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MPJE JERSEY
NEW JERSEY BOARD OF PHARMACY REGULATIONS
| Question | Answer |
|---|---|
| immediate personal supervision | RPH shall be physically present |
| pharm tech: | responsibilities do not include professional judgement |
| fines by NJ BOP must be paid within: | ten days $10 |
| opportunity to be heard: what is it? | anytime the board seeks to impose discipline, the RPH may be heard |
| passing grades on NAPLEX AND MPJE are: | 75s and above |
| what happens when an applicant fails three times? | board may mandate remedial courses |
| changes of name or address of record must be made within | 30 days-standard change, standard time |
| license renewals after how long? | every two years, biennially, just like CE credits needed |
| when must a license be renewed in relation to the deadline? | rph has 30 days after expiration to renew |
| what happens when license is renewed after 30 days of expiration? | fine is paid for late fee |
| what happens when RPH waits 30 days after license expiration to renew? | license will be suspended without a hearing |
| what happens if a pharmer practices without a license? | penalty: unauthorized practice of pharmacy |
| how long does a pharmer have to renew his license if after 30 days of expiration? | five years |
| what must an RPH do if license is suspended? | must apply with appl, employment history, past due renewal fees, reinstatement fee, and any outstanding penalties imposed by the board in addition to CE credits |
| what happens if license is suspended for more than five years? | RPH must retake tests |
| inactive licensure: may resume NJ practice if: | -practiced for 1,000 hours in another state in the 2 years prior, or -15 CE credits/year |
| reciprocal licensure ok if: | -1000 hours within two years -met internship requirements within the one year immediately prior to application -license is in good standing in the past five years -no crime involving moral turpitude -must take background check |
| CE requirements | 30, 10 via didactic instruction, 3 via pharmacy law, 10 may be rolled over if within 6 months of the next period |
| CE credit criteria | must be at least fifty minutes per credit, half credit for 30 minutes thereafter. must complete program |
| telephone didactic? | yes, if interactive |
| CE credit: how much is graduate course work worth? | 3 CE |
| CE credit: how much is teaching and/or research appoitments worth? | 3 CE/new course, max 6 CE: FULL TIME TEACHER NOT ELIGIBLE |
| CE credit: preceptor? | 3 CE/student, max 6 |
| CE credit: publication of journal | 3 CE/article, max 6 |
| CE credit: sponsors must keep record of attendees for: | 5 years |
| CE reporting procedure: | put it on license renewal app. |
| CE documentation needed to be kept for: | 5 years |
| CE waiver of requirements if: | military, illness, disability, or hardship |
| what to do if eligible for CE waiver of requirements: | write the board |
| CE sponsor host requirement: | BS Pharm or D with experience or five years of experience, or practitioner with special expertise |
| in order for a CE sponsor host to host a CE event, they must | notify the board 45 days in advance |
| at the CE event, sponsor must: | give receipts to those in attendance |
| CE sponsor must note what on receipt? | name addy phone of sponsor, name and certificate number of course and number of CE awarded |
| new pharmacy permit application needs: | names and addies of all officers, stockholders, and/or pharmacists whether its a publicly traded company, PIC name |
| before a pharmacy permit is given, board will: | inspect the premises |
| if ownership of pharmacy is changed, how long does the new PIC have to get a new permit? | 60 days |
| what does the board need in order for change in ownership to occur? | inventory and proof of change of ownership |
| change of corporate officers or stockholders of public companies: what happens when 10% or more of the stock changes? | corporation will file an affidavit with the board within 30 days |
| does a change in location require a new permit? | yes |
| Discontinued pharmacies: what to do | kill the signs, notify the board as to where the RX records are, return the permit within 30 days, tell the DEA, SBOP, and the office of drug control of the closing |
| availability of records upon termination of business: patrons have the right to | retrieve valid prescriptions and know where they can do so for 6 months |
| availability of records upon closing: what must RPH do to notify patrons of their rights? | newspaper publication for two weeks, sign in window, and by notifying the board |
| pharmacies must be open for how many days and hours per week? | 40 hours and 5 days |
