FL DR Exam

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esekerak
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226358
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FL DR Exam
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2013-07-08 21:38:47
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FL DR
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FL DR Exam Prep Questions
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  1. True or False?
    The Department has the authority to enforce the drug related laws of the United States and the State of Florida.
    True
  2. Which of the following is not an intended use of a medical device used for humans or animals?

    A. Diagnose a condition
    B. Cure a disease 
    C. Prevent a disease
    D. Metabolize in the body 
    D. Metabolize in the body

    A medical device used for a human or animal is intended to prevent a disease, cure a disease, diagnose a condition but not metabolize in the body.
    (this multiple choice question has been scrambled)
  3. To be considered a manufacturer, which of the following actions
    is not necessary?

    Choose one answer.

    a. Holds an application for the product manufactured 

    b. Contracts production of the drug, device or 
    cosmetic to another manufacturer

    c. Produces a drug, device or cosmetic 

    d. Manufactures it's own drug, device or cosmetic
    d. Manufactures it's own drug, device or cosmetic
  4. A manufacturer means any person who prepares, 
    • derives , manufactures, or produce a drug, device or cosmetic. It is not
    • necessary for the manufacturer to manufacture their own product. Production may be contracted to another firm. The manufacturer must be the holder of an NDA ,
    • ANDA, BLA, NADA or 501K.
  5. A restricted Rx drug distributor-health care entity permit is not required for which of the following activities?


    a. Transferring a prescription drug from a government agency to a subcontractor for dispensing to eligible patients.

    b. Transferring a prescription drug from a university warehouse for the purpose of university research.

    c. Transferring drugs between health care facilities under one common control.
    • a. Transferring a prescription drug from a government agency to a subcontractor for
    • dispensing to eligible patients.
  6. True or False?
    The term medical oxygen retail establishment
    includes a pharmacy licensed under chapter 465 addressing pharmacy laws.
    False
  7. An over-the-counter (OTC) manufacturing permit is required for
    anyone engaging in which of the following activities?

    Choose one answer.

    a. Manufacturing and repackaging OTC drugs. 

    b. Purchasing or possessing prescription drugs. 

    c. Manufacturing or repackaging cosmetics.

    d. Operating a pharmacy selling OTC drugs.
    d. Operating a pharmacy selling OTC drugs.
  8. It is a federal requirement to obtain a license if engaging in the wholesale distribution of prescription drugs. Choose all the information
    that is required on a license application as a wholesale drug distributor.

    a. Name, address and telephone 

    b. All trade and business names used by the licensee.

    c. All contact information for all facilities used for all operations by the
    licensee.

    d. The type of ownership

    e. Name of the owner and/or operator of the licensee.
    a. b. c. d. e. (all correct)
  9. True or False?
    The information supplied by an applicant for a new prescription drug wholesale distribution permit is often considered as trade secrets. The department of health of the state of Florida is allowed to post
    this information as FOI (freedom of information).
    False
  10. If you are submitting an application for a permit for a restricted prescription drug distributor government programs, which of the following will you be required to include with the application? (check all that
    apply)

    a. A detailed plan justifying the need for the permit.

    b. A copy of the applicant's pharmacy license

    c. A list of all intended contractors/subcontractors that will receive prescription drugs

    d. The permit numbers of the contractors/subcontractors

    e. A copy of a contract indicating all contractors/subcontractors are at least 18
    years of age
    a, c, d, e
  11. Fingerprints are a requirement as part of the supporting documentation included with some permit applications for wholesale distributors. Which of the following is not applicable to the process of submitting
    fingerprints?  (choose one answer)

    a. Notarizing the fingerprint card.

    b. Obtaining a fingerprint card from the department

    c. Submission of the fingerprint card for background checks. 

    d. Payment of applicable fee with each fingerprint card.

    e. Submitting a legible fingerprint card
    a
  12. The department of health of the state of Florida can deny or
    reject an application for a wholesale distributor permit for criminal activity
    of the applicant. Which of the following would not cause the department to
    reject or deny the application? (choose one answer)


    a. The applicant is charged with a felony.

    b. An affiliated party to the applicant has had a permit revoked. 

    c. The applicant has been found guilty to a felony. 

    d. The applicant possesses a strong business and 
    financial background.

    e. The applicant furnished fraudulent information on the application
    • d.  The department of health of the state of Florida expects the applicant for a
    • permit to have a strong financial and business experience background to
    • successfully operate in compliance with the permit that is being sought.
    • Additionally, the applicant and any affiliated party must not have a criminal
    • background, submit false or fraudulent information on the application nor have
    • any history of disciplined, suspended or revoked permits that have not been
    • reinstated.
  13. True or False?
    A Permittee that has submitted a renewal
    application in accordance with the regulations of the department of health of
    the state of Florida may continue to operate under its permit, unless the permit
    is suspended or revoked, until final disposition of the renewal
    application.
    True
  14. There are exceptions to many rules and regulations. Choose from
    the following choices an acceptable exception to the requirements for the
    wholesale distribution permit process.  (Choose one answer)


    a. A separate permit is required for the purpose of temporary storage at all times.

    b. A separate permit is not required for the purpose of temporary storage up to 16 days.

    c. A separate permit is not required for the purpose of temporary storage up to one month.

    d. A separate permit is not required for the purpose of temporary storage up to 2 weeks.
    b.
  15. The purpose of the submission of a $20,000 bond to the department when applying for a limited prescription drug veterinary wholesale distributor permit is which of the following? (choose all that apply)

    a. To secure any payment of fines 60 days after any legal proceeding is concluded

    b. To secure payment of any fees and costs incurred which the distributor fails to
    pay within 30 days

    c. To secure payment of any administrative penalties imposed by the department

    d. To secure payment of any fines up to 1 year after the license is valid
    a, b, c, d  (all are correct)
  16. To be eligible for licensure from the department of health of the state of Florida, an applicant must not have which of the following?

    Choose one answer.

    a. An out-of-state prescription drug wholesale distributor permit. 

    b. A limited prescription veterinary wholesale 
    distributor permit.

    c. A record of a felony or conviction of a violation of a law relating to drugs, devices or cosmetics in Florida.

    d. An occupational license from a local county or municipality.
    c.

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