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FL CDR SAMPLE QUESTIONS MODULE 9-
A quarantine area at Prescription drug wholesale distributor is used to store: A) Expired drugs B) Damaged drugs C) Misbranded drugs D) Adulterated drugs E) All of the above* Upon receipt of a prescription drug, prior to accepting the permittees inventory, a prescription drug wholesale distributor must perform which of the following tasks? A) Visually examine each outside shipping container for identity and to prevent accepting contaminated prescription drugs B) Authenticate each and every transaction of the incoming pedigree C) Create the corresponding outgoing pedigree noting the lot # of the incoming drugs D) All of the above E) Only A&B above* A vehicle used to deliver medical oxygen must meet which of the following requirements? A) The vehicle must be locked inside a fenced compound or alarmed if medical oxygen is stored in the vehicle and not being used immediately for deliveries* B) If a vehicle used to stored medical oxygen is parked overnight at the residence of the driver, it must have an audible alarm C) If medical oxygen is stored at a residence prior to delivery, the residence must be secured by an audible alarm D) Medical oxygen storage does not require being secured by alarms Which of the following statement reflect correct mandatory temperature and/or humidity requirements for prescription drug storage? A) Compressed medical oxygen, unless otherwise stated, may be stored to protect from freezing, excessive heat or flame B) Prescription drugs, unless otherwise stated, must be stored according to manufacturer labeling or as noted in the U.S.P. C) In the absence of electronic monitoring, two thermometers must be mounted within 6 feet of the drugs in the warmest and coolest area of the drug storage room D) All of the above are correct requirements*
Prescription Medical Oxygen may be stored outside in an area surrounded by a fenced enclosure with a lock? True* False If the power is lost due to a Natural Disaster at a Prescription Drug Wholesaler, the owner is allowed to take the refrigerated products to his home refrigerator (if it is dedicated to medications) if the owner provides an inventory and keeps temperature logs? True False* Any establishment that is permitted as a prescription drug wholesaler or repackager must notify the department in writing within _______ working days of discovery of a significant loss or theft of prescription drugs. A) 1 B) 2 C) 3* D) 7 E) 10 In which of the following ways can complimentary or sample prescription drugs be disposed of? A) Returned to the manufacturer from where they came. B) Sending to a non FL licensed destruction company acting on behalf of the manufacturer C) Incineration D) All of the Above* E) Only A above is correct. An entity who maintains a permit as a Prescription Drug Manufacturer with the State of Florida MUST also obtain which of the following permits if they want to distributor samples of prescription drugs? A) Complimentary Drug Distributor permit* B) No additional permit is required in this scenario C) A Prescription Drug wholesale distributor permit or a Non-resident prescription drug wholesaler permit. D) Any of the above permits noted in A or C would allow distribution of sample Rx drugs. Ephedrine is best described as _______________ under Florida law?
A) A licensed physician B) A licensed Health Care Clinic Establishment C) A licensed dispensing physician D) None of the above* E) All of the above Which of the following distribution scenarios are FALSE wtih regards to Complimentary Human prescription drug distribution? A) Complimentary drugs may be distributed, upon their request, via US Mail to practitioners licensed to prescribe. B) Complimentary drugs may be distributed by a common carrier, at the request of the licensed practitioner, to a pharmacy or hospital. C) Complimentary drug distribution may be conducted in response to an oral or written request by a licensed practitioner.* D) Each entity that distributes complimentary drugs must maintain, for a period of six years, the records that include the request forms records of the complimentary drug transactions. Which of the following are requirements for the storage of complimentary drugs? A) Sample drugs do not have specific storage requirements since they are not full sized products available for commercial sale. B) Drug manufacturers are required to conduct a biennial complete and accurate inventory of all drug samples in the possession of their representatives. C) Drug manufacturers must maintain a list of the names and addresses or each of its representatives who distribute sample drugs and the sites where drugs are stored* D) All of the above are correct statements E) None of the above are correct statements Which of the following scenarios is the best representation of procedures required for destruction of prescription drugs? A) An inventory of the products to be destroyed must at a minimum contain: the name of the product, whether it is a drug or sample, the manufacturer, the quantity and the NDC.* B) No security or temperature controls are required at destruction companies since the products are adulterated and being sent for destruction. C) Sample drugs can be destroyed by any licensed destruction company at the request of any properly licensed distributor if all the documentation is provided. D) A certificate of destruction is only required when the products to be destroyed are controlled substances. Compressed Medical Oxygen is classified as which type of product?
