Section 1
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Under patient counseling and provision of drug information rules, a pharmacist may exercise professional judgment when communicating information about the prescription drug or device to a patient or patient's agent. A. True B. False
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Cards (229)
Section 1
(50 cards)
Under patient counseling and provision of drug information rules, a pharmacist may exercise professional judgment when communicating information about the prescription drug or device to a patient or patient's agent. A. True B. False
A
. The requirements for closing a pharmacy include: I. Giving written notice to DEA 10 days prior to closing II. Sending a letter to DPS 14 days prior to closing III. Sending a letter to the Texas State Board of Pharmacy after closing A. I only B. III only C. I and II only D. II and III only E. I, II, and III
B
Which of the following inventories does NOT have to be notarized within 72 hours? Select all A. Change in Pharmacist-in-charge B. Annual C. Change of Ownership D. Initial
A, D
. John owns a pharmacy that has just been bought out by another pharmacy. Which of the following would be correct regarding the transfer of inventory A. The inventory may be transferred without notification to the DEA B. The inventory may not be transferred and must either be returned to the supplier or destroyed C. The inventory may be transferred if prior notification is given to the DEA and the DEA sends notice approving the transfer D. The inventory may be transferred if prior notification is given to the DEA and the DEA does not send notice that the transfer may not occur.
D
Under Texas law, the time limit for filling Schedule II prescriptions is 10 days. A. True B. False
B
Which of the following inventories does NOT have to be notarized within 72 hours? Select all A. Change of Ownership B. Initial C. Change in Pharmacist-in-charge D. Annual
B, C
Under Texas law, unless a state of disaster has been declared, the quantity dispensed in an emergency refill of a prescription drug must not exceed a _________supply. A. 36 hour B. 72 hour C. 10 day D. 30 day
B
Class B pharmacy is an example of what type of pharmacy? A. Institutional B. Community C. Nuclear D. Clinic
C
Under Texas law, which is false regarding the regulation of the practice of pharmacy by the Board? A. The Board may determine the degree requirements of colleges of pharmacy B. The Board may review suspend, revoke, retire, or restrict a license to practice pharmacy or to operate a pharmacy C. The Board may issue a license after examination or by reciprocity D. The Board may approve Canadian pharmacies
D
Approved drugs that are considered therapeutically equivalent in the Orange Book would be rated. A. AB B. BA C. BC D. TA
A
HIPAA. True or False. A covered entity may not disclose protected health information to law enforcement officials without first providing the patient with an opportunity to object to the disclosure. A. True B. False
B
Which of the following would be correct regarding the issue of whether there should be a third class of drug, also known as "behind the counter" drugs: A. Pharmacists have historically opposed the concept until recently B. The FDA has historically opposed the concept until recently C. States most likely have the authority to create this class of drugs D. Statements A & B are correct E. Statements B & C are correct
B
If records are requested during a pharmacy inspection by the Board of Pharmacy and cannot be produced at the time of the inspection, the records must be supplied to the Board: A. Within 72 hours B. Within 30 days C. Within 10 days D. Within 3 business days
A
Under Texas law, a pharmacist may dispense a generically equivalent drug product if: I. The generic product costs the patient less than the prescribed drug product II. The patient does not refuse the substitution III. The practitioner does not properly certify on the prescription form that a specific prescribed brand is medically necessary A. I only B. III only C. I and II only D. II and III only E. I, II, and III
E
Destruction of drugs dispensed to patients in a nursing home requires all EXCEPT: A. Drugs inventoried and verified by consultant pharmacist B. Render drug unfit for human consumption C. Requires only the signature of a pharmacist D. Records maintained for 2 years
C
According to the Official Prescription Form, which of the following information is allowed to be changed by the pharmacist with permission of the prescriber? A. Practitioner's name B. Dosage form C. Name of drug D. Name of patient
B
Which of the following forms should be completed when a drug is lost or stolen? A. DEA Form 224 B. DEA Form 106 C. DEA Form 41 D. DEA Form 222
B
Mrs. Nelson visits the pharmacy and requests to buy a particular OTC product, Drug A. Pharmacist Phil does not have Drug A in stock, but he does have Drug B in stock, which contains the same strength of drug, but is a prescription medicine. Since it is the same drug with the same strength, what could Phil do? A. Provide Drug B to Mrs. Nelson, charging her the price of Drug A. B. Provide Drug B to Mrs. Nelson after explaining to her that though the products have different names, they are the same thing. C. Provide Drug B to Mrs. Nelson after verifying with her that her condition requires the product. D. Explain to Mrs. Nelson that he is unable to provide her with Drug A at this time.
D
Under Texas law, a pharmacist may not dispense a prescription drug if the pharmacist knows or should know that the prescription was issued on the basis of an Internet-based or telephonic consultation without a valid practitioner-patient relationship, except in an emergency. A. True B. False
A
Pharmacist Phil has been receiving several prescriptions from dermatologists for a commercially manufactured ointment for skin rash. Phil discovered that several other area pharmacies also receive prescriptions for the ointment. Phil determines that he can easily make the ointment for considerably less money than for which he purchases it and receives permission from the dermatologists to substitute his compounded product for the manufacturer's. Phil also offers to compound and sell the product to the other pharmacies. Should Phil be concerned with his actions regarding his preparation? A. No. Phil is a pharmacist and is allowed to compound drug products as he desires. B. Yes. Although the FDA would not have concerns with Phil compounding the product for his prescriptions, it would with regard to Phil selling the product to other pharmacies. C. Yes. Although the FDA would have concerns with Phil compounding the product for his prescriptions, it would not have concern with Phil selling the product to other pharmacies D. Yes. The FDA would have concerns both with Phil compounding a commercially manufactured product as well as selling it to other pharmacies.
D
Under Texas law, a pharmacist whose license has been inactive for no more than ___________ may be allowed to reactivate her license in an emergency caused by a natural or manmade disaster or any other exceptional situation that causes an extraordinary demand for pharmacist services. A. 6 months B. 18 months C. 1 year D. 2 years
D
True or False. Therapeutic Optometrists may administer or prescribe drugs to treat glaucoma and other diseases of the eye. A. True B. False
B
Under Texas Pharmacy law, a pharmacist may release a confidential record only to: I. The patient or the patient's agent. II. A practitioner or another pharmacist. III. The state board of pharmacy A. I only B. III only C. I and II only D. II and III only E. I, II, and III
E
The State Controlled Substance Agency in Texas is: A. Dept of Controlled Substances B. Dept of Public Services C. Dept of Public Safety D. The Board of Pharmacy
C
Under Texas law, an agent of the pharmacist may deliver a prescription order to the patient during short periods of time when the pharmacist is absent, provided the short period of time does not exceed _______ hours. A. One hour B. Two hours C. Two and one-half hours D. Three hours
B
All of the following are classified as registrants EXCEPT: A. pharmacists B. physicians C. researchers D. hospitals
A
A continuing education (CE) record should be maintained for 2 years. A. True B. False
B
1. Regarding the Omnibus Budget Reconciliation Act of 1990 (OBRA-90), which of the following is false? A. The law established a threshold legal standard for patient counseling. B. Compliance with the law is voluntary for participation in the state-managed Medicaid program. C. The patient counseling provisions of the law require that a pharmacist make an offer to discuss medications with each patient. D. The patient, or the patient's agent, may waive the right to be counseled.
