FLORIDA CDR Test Questions and Complete Solutions Graded A+.

FLORIDA CDR Test Questions and Complete Solutions Graded A+ The department can, on the power of its own initiative, administer oaths, take depositions, issue and serve Subpoenas, and compel the attendance of a witness and the production of books, paper, documents, or other evidence. - Answer: True In order to transport prescription drugs, which of the following entities must obtain a permit from the department of business and professional regulation's (DBPR)? - Answer: Freight forwarders A Director, officer, trustee, partner or committee member of an applicant or at subsidiary is known as? - Answer: And affiliated party and someone requires to file a personal information statement The five largest natural shareholders must own at least ___________% of the applicants to meet the definition of an "affiliated party" - Answer: 5% If a drug has a label, identifying mark or imprint that was not authorized by the manufacturer, the drug would be considered: - Answer: Contraband and counterfeit If one license wholesaler A, transfer a prescription drug to another wholesaler B, at no charge, this transaction would be best known as? - Answer: A wholesale distribution Which of the following entities could be considered a Manufacturer as defined by Chapter 499? - Answer: A person who owns the ANDA or NDA, And an affiliate of the person who owns the ANDA or NDA and An entity that manufactures the product If a certified designated representative is to have an " authorized absence ", he/she must meet the following requirements: - Answer: Who would be considered an " authorized recipient of prescription drugs on an ocean going vessel"? - Answer: A license ship captain and first officer of the ship A broker only prescription drug wholesale distributor can only possess the following prescription drugs: - Answer: They can never possess prescription drugs If a wholesale distributor sells a portion of his business to a new partner, the new partner would have to purchase more than ______% Of the controlled interest to be considered a charge of ownership by the department? - Answer: 50% Readily retrievable, as it relates to audit trail records of prescription drug transactions for in-state Florida permits, has been defined by the Florida rules as which of the following? - Answer: Retrievable in minutes The following alterations to a container would be repackaging under Florida laws and rules: - Answer: Changing the label on the bottle, changing the labeling insert contained in the packaging, breaking a multi unit pack and selling an individual fully labeled unit. It is unlawful to perform which of the following acts in Florida? - Answer: Adulterating or this branding a drug, device or cosmetic. Constructive refusal to allow the department to inspect your car if it is transports drugs or devices or cosmetics. Not allow a department agent to take samples of drugs devices or cosmetics Who must allow inspection of any record of the establishment and allow a department inspector to enter and inspect during operating hours even in the absence of the owner and/or the CDR. - Answer: The Establishment that manufactures, processes, packages, repackages, sells, brokers drugs devices or cosmetics. Prescription drugs can be purchased properly by a licensed entity using which of the following methods? - Answer: Credit card and check What does authorized trading partner mean? - Answer: The entity is properly permitted or licensed. When must a T3 be received? - Answer: T3 must be received and transmitted at the time of the transaction What does F. S. = - Answer: Florida statutes or Florida state The department and it's own initiative without judicial or police action can: - Answer: Inspect, take statement, and conduct inspections What is the purpose of the Florida drug and cosmetic act 499? - Answer: To safeguard the public health and promote public welfare by protecting the public from injury by product used in merchandising deceit involving drugs, devices and cosmetics What is ARI also known as? - Answer: Active Pharmaceutical ingredients What is an active pharmaceutical ingredient? - Answer: Any substance or mixture of, intended, represented or labeled Adulterated, counterfeit - Transaction history, info & statement do not exist or has been forged, counterfeited, falsely created or contains altered or falsely misrepresented matter - Answer: Contraband Contains seal/labeling of which without authorization bears the trademark, tradename or other identifying marks, imprint or any likeness therefore falsely represents to be the product - Answer: Counterfeit Who can never take physical possession of prescription drugs? They can only buy, purchase and participates in a wholesale distribution: - Answer: Broker Excluding soap, anything intended to beautify, cleansing, promoting attractiveness or altering appearance is known as? - Answer: A cosmetic Means to sell purchase, trade, deliver, handle store or receive. Does not mean to administer or dispense - Answer: Distribute or distribution Intended to diagnose, cure, mitigation, treatment, therapy and prevention of disease - Answer: Drug A person who receives prescription drugs which are owned by another person and designated by that person for export & Is not a third-party logistics or common carrier - Answer: Freight forwarder A freight forwarder is a third-party logistics and common carrier True or False - Answer: False What does DBPR Stand for? - Answer: Department of business and professional regulation also called the department What does DOH stand for? - Answer: Department of health What does CDR stand for? - Answer: Certified designated representative Is a CDR an affiliated party? - Answer: Yes, A CDR is an affiliated party What is the Abbreviation for the new drug application? - Answer: ANDA The new drug application is also known as? - Answer: NDA A wholesaler cannot repackage in anyway. True or false - Answer: True Display written, printed or graphic matter upon the immediate container of any drug is known as? - Answer: Label or labeling A T3 is also known as: - Answer: Transaction history/ TH, transaction information/TI or transaction statement /TS The department may revoke or suspend a permit if the permit was obtained by misrepresentation or fraud. True or false - Answer: True No permittee can possess a sample unless they have a permit not even the manufacturer. Must have a stand alone complementary drug permit. This is to distribute what? - Answer: Complementary samples Embargo is better known as: - Answer: Stop Sale Does a T3 apply to a medical convenience kit? - Answer: No, it is exempt A medical Convenience kit - Answer: Means packages or units that contain combination products A medical convenience kit contains controlled substances. True or false - Answer: False It is a violation of the Florida law if a transaction history, information in statement (T3)for a prescription drug is not received under the following conditions? - Answer: With or Prior to the shipment of prescription drug products and from all prescription drug product manufacturers in wholesalers. It is prohibited act for permitted establishment to do which of the following - Answer: Constructively Refusing the department to enter or inspect and establishment where drugs or hell, refusal to allow the department to take samples of a drug, refusal to allow the department to inspect any vehicle used to transport drugs and purchasing or selling prescription drugs in exchange for currency. A Florida license prescription drug wholesale distributor commits a _________ if they know any traffic in over $25,000 in contraband - Answer: A first-degree felony Refusal or constructive refusal to allow inspection of a facility that is suspected to hold drugs, devices or cosmetics can be classified as what type of violation? - Answer: Trafficking in contraband prescription drugs is defined as a person who knowingly sells, purchases, manufacturers, delivers, or brings into the state any amount of contraband worth in excess of $_____________ - Answer: $25,000 Trafficking in contraband prescription drugs in the state of Florida is a_________? - Answer: First-degree felony What does FDA stand for? - Answer: United States food and drug administration In determining if a drug registration application is complete the department can review the following : - Answer: The federal, food drug and cosmetic act to assure the product also Complies with the act, catalogs and labeling of the product, DESI listing and other literature as needed What are the labeling requirements for prescription drugs? - Answer: Drug name, strength, dosage, manufactures name, lot number, expiration date, must be on the label. NDC is not required Any person who manufactures, packages, three packages, labels or relabels a drug in the state must register such drug annually with the department. True or false - Answer: False A repackage prescription drug must follow the rules of the federal act and must include all of the following on the label : - Answer: Manufactures name and lot number, name of drug, dosage form, strength and expiration of the drug A Florida product record registration for prescription drugs must be renewed how often? - Answer: Biennially, every two years A prescription drug for which they require transaction history, information or statement is missing or incomplete is considered : - Answer: Adulterated and contraband If a prescription drug is expired it is considered to be : - Answer: Adulterated A drug is considered adulterated if the strength, quantity and or purity falls below that of which is in the official compendium (USP). True or false - Answer: True A drug is considered misbranded if it has which of the following characteristics? - Answer: The label of the product is in anyway false or misleading Which of the following are characteristics of misbranded product? - Answer: Prescription label does not bear the statement "RX Only" or similar notation, contents in terms of weight or numerical count is inaccurate, if it is color additive is not in conformity with the packaging . A prescription drug manufacturer must follow all the laws and rules of chapter 499 FS and FAC 61N-1 : - Answer: A manufacturer should have all of the below, recordkeeping, storage, transaction history, information and statement and security. A prescription drug repacker permit may engage in the wholesale distribution of prescription drugs they repack. true or false - Answer: True A non-resident prescription drug repacker will follow all the laws and rules of chapter 499 but does not have to do the following: - Answer: Obtain a nonresident prescription drug