Prescription Drug Wholesale Distribution Regulations in Florida, Exams of Advanced Education

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Which of the following entities could be considered a Manufacturer as defined by Chapter 499? - Correct Answer-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 acceptable to be purchased, stored, sold or brokered in or into the State of Florida by a properly licensed Prescription Drug Wholesale Distributor? - Correct Answer-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? - Correct Answer-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 alterations to a container would be "repackaging" under Florida laws and rules: - Correct Answer-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* If a Certified Designated Representative is to have an "authorized absence", he/she must meet the following requirements: - Correct 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 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 - Correct Answer-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: - Correct Answer-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. - Correct Answer-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? - Correct Answer-A) Retrievable within minutes.* B) Retrievable 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? - Correct Answer-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: - Correct Answer-A) Allow inspection of ANY record of the establishment. B) Allow a Department inspector to enter and inspect during operating hours even in the absence of the owner and/or CDR.

C) Both of the above* D) Neither of the above Prescription drugs can be purchased by a properly licensed entity using which of the following methods? - Correct Answer-A) Cash B) Credit Card C) Check D) All of the above E) Only B & C can be used.* It is a violation of the Florida Law if a Transaction history, information and statement (T3) for a prescription drug is NOT received under the following conditions? - Correct Answer-A) With or prior to the shipment of prescription drugs products. B) For all prescription and over the counter drugs C) From all prescription drug product manufacturers and wholesalers D) Only A & C are correct* E) All of the above It is a prohibited act for a permitted establishment to do which of the following? - Correct Answer-A) Constructively refusing the department to enter or inspect an establishment where drugs are held. B) Refusal to allow the department to take samples of any drug. C) Refusal to allow the department to inspect any vehicle used to transport drugs. D) Purchasing or sale of a prescription drug in exchange for currency. E) All of the above.* A Florida licensed prescription drug wholesale distributor commits a ________________ if they knowingly traffic in over $25,000 in contraband precription drugs? - Correct Answer-A) A first degree felony* B) A second degree misdemeanor C) A third degree felony D) A regulatory violation Failure to deliver a complete and accurate transaction history, information and statement at the time of distribution of a prescription drug makes the prescription drug a ________________ product. - Correct Answer-A) Mislabeled B) Counterfeit C) Misbranded D) Contraband* Refusal or constructve refusal to allow inspection of a facility that is suspected to hold drugs, devices or cosmetics could classified as what type of violation? - Correct Answer-A) Criminal Felony B) Regulatory Compliance Violation 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 State any amount of contraband drug worth in excess of $____________. - Correct Answer-A) $5,000. B) $10,000. C) $15,000. D) $20,000. E) $25,000.00* In determining if a drug registration application is complete the Department can review the following: - Correct Answer-A) The Federal, Food, Drug and Cosmetic Act to assure the product also complies 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. - Correct Answer-A) Name of drug, strength, dosage form and expiration 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. - Correct Answer-True False* A Florida product registration for prescription drugs must be renewed how often? - Correct Answer-A) Biennially B) Every 2 years C) Annually D) Biannually E) A & B are correct* A prescription drug for which the required Transaction history, information or statement is missing or incomplete is considered: - Correct Answer-A) Adulterated B) Misbranded C) Contraband D) Only A & C* E) All of the above If a prescription drug is expired it is considered to be _________________. - Correct Answer-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). - Correct Answer-A) True* B) False A drug is considered "misbranded" if it has which of the following characteristics? - Correct Answer-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 misleading.* D) The product is contaminated. Which of the following are characteristics of a misbranded product? - Correct Answer-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 create a misbranded drug E) 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 does not exist. - Correct Answer-True* False Which of the following is true regarding a prescription drug repacker permit: - Correct Answer-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: - Correct Answer-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: - Correct Answer-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 a State of Florida Inspector