B
A designated agent is allowed to communicate a prescription to the pharmacist over the phone. A. True B. False
A
A physician prescribing an FDA approved prescription drug for use not listed in the drug labeling is called: A. Off-label B. Illegal C. Unprofessional conduct D. Orphan drug use
A
Under Texas law, the records and notifications to practitioners of immunizations or vaccinations shall be available for at least ________ from the date such record was made. A. 6 months B. 12 months C. 2 years D. 4 years
C
Which class of drug recalls applies to circumstances where a product is not likely to cause adverse health consequences? A. Class I B. Class II C. Class III D. Class IV E. Class V
C
If you receive a Preliminary Notice Letter from the Board of Pharmacy for an informal conference, all of the following apply EXCEPT: A. You may be represented by an attorney B. You must attend the informal conference C. No official transcript or written record is made D. You do not have answer to the questions posed to you by the Board's legal Counsel
B
True or False. Texas law requires that practitioners write the quantity prescribed only numerically on the prescription. A. True B. False
B
Under Texas law, in addition to the other requirements in the application process, an applicant for a license to practice pharmacy may be required to submit fingerprint information. A. True B. False
A
Floor stock records must be reviewed at least every 7 days. A. True B. False
B
True or False. Texas law does not prohibit physicians from prescribing a dangerous drug for himself/herself or for family members. A. True B. False
A
True or False. Under the Program to Aid Impaired Pharmacists, the records and proceedings of the Board of Pharmacy are confidential and not considered public information. A. True B. False
A
Which of the following medications may Optometric Glaucoma Specialists prescribe and administer? I. 3 day supply of C-II II. 10 day supply of antibiotics III. 72 hour supply of oral antihistamines A. I only B. III only C. I and II only D. II and III only E. I, II, and III
D
2. Under Texas law, for the delivery of a completed prescription at the pharmacy but when the pharmacy department is closed, which is/are true statement(s)? I. An agent of the pharmacist may not deliver a prescription order to the patient during short periods of time when the pharmacist is absent. II. A Class A pharmacy must make available for use by the public a source of dispensing information designed for consumer. III. An agent of the pharmacist may deliver a prescription order to the patient during short periods of time when the pharmacist is absent. A. I only B. I and II only C. II and III only. D. All
C
A Board of Pharmacy representative can inspect the following during a pharmacy inspection EXCEPT: A. Inventory records B. Financial records C. Equipment D. Drug security
B
True or False. The Executive Director of the Board of Pharmacy serves as secretary to the board and is a voting member. A. True B. False
B
According to Federal law, there is no time limit for filling a Schedule II prescription. A. True B. False
A
Under Texas law, a pharmacist may dispense a dosage form of a drug product different from that prescribed, such as tablets instead of capsules or liquid instead of tablets, provided: TWO ANSWERS A. the patient consents to the dosage form substitution B. the pharmacist notifies the practitioner of the dosage form substitution C. the dosage form contains the identical amount of the active ingredients as the dosage prescribed for the patient, is not an enteric-coated or time release product, and does not alter desired clinical outcome D. All of the above
A, C
Under Texas law, how many refills are allowed for a Schedule III drug? A. None B. 1 refill C. 3 refills D. 5 refills
D
A perpetual inventory of the pharmacy should be conducted every ____ year(s). A. 1 B. 2 C. 3 D. 4
A
If the practitioner has prohibited substitution through a dispensing directive, a pharmacist can only substitute a generically equivalent drug product by obtaining written authorization from the practitioner. A. True B. False
B
When the pharmacist is temporarily absent from the pharmacy, a pharmacy intern shall be considered a _______________________. A. Registered pharmacy technician B. Pharmacy intern C. Pharmacy technician trainee D. Certified pharmacy technician
A
Under Texas law, which of the following is/are false statement(s) regarding an emergency medication kit? I. An emergency medication kit may be located at a nursing home. II. An emergency medication kit may not contain controlled substances. III. A record of all drugs sent to and returned from the remote location must be maintained. A. I only B. III only C. I and II only D. II and III only E. I, II, and III
D
A drug product's label states that the drug is 0.25 mg. Tests show that the product is actually 0.5 mg. This product is: A. Adulterated B. Misbranded C. Neither adulterated or misbranded D. Both adulterated and misbranded
D
Section 2
(50 cards)
DPS can inspect and copy any record they want including financial and pricing data. A. True B. False
B
Each resident of an LTCF must have their drug regimen reviewed by a pharmacist: A. Daily B. Weekly C. Monthly D. Quarterly
C
If the pharmacist discovers the loss of hydrocodone tablets from the pharmacy, the pharmacist shall: I. Notify the Board of Pharmacy immediately on discovery of the loss II. Notify DEA and DPS immediately upon discovery of the loss III. Submit a copy of DEA form 106 to the Board A. I only B. III only C. I and II only D. II and III only E. I, II, and III (only notify board when it is sig. loss)
E
Pharmacist licenses in Texas must be renewed A. Every year B. Every 2 years C. Every 3 years D. Every 4 years
B
A drug with a high potential for abuse, and that has no current medical use in treatment in the United States would correctly define: A. Marijuana B. Codeine C. Amobarbital D. Secobarbital
A
1. General requirements for inventories include: I. Estimated count of all controlled substances in Schedules II, IV, V II. Exact count of all Schedule II controlled substances III. Schedule II controlled substances listed separately on inventory A. I only B. III only C. I and II only D. II and III only E. I, II, and III only
D
How long must a pharmacist maintain record of completed continuing education credits? A. 1 year B. 2 years C. 3 years D. 5 years
C
According to Federal law, Schedule II prescriptions for patients in a long-term care facility are valid for no longer than ______ days from the date of issuance. A. 30 days B. 60 days C. 90 days D. 120 days
B
A formal disciplinary case against a pharmacist is conducted in front of: A. The full Texas State Board of Pharmacy B. A panel of the Board of pharmacy including one Board of Pharmacy member and the Board of Pharmacy staff C. An Administrative Law Judge D. A judge from the state district court in Austin
C
Most state pharmacy boards are composed of: A. Entirely community pharmacists B. Entirely hospital pharmacists C. Pharmacists from different practice settings D. Pharmacists elected by voters
C
Which of the following is NOT a ground for discipline of a pharmacist's license? A. Sharing money with a prescriber for prescriptions dispensed B. Copying, retaining, repeating, or transmitting questions contained on the NAPLEX or MPJE examinations C. Failing to maintain effective controls to prevent diversion of controlled substances D. Failure to repay a guaranteed student loan E. None of the above (all are grounds for discipline)
E
Which of the following would be correct regarding the storage requirements of controlled substances? A. Pharmacies may disperse most all Schedule II, III, IV, or V drugs throughout their inventory. B. Pharmacies must store all Schedule II drugs in a securely locked cabinet, but may disperse Schedule III, IV, and V controlled substances. C. Individual practitioners must store Schedule II drugs in a securely locked cabinet, but not Schedule III, IV, and V substances. D. A & B E. A & C
A
A prescription for Lipitor in Texas for a 30 day supply supply with 2 refills: A. Must be dispensed as a 30 day supply B. May be dispensed as a 90 day supply as long as the patient consents and the physician is notified C. Must be filled within 21 days D. Both b and c
B
If you administer a vaccination to a patient in your pharmacy, who must be notified within 14 days? A. The patient's primary care doctor B. The physician under whose protocol the immunization was administered C. The patient's insurance company D. All of the above
A
Schedule III FDA approved drugs include: I. Dronabinol II. GHB III. Amphetamine IV. Codeine with Aspirin A. I B. I, II, IV C. I, II, III, IV D. IV E. I, IV
B
A state pharmacy board revoked the license of a pharmacist in Arizona. The pharmacist also held a license in another state and moved there to practice. Which of the following would be correct: A. The other state pharmacy board would likely automatically revoke the pharmacist's license and the pharmacist would not be entitled to a hearing. B. The other state pharmacy board would likely revoke the pharmacist's license, however the pharmacist would likely be entitled to a hearing. C. The other state pharmacy board would not likely find out about the revocation in Arizona. D. The other state pharmacy board would not likely take any action against the pharmacist's license even with knowledge of the revocation in Arizona.