| any temporary changes in pharmacy hours must: | be posted on the window |
| temporary closings of > than x must be approved by the board | 48 hours |
| does RPH need a new permit if pharmacy changes name? | no, just submit it |
| pharmacy in larger establishment: what information must the whole store manager have? | PIC phone number |
| pharmacy within larger store: describe the drop-off device | one-way only, and irretrievable |
| pharmacy may perform centralized RX handling iff | they all have the same owner, they got the board's permission, there is an audit trail that is 5 years retrievable with 4 years retrievable within 2 weeks and most recent year retrievable and readable within one day |
| for central RX, the label must: | have the name of the drug and patient name and directions in bold or special print |
| retail pharmacy sign requirement: | must be conspicuously outside unless lease says no |
| a pharmacy must be at least how big? | -150 sq. feet -300 sq. feet for a nuclear pharmacy |
| prescription counter requirements: | 12 feet x 1.5 feet |
| sink requirements: | must be readily accessible from rx counter, must do hot and cold |
| pharmacies must have what extras in order to operate? | class A balance with a complete set of metric weights or equivalent weighing device, volumetric devices 0.3mL to 500mL, glass mortar and pestle, glass funnel with rods, steel and rubber spatula, parchment paper, two DUR council placards, supp. balance |
| special requirements for weights and measures in a pharmacy: | must be sealed and recalibrated every 12 months |
| PIC may be on vacation for no more than | 30 days |
| if PIC is gone for more than 30 days, PIC and permit holder will: | notify the board and make a temporary PIC |
| how many pharmacies may a PIC be in charge of? | one |
| what happens when there is a changing of the PIC's? | CS inventory and tell the board |
| what is the minimum hourly working requirement for a PIC every week? | 35 hours |
| what must name tags include? | name and title |
| meal breaks: how long? | 30 min |
| 30 min meal break stipulations: | pharmer stays, sign goes up |
| how many techs can a pharmer supervise at one time? | 2 only |
| yearly permit renewal applications: what goes on it with regard to employees? | technicians |
| what kind of prescriptions may be filled in NJ? | only NJ ones and faxed and electronic ones |
| what happens when an MD forgets to put directions? | rph will attempt and document finding the MD--if no, put UTD |
| emergency dispensing of regular rxs: quantity max | 72 hour supply |
| what kind of drug may be emergency dispensed? | chronic drug or device |
| under what conditions may a drug be emergently dispensed? | if no rx meant that health or welfare of patient would be endangered |
| what must an RPH do before dispensing an emergent medication? | make sure it was prescribed by an MD, rph will document the communication and require the patient to provide ID and sign a statement attesting to the need |
| what must be kept by the pharmacy with regard to RPH signatures and for how long? | initials, names, and signatures for 6 years |
| what requires the rph signature? | each rx and refill (on the back), unless there is computer |
| all prescription records, including original and refilled RX data and the number of refills authorized by the prescriber shall be maintained for a period of not less than | 5 years: oldest 4 years retrievable within 2 weeks and year retrievable immediately |
| is auto-initialing allowed on RXs? | no |
| what to do if patient asks for a copy of a RX? | give it, then write, "copy for information only." underlined. |
| may CS be faxed in? | yes, as long as it's not faxed by a patient |
| when may faxed CII orders be filled without a written? | LTCF, direct admin by IV IM SUBQ, or hospice |
| are electronic CII fills allowed without a written? | no |
| what must pharmacy label contain? | manuf. if generic, RPH initials, aux labels, and use by date |
| may CIII-V electronic RXs be filled without written rx? | no, need fax or oral or written |
| right to refuse service with regard to rph | professional judgement is binding |
| advertising rx drugs: quotations shall include: | effective date, usual cost, all services included, strength and quantity |
| what happens if patient or caregiver not there to counsel? | offer will be made in writing with the RX. the written offer should be bold, easily read, and should include hours reachable with a phone number |
| during downtime and recently uptime, how long does the pharmacy have to update the system with missed data? | 3 days |
| pharmacy extern: | 5th or 6th year or 3rd or 4th pro year at an accredited |