A) A Prescription Drug* B) An Over the Counter Drug C) A Medical Device D) A Cosmetic E) None of the above A Compressed Medical Oxygen Manufacturer must follow which of the following laws and rules regulating Medical Oxygen? A) FDA Good Manufacturing Practices B) Detailed Written Policies and Procedures C) Labeling that includes manufacturer, gas name, volume, lot#, usage directions, warning and a prescription statement. D) Security E) All of the above* Which of the following requirement must both a prescription drug manufacturer and a compressed medical gases manufacturer follow? A) Both must obtain and maintain a permit from the Deparment to manufacture their drugs B) Both must draft and follow written policies and procedures compliant with Chapter 499, Fla. Stat. C) Both must comply with State and Federal current good manufacturing practice regulations for prescription drug products D) Both must label their products with an accepted derivation of "Rx only" E) All of the above are required* A Medical Oxygen Retailer permit are not required to designate hours of operation on their permit if they are available by phone from 8:00 am to 5:00 pm Monday through Friday to set up an appointment the next business day. True False* A prescription drug wholesale distributor who is seeking to distribute medical oxygen must comply with which of the following requirements? A) Apply to the State for a Medical Oxygen wholesale distributor permit. B) Undergo an additional onsite inspection for a Medical oxygen permit. C) Obtain an additional Designated Representative. D) None of the above are required for this scenario.*
above and the agent is not required to announce the inspection. D) An Agent must be issued a search warrant by a Court of proper jurisdiction to allow the Agent to enter, inspect and investigate. E) A, B & C could be correct* Which of the following observations and activities may NOT be conducted by a State Agent during an inspection of a facility that manufactures, wholesales, re-packs or distributes drugs, devices or cosmetics? A) Questioning of persons who may have information relating to the ongoing inspection or investigation. B) Detaining an employee* C) Copying of any and all records whatsoever related to drugs D) Securing or removing of drugs that are potentially misbranded or adulterated from commerce or public access from the facility that is under inspection or investigation. E) B & C are generally not allowed The Department is granted the authority to adopt rules to enforce Chapter 499, F.S.. Rules that relate to Chapter 499 include, Florida Administrative Code Chapter 61N-1. True* False The Department publishes to the public on at least a monthly basis a list of all wholesalers and other permittees upon which the Department has started enforcement actions. True* False When a duly authorized agent of the department finds or has probable cause to beleive that a drug is in violation of F.S. Chapter 499, he or she may issue what kind of notice to the owner or the person in possession of the drug. A) Stop-sale B) Stop-use C) Hold Order D) Any of the above.* When a drug is embargoed via issuance of a notice by a State Agent, the State must within _____ days after the issuance of such notice, petition the circuit court for an order of condemnation or the Agent must recind the embargo.
A) 10
B) 30
C) 60
D) 90*
E) 120
Violation of a stop-sale order issued by a State Agent by removing or disposing of an article that was detained could be considered as high as a ______________? A) 2nd degree felony* B) 3rd degree felony C) 3rd degree misdemeanor D) 2nd degree misdemeanor E) Regulatory violation To protect the public from adulterated prescription drugs the department may seize and remove any prescription drug that poses a threat. The owner of any property seized must apply to the appropriate court within _____ days or the department may destroy the contraband. A) 10* B) 15 C) 20 D) 25 E) 30 If the State, after an embargo, obtains a Court Order to destroy the drugs they took from your facility, the cost of the court fees, storage fees and destruction fees must be paid for by the State of Florida. True False* Which of the following best describes the relationship where one business entity controls or have the power to control the other business entity or a third party controls or have the power to control both business entities? A) Trading Partners B) Affilate* C) Authorized Entity D) Affiliated Parties The Definition of "Product" includes which of the following?