B
. Long Term Care Facilities are required to make sure that each resident's drug therapy is free from unnecessary drugs. Which of the following would constitute and unnecessary drug? I. Drugs without adequate indications for use II. Drugs given for excessive duration III. Drugs not monitored adequately A. I only B. I and II only C. II and III only D. I, II, and III
D
Which of the following practitioners in Texas has independent authority to write prescriptions for dangerous drugs? A. Physician's Assistants B. Advanced Nurse Practitioners C. Podiatrists D. Naturopaths
C
How long does a pharmacist have to notify the State Board when they change their name (e.g., through marriage)? A. 3 days B. 7 days C. 10 days D. 14 days
C
APNs and PAs may "carry out" or "sign" a prescription drug order for controlled substances for: A. a refill that has been authorized after consulting with the delegating physician B. more than a 30 day supply C. less than a 30 day supply D. a drug in schedule III, IV, or V E. All of the above
E
What is the maximum number of physicians for which a Texas Pharmacist may perform Drug therapy Management under a written protocol? A. No more than 2 physicians B. No more than three physicians C. No more than 4 physicians D. No more than 5 physicians within a 90 mile radius E. There is no maximum number
E
Interns or residents of a hospital are exempt from DEA registration. A. True B. False
A
True or False. A prescription that contains narcotics in an amount greater than the maximum allowed for Schedule V then becomes a Schedule II. A. True B. False
B
Which of the following would be correct regarding 340B drugs? A. They are drugs sold by manufacturers at special prices to designated entities serving underserved and uninsured populations. B. They are outdated drugs given by manufacturers to designated entities serving underserved and uninsured populations. C. They are drugs available to designated entities serving underserved and uninsured populations through state drug repository programs D. Statements A & B are correct E. Statements A & C are correct
A
Which of the following disciplinary actions means that your license is not in effect for a specified period of time? A. Reprimand B. Suspension C. Restriction D. Revocation
B
Which of the following would be exempt from registering under the CSA? A. Pharmacists dispensing controlled substance Rxs in a DEA registered pharmacy B. Physicians who prescribe, but do not administer or dispense controlled substances C. Hospitals who dispense and administer controlled substances only to inpatients D. A & B E. A & C
A
Which of the following forms should be completed when applying for registration? A. DEA Form 224 B. DEA Form 41 C. DEA Form 222 D. DEA Form 106
A
The maximum amount of codeine that can be contained in a Schedule V cough syrup is: A. 100 mg per 100 ml B. 50 mg per 100 ml C. 200 mg per 100 ml D. 1800 mg per 100 ml E. 300 mg per 100 ml
C
A pharmacist is licensed in New Jersey and wishes to practice pharmacy in Connecticut. Which of the following would be the best answer: A. The pharmacist most likely must pass the NAPLEX in Connecticut and become licensed in Connecticut in order to practice B. The pharmacist most likely could engage in license transfer without having to retake the NAPLEX to become licensed in Connecticut in order to practice C. The pharmacist could practice in Connecticut without being licensed in Connecticut
B
According to the Official Prescription Program, partial filling is allowed for patients that do not reside in a long-term care facility as long as the balance is dispensed with ______ hours. A. 24 hours B. 48 hours C. 72 hours D. 96 hours
C
True or False. According to a recent law change, the Texas Controlled Substances Act allows pharmacists to dispense prescriptions for controlled substances under a written, oral, or telephonically prescription from an out-of-state physician assistant (PA). A. True B. False
B
A pharmacy may distribute what percentage of the total controlled substance units it distributes and dispenses in a year without having to register as a distributor? (>5%/yr considered wholesaler) A. Not more than 5% B. Not more than 1% C. Not more than 10% D. Not more than 20%
A
Under Texas law, how many refills are allowed for a Schedule II drug? A. None B. 1 refill C. 3 refills D. 5 refills
A
The State Board of Pharmacy requires representation from which of the following pharmacy classes? (SELECT ALL THAT APPLY) A. Class A B. Class B C. Class C D. Class D E. Class E
A, C
The National Association of Boards of Pharmacy performs which of the following roles: A. Disciplines pharmacists B. Enacts state pharmacy practice acts C. Selects state pharmacy board members D. Oversees the administration of NAPLEX for pharmacist licensure
D
How may pharmacist members serve on the Texas State board of Pharmacy? A. 3 B. 6 C. 9 D. 12
B
Individual practitioners (IPs) employed by a hospital may utilize the hospital's DEA number to prescribe, dispense or administer controlled substances provided that among other requirements: A. The IP has his/her own DEA number B. The hospital has assigned the IP a specific internal code in the form of a prefix to the hospital's DEA number. C. The hospital has assigned the IP a specific internal code in the form of a suffix to the hospital's DEA number. D. Statements B & C are correct E. Statements A, B & C are correct
C
Most state pharmacy boards have the authority to implement which of the following disciplinary actions against a pharmacist: A. Incarceration B. Temporary suspension of license C. Monetary penalties D. Statements B & C are correct E. Statements A, B & C are correct
D
Which of the following tasks may be performed by a technician in an institutional pharmacy? A. Receiving and interpreting drug orders B. Interpreting patient profiles C. Bulk compounding D. Verifying receipt of controlled substances by initialing invoices.