| pharmacy intern: | graduate or foreign grad employed in an approved training pharmacy to acquire experience |
| procedure to be a preceptor: | must write the board and apply and give evidence of registration and employment for two years in NJ |
| how many interns may a preceptor supervise at any given time? | 1 |
| pharmacy training site requirements | -20,000 annual rx -1 intern or extern/20,000 rx |
| internship min. experience | 1000 hours with no less than 24 weeks supervised. each week should be between 20 and 45 hours of actual service |
| will credit be given for intern hours done before the board receives the application? | no |
| 75% of intern hours must be: | with direct involvement with consumers or patients, rph, and other practitioners. |
| cap of intern hours per week | 45 |
| change in intern status: | an intern applying for registration as a pharmacist shall notify the board within 10 days of any change in the internship or employment or preceptor |
| HC facility | licensed by the dept of health and senior services |
| HC system | one or more HC facilities owned by the same legal entity |
| institutional pharmacy | area in a HC facility or system licensed by the BOP that maintains an institutional permit that includes areas with pharmaceutical storage compounding, and dispensing |
| medication order | written request for meds intended for pt use in HC facility--not for employees--electronic sig or pw is ok |
| PT commitee | liaison between the medical service and pharmacists staff to review and promote rational drug therapy and utilization in the facility |
| unit dose drug distrib | daily drug delivery |
| unit doses must contain | lot, use by date, manuf, physical description if more than one unit inside |
| hospital advisory committees: who must be present? | PIC or designee |
| P&T committee members: | one must be RPH and others must be varied--those without it, PIC must institute policies himself |
| what happens when a hospital has no pharmacy and it contracts outside? | the pharmacist of both institutions shall direct and control the pharmaceutical services |
| hospital oral orders: who must sign? | both rph and MD |
| are oral CII orders allowed in a hospital seetting? | yes, but only in an emergency |
| what happens to the meds left over after a patient is discharged? | it is given to the patient in a multi-dose container as long as the MD says its ok |
| monitoring patient drug therapy: the pharmacist's role in a HC facility | pharmacist must review drug profile before any dispensing |
| use of pts own meds in a hospital setting: | not permitted most of the time, unless the P&T committee says so |
| what is the process by which a patient's own meds can be used? | MD signs and dates an order |
| drug dispensing devices: when may it be used? | when the RPH is not there or is there |
| how long may an RPH be gone in the hospital for? | 24 hours |
| who is in charge of dispensing drug dispensing devices? | PIC |
| how often should the device data be checked and by whom? | pharmacist every 24 hours |
| who is in charge of packing and cleaning the dispensing devices? | pharmacist, or people under RPH supervision |
| special considerations for CS and abused meds in drug dispensing devices: | should be limited to unit doses, with data needing to be checked every 24 hours by a pharmacist or designee |
| with regard to drug dispensing machines, what should be recorded? | identity of person who accesses |
| how long does the pharmacist have from the time an order is written for a machine to checking it? | 24 hours |
| disposal of unused medications in hospital setting: what is it done to and how? | meds with no lot and expiration thrown away via its own protocol |
| what medications that are returned by patients in a hospital setting may be redispensed? | absolutely none |
| record of killed or wasted meds in hospital setting shall be signed for by whom? | signed and cosigned and witnessed by a licensed nurse, MD or RPH, or admin if its allowed |
| who is responsible for the records and reports of pharm services for the provider pharmacy? | PIC |
| all notations made on patients' profiles made by pharm staff need what? | verification and countersignature (manually or electronically) by the supervising pharmacist |
| how long must patient records be kept for ina hospital? | five years, this year readily retrievable immediately, oldest four years within 2 weeks |
| who reviews the adverse accidents? | QA and PT |
| who is responsible for maintaining the QA and PT system of a hospital? | PIC makes sure that all are submitted to state and local agencies |
| who is responsible for maintaining drug standards and references for everyone in the hospital? | RPH |