C) Also obtain a Non-Resident Prescription drug wholesaler permit in the State of Florida.* D) Provide Transactional history, information or statements to their Florida customers E) The must do all of the above without exception. An Out of State Rx drug wholesaler must meet all the same requirements as a FL Rx drug wholesaler with the following exceptions: - Correct Answer-A) The bond amount required is reduced for an Out of State application B) No CDR is required for the out of State facility C) No FL permit is required by the Out of State facility if they are transferring to a facility in the state of FL doing business in the same business name* D) none of the above apply E) All of the above apply A Retail Pharmacy Wholesaler permittee can wholesale distribute which of the following products to which entities? - Correct Answer-A) Prescription drugs to a licensed retail pharmacy in this state. B) Prescription drugs to a Modified Class II institutional pharmacy in this State. C) Prescription drugs to a licensed health care practitioner in this State. D) All of the above* E) Only A above is correct. An Licensed Prescription drug wholesale distributor can buy prescription drugs from which of the following entities? - Correct Answer-A) A restricted prescription drug distributor permit. B) A prescription drug repackager permit. C) A retail pharmacy drug wholesaler permit. D) A limited prescription drug veterinary wholesaler distributor permit. E) All of the above Which of the following applies to a third party logistics provider (3PL) permit? - Correct Answer-A) A 3PL never takes ownership of the drugs.* B) A 3PL never has to licensed by the State or FDA C) 3PL permitees are not required to maintain records of distribution D) All of the above are correct. What permit would be appropriate for a veterinarian establishment to apply for if they wanted to buy some human drugs to sell to veterinarians? - Correct Answer-A) Limited Veterinarian Wholesaler B) Retail Veterinarian Wholesaler C) Special Veterinarian Wholesaler D) Closed System Veterinarian Wholesaler A Prescription Drug Wholesale distributor, Broker Only, is allow to possess which of the following? - Correct Answer-A) Prescription Drugs B) Prescription Sample Drugs

C) Medical Oxygen, but no prescription drugs 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: - Correct Answer-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) None of the above A prescription drug wholesaler distributor cannot be issued to the same address as a: - Correct Answer-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* E) Only B & C The following must be accomplished upon applying for a new or renewal application for an Rx drug wholesale distributor permit: - Correct Answer-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 receipts 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 complete a background check D) All of the above E) A & B only are correct The following conditions require pre-notification to the Department: - Correct Answer-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: - Correct Answer-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? - Correct Answer-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: - Correct Answer-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: - Correct Answer-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) Receive 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: - Correct Answer-A) Outside normal business 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: - Correct Answer-A) Security cameras places in strategic areas of the warehouse 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: - Correct Answer-A) The United States Pharmacopoeia (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 Pharmaceutical Ingredients (API): - Correct Answer-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 recipient; 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 the drugs; and the transaction dates and financial information. D) Specific information is not required for a Business record of an API. Inventories of all Rx drugs present at a wholesaler facility must be inventoried and kept on file for inspection on which of the following schedules? - Correct Answer-A) Annually* B) Every 2 years C) Never if a computerized perpetual inventory is being kept D) Twice a year 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. - Correct Answer-A) 2 B) 3 C) 4 D) 6 E) 10 If records regarding the transaction of prescription drugs are requested from a Florida permitted facility whose offices are all located in the State of FL, the permittee has how long to produce the records to the inspector? - Correct Answer-A) Within 2 working days B) As soon as they are able to be copied C) They must be readily available D) They must be produced within minutes E) Both C & D* All Rx wholesale distributors must create and follow policies and procedures that at a minimum contain the following information: - Correct Answer-A) Receipt, security, storage, inventory including first in and first out, distribution, loss and theft tracking and error reporting, recalls, natural disasters, quarantine, destruction and/or returns* B) All the above in "A" except inventory including first in and first out C) All the above in "A" except loss and theft tracking D) All the above in "A" except recalls E) All the above in "A" except quarantine Which of the following are requirements that a prescription drug wholesaler must meet if they sell control substances, schedule II and/or III to physicians? - Correct Answer-A) The Florida wholesaler shall report only sales of controlled substances into the State of Florida. B) Reports of controlled substances must be reported by the 20th of the next month.*

C) The wholesaler must assess all transactions involving more than 500 unit doses of any one controlled substance in any one month. D) If the wholesaler does not buy or sell any controlled substances there are no reports due for the month. Drug Sample - Correct Answer-"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.