C
A pharmacy is permitted to re-dispense a returned prescription drug product as long as it is in the original, unopened, tamper-evident packaging. A. True B. False
B
Which of the following is classified in Schedule IV (C-IV)? I. Seconal II. Diazepam III. Propoxyphene A. I only B. III only C. I and II only D. II and III only E. I, II, and III
D
How can a prescriber prohibit generic substitution on a written prescription in Texas? A. By checking a box that says "Do not substitute" B. By signing the prescription over the "Dispense as Written" signature line C. By writing the words "medically necessary" or "brand medically necessary" in their own handwriting on the prescription D. All of the above
C
A patient discovered that she had been dispensed and had taken the wrong medication and called the pharmacy in a very angry mood and very distraught. The pharmacist confirmed that the wrong medication had been dispensed and told the patient that she could not discuss the issue any further without talking to management. She then told the patient to contact the prescriber. Which of the following would be the best answer: A. The pharmacist acted appropriately B. The pharmacist should have told the patient that she was negligent and the pharmacy would pay for whatever injury or inconvenience results. C. The pharmacist should have empathized with the patient, showed concern, asked about the patient's well being, and have contacted the prescriber. D. The pharmacist should have not admitted to the patient that an error had been made until she spoke to management.
C
The purpose of state pharmacy boards is: A. To protect the profession B. To protect pharmacists C. To protect the public D. To protect state government
C
Technician trainees must pass their certification exam and become a registered technician within 2 years of starting employment with a pharmacy. A. True B. False
B
Texas requirements for pharmacist continuing education include: A. 15 hours with 1 hour each year of law-related CE B. 30 hours every two years with 2 hours of law-related CE C. 30 hours every 2 years with 6 hours of live(seminars, etc) CE D. 30 hours every two years of approved programs of any type (1 hr has to be law)
D
Which of the following requires immediate notification to the Board of Pharmacy? A. Change of pharmacy managing officers of a corporation B. Change of pharmacist place of employment C. Closing of a pharmacy D. Significant loss of dangerous drugs
D
A state decided to reschedule all opioid drug products scheduled as C-III under federal law to C-II pursuant to state law. Which of the following would be correct? A. The federal CSA preempts states from scheduling drug products B. The state law would not conflict with federal law and thus likely not be preempted C. If the state law is valid, pharmacists should follow federal law and dispense the products as C-III D. Statements A & C are correct E. Statements B & C are correct
B
According to Federal law, all of the following information is required on written or verbal Schedule II prescriptions EXCEPT: A. date dispensed B. drug name C. DEA number of practitioner D age of the patient
A
Which of the following is NOT classified in Schedule II (C-II)? I. Morphine II. Preludin III. Pentazocine A. I only B. III only C. I and II only D. II and III only E. I, II and III
B
Section 3
(50 cards)
Which of the following would be correct regarding whether the DEA considers nurses in long term care facilities as agents of a prescriber? A. Nurses are considered agents B. Nurses are not considered agents C. Nurses are considered agents only if a formal, written agency agreement is established
C
A pharmacy receive a prescription for a C-III medication. The strength of the medication was not indicated on the prescription. Which of the following would be the best answer: A. The pharmacist may legally add it without contacting the prescriber B. The pharmacist may legally add it after contacting the prescriber and documenting that the prescriber agreed to the strength C. The prescription is not valid and cannot be dispensed D. The prescription is not valid and cannot be dispensed, however, the pharmacist may contact the prescriber and execute a new oral order.
B
If controlled substances are stolen or lost, the pharmacy must report (best answer): A. Theft to the DEA, but not loss B. Loss to the DEA, but not theft if a police report is filed C. Theft to the DEA and loss if significant D. Theft to the DEA and loss if significant within one day of discovery
D
Specifications for testing of non child resistant containers are found in: A. The Poison Prevention Packaging Act B. Food Drug and Cosmetic Act C. Federal Hazardous Substances Act D. Tamper -Resistant Packaging Regulations
A
. A patient by the name of Sue Sonny has just moved to town. After arriving in town, Sue found a new physician to transfer to and help treat her for her long-time chronic pain. Sue then contacts Pharmacist Phil to see if he has all the drugs she will be taking in stock. Sue is in need of over 5 controlled drugs at high doses. How should Phil respond to Sue? A. Phil should inform Sue that he is unable to fill her prescriptions since they are all controlled drugs at high doses. B. Phil should inform Sue that taking a lot of controlled drugs at high doses could be illegal, and that he would need to contact the DEA agent prior to filling any prescriptions for her. C. Phil should inform Sue that he would need to contact her physician to verify the need for all the drugs at the given doses, and will then order them thereafter to have in stock for her. D. Phil should inform Sue that he has no restrictions on filling controlled drugs and that obtaining them will not be a problem.
C
Which of the following is an appropriate method of storing Schedule II controlled substances within a Class C pharmacy? A. In a secured cabinet that is locked. B. Dispersed throughout the non-controlled stock to deter theft. C. On a non-secured shelf within 10 feet of the pharmacist's verification station. D. A and B only
A
Bling Pharmacy called Zing Phamacy requesting a transfer of a C-III Rx to Bling for a patient. The prescription had 2 refills remaining. Which of the following would be correct (assume that Bling and Zing do not share common electronic files). A. The pharmacist at Zing could instruct the technician to orally transfer the required prescription information to Bling. B. If the patient wants the last refill at Zing, Bling could subsequently transfer the prescription back to Zing. C. Bling must record on the prescription it transcribes from Zing the word "transfer" together with several other points of information including Zing's prescription number. (only one transfer unless shared among same database) D. Statements A & C are correct E. Statements B & C are correct
C
Pharmacist Phil receives a call from a chain pharmacy located in a different state. Mrs. Neely is on vacation and would like to transfer her prescription for Ativan (schedule IV), which she has 3 refills remaining. The state Phil is in and the state Mrs. Neely is visiting follow the same restrictions that the CSA has regarding transferring of controlled substances. Can Phil legally transfer the prescription? A. No. The CSA prohibits controlled drugs prescriptions from being transferred to a different state. B. No. The CSA prohibits the transferring of any controlled substances. C. Yes. The CSA would allow Mrs. Neely to transfer her controlled prescription to another state this time and then back to Phil's pharmacy for the next fill. D. Yes. The CSA would allow Mrs. Neely to transfer her controlled prescription this one time only.
