FSDLE: Virginia Law Part 1: Licensing, Registration, and Inspection Exam Questions and answers. 2022/2023.

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FSDLE: Virginia Law Part 1: Licensing, Registration, and Inspection Exam Questions and answers. 2022/2023. How many interns may a pharmacist supervise? - ✔✔1 pharmacist supervises 1 intern ... How many hours of continuing education do you need to renew a license? - ✔✔15 hours of continuing education or 1.5CEUs. You can skip this for the first renewal. Extra hours do not carry over to the next year How long do you keep records of your continuing education? - ✔✔2 years What types of programs count for continuing education? - ✔✔Those approved by the American Council on Pharmacy Education, a category 1 continuing medical education on a pharmacy topic, and those approved by the Board of Pharmacy How many hours of practical experience are required in VA? - ✔✔1500 hours of practical experience are required What happens if you fail to renew your license by the expiration date? - ✔✔A pharmacist who fails to renew his license by the expiration date may renew his license at any time within one year of its expiration by submission of the renewal fee and late fee, renewal form, and statement of compliance with continuing education requirements What happens if you fail to renew your license for more than one year following the expiration date? - ✔✔A pharmacist who fails to renew his license for more than one year following expiration and who wishes to reinstate such license shall submit an application for reinstatement, pay the current renewal fee and a reinstatement fee, and submit documentation showing compliance with continuing education requirements. What do you have to do if you have been registered inactive for more than one year? - ✔✔A pharmacist who has been registered as inactive for more than one year must apply for reinstatement, submit documentation showing compliance with continuing education requirements, and pay the current year active renewal fee in order to resume active licensure. What do you have to do to reactivate or reinstate a license to the active status? - ✔✔In order to reactivate or reinstate a license to active status, a pharmacist who holds an inactive license, who has allowed his license to lapse, or who has had his license suspended or revoked must submit evidence of completion of CEU's or hours equal to the requirements for the number of years in which his license has not been active, not to exceed a total of 60 hours of CE. What do you have to do if your license has lapsed, has been inactive, or suspended or revoked for more than 5 years? - ✔✔A pharmacist whose license has been lapsed, in inactive status, or suspended or revoked for more than five years shall, as a condition of reinstatement in addition to 60 hours CE, take and receive a passing score on the board-approved law examination and furnish acceptable documentation of one of the following: 1. Active pharmacy practice within the past five years as a properly licensed pharmacist in another state; or 2. Practical experience as a pharmacy intern registered with the board of at least 160 hours within six months immediately prior to being reinstated. Does CE earned for a license in another state count toward your Virginia CE? - ✔✔Yes Can you get an exemption from the CE requirement - ✔✔Yes, but it is rare and only granted for circumstances out of your control. You can get a 1 year extension with a written request, and further extensions only with good reason. You are still responsible for all of the CE required for that time period. If your license is inactive, are you still responsible for the CE? - ✔✔Yes What dispensing activities can only be done by the pharmacist, and not pharmacy technicians? - ✔✔Review prescriptions Take an oral prescription Conduct prospective drug review Counsel patients and provide drug information Communicate with prescriber or agent about any change to therapy except a refill Verify a prescription prior to dispensing Supervise pharmacy interns and technicians Can a pharmacy intern perform the dispensing activities done by a pharmacist? - ✔✔Yes, if a pharmacist directly supervises the intern When can a pharmacy technician at a nuclear pharmacy accept oral prescriptions? - ✔✔A technician at a nuclear pharmacy can accept oral prescriptions for non patient specific radiopharmaceuticals What is the maximum number of technicians a pharmacist may supervise? - ✔✔Four. As many as two of them can be trainees who are not registered technicians yet. Can a technician compound extemporaneous preparations? - ✔✔Yes, but a pharmacist must personally supervise the preparation What does a pharmacist have to do after an order has been prepared prior to delivery? - ✔✔Inspect and initial it to certify accuracy What is required to become certified as a pharmacy technician? - ✔✔A technician must hold current certification by the Pharmacy Technician Certification Board or complete an approved training program and pass an exam Can an unregistered technician work while training to get registered? - ✔✔Yes, as long as they are directly supervised by a pharmacist Does a technician who only works in a free clinic have to be registered? - ✔✔Yes. The Board lets them get a limited use registration (free clinic only). The Board waives the initial registration fee and first examination fee for this. If they want to switch