If a State or Federal Agency requests information in the event of a recall or suspect product, the wholesale distributor has how much time, after receiving the request, to provide the Agency with the transaction data? A) A total of 48 hours* B) Three business days C) It depends on the scope of the request and time allowed can be up to 7 business days D) If your company uses a third party logistics company, the Agency will allow three business days. A prescription drug wholesale distributor that maintains a physical location that stores prescription drugs, BUT that location functions solely to perform intracompany transfers to members of its affiliated group could also be known as a: A) Chain pharmacy warehouse* B) Closed system pharmacy C) Retail pharmacy wholesaler D) Both A & B are correct E) None of the above are correct. A prescription drug could be considered ___________ if it has ANY of the following characteristics: Adulterated, counterfeit, Transaction information, history or statement (T3) does not exist or T3 is false. A) Contaminated B) Contraband C) Subject to seizure D) Subject to stop sale E) All of the above An Active Pharmaceutical Ingredient (API) can be classified as: A) A prescription drug* B) A device C) An excipient D) A finished good A Licensed Prescription Drug Manufacturer can wholesale distribute the following products? A) Any prescription drug if they pass Transaction History, Information and Statement (T3). B) Only prescription drugs they qualify as the manufacturer for, if they pass the proper T3.* C) Only prescription drugs they manufacture but no T3 is required by a manufacturer. D) A Manufacturer is not permitted to wholesale distribute any drugs.
A Non-resident prescription drug manufacturer permit is NOT required for the manufacturer to ship/sell Active Pharmaceutical Ingredients (API) into the State of FL under the following circumstances: A) If the non-resident manufacturer ships into FL what it manufactured to a permitted manufacturer in this State. B) If the API quantities are "limited." C) If the API is only being used for research and development. D) If all record keeping requirements, required under Chapter 499 are met. E) All of the above* A Prescription drug wholesale distributor must obtain which of the following documentation as part of the "audit trail" when exporting a prescription drug? A) A copy of the airway bill or bill of lading as proof that the drug was exported.* B) A copy of the permit of the foreign entity that allows the entity to buy prescription drugs. C) Proof that the foreign entity received their Transaction History, Information and Statement documentation. D) A copy of the foreign companies most recent inspection by their inspection authority. E) B & C above are correct. Which of the following are true for an Prescription Drug wholesale distributor? A) The permit issued by the Department must be displayed in a conspicous place. B) A copy of Fla. Stat. Chapter 499 and FAC 61N-1 must be onsite at the permitted establishment. C) A copy if the deed or lease must be provided to the Department. D) Whenever a vendor changes, the wholesale distributor must notify the Department within 10 business days. E) All of the above* Which of the following methods can be used as part of due diligence review of your prescription drug vendors: A) A telephone call placed to the vendor to verify their current address and permit #. B) An onsite inspection of the vendors business at least every 2 years. C) Obtain a copy yearly of their most recent inspection report on their wholesale establishment.* D) Enter into a contract with the vendor that allows them to sell to you. E) All of the above
If prescription drug wholesale distributor "X" sold a Product to prescription drug wholesale distributor "Y" then "Y" attempted to verify the Transaction data (T3) from "X" finding during verification a step in the Transaction history may be false or incomplete. The Product that is part of this transaction could be considered which of the following? A) Contraband B) Adulterated C) Suspect D) Any or all of the above could be correct* A Florida licensed prescription drug wholesale distributor who is seeking to distribute medical oxygen must comply with which of the following? A) Apply with the Department (FL) for a medical oxygen wholesale distributor permit B) Undergo an additional onsite inspection for medical oxygen prior to obtaining their new permit C) Full Transactional data (T3) requirements for all prescription drugs including medical oxygen D) None of the above would be required* Which of the following means of transportation may a wholesaler use to distribute prescription drugs? A) Common carrier B) Freight Forwarder C) Independent Contractor who is an agent of the buyer or seller under a written contract. D) Their Companies own vehicle E) All of the above may be permitted* Two temperature records must be taken at least _____ times a week and ______ times a day for all facilities that store prescription drugs? A) 7 & 1 B) 5 & 2* C) 3 & 2 D) 4 & 1 E) None of the above are correct Which of the following terms are used in Chapter 499, Fla. Stat., to indicate that a prescription drug is a "drug sample" and not to be sold or purchased? A) Starter pack B) Complimentary drug C) Trade package