D
Which of the following accurate describe(s) the law related to dispensing controlled substance prescriptions in the ordinary course of practice: A. Treating an addict for the addiction is a legitimate medical purpose B. Responsibility for the legitimacy of a prescription rests only with the prescriber C. Responsibility for the legitimacy of a prescription rests with the prescriber and the pharmacist D. Statements A & B are correct E. Statements A & C are correct
C
. Dr. New is out of town for a conference and receives a call from a cancer patient of his that needs a new prescription for Oxycontin (schedule II). Dr. New calls pharmacist Phil to see if he can call in a verbal order for Oxycontin since he will be at the conference for 5 days. Which of the following would be allowable for Phil to do? I. Phil could take an emergency phone order from Dr. New for the Oxycontin under the given circumstances. II. Phil should inform Dr. New that a written prescription will have to be delivered within 7 days. III. Phil should inform Dr. New that only a three day supply of the drug can be called in. A. I only B. I and II only C. II and III only D. I, II, and III
B
If a pharmacist partial fills a prescription for a Schedule II controlled substance, how long does the pharmacist have to fill the balance of the prescription? A. 3 days B. 7 days C. 60 days D. May not be partially filled
A
Which of the following is true with regard to drug recall procedures? A. The FDA can recall drugs under Class I, II, or III procedures B. Class II recalls involve the potential for temporary or medically reversible adverse health consequences C. Class III recalls are the most serious D. Recalls can be achieved through internet notification only
B
A pharmacy received a prescription from Dr. Robert Jed. The DEA registration number on the prescription reads BJ2385121. Which one of the following is most correct: A. The number is clearly valid B. The number is clearly invalid C. The number could be valid D. There is no way to tell if the number could be valid or not
C
A faxed prescription for any C-II drug from the prescriber to the pharmacy is acceptable in place of the original for which of the following: A. In any situation B. A resident of a skilled nursing facility C. An emergency situation D. For terminally ill patients (hospice)
D
Drugs which are exempt from the Poison Prevention Packaging Act include the following except: A. Chewable isosorbide dinitrate in dosage form containing 10mg or less B. Sublingual nitroglycerin C. Aspirin D. Medroxyprogesterone acetate tablets
C
If a distributor partially distributes an order for a Schedule II controlled substance, how long does the distributor have to complete the balance of the order? A. 3 days B. 7 days C. 60 days D. A distributor may not partially distribute
C
How long does a physician have to get a hard-copy prescription to the pharmacy or have it post-marked, after calling in an emergency prescription for a C-II? A. 3 days B. 7 days C. 14 days D. 21 days
B
A recall of a medical device implantable infusion pump that could stall without warning causing return of the patient's symptom or withdrawal which could then lead to death if not treated immediately and effectively would be classified as a: A. Class I B. Class II C. Class III D. Class IV
A
Under Texas law, patient counseling and provision of drug information - I. Must be provided for any prescription drug order dispensed by the pharmacy on the request of the patient. II. Should be communicated orally in person if the patient or patient's agent is in the pharmacy. III. Does not require reinforcement with written information A. I only B. I and II only C. II and III only. D. All
B
. A physician calls a pharmacy from the golf course and says he is calling in a two week supply of a C-II Rx for a patient for hydrocodone. The pharmacist is familiar with the patient and the physician and knows the patient is terminally ill and has received hydrocodone Rxs before. The physician says the patient's wife will be in to pick up the medication in about an hour. Which of the following would be the best response from the pharmacist to the physician, combining federal and state law: A. "We cannot dispense a two week supply, but only enough hydrocodone for the emergency period. We must receive an original written prescription with the notation "Authorization for Emergency Dispensing" within 7 days." B. "We cannot dispense a two week supply, but only enough hydrocodone for the emergency period. The oral order will substitute for an original written Rx." C. "We cannot dispense a two week supply, but only enough hydrocodone for the emergency period." D. "We can dispense a two week supply. We must receive an original written prescription with the notation "Authorization for Emergency Dispensing" within 7 days." E. "This is most likely not an emergency situation and we cannot dispense the prescription."
A
Dr. Jones is a new dentist in town. He asks the pharmacist at Friendly Pharmacy if he can obtain Ativan, a schedule IV anti-anxiety drug, to use on his patients in the office prior to procedures. Dr. Jones would like to write a prescription for office use. Is this allowable? A. Yes. Practitioners have no restrictions in writing controlled substance prescriptions for office use. B. Yes. Dr. Jones is an individual practitioner under the law and is permitted to obtain schedule III-V medications in this manner. C. No. Dr. Jones is a dentist and not a physician, and therefore is unable to obtain Ativan in this manner for office use. D. No. Pharmacies are restricted from filling controlled substance prescriptions written for office use.
D
Which of the following would be correct regarding records of controlled substances: A. They must be kept for at least 2 years B. Any record may be kept centrally rather than at the registered location C. Records of C-II drugs must be maintained separately from non-controlled substance records, but not separate from other controlled substance records D. Statements A & B are correct E. Statements A & C are correct
A
A community pharmacy received a prescription from a medical resident of a local hospital. The hospital's DEA registration number was on the prescription with the internal code number assigned to the resident. The prescription was signed by the resident but the resident's name was nowhere else on the prescription. Which of the following would be correct: A. A prescription from a resident using a hospital registration number is not valid outside the hospital pharmacy. B. The prescription is not facially valid because the resident's name must be stamped, typed or handprinted on the prescription. C. The prescription is facially valid D. Statements A & B are correct E. Statements A & C are correct
B
Pharmacist Phil calls Dr. Smith's office to inform the office that Mrs. Jones is out of refills on her Ativan (Sch. IV) prescription, and that she is requesting additional refills for it. Nurse Nancy tells Phil that Dr. Smith is on vacation but that he authorized her to use her judgment on any refill authorizations and thus told Phil to refill the prescription. Can Phil legally fill the Ativan prescription for Mrs. Jones one more time? (agents of physician can't use judgement) A. Yes. Phil contacted the office and verified that Mrs. Jones is allowed to receive one additional refill. B. Yes. Dr. Smith properly delegated authority to Nancy to add refills. C. No. Nurse Nancy would have to verify with Dr. Smith first prior to allowing the refill. D. No. Refill requests and authorizations for controlled drugs can not be made over the phone
C
In some states certain C-V codeine cough syrups can be sold without a prescription. Which of the following correctly describe(s) the requirements to do so: A. No more than 4 ounces per day per person may be sold B. No more than 20 ounces per person may be sold over a 7 day period C. Pharmacy technicians may dispense and sell the drug D. All purchases must be recorded in a bound record book
D
Prescribers wishing to transmit controlled substance prescriptions electronically (by means of data transmission) must: A. Undergo identity proofing B. Sign and transmit pursuant to a 2-factor authentication method C. Utilize a system that has been verified or certified as having met all DEA requirements D. Statements A & B are correct E. Statements A, B, & C are correct
E
Pharmacist may obtain blanket authorizations from a patient to waive the requirements of the Poison Prevention Packaging Act. A. True B. False
A
Which of the following would be a legal prescription in Texas? A. A written prescription for Valium from a medical doctor in Mexico. B. A telephone prescription for amoxicillin from a physician's assistant in Florida. C. A written prescription for a 30 day supply of Xanax from an advanced nurse practitioner located in OK. D. A written prescription for oxycodone from a therapeutic optometrist in TX. E. Both b and c
B
HIPAA. Which of the following is/are true statement(s) regarding the Health Insurance Portability and Accountability Act of 1996? I. Individually Identifiable Health Information (IIHI) is information about the physical or mental health of an individual that is created or received by a covered entity and that identifies or can reasonably be used to identify the individual. II. A health care provider who transmits any health information in electronic form is a covered entity. III. A pharmacy is a covered entity under HIPAA. A. I only B. I and II only C. II and III only D. All
D
Which of the following would be correct regarding who is allowed to prescribe controlled substances? A. Mid-level practitioners may prescribe controlled substances if authorized by state law B. An agent or employee may communicate the prescription to a pharmacist C. An agent or employee may prepare the prescription for the individual practitioner's signature D. Statements B & C are correct E. Statements A, B & C are correct
E
Which of the following is used to seek approval to market a generic drug? A ANDA: B. SNDA C. PMA
A
Under the federal methamphetamine prevention laws, which of the following would be correct regarding the sale of pseudoephedrine from a community pharmacy? A. No more than 3.6 gms of base may be sold to a single purchaser per day and no more than 9 gms within a 30 day period B. All sales must be recorded in an electronic logbook C. All sales must be recorded and the government's preference is that the logbook be electronic. D. Statements A & B are correct E. Statements A & C are correct
E
Schedule III prescriptions may be: A. Phoned to the pharmacy B. Faxed to the pharmacy C. Written for over a 30 day supply D. A and B E. A, B, and C
E
Under federal law, methadone may be legally dispensed from a community pharmacy as prescribed by a physician within the regular course of medical practice for which of the following purpose(s)? A. As an analgesic B. As an analgesic and antitussive C. As an analgesic, antitussive and for the maintenance and detoxification of addicts. D. Methadone may be legally prescribed and dispensed for any purpose since approved drugs may be prescribed and dispensed for off-label uses.
