that utilizes a Centralized Processing System shall place name, address and telephone number of which of the following on a dispensing label? a. Intake Pharmacy b. Central Processing Pharmacy c. Central Fill Pharmacy d. Dispensing Pharmacy e. Any or All of Above

Answer: (e) Any or All of Above, [New Jersey Administrative Code 13:39-4.19(4)(Xii)]. The name, address and telephone number of any or all of the following: (1). The intake pharmacy; (2). The central processing pharmacy; (3). The central fill pharmacy; and/or (4). The dispensing pharmacy.

Which of the following is/are TRUE about dispensing Schedule II controlled substances in the case of an emergency situations? I. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period not to exceed 72 hours. II. The prescription shall be immediately reduced to writing by the attending pharmacist and contained all the information required by the law. III. The authorized prescriber shall deliver the written prescription for the emergency quantity prescribed to the dispensing pharmacy within 7 days after authorizing an emergency oral prescription. a. I only b. I and II only c. II and III only d. All Answer: (d) All, [New Jersey Controlled Dangerous Substances Act 13:45H-7.8(d)(1)(2)(3)].

The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period not to exceed 72 hours. The prescription shall be immediately reduced to writing by the attending pharmacist and contained all the information required by the law. The authorized prescriber shall deliver the written prescription for the emergency quantity prescribed to the dispensing pharmacy within 7 days after authorizing an emergency oral prescription.


Kaugnay na mga set ng pag-aaral

ERP Domain 2: Nutrition Care for Individuals & Groups

View Set

Arts and Humanities Quick Recall Questions Part II

View Set

Unit 11 - Deceptive Trade Practices and Consumer Protection Act

View Set

Homework 1: Scientific Method, Research Articles, & Data Analysis

View Set

Accounting Midterm 1 (Ch. 1 - 5)

View Set

Marketing 340 Practice Quiz Questions

View Set

Chapter 8 - Prioritization, Delegation, and Assignment

View Set