to an unlimited registration, all they have to do is pay the current renewal fee When does a technician need to renew his or her license? - ✔✔Before December 31st each year. A technician who is newly licensed July 1st or later does not need to renew the license until December of next year What if a technician renews his or her license late? - ✔✔A pharmacy technician who fails to renew his registration by the expiration date may renew his registration at any time within one year of its expiration by submission of the renewal fee and late fee, renewal form, and proof of required continuing education. What happens if a technician fails to renew his or her registration for more than one year following expiration? - ✔✔A pharmacy technician who fails to renew his registration for more than one year following expiration and who wishes to reinstate such registration shall submit an application for reinstatement, pay the current renewal fee and a reinstatement fee, and submit documentation showing compliance with continuing education requirements. What happens if a technician fails to reinstate a registration within 5 years of expiration? - ✔✔A person who fails to reinstate a pharmacy technician registration within five years of expiration, shall not be eligible for reinstatement and shall repeat an approved training program and repeat and pass the examination, or hold current PTCB certification, before applying to be reregistered. How much CE is required each year for a registered pharmacy technician? - ✔✔5 hours of CE or 0.5 CEUs. It is possible to get an extension of 1 year with written request, but the technician still needs to do the full amount of CE. How long is a technician required to keep record of CE? - ✔✔2 years What documents must be maintained by a pharmacy that employs technicians? - ✔✔A site-specific training program and manual Documentation of completion of training for each technician that is kept for 2 years after they leave the job For technician trainees, proof that they are enrolled in an approved training program How long can a technician trainee work before getting certified? - ✔✔9 months Define supervison. Can a pharmacist supervise over the phone? Leave written instructions? Use any kind of electronic monitoring? - ✔✔No. Supervision must be in person, by a pharmacist who is physically present and available for immediate oral communication What are grounds for revocation or suspension of a pharmacist license? - ✔✔Negligence Unprofessional conduct Incompetence due to a mental or physical condition Use of drugs or alcohol to the extend that the pharmacist is rendered unsafe to practice Fraud or deceit Engaging in activities beyond the scope of the license Allowing unlicensed persons to practice duties for which a license is required Violating or cooperating in violating a law or regulation relating to pharmacy What are grounds for revocation or suspension of a pharmacist license? - ✔✔Revocation of registration by DEA or other federal agency Engaging in theft or diversion of controlled substances Violating any federal or state drug law Revocation of license in another state Conviction of any felony or misdemeanor involving moral turpitude Issuing statements intended to deceive or defraud about his professional service Practicing in such a manner as to be a danger to the health and welfare of the public Failing to comply with continuing education requirements Who can suspend the license of a pharmacist? - ✔✔Any health regulatory board Is a hearing required to suspend the license of a pharmacist? - ✔✔No, The license may be immediately suspended if there is danger to public health or safety. A hearing will be scheduled within a reasonable time What do you do if you know a pharmacist has done something that endangers public health? - ✔✔Submit allegations in writing to the Board of Pharmacy If your license is revoked or suspended in another jurisdiction, or if you have been convicted of a felony or adjudicated incapacitated, what will the director of the Department of Health Professions do? - ✔✔Immediately suspend the license without a hearing What if the conviction is not final? - ✔✔The director can decline to suspend the license if there is a likelihood of injury to the public if the pharmacist's services are not available If your license is suspended, how do you apply for reinstatement? - ✔✔You can bring counsel and witnesses to the hearing. You need 3/4 of the board members at the hearing to vote for reinstatement, and the Board might reinstate upon terms or conditions it deems appropriate Can you participate in kickbacks, fee-splitting, or special charges in exchange for prescription orders? - ✔✔Yes, but it must be fully disclosed in writing to the patient and any third party payor Can you interfere in the patient's right to choose a supplier of medication? - ✔✔NO Can you cooperate with anyone in denying a patient the opportunity to select his supplier of prescribed medications? - ✔✔NO When a permit to conduct a pharmacy is issued, who or what is it issued to? - ✔✔It is issued to the PIC or the Pharmacist in Charge What has to be on the application to conduct a pharmacy? - ✔✔The pharmacy's corporate name and trade name Any pharmacist in addition to the PIC who will work there The hours the pharmacy will be open The pharmacy owner if someone other than the pharmacist is making the application What must be done if the hours of operation