wholesaler permit in the state of Florida An out-of-state RX drug wholesaler must meet the same requirements as a Florida Rx wholesaler with the following exceptions: - Answer: No Florida permit is required by the out-of-state facility if they are transferring to a facility in the state of Florida doing business in the same business name. A retail pharmacy wholesaler permitee can wholesale distribute which of the following products to which entities? - Answer: Prescription drugs to a licensed retail pharmacy in the state, prescription drugs to a modified class to instructional pharmacy in the state and prescription drugs to a licensed healthcare practitioner in the state. A license prescription drug wholesaler distributor can buy prescription drugs from which of the following entities? - Answer: A prescription drug repackaged permit. The following applies to a third-party logistics provider 3PL permit : - Answer: A three PL never takes ownership of the drugs A prescription drug wholesale distributor/broker only is allowed to possess which drugs? - Answer: Brokers are not allowed to possess any drugs What permit would be appropriate for a Veterinarian establishment to apply for if they wanted to buy some human drugs to sell to veterinarians? - Answer: Limited Veterinarian wholesaler When is a wholesaler repacker or permit needed? - Answer: A wholesaler cannot repack anything unless they have a repacker permit which is required if there's any repacking, labeling or relabeling. Florida does not permit wholesalers from out of the US. True or false - Answer: True It is illegal to purchase in Florida from a non-US wholesaler. true or false - Answer: True Wholesalers need a permit granted from the state and are also required to register with the FDA. True or false - Answer: True A 3PL does not take ownership. It just holds and moves products at your direction. A 3PL can work for a wholesaler or a manufacture. A 3PL Is required to be registered with the FDA. True or false - Answer: True A prescription drug manufacture must comply with all appropriate state and federal good manufacturing practices - Answer: Know this definition A licensed drug manufacturer can only ___________those drugs that it qualifies as the manufacture of - Answer: Distribute A non-resident prescription drug manufacturer is just like a resident permittee, but they must be ____________ first in the state of the results - Answer: Permitted They manufacture outside the US can apply for a __________ manufacturer permit. - Answer: Non resident A _____________ drug distributor permit is required for any person that engages in the distribution of complementary drugs, subject to the requirements of 499.028. - Answer: Complementary Any permit he that handles samples must have a ______________permit. - Answer: Complementary drug distributor permit A manufacturer would have to have a _______________permit even if they are the manufacturer of the samples. - Answer: Complementary drug distributor permit Would a manufacturer have to have a dual permit to hand out complementary samples in the State of Florida? - Answer: Yes A ____________.________________must provide a source of prescription drugs with a validated airway bill, bill of lading or other appropriate documentation to evidence the exportation of the product. - Answer: Freight forwarder A common carrier such as UPS and FedEx do not need a freight forwarder permit . True or false - Answer: True Biannual means - Answer: Twice a year Biennial means - Answer: Every 2 years If a certified designated representative is to have an authorized absence he/she must meet the following requirements : - Answer: A inform their employer they will not be at work that day and when they will return. If they are the owner then inform the manager that they will not be at work that day and when they will return. We cannot exceed 90 calendar days in a 365 day period for specifically defined family issues. See all extended absences are permitted as long as they are in writing and authorized by the owner A inform their employer they will not be at work that day and when they will return. If they are the owner then inform the manager that they will not be at work that day and when they will return. We cannot exceed 90 calendar days in a 365 day period for specifically defined family issues. See all extended absences are permitted as long as they are in writing and authorized by the owner - Answer: It is a violation of the Florida law is a transaction history, information and statements T3 for a prescription drug is not received under the following conditions? - Answer: With or prior to the shipment of prescription drugs and products And from all prescription drug product manufacturers and wholesalers. Refusal or constructive futile to allow inspect of a facility that is suspected to hold drugs, devices or cosmetics would classify as what type of violation? - Answer: Refusal or constructive futile to allow inspect of a facility that is suspected to hold drugs, devices or cosmetics would classify as what type of violation?This would be a criminal felony and regulatory compliance violation. Trafficking in contraband prescription drugs is defined as a person who knowingly cells, purchases, manufacturers, delivers, or brings into the state any amount of contraband drugs worth an excess of? - Answer: Trafficking in country brand prescription drugs is defined as a person who knowingly cells, purchases, manufacturers, delivers, or brings into the state any amount of contraband drugs worth in excess of? $25,000. In determining if a drug registration application is complete the department can review the following - Answer: The federal food drug and cosmetic act to assure the product also complies with this act. Catalogs in labeling for the product. DESI listing and other literature as needed. Any person who manufactures, packages, repackages, labels or relabels a drug in the state must register such drug annually with the department - Answer: Any person who manufactures, packages, repackages, labels or relabels a drug in the state must register such drug annually with the department: False True or false; a drug is considered adulterer if the strength, quality and/or purity falls below that of which is in the official compendium (USP) - Answer: True A drug is considered misbranded if it has which of the following characteristics? - Answer: A drug is considered misbranded if it has which of the following characteristics?The label of the product is in anyway false or misleading. Which of the following is true regarding a prescription drug repack her permit - Answer: The permit he may engage in the wholesale distribution of prescription drugs they repack. A retail pharmacy wholesaler permittee Can wholesale distribute which of the following products to which entities? - Answer: Prescription drugs to a licensed retail pharmacy in this state. Prescription drugs to a modified class to institutional pharmacy in the state. Prescription drugs to a licensed healthcare practitioner in this state. And licensed prescription drug wholesale distributor can buy prescription drugs from which of the following entities? - Answer: A prescription drug repackage your permit The bond required to apply for prescription drug wholesaler permit can be in the form of? - Answer: A cash deposit in a trust account payable to the Florida professional regulatory trust fund. A prescription drug wholesaler distributor cannot be issued to the same address as a : - Answer: Healthcare entity, a pharmacy licensed under chapter 465FS with the exception of a nuclear pharmacy and a personal residence. The following conditions require pre-notification to the department? - Answer: Change of address When a permitteeCloses, the following process must be observed - Answer: A) The permit he must notify the department in writing prior to closure. B) The permit must be returned to the department. C) If RX drugs are present, the permittee must notify the department of the disposition of the drugs. D) The permittee must provide the name and address of the person to contact for records. All of the above are correct. During the prescription drug wholesaler application process, which of the following persons must be identified on the application? - Answer: An owner, a corporate officer, a shareholder who owns 5% or more of the outstanding stock. All of the above A timely renewal that does not require additional monies or a late fee occurs - Answer: At least 45 days prior to the permit expiration. To qualify to be a CDR one must accomplish the following - Answer: Be at least 18 years of age A CDR must be present at the RX drug wholesale establishment except for in the following situations - Answer: Outside normal business hours The following are required security for him prescription drug wholesale distributor - Answer: And after hours alarm system, a building perimeter that is well light, Hey security system for the computer if appropriate to protect records Controlled room temperature storage for prescription drugs is defined by - Answer: The United States Pharacopoeia (USP). The national formulary (NF) The following information is required to be placed on business record for all prescription drugs including active pharmaceutical ingredients (API) - Answer: Name and address of the seller and the recipient the name, dosage form, strength and quantity of the drugS; The transaction dates, financial information and permit numbers of the seller and recipient. Inventories of all our extra rugs present at a wholesale facility must be inventoried and kept on file for inspection and which of the following schedules? - Answer: Annually All records regarding prescription drugs, API, OTC drugs, medical devices and cosmetics must be available for inspection and photocopying for a period of _________years from the date of disposition - Answer: If records regarding the transaction Of prescription drugs are requested from a Florida permitted the facility who is offices are all located in the state of Florida, the permittee has how long to produce the records to the inspector? - Answer: They must be readily available and they must be produced within minutes They must be readily available and they must be produced within minutes - Answer: Which of the following are requirements that a prescription drug wholesaler must meet if they sell control substances, scheduled II and/or III to physicians? - Answer: Reports of controlled substances must be reported by the 20th of the next month. A quarantine area at prescription drug wholesale distributor Is used to store - Answer: Is used to store expired drugs, damage drugs, this branded drugs and adult