A
A pharmacist has a bottle of expired Demerol tablets that he sends to the a reverse distributor for destruction. Which form is used to record this transaction? A. DEA Form 222 B. DEA Form 41 C. DEA Form 225 D. TX Official Prescription Form
A
A pharmacist received a prescription for 500 oxycodone tablets with the directions such that the patient was to significantly taper down the dosage over the next 4 weeks. The pharmacist called the prescriber who informed the pharmacist that the patient is an addict and that the prescriber is trying to detoxify the patient. Which of the following would be correct: A. This prescription is not for a legitimate medical purpose and should not be dispensed. B. This prescription is for a legitimate medical purpose and should be dispensed C. This prescription would be valid under DATA. D. Statements A & C are correct E. Statements B & C are correct
A
Friendly Pharmacy receives a call from a local dentist who would like to purchase Ativan (schedule IV) for office use. Which of the following would be proper for the pharmacist at Friendly Pharmacy to do? A. Have the dentist buy the drug using his DEA 222 form. B. Have the dentist buy the drug documenting on the invoices the sale. C. Have the dentist write a prescription for office use, filling it under the dentists name. D. None of the above would be legal since prescribers are not allowed to obtain controlled drugs for office use.
B
A pharmacist received a prescription from a prescriber for a very suspicious person from out of state. The pharmacist suspected that the person was a diverter and not really a patient but could not confirm it and dispensed the prescription anyway. Later the pharmacist was visited by the DEA and the BOP who told the pharmacist that the person had been duping physicians all over the area into writing controlled substance prescriptions and was selling the drugs on the street. Which of the following is the best answer: A. The pharmacist has not violated the law since the prescription was facially valid from an authorized prescriber. B. The pharmacist has violated the law since the prescriptions was not for a legitimate medical purpose. C. The pharmacist has not violated the law unless it can be established that the pharmacist acted negligently D. The pharmacist has not violated the law unless it can be established that he filled the prescription knowing it was not for a legitimate medical purpose (look for clues in law book when Rx is not a diverter)
D
If manufactured under conditions that are not GMP, product is a A. Adulterated B. Misbranded C. Contaminated D. Unsanitary
A
Patient package inserts or medication guides are required for all of the following except A. Relafen B. Estrogens C. Amoxicillin
C
Which of the following is used to seek approval to initially market a new drug? A. ANDA B. SNDA C. NDA D. PMA
C
Who may order C-II drugs under the law? A. The person listed on the DEA registration form (registrant). B. Any pharmacist employed at the pharmacy. C. Any person named on a power of attorney form executed between the DEA registrant and the named person. D. Statements A & C are correct E. Statements A, B & C are correct
D
Which of the following would be the best answer regarding the refilling of controlled substance prescriptions assuming prescriber authorization. A. C-III and C-IV prescriptions may only be refilled five times or within six months, whichever comes first. B. C-III, C-IV and C-V prescriptions may only be refilled five times or within six months, whichever comes first. C. C-III and C-IV prescriptions may be refilled, but only if the pharmacy contacts the prescriber each time for specific authorization D. C-III, C-IV and C-V prescriptions may be refilled without restrictions
B
Which of the following would be the best answer regarding the partial filling of a C-II drug? A. It is not permitted B. It is permitted provided the pharmacist is unable to supply the full quantity. C. It is permitted, and if the balance is dispensed it must be within 72 hours D. It is permitted provided the pharmacist is unable to supply the full quantity, and if the balance is dispensed it must be within 72 hours E. It is permitted, however, the balance may not be dispensed.
D
Harry Smith lives in a long-term care facility. The prescriber faxed to pharmacist Phil a prescription for Oxycontin (schedule II) for 90 pills. Harry's insurance will only pay for 30 pills at a time. Could Phil fill the prescription for 30 pills at a time until all 90 are dispensed? A. Yes, however, all the tablets must be filled within 60 days from the date of the issuance of the prescription B. Yes, however, Mr. Smith must also be diagnosed as a terminally ill patient. C. Yes, however, Phil must obtain a new written prescription for his records each time he fills another 30 pills. D. No, if Harry decides to get less than 90 tablets, he will be unable to obtain the remainder since schedule II drugs cannot have refills.