| on each pt care unit, the RPH shall maintain: | formulary copy, drug references for all formulary drugs, and the poison control center phone number |
| who has access to CII-V meds in the pharmacy stock? | RPH only |
| who gets CII-V from pharmacy stock in RPH is not there or if the pharmacy is closed? | designee nurse can get the meds that will be used before pharmacy opening |
| what records needs to be kept by a nurse if she took any meds for a patient while the RPH was away or pharmacy was closed? | a record of drugs with name dosage size, amount, date, patient's name and location with signature |
| the designated nurse may remove the following from the pharmacy if closed or if RPH is away | pre-packaged unit doses or drugs in its original container for patients |
| all records of drugs removed by the nurse for patients in RPH absence must be kept for: | 5 years, last year immediately retrievable, else retrievable within 2 weeks |
| storage and security in a hospital setting: spot checks for expiration, integrity, and misbranding should be done every x and by whom | 2 months by the PIC or staff with PIC sig |
| may drugs be dispensed from sat pharmacies without an RPH | no, unless its closed and RPH not there |
| RX transmission in an institution: may CII be filled without original signed RX? | no, unless LTCF, hospice, or immediate IV IM SUBQ admin--fax shall serve as original RX |
| RX transmission in an institution: may CIII-V be filled without original signed RX? | no |
| can permit or license holders give tech devices to RX writers? | no |
| a pharmacy may use an automated medication system if: | its tested for accuracy, available to the board to validate accuracy and its been inspected, and the PIC is responsible for supervision of it |
| how often and who must inspect automated medication system for expiration, misbranding, and integrity? | PIC or RPH MONTHLY |
| policies and procedure manual of automated medication system shall include: | table of contents, description of procedures, record of changes to the P&P for the past two years, ability to ensure that every order is reviewed by the RPH |
| where must a copy of the policy and procedures of the amd operation be? | at the pharmacy and the HC facility |
| how often should the pharmacy review the P&P for the AMD | yearly |
| who is responsible for training staff on AMD | PIC |
| how often must the accuracy of the AMD be checked? | -every 6 months -important, like checking microbes in a hood |
| recurring error is defined as: | an error made more than once in a fourteen day period |
| disaster planning: explain | pharmacy must have a system in place if they have an AMD--planning, response, notification of resuming of service, |
| ISO class air conditions: what classes exist, and its respective particles per cubic foot? | 5-7, 100, 1000, 10,000 |
| ISO class 5 air quality conditions | no greater than 3520 particles of 0.5 micrometers and larger per cubic meter of air 100 particles per c. foot |
| ISO class 6 air quality conditions | no greater than 35,200 particles of 0.5 micrometers and larger per cubic meter of air 1000 particles per c. foot |
| ISO class 7 air quality conditions | no greater than 352,000 particles of 0.5 micrometers and larger per cubic meter of air 10000 particles per c. foot |
| sterile admixtures may be made in either a | laminar hood or a glove box |
| in order to compound sterile admixtures, one must first: | notify the board 60 days in advance and must have approval |
| who supervises sterile and or nonsterile compounding? | PIC |
| RPH may delegate the following tasks to interns and techs: | in, pull, typing, and compounding |
| how often does one need to be trained in order to compound sterile preparatiosn? | annually |
| how often does the pharmacist have to test the aseptic technique of staff? | yearly |
| may a pharmacist prepare a compounded med without an rx just yet? | yes, as long as there is history to back it up |
| what are the documented compounding steps? | receipt of order, profile log it, selection, container, diluent all before comopunding, CLASS 5 conditions at all times |
| what should go on compounded label | date and time, prescriber for retail, name and quantity of all ACTIVEs, pharmacist, use by time, "cytotoxics are biohazardous" |
| closed system aseptic transfer: why is it special? | it does not permit exposure of the pharm components to theenvironment, prepared in a class 100 laminar air flow hood |
| closed system aseptic transfer: | in a class 100 laminar air flow hood--does not permit exposure to environment |
| use by date for steriles are: | 24 hours, unless literature says so otherwise, in which case it must be documented |