D) Initial dose pack E) All of the above are recognized terms* As a part of the initial application process, which of the following items must be produced by an applicant for a prescription drug wholesaler permit? A) A copy of the deed or lease on the property B) A list of all the permits issued to the applicant by any other State C) The sources of all the funds use to purchase prescription drugs and finance the property D) A list of all the financial institutions in which the applicant has an account and used to finance the operation E) All of the above must be provided* Which of the following statements are correct? A) Prescription drugs must be examined every 12 months and expired drugs must be removed B) Record keeping requirements for a prescription drug as defined by FAC 61N-1, must also be followed for outdated/quarantined drugs, with minor exceptions C) Inventories of prescription drugs must be maintained for inspection for a period of 6 years following the disposition. D) When Transaction History, information and Statements (T3) are required, a wholesale distributor must maintain the T3 in a way that is can be produced for inspection if requested. E) All the above are correct.* If records of drugs, devices and cosmetics, are manitained by electronic methods, such as computers or imaging devices, which of the following apply? A) Original or true copies of the required audit trail documents must be maintained or computer security is required to protect against tampering with the electronic records. B) If records are requested by the Florida Department of Law Enforcement (FDLE), FDLE must be able to review all automated records without requesting specifics. C) All records produced must contain all required information and cannot be defaced or altered in any way to conceal information. D) All of the above are true* Which of the following business hour requirement(s) is/are correct as noted in FAC 61N-1, et.al? A) A prescription drug wholesale distributor establishment must designate a minimum of 40 hours weekly between the hours of 8am - 5pm Monday through Friday. B) A medical oxygen retailer establishment that does NOT transfill medical oxygen must be open a minimum of 4 hours weekly between 9am - 5pm Monday through Friday* C) A prescription drug manufacturer permit must operate a minimum of 20 hours a week
A prescription drug wholesale distributor must notify the Department within ______ days after the last day of the CDR's employment with the wholesale permittee? A) 5 B) 10* C) 15 D) 20 E) 25 A prescription drug wholesale distributor permitee must cease operations when their CDR resigns unless a new CDR is hired and the Department notified within _______ days after the last day of the CDR's employment. A) 5 B) 10* C) 15 D) 20 Which of the following statement(s) BEST represents the provision of "imminent danger" as described in Chapter 499, Fla.Stat.? A) To protect the public health, a State Agent may seize and destroy drugs, devices or cosmetics that the Agent has probable cause to believe are contaminated. B) A State Agent may obtain permission from the State Surgeon General to seize a drug, device or cosmetic determined to be a threat to the public health. C) The Department may determine that an establishment that manufactures or possesses drugs, devices or cosmetics, required to be permitted under Chapter 499, Fla. Stat., is a threat to the public health. D) A refusal to allow entry, during reasonable hours, or the refusal to provide the Department with the documents required for inspection constitutes an imminent danger to the public health.* Which are the following is FALSE with regards to the requirements for the proper destruction of a prescription drug? A) A Certificate of Destruction must be received from the facility responsible for the ultimate destruction or incineration of the prescription drugs. B) This certificate shall provide the weight of the prescription drugs destroyed, the manner of destruction, and the time, date and location of the destruction. C) The inventory must identify the name of the product to be destroyed and whether it is a prescription drug sample, the manufacturer, and the quantity for each prescription drug to be destroyed. For partially filled containers, the quantity, at a minimum, must be estimated.
Records are required for each transfer of prescription drugs until the drugs have been destroyed. D) For the inventory, the NDC code may be used to identify the manufacturer. E) All of the above are TRUE.* Violation of the US Code 331, for example, misbranding of any drug, can carry a penalty of Imprisonment up to 1 year, up to $1k fine, or both; imprisonment up to 3 years, up to $10k fine, or both for a second violation