A
One of the requirements of the FDCA of 1938 was: A. The FDCA requires proof of safety prior to marketing B. The FDCA requires proof of efficacy prior to marketing C. The FDCA requires inspections prior to marketing D. The FDCA requires approval of advertisements before marketing
A
Class A pharmacies are required to maintain a perpetual inventory of Schedule II Narcotics. A. True B. False
B
A prescriber calls a pharmacist seeking the pharmacist's advice. The prescriber says that a particular patient, whom the pharmacist knows well as a regular patient of the pharmacy, will require maintenance therapy on a particular C-II drug for at least the next six months. The physician and the patient want to make obtaining the drug as easy as possible. Which of the following represent legal options for the patient and the prescriber assuming legitimacy is not an issue. A. The prescriber could issue one C-II Rx for a six-month supply. B. The prescriber could issue 3 prescriptions, each for a 60 day supply. Each Rx except the first specifying the earliest date upon which the prescription can be filled. C. The prescriber could issue 3 prescriptions, each for a 30 day supply. Each Rx except the first specifying the earliest date upon which the prescription can be filled. The patient must get a new Rx or new set of Rxs for the remaining 90 day supply. D. Statements A & C are legally permissible E. Statements A, B & C are legally permissible
D
A pharmacy has on hand several tablets and capsules of various controlled drugs. The wholesaler and manufacturer will not take them back and the pharmacy wants to destroy them. Which of the following would be correct: A. The pharmacy must notify the DEA in advance and destroy the drugs in the presence of DEA agents B. The pharmacy must notify the DEA in advance and destroy the drugs in the presence of a DEA agent or other authorized person C. The pharmacy must notify the DEA and the state board of pharmacy and destroy the drugs in the presence of DEA agents or BOP agents. D. The pharmacy may destroy the drugs in front of witnesses and subsequently notify the DEA E. The pharmacy must send the drugs to the DEA for destruction
B
Pharmacies dispensing controlled substances in Texas must report that information to DPS: A. Within 15 days of the last day of the month in which the prescription was completely filled B. Within 15 days of the date the prescription was completely filled C. Within 7 days of the last day of the month in which the prescription was completely filled D. Within 7 days of the date the prescription is completely filled
D
Section 4
(50 cards)
A pharmacy employee inadvertently entered the wrong NDC number for a Medicaid reimbursement claim resulting in the pharmacy receiving $100 more than it should have received. The mistake was detected by the state Medicaid agency. A. The pharmacy has likely violated the federal fraud and abuse statute B. The pharmacy has likely not violated the federal fraud and abuse statute
B
OBRA 90 mandates prospective drug use review and patient counseling on all new prescriptions in Texas. A. True B. False
A
Which of the following would be correct regarding the authority of physicians to dispense medications: A. Physicians are not permitted to dispense medications under federal law B. The Durham-Humphrey Amendment dispensing standards may not apply to physicians C. Regulation of physician dispensing is determined by state law D. Statements a & b are correct E. Statements b & c are correct
C
Under the Prescription Drug Marketing Act it would be illegal for a hospital to resell prescription drugs that it purchases except: A. A pursuant to prescription B. To physicians in community practice on a regular basis C. To community pharmacies on a regular basis D. To drug wholesalers
A
Which of the following would be the best answer regarding the dissemination of off-label use information by manufacturers to health care professionals. A. The FDA strictly prohibits any such dissemination B. The FDA allows the dissemination of any off-label use information provided it is accompanied with a notice that the use is off-label C. The FDA allows the dissemination of off-label use information provided the FDA has approved the information prior to dissemination D. The FDA allows the dissemination of off-label use information provided the information is in the form of peer-reviewed publications and accompanied by approved labeling.
D
Pharmacists are required to dispense FDA approved Medication Guides for: A. All prescription drugs B. Prescription drugs as determined by the FDA that pose a serious and significant concern to public health C. Prescription drugs as determined by the pharmacist that pose a serious and significant concern to public health D. Oral contraceptives
B
Which of the following accurately describe(s) black box warnings: A. They are required for most drugs on the market B. They have not been regarded as very effective C. They are required to be conveyed to the patient D. Statements A & B are correct E. Statements A & C are correct
B
Under the current Food, Drug, and Cosmetic Act, the definition of "drug" includes: I. Articles intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of a disease II. Articles intended to affect the structure of any function of the body III. Products intended to supplement the diet A. I only B. I and II only C. II and III only D. I, II, and III
B
Special warning requirements for Ipecac Syrup under Federal regulations include all EXCEPT: A. May only be sold in 10z. (30ml) containers B. For emergency use to cause vomiting in poisoning C. Warning: Keep out of reach of children D. Usual dosage is 10ml in individuals over 1 year of age
D
Under HIPAA, a pharmacist may disclose protected health information about an individual whom the pharmacist reasonably believes to be a victim of abuse, neglect, or domestic violence to a government authority without the patient's authorization. A. True B. False
A
Mrs. Smith pays cash for all of her prescriptions. A friend has recently informed her that she can buy her medicines online from a Canadian pharmacy and save a lot of money. As Mrs. Smith's pharmacist, she asks for your advice on purchasing her drugs from Canada. What would be the best information to provide? A. Inform Mrs. Smith that the FDA does allow limited quantities of prescription drugs to be purchased from different countries and that she could safely buy her current medications from any country, including Canada. B. Inform Mrs. Smith that buying medications only from Canada, but not other countries, is legal under the FDCA. C. Inform Mrs. Smith that she is only allowed to purchase her medications in the United States, and assist her in finding alternative ways to save money. D. Inform Mrs. Smith that Canadian pharmacies are only permitted to fill maintenance medications; therefore, she will be limited in what drugs she can purchase over the internet.
C
Pharmacies must dispense medications in a child resistant container unless: A. The patient requests otherwise B. The physician requests otherwise C. The pharmacist believes it would not be prudent D. Statements a & b are correct E. Statements a, b & c are correct
D
In a Class A pharmacy, a pharmacist should be able to locate the following records (SELECT ALL): A. Drug destruction reports B. Theft and loss reports C. All prescriptions D. Annual inventories E. Executed DEA 222 forms
ABCDE
Which of the following statements concerning the Poison Prevention Packaging Act is/are true? A. Most prescriptions are exempt from the requirements of the act. B. A pharmacist may dispense prescription drugs in a noncompliant container when the pharmacist feels it is in the best interest of the patient C. A patient may legally request a noncompliant container orally, but it is a good idea to get such a request only in writing. D. Only a physician can authorize a blanket request that all of a patient's prescriptions be dispensed in noncompliant
C
Which of the following is NOT an act of misbranding under the FDCA? A. Contains an unsafe color additive B. False or misleading labeling C. Does not bear the generic name of the active ingredient D. Packaging or labeling is in violation of Poison Prevention Packaging Act
A
Which of the following accurately describe(s) the 1938 FDCA? A. The catalyst for the law was the sulfanilamide elixir event B. The law required that new drugs must be proven safe and effective prior to marketing. C. The law grandfathered drugs marketed prior to 1938. D. Statements A & C are correct E. Statements A, B & C are correct
D
