FL CDR Sample questions module 9-15: Sample Questions & Answers: CDR Module 9-15: Guaranteed A+ Score Solution

A Florida licensed prescription drug wholesale distributor can purchase which of the following products from a Florida licensed manufacturer or another wholesaler? – A) Medical Oxygen B) Medical Devices C) Drug Samples or Complimentary Drugs D) All of the above are correct. E) Only A & B above are correct.* *Which of the following permits can a Florida licensed prescription drug distributor also obtain at their same location? – A) Restricted Drug Distributor - Destruction Company B) Retail Pharmacy Wholesaler C) Complimentary Drug Distributor* D) All of the above. A licensed Complimentary Drug Distributor can sell prescription drug samples to which of the following permittees? – 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 with 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 Department 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. * Medical Oxygen Retail establishments are required to comply with which or the following requirements? – A) Current good manufacturing practices as promulgated by the FDA. B) Assure that oxygen is labeled as "Rx Only," or similar legend. C) Obtain a Florida Prescription Drug Wholesale Distributor permit. D) All of the above are required E) Only A & B are required* An Agent of the Department must do the following before they can conduct an inspection of a facility known or suspected of manufacturing or in possession of prescription drugs? – A) Show proper identification. * B) Notify the business they will be conducting an inspection. C) Assure that the facility they are asking to inspect has a Florida permit. D) Provide evidence showing cause that the facility can be inspected. E) Assure it has been a year since the prior inspection and then enter with proper identification during normal business hours. During an inspection a State Agent can review, all but which of the following items at a licensed Florida drug wholesale distributor? – A) Financial Documentation showing drug purchases and sales. B) Documents that the wholesaler considers proprietary if related to drug purchases. C) Batch records of a drug manufacturer. D) An employees automobile who works in the drug warehouse. E) An inspector can review any and all of the above* A State inspector may conduct an inspection of any Florida licensed or unlicensed facility to collect the following information: - A) Receiving and Shipping documents B) Photographs of the facility C) Interviews and Sworn Statements D) Only A&B above are permitted. E) Any of the above are permitted.*