of the pharmacy change? - ✔✔If the change will last more than a week, report the change to the Board in writing and post a notice 14 days in advance in a conspicuous place What happens if the PIC leaves the job? - ✔✔The pharmacy permit must be surrendered to the Board, and an application for a new permit made In what circumstance does the PIC need to turn in the pharmacy permit and make a new application? - ✔✔If there is any change in ownership of the pharmacy, such as change in partnership composition or acquisition Can a pharmacy keep operating if it fails to designate a new PIC after the old one leaves? - ✔✔No. It is not even allowed to maintain a stock of prescription drugs If the pharmacy does not have a PIC, the pharmacy receives a notice that it has no valid permit, and is required to do what? - ✔✔Dispose properly of all Schedule II through VI drugs and devices on the premises within 15 days What if the pharmacy fails to do this? - ✔✔The Board of Pharmacy will seize all Schedule II through VI drugs and devices still on the premises and notify the owner To claims the drugs, the owner must pay a fee for storage cost, and provide for proper disposition of the drugs If the owner has not claimed the drugs after 6 months, the drugs may be destroyed What does a new PIC have to do when taking over responsibility for a pharmacy? - ✔✔Inventory all Schedule II,III, IV,and V drugs on the day he or she becomes PIC. The inventory must be completed BEFORE opening for business How long is a pharmacy permit good for? - ✔✔One year Can you be the PIC of more than one pharmacy? - ✔✔Yes, you may be PIC of a maximum of 2 pharmacies Can the non-pharmacist owner of a pharmacy make decisions that override the decisions of the PIC or the pharmacist on duty? - ✔✔No, that would be considered practicing pharmacy without a license When the PIC leaves, how long does the pharmacy have to file an application naming a new one? - ✔✔14 days Is it possible to get a special or limited use pharmacy permit? - ✔✔Yes. This is up to the discretion of the Board of Pharmacy. You need to list the regulatory requirements you want waived and why. You must also maintain a policy and procedure manual outlining the type of operation and schedules of drugs maintatined One pharmacy is being acquired by another. Do current patients need to be notified? - ✔✔Only if prescription records are going to be used for something other than continuity of pharmacy services at substantially the same level. If so, a written notice must be given 14 days prior to the acquisition. If the pharmacy is changing locations, or if structural changes are being made, does the Board need to be notified? - ✔✔Yes, the pharmacy need to be inspected by an agent of the Board Give the Board at least 14 days notice before you would like the inspection. The dispensing area needs to comply with requirements at the time of the inspection. If re-inspection is required, there is a fee Before the inspection, can you stock drugs in the pharmacy? - ✔✔No and they cannot be moved into a new location either. If you don not have a permit, you cannot stock drugs Is the pharmacy required to display its permit? - ✔✔Yes, it must be displayed prominently When is the pharmacy required to renew its permit? - ✔✔Annually If the pharmacy is being sold, can the pharmacy permit be transferred to the new owners? - ✔✔No, the permit is nontransferable Can the pharmacy operate with no pharmacist on duty? - ✔✔No What is the PIC of a hospital pharmacy responsible for? - ✔✔Establishing procedures for and assuring maintenance of the proper storage, security, and dispensing of all drugs throughout the hospital Providing reviews of drug therapy Is the PIC of a hospital pharmacy required to attend the meetings of the Pharmacy and Therapeutics committee? - ✔✔No, but most of them do The hospital pharmacy is going to open a satellite pharmacy. Does the Board need to be notified? - ✔✔Yes, an inspection is required. No drugs may be stocked until the inspection is completed and approval given The PIC can delegate ordering and distribution of certain drugs to non pharmacy personnel. Which drugs? - ✔✔Large volume parenteral solutions that contain no active therapeutic drug other than electolytes Irrigation solutions Contrast media Medical gases Sterile sealed surgical trays that may include a Schedule VI drug; an Blood components and derivatives, and synthetic blood components and products How do these things have to be stored/ - ✔✔They must be locked when authorized staff is not present One medical gas must be locked up all the time, even when authorized staff is present. Which one? - ✔✔Nitrous oxide What are the requirements for the prescription department? - ✔✔It must be at least 240 square feet not including patient waiting area or the area used for counseling, devices, cosmetics, and proprietary medicines Rest rooms and stock rooms must not be accessible through the prescription area. If there is a restroom within the prescription area, it must be for pharmacy personnel only There must be a sink with hot and cold running water There must be a refrigerator Can you use a trailer as a pharmacy? - ✔✔No, a pharmacy must be permanent and secure What is the minimum equipment required in a pharmacy? - ✔✔A current dispensing information reference source Either an electronic scale or a set of prescription balances (sensitive to 15 mg ) and weights Other equipment, supplies, and