| in an instutional pharmacy, any sterile compounded preparation which is prepared under ISO class 5 laminar air flow hood which is not ina clean room shall be labeled to indicate that admin should be started AND COMPLETED within | 28 hours from prep time |
| if steriles from manufacturers into sterile containers, admin should be completed within: | 30 days |
| P&P for compounding: shall include | risk management QA, security, equipment, reference, etc |
| all compounding processes must be sterile tested and validated at least every | 1 year |
| air and surface sampling for ISO class 5 laminar air flow hoods should be done | every six months and every time it is moved |
| ISO class 6 and 7 flow hoods shall be certified every | 6 months and every time they are moved |
| what is a controlled environment? | where compounding takes place |
| characteristics of a controlled environment: *** | 59 to 77 degrees fahrenheit accessible only to designees, used only for steriles, isolated |
| controlled enviroment construction: | non-shedding, sanitizing damage resistant, epoxy-coated gypsum board, vinyl floors, no dust overhangs, airtight light fixtures, |
| controlled environment shall only have: | nonshedding things that have been cleaned immediately prior, and things should not be removed from there unless for calibration |
| controlled environment should have the following supplies: | gloves, masks, gowns, needles syringes, sanitizings, towels, handsoap, and all necessary compoundings |
| clean room shall NOT have: | floor drains or sinks |
| clean room minimum size | 100 square feet |
| clean room minimum ISO requirements | class 6 |
| clean room shall contain what equipment: | class 5 hood or better, waste container, ancillary supplies |
| anteroom ISO requirements: | ISO class 7 or better |
| anteroom has what equipment: | sink with hot and cold, waste containers for personal protective equipment, eyewash station, hazardous waste spill kit, fridge |
| where should antineoplastics be compounded? | VERTICAL ISO class 5 laminar air flow hood |
| self-contained sterile ISO 5 glove BOXES: when should be certified by an independent? | at installation, moving, and every six months |
| radiopharmaceutical: | exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and inclues any such drug which is intended to be made radioactive--does not include carbon containing compounds or potassium containing compounds |
| nuclear permits are awarded to pharmacies with: | a qualified nuclear pharmacist |
| where should the nuclear pharmacy be in relation to the regular? | away and inaccessible to unauthorized personnel |
| nuclear pharmacies will be provided with a: | radioactive storage and decay area |
| nuclear pharmacy requirements: | ventilation shall prevent radioactives to going to unrestricted areas, contamination must not occur, and radioactives will be contained |
| nuclear pharmacy: immediate outer container of a radioactive drug will have: | radioactive symbol, "caution, radioactive symbol," radionuclide, chemical form, amount in mLcuries or microcuries, or volume in mL, requested calibration time, name addy phone pharmacy, RX number, date and pt name |
| nuclear pharmacy: immediate container shall have: | radiation symbol, "caution, radioactive material," name of radiopharmaceutical |
| may nuclear pharmacists handle non-drugs that are radioactive? | yes |
| what privileges does a specialized nuclear-only pharmacy have? | may be exempt from applying for a special nuclear pharmacy license |
| how many refills are allowed on nuclear pharmaceuticals? | none |
| are nuclear phone orders authorized? | yes, only if the pharmer recognizes the MD |
| what privileges do nuclear pharmacy staff have? | whatever the RPH says they have |
| nuclear pharmacist general requirements: | licensed, trained in radioactives in accordance with the requirements of the US nuclear regulatory commission and the NJ bureau of radiation protection |
| nuclear pharmacy space requirement for hot lab and storage area: | 120 square feet (100sq. feet for clean room in hospital FYI) |
| nuclear pharmacy space requirement for compounding and dispensing area: *** | 300 square feet |
| nuclear pharmacy equipment: | fridge, dose calibrator, drawing station, well scintillation counter, microscope, chromatographic apparatus, radiation survey equipment, and other necessaries as deemed by the US nuclear regulatory commission or the N bureau of radiation protection |
| which books must the nuclear pharmacy have? | up to date texts or unabridged computer versions, laws, nuclear laws, and texts of practice of nuclear pharmacy and radiation safety |
| who is responsible for the quality control of a nuclear pharmacy? | holder of the permit |
