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FL CDR Sample questions module 1-8 Which of the following entities could be considered a Manufacturer as defined by Chapter 499? a. a person who owns the ANDA or NDA b. an affiliate of a person who owns the ANDA or NDA c. an entity that manufactures the product d. all of the above* e, answers A and C are correct Which of the following items are generally acecptable to be purchased, stored, sold or brokered in or into the State of Florida by a properly licensed Prescription Drug Wholesale Distributor? A) Veterinary Prescription Drug B) Complimentary Prescription Drug C) Active Pharmaceutical Ingredients (API) D) Medical Gases E) All of the above are correct EXCEPT B.* Which of the following statements/definitions are correctly stated? A) An Intracompany transfer is the sale of a prescription drug between two companies owned by the same company. B) The definition of a "sale" includes a gift if ownership transfers. C) An authorized recipient includes any entity that is properly permitted to purchase, recieve, distribute, etc. prescription drugs. D) All of the above are correct* E) None of the above are correct. The following altcrations to a container would be "repackaging" under Florida laws and tules: A) Changing the label in the bottle B) Changing the labeling insert contained in the packaging C) Breaking a multi-unit pack and selling an individual fully labeled unit D) Only A & B E) All of the above* Ifa Certified Designated Representative is to have an "authorized absence", he/she must moect the following requirements: 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 they will not be at work that day and when they will return. B) Cannot exceed 90 calendar days in a 365 day period for specifically defined family issues. C) All extended absences are permitted as long as they are in writing and authorized by the owner and/or manager of the permittee. D) Cannot exceed 60 calendar days in a 365 day period for specifically defined family issues.* E) Answers A & C are correct. Who would be considered an "authorized recipient" of prescription drugs on a ocean going vessel A) A licensed Ship Captain B) The First Officer of the ship C) An Agent of the ship D) Any marine broker E) Both A & B above are correct* A broker only prescription drug wholesale distributor can only possess the following prescription drugs: A) Sample packages B) Returns for destruction C) No prescription drugs at all* D) Starter packs and sample packages only 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 change of ownership by the Department. A) 50%* B) 30% C) 40% D) 60% "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? A) Retrievable within minutes.* B) Retricvable within a reasonable amount of time. C) Retrievable within the same day. D) Retrievable within 24 hours. It is unlawful to perform which of the following acts in Florida? A) Adulterating or misbranding a drug, device or cosmetic. B) Constructive refusal to allow the department to inspect your car if it transports drugs, devices or cosmetics. C) Not allow a Department Agent to take samples of drugs, devices or cosmetics. D) Only A E) All of the above* The establishment that manufacturers, processes, packages, repackages, sells, brokers, drugs devices or cosmetics must: C) Neither A or B D) Both A and B* Trafficking in contraband prescription drugs is defined as a person who knowingly sells, purchases, manufactures, delivers, or brings into this Stale any amount of contraband drug worth in excess of $ A) $5,000.00 B) $10,000.00 C) $15,000.00 D) $20,000.00 E) $25,000.00* In determining if a drug registration application is complete the Department can review the following: A) The Federal, Food, Drug and Cosmetic Act to assure the product also complics with this Act. B) Catalogs and labeling for the Product C) Nothing is required other than the application if the products are already registered with the FDA. D) DESI listing and other literature as needed. E) A, B and D all include required review items* A repackaged prescription drug must follow the rules of the Federal Act and must include all of the following on the label. A) Name of drug, strength, dosage form and cxpiration of the drug. B) Name of drug, strength and expiration date of drug. C) Manufacturer's name and lot #, name of drug, dosage form, strength and expiration of the drug.* D) Maufacturer's name and lot #, name of drug, strength and dosage form of the drug. Any person who manufactures, packages, repackages, labels or relabels a drug in this State must register such drug annually with the department. True False* A Florida product registration for prescription drugs must be renewed how often? A) Biennially B) Every 2 years C) Annually D) Biannually E) A & Bare correct* A prescription drug for which the required Transaction history, information or statement is missing or incomplete is considered: A) Adulterated B) Misbranded C) Contraband D) Only A & C* E) All of the above Ifa prescription drug is expired it is considered to be A) Adulterated* B) Misbranded C) Counterfeit D) Proprietary True of False: A drug is considered adulterated if the strength, quantity and/or purity falls below that of which is in the official compendium (USP). A) True* B) False A drug is considered "misbrandcd" if it has which of the following characteristics? A) The label of the product has not been reviewed by the State. B) The product is expired. C) The label of the product is in anyway false or mislcading.