references consistent with the pharmacy's scope of practice and with public safety Are pharmacies required to have a security system? - ✔✔Yes, if the pharmacy ever closes. No security system is required for pharmacies that are open 24 hours a day, 7 days a week, and are always staffed by a pharmacist What are the requirements for devices used as pharmacy security systems? - ✔✔It must be a generally accepted device such as sound microwave, photoelectric or ultrasonic It must be in working order had have a backup power supply It must fully protect the prescription area Who may have access to the alarm system? - ✔✔Pharmacists working at the pharmacy When is the security system activated? - ✔✔Whenever the prescription department is closed for business What are the requirement for the enclosure around the prescription department? - ✔✔It must protect controlled drugs from unauthorized entry and theft It must be high enough to keep people from reaching in to gain access to drugs The gap between the floor and the door must be no more than 6 inches The door must be at least as high as the adjacent structure There must be a lock on the door Who can have keys to the pharmacy? - ✔✔Only pharmacist who practice the pharmacy and are authorized by the PIC may have keys to the pharmacy, or to the alarm access code Is the PIC allowed to keep a key available for emergencies? - ✔✔Yes, the key or alarm access code may be placed in a sealed envelope or other container with the pharmacist's signature across the seal. It must be kept in a safe or vault within the pharmacy or other secured place If the pharmacist is unavailable, can a technician go into the prescription department to get a prescription that has already been filled and checked? - ✔✔Yes, but only in an emergency. An emergency includes an unplanned absence of a pharmacist scheduled to work during regular pharmacy hours, and an inability to obtain alternate pharmacist coverage The technician must be accompanied by a member of the pharmacy's management or administration Does the PIC need to give permission in order for someone to go into the prescription department in the absence of a pharmacist? - ✔✔Yes, verbal permission is required After the technician goes into the prescription department without a pharmacist, what needs to happen? - ✔✔A recored must be made and kept for 1 year The technician must reseal the key or alarm access code after using it A pharmacist must change the access code within 48 hours Can prescriptions prepared for delivery to the patient be stored outside of the prescription department? - ✔✔Yes, they may be placed in a secure place if access to the prescriptions is restricted to designated clerical assistants If prescription are delivered to a patient when a pharmacist is not present, do any records need to be kept? - ✔✔Yes, a log must be kept to include the patient's name, prescription number, date of delivery, and the signature of the person receiving the prescription. This record must be kept for one year Can schedule II drugs be stored with other schedules of drug? - ✔✔Yes , or they may be separately locked up Can schedule II drugs be left unlocked while there is pharmacist on duty and the prescription department is opened? - ✔✔Yes What about controlled paraphernalia? - ✔✔They must be stored where the pharmacist can exercise reasonable supervision and control Where are expired medications stored? - ✔✔They must be kept separate from other drugs Can drugs in the emergency room be left out in the open? - ✔✔No, they must be kept where unauthorized people cannot have access Can a doctor or other practitioner dispense drugs in the emergency room? - ✔✔Yes, if it is a bona fide medical emergency, pharmaceutical services are not available, and it is permitted by the hospital. The same labeling requirements apply as for prescriptions dispensed anywhere else. A separate record must be kept for 2 years Is after hours access to a hospital pharmacy allowed? - ✔✔Yes, if the PIC authorizes it, a nurse may get emergency medications that are in the manufacturer's original packaging, or in units prepared and labeled by a pharmacist Do any records need to be kept? - ✔✔Yes, a record must be kept for 1 year with the date, patient's name, drugs taken, and the signature of the nurse The pharmacy is going to close for a short while because the pharmacist/owner is on vacation. What are the rules? - ✔✔If it will be closed for more than 1 week, the pharmacy must post a notice 30 day prior to closing or mail a notice 14 days prior to closing to every customer with refills available The notice must include the name of the pharmacy that records will be transferred to unless patients indicate preference to the contrary If there is a change in pharmacy ownership, which records must be transferred? - ✔✔The last 2 years worth of prescription dispensing records and patient records The pharmacy refuses to process a request for prescription dispensing records or other records tendered in accordance with law. What is this? - ✔✔This constitutes a closing of the phramacy The pharmacy is closing. Does the Board need to be notified? - ✔✔Yes, you must report how you intend to dispose of all SII-VI drugs, prescription and dispensing records, including the name and address of licensee who will receive the drugs and records, and the date of transfer [Show More]

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