USP guidelines stipulate that a pharmacist should label the beyond-use date for multiple-unit containers as: A. The expiration date on the manufacturer's container B. One year from the date the drug was dispensed C. Either the expiration date on the manufacturer's container or one year from the date the drug was dispensed D. Either the expiration date on the manufacturer's container or one year from the date the drug was dispensed, whichever is earlier
D
A pharmacist received a prescription for Zostat with the direction to take tid for migrane headaches. Zostat is indicated for anxiety and labeled for once a day use. Which of the following would be the best answer? A. Under the FDCA the physician may legally prescribe and the pharmacist may legally dispense Zostat for this purpose and in this dose B. The pharmacist should confirm the accuracy of this prescription with the prescriber and if confirmed exercise professional judgment regarding the reasonableness of the risk in deciding whether to dispense the prescription or not. C. The pharmacist should confirm the accuracy of this prescription with the prescriber and if confirmed dispense the drug without further consideration D. Statements A and B together constitute the best answer E. Statements A and C together constitute the best answer
B
Drug classes requiring Medication Guides include A. Naprosyn B. Jantoven(Coumadin) C. Relafen D. MS Contin E. All of the above
E
The Kefauver-Harris Amendment of 1962 provided for all of the following EXCEPT: A. provided controls for clinical investigations B. established Good Manufacturing Practices C. provided controls over prescription drug advertising D. extended scope of FDCA to medical devices and cosmetics
C
Class A pharmacies may sell, purchase, trade, or possess prescription drug samples. A. True B. False
B
Recent regulations regarding the Package Insert require which of the following: A. That it be written in consumer friendly language B. That it contain a Highlights section at the beginning C. That it contain a Patient Counseling section for prescribers D. Statements B & C are correct E. Statements A, B & C are correct
D
Controlled substances mail be mailed under the following requirements (Select all). A. Prescription container must be labeled in compliance with prescription labeling rules B. Outer wrapper in which prescription is placed must be free of markings that would indicate nature of contents but the name of the pharmacy as part of return address is allowed C. No markings of any kind may be placed on package to indicate nature of contents
A, C
When a pharmacist fills a prescription without authorization from a physician it is misbranding. A. True B. False
A
A pharmacist can be a pharmacist-in-charge (PIC) for up to two Class A pharmacies open simultaneously as long a the PIC works at least 15 hours per week in each pharmacy. A. True B. False
B
In a Class A pharmacy, a pharmacy technician must complete a minimum of 30 hours of instruction and experience in sterile compounding. A. True B. False
B
Which of the following would be correct regarding drug recalls: A. Manufacturers are responsible for notifying pharmacies B. The FDA is responsible for notifying pharmacies C. Pharmacists are responsible for knowing a product has been recalled D. Statements A & C are correct E. Statements B & C are correct
D
The following drug(s) are in the REMs program (Select All). (think Accutane) A. Isotretinoin B. Clozaril C. Oxycontin D. Tikosyn E. All of the above
E
Under Texas Pharmacy law, a pharmacist may release a confidential record only to a: I. The patient or the patient's agent. II. A practitioner or another pharmacist. III. The state board of pharmacy A. I only B. I and II only C. II and III only D. All
D
A pharmacy is never allowed to sell, purchase, trade, or possess prescription drug samples. A. True B. False
B
Which of the following would be correct regarding patient package inserts: A. They are required for all prescription drugs B. They are also called medication guides C. They are required for hospital and community pharmacies D. Statements A & C are correct E. Statements A, B & C are correct
C
Pregnancy category in which studies in animals or reports in pregnant women indicate that the risk of damage caused by the drug clearly outweighs any possible benefit: A. Category A B. Category B C. Category C D. Category D E. Category X
E
Which of the following would be correct regarding the United States Pharmacopeia (USP)? A. The FDA publishes the USP B. A product cannot be considered a drug unless published in the USP C. It sets uniform standards for drugs D. Statements A & C are correct E. Statements A, B & C are correct
C
In a Class C pharmacy, the ratio of pharmacists to pharmacy technicians is ________. A. None B. 1:1 C. 1:2 D. 1:3
A
Patient package inserts are required for: i. Oral contraceptives ii. Intrauterine contraceptive devices iii. Antibiotics iv. Opioids A. I only B. II only C. I & II D. I, II, & III E. I, II, III, & IV
C
In a Class C pharmacy that is licensed for 100 beds or less, there may be one full-time, part-time, or consulting PIC for no more than ______ facilities or 150 beds. A. 1 B. 2 C. 3 D. 4
C
Bulk containers shipped to manufacturers, wholesalers, pharmacies (not intended for household use) are exempt from the child-resistant containers requirement. A. True B. False
A
Reusing a prescription vial when refilling a prescription is allowed. A. True B. False
B
Which of the following would be correct regarding the CGMP? A. It does not apply to dietary supplements B. It does not apply to generic drugs C. It is a set of regulations establishing requirements for manufacturing methods, facilities and controls. D. Statements A & C are correct E. Statements B & C are correct
C
A Class A pharmacy which also operates a Class B pharmacy is only required to secure a Class A license. A. True B. False
B
Which of the following act(s) by a manufacturer would generally violate the FDCA as misbranding: A. If the drug is Rx and pharmacoeconomic data of any type is supplied to practitioners. B. If the drug is an OTC drug and not manufactured in a tamper-resistant container. C. If the drug is Rx or OTC and labeled with the name of the wrong manufacturer. D. Statements A & C are correct E. Statements B & C are correct
E
An annual inventory of a Class A pharmacy: I. Must include all controlled substances, Nubain, and Soma II. Must be performed within 3 days of specified date III. Must be signed and dated by person taking and Pharmacist in Charge and signatures notarized within 2 working days A. I only B. III only C. I and II only D. II and III only E. I, II, and III
C
The Poison Prevention Packaging Act and its regulations specify that: A. only products labeled for children must have child-resistant containers (CRCs) B. all OTC products must have child-resistant containers (CRCs) C. only oral dosages forms of non-exempt prescription drugs must have child-resistant containers (CRCs) D. only the products listed by name in the Act must have child-resistant containers(CRCs)
C
Which of the following would be correct regarding the issue of whether there should be a third class of drug, also known as "behind the counter" drugs: A. Pharmacists have historically opposed the concept until recently B. The FDA has historically opposed the concept until recently C. States most likely have the authority to create this class of drugs D. Statements A & B are correct E. Statements B & C are correct
B
In a Class A pharmacy, the ratio of pharmacists to pharmacy technicians/pharmacy technician trainees is ______ provided at least one is a pharmacy technician and not a pharmacy technician trainee. A. 1:1 B. 1:2 C. 1:3 D. 1:4
D
In a Class A pharmacy that engages in sterile compounding, the ratio of pharmacists to pharmacy technicians is ______. A. 1:2 B. 1:3 C. 1:1 D. 1:4
D
The Durham-Humphrey Amendment of 1951 did which of the following: A. Specifically allowed prescriptions to be transmitted in writing, orally or electronically. B. Exempted prescription labels dispensed by pharmacies from many of the label requirements imposed by law on manufacturers. C. Categorized drugs as either prescription or over the counter D. Statements A & C are correct E. Statements B & C are correct
E
The temporary absence of a pharmacist in a Class A pharmacy should not exceed: A. 30 minutes in a 12 hour period B. 30 minutes in an 8 hour period C. 1 hour in a 12 hour period D. 2 consecutive hours in a 24 hour period
D
In a Class C pharmacy, a facility licensed for 101 beds or more must have the services of a part-time pharmacist. A. True B. False
B
Destruction of a stock bottle of diazepam 10mg tablets by a Class C pharmacy requires all EXCEPT: A. Copy of the inventory on DEA form 106 must be sent to DEA B. Can be performed anytime with prior DEA approval C. Destruction in front of one witness D. Copy of the inventory must be kept for 2 years in the pharmacy
A
Section 5
(29 cards)