| where wouldone find the drugs do not appear on the orange book but are still ok to be interchanged? | the existing state formulary |
| if a drug was removed from orange book by FDA, then | it is no longer interchangeable |
| will the orange book and the state formulary always be concurrent? | no, the orange book will eventually catch up |
| eventually, what will be the exclusive interchange source be? | the orange book |
| when the MD and PT elect sub., RPH must: | select a LESS expensive product and pass on the savings in full |
| are forms and strengths that are not listed still subbable? | NO |
| are different dosage forms of the same strength of drug equivalent? | not necessarily |
| what is not included on the orange book? | drugs that are usually dispensed as generics anyways |
| what may always be substituted? the details of the drug, please | same salt, form, strength, and drug--if it meets all of the above yet are not recognized by the FDA may NOT be subbed |
| MDs shall advise all patients by adequate notice what and by how that they can fill generically via: | sign or pamphlet |
| can an RPH sub to a drug NOT on the formulary if the MD writes sub ok? | no, only with MD approval |
| does the pharmacist have to sub a less expensive product if MD wrote sub ok and the drug is on the formulary? | yes |
| if MD said gen. ok and the drug is on the formulary BUT generic is unavailable, can RPH dispense brand? | yes, but only with pt consent |
| if MD wrote sub ok and generic and brand cost the same, can RPH dispense brand? | yes, but only with pt consent |
| does the pharmacist have to dispense the LEAST expensive drug on the formulary? | no, only a less expensive one |
| what may the pharmacist do if the prescriber prescribes by generic name? | may dispense any appropriate generic without need to refer to the formulary |
| generic sign in retail settings must say and be: | no less than 12x12 inches, in dispensing area and in waiting area, pt may have brand if cost savings not enough, consumer shall be told the price, savings, |
| how is the rph to notate a pt's rejection of generic | notate on RX blank |
| must a pharmacist stock an approved generic equiv. for all formulary products? | no, but they may lose a lot of business |
| if patient brings in an RX but is not the person on RX, can he refuse gen. sub.? | yes |
| LTCF: what goes on outside cover of patient chart? | nKDA |
| LTCF: facility shall have what kind of RPHs | consultant pharmacist and (a provider pharmacist OR a director of pharmaceutical services OR if facility has an in house pharmacy, a director of pharma services |
| LTCF facility shall also have what to oversee pharmaceuticals? | P&T |
| LTCF: who must be on PT | consultant pharmacist |
| LTCF: how often should PT committee meet? | every 3 months |
| LTCF: consultant pharmacist may not be: | the provider pharmacist or the director of pharma services |
| LTCF: who may self-admin? | those who PT deem ok to |
| LTCF: self-admin governed under what rules? | med storage in room, MD order, directions, methods for documentation of self admin, training of residents, policies to assess ability to self admin |
| LTCF: how often must RPH review drug regimens? | every 1 month |
| LTCF: stop orders, special considerations | upon last dose, APnurse or MD must be notified |
| LTCF: what happens if a med is withheld? | documentation on why must be performed |
| LTCF: what happens if there is an adverse? | should be reported immediately to the director and it should be entered in the medical record |
| LTCF: labels must have: | lot number, manufacturer if generic |
| LTCF: requirements if on a unit dose system: | -each resident own tray with name and location, changed every 24 hours -name w/ manuf, stren, lot, expiration, and dose -floor stock may be kept |
| LTCF: consultant pharmacist duties every month include: | -monthly inspections of areas where meds are dispensed, admin, or stored |
| LTCF: who approves the contents of emergency kits? | PT |
| LTCF: where are emergency kits stored? | nurse stations not under lock and key |
| LTCF: how often are emergency kits checked by consultant pharmacist? | every month |
| LTCF: conditions under which medications may be destroyed: | 2 witnesses, each a RPH, RN, or other nurse |
| special considerations for CS and abused meds in drug dispensing devices: how often does a pharmacist need to check for accuracy? | every 24 hours |
| what to do with CS when business ends in NJ | return DEA-222s, fill out DEA-41s, also fill out DDC-51 and wait for DCU instructions |
| if RX pad stolen, doctor has how long to tell DCU? | 3 days |
| when do pharmacy permits expire in NJ every year? | June 30th |
| how many board members on the NJ BOP? | 11 |
Created by:
vitasoy