* D) The product is contaminated. Which of the following are characteristics of a misbranded product? A) Prescription label does not bear the statement "Rx only" or similar notation. B) Contents in terms of weight or numerical count is inaccurate. C) If its color additive is not in conformity with the packaging. D) A & B only ercate a misbranded drug FE) All of the above are correct.* Contraband includes in its definition adulterated, counterfeit and also means a prescription drug for which the Transaction History, Information and/or Statement docs not exist. True* False *Which of the following is true regarding a prescription drug repacker permit: A) A repacker can apply for a repacker permit both in FL and if they are outside of FL and plan to ship into FL. B) A certified designated representative must be onsite during normal business hours. C) This permittee may engage in the wholesale distribution of prescription drugs they repack* D) No pedigree is required to be passed by a repacker permit. A prescription drug manufacturer must follow all the laws and rules of Chapter 499, F.S. and F.A.C. 61N-1 with the exception of: A) Record keeping B) Storage C) Transactional history, information and statement D) Security E) A manufacturer must follow all of the above* A Non-resident prescription drug repacker must follow all the laws and rules of Chapter 499, F.S. and F.A.C. 61N-1 but does not have to do the following: A) Apply for a permit in Florida in order to do business with Florida B) Since they are out of the State they are not required to make their records available to D) All of the above E) None of the above* *The bond required to apply for a prescription drug wholesaler permit can be in the form of: A) A bond for $75,000. B) A revocable letter of credit. C) A cash deposit in a trust account payable to the Florida Professional Regulation Trust Fund.* D) All of the above E) Nonc of the above A prescription drug wholesaler distributor cannot be issued to the same address as a: A) Health care entity B) A pharmacy licensed under Chapter 465, F.S. with the exception of a nuclear pharmacy C) A personal residence D) All of the above* F) Only B & C *The following must be accomplished upon applying for a new or renewal application for an Rx drug wholesale distributor permit: A) The application must be filed on forms furnished by the Department B) A surety bond must be obtained in the amount of $100,000. If the annual gross reccipts of the applicant's previous tax year are $10 million or less, a bond in the amount of $25,000. C) All persons that own 10% of more of the company must complete a Personal Information Statement and complcte a background check D) All of the above E) A &B only are correct* *The following conditions require pre-notification to the Department: A) Change of address* B) A greater than 30% change of ownership C) Application to the DEA for a controlled substance permit D) All of the above When a permiteee closes, the following process must be observed: A) The permittee 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 E) All of the above* During the prescription drug wholesaler application process, which of the following "persons" must be identified on the application? A) An owner B) A corporate officer C) A shareholder who owns 5% or more of the outstanding stock D) All of the above* E) A&B only A timely renewal that does not require additional monies or a late fee occurs: A) Anytime prior to the permit expiration B) At least 45 days prior to the permit expiration* C) On the date of expiration D) No more than 30 days post expiration To qualify to be a CDR one must accomplish the following: A) Be employed at least part time with a licensed Rx wholesaler distributor in a managerial position B) Be at least 18 years of age* C) Reecive a passing score of at least 70% on the CDR exam D) Have not less than 2 years of a verifiable work experience, full or part time in a pharmacy or Rx drug wholesale distributor E) All of the above A CDR must be present at the Rx drug wholesaler establishment except for in the following situations: A) Outside normal busincss hours* B) While working at another Rx drug wholesale distributor C) While training other CDR's D) Whenever the Department is notified of the absence E) All of the above The following are required security for an Prescription drug wholesale distributor: A) Sccurity cameras places in strategic arcas of the warchouse that record information B) An after hours alarm system C) A building perimeter that is well lighted D) A security system for the computer if appropriate to protect records E) B, C and D only* Controlled room temperature storage for prescription drugs is defined by: A) The United States Pharmacopocia (USP) B) The Orange Book C) The Red Book D) The National Formulary (NF) E) A & D Only* The following information is required to be placed on business record for all prescription drugs including Active Pharmaccutical Ingredients (APD: A) Name, address of the seller and the recipient; the name and dosage form of the drug; the dates of distribution; the lot number; the signature of the seller and the recipient. B) Name and address of the seller and the recipicnt; the name, dosage form, strength and quantity of the drugs; the transaction dates, financial information and permit #'s of the seller and recipient.* C) Name and address of the seller and the recipient; the name and lot # and quantity of "Drug sample," or "complimentary drug," means a human prescription drug that is labeled "sample," "not to be sold," "complimentary," or other words to that effect, that is provided as a courtesy, that is not intended to be sold, and that is intended to promote the sale of the drug. 
