FL CDR Sample questions module 9-15
*Which of the following permits can a Florida licensed prescription drug distributor also obtain at
their same location? - ANS-A) Restricted Drug Distributor - Destruction Company
B) Retail Pharmacy Wholesaler
C) Complimentary Drug Distributor*
D) All of the above.
\A ___________________________ is an entity that provides or coordinates warehousing, or
other logistics services of a product in interstate commerce on behalf of a manufacturer,
wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor
have responsibility to direct the sale or disposition of the product. - ANS-A) Third Party Logistics
Provider
B) Common Carrier
C) Trading Partner
D) Both A and C could be included in this definition*
E) All of the above could be included in this definition
\A charitable donation of a sample or complimentary prescription done can be done in which of
the following ways: - ANS-A) All properly licensed manufacturers can distribute their own
sample products.
B) All properly licensed wholesalers can distribute sample drugs if recevied from a licensed
vendor.
C) A licensed charity can distribute sample drugs that are expired if the drugs are otherwise not
adulterated or misbranded.
D) Sample drugs that become adulterated can be sent to any properly licensed destruction
company as long as a certificate of destruction is obtained.
E) None of the above are correct*
\A Complimentary Drug Distributor can sell prescription drugs to which of the following entities?
- ANS-A) Licensed pharmacies
B) Licensed physicians
C) Health Care Clinic Establishments
D) Other wholesale distributors
E) None of the above*
\A Compressed Medical Oxygen Manufacturer must follow which of the following laws and rules
regulating Medical Oxygen? - ANS-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*
\A Florida licensed prescription drug wholesale distributor can purchase which of the following
products from a Florida licensed manufacturer or another wholesaler? - ANS-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.*
\A Florida licensed prescription drug wholesale distributor who is seeking to distribute medical
oxygen must comply with which of the following? - ANS-A) Apply with the Department (FL) for a
medical oxygen wholesale distributor permit
B) Undergo an additional onsite inspection for medical oxygen prior to obtaining their new
permit
C) Full Transactional data (T3) requirements for all prescription drugs including medical oxygen
D) None of the above would be required*
\A licensed Complimentary Drug Distributor can sell prescription drug samples to which of the
following permittees? - ANS-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
\A Licensed Prescription Drug Manufacturer can wholesale distribute the following products? -
ANS-A) Any prescription drug if they pass Transaction History, Information and Statement (T3).
B) Only prescription drugs they qualify as the manufacturer for, if they pass the proper T3.*
C) Only prescription drugs they manufacture but no T3 is required by a manufacturer.
D) A Manufacturer is not permitted to wholesale distribute any drugs.
\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. - ANS-True
False*
\A Non-resident prescription drug manufacturer permit is NOT required for the manufacturer to
ship/sell Active Pharmaceutical Ingredients (API) into the State of FL under the following
circumstances: - ANS-A) If the non-resident manufacturer ships into FL what it manufactured to
a permitted manufacturer in this State.
B) If the API quantities are "limited."
C) If the API is only being used for research and development.
D) If all record keeping requirements, required under Chapter 499 are met.
E) All of the above*
\A prescription drug could be considered ___________ if it has ANY of the following
characteristics: Adulterated, counterfeit, Transaction information, history or statement (T3) does
not exist or T3 is false. - ANS-A) Contaminated
B) Contraband
C) Subject to seizure
D) Subject to stop sale
E) All of the above
\A prescription drug wholesale distributor must notify the Department within ______ days after
the last day of the CDR's employment with the wholesale permittee? - ANS-A) 5
B) 10*
C) 15
*Which of the following permits can a Florida licensed prescription drug distributor also obtain at
their same location? - ANS-A) Restricted Drug Distributor - Destruction Company
B) Retail Pharmacy Wholesaler
C) Complimentary Drug Distributor*
D) All of the above.
\A ___________________________ is an entity that provides or coordinates warehousing, or
other logistics services of a product in interstate commerce on behalf of a manufacturer,
wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor
have responsibility to direct the sale or disposition of the product. - ANS-A) Third Party Logistics
Provider
B) Common Carrier
C) Trading Partner
D) Both A and C could be included in this definition*
E) All of the above could be included in this definition
\A charitable donation of a sample or complimentary prescription done can be done in which of
the following ways: - ANS-A) All properly licensed manufacturers can distribute their own
sample products.
B) All properly licensed wholesalers can distribute sample drugs if recevied from a licensed
vendor.
C) A licensed charity can distribute sample drugs that are expired if the drugs are otherwise not
adulterated or misbranded.
D) Sample drugs that become adulterated can be sent to any properly licensed destruction
company as long as a certificate of destruction is obtained.
E) None of the above are correct*
\A Complimentary Drug Distributor can sell prescription drugs to which of the following entities?
- ANS-A) Licensed pharmacies
B) Licensed physicians
C) Health Care Clinic Establishments
D) Other wholesale distributors
E) None of the above*
\A Compressed Medical Oxygen Manufacturer must follow which of the following laws and rules
regulating Medical Oxygen? - ANS-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*
\A Florida licensed prescription drug wholesale distributor can purchase which of the following
products from a Florida licensed manufacturer or another wholesaler? - ANS-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.*
\A Florida licensed prescription drug wholesale distributor who is seeking to distribute medical
oxygen must comply with which of the following? - ANS-A) Apply with the Department (FL) for a
medical oxygen wholesale distributor permit
B) Undergo an additional onsite inspection for medical oxygen prior to obtaining their new
permit
C) Full Transactional data (T3) requirements for all prescription drugs including medical oxygen
D) None of the above would be required*
\A licensed Complimentary Drug Distributor can sell prescription drug samples to which of the
following permittees? - ANS-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
\A Licensed Prescription Drug Manufacturer can wholesale distribute the following products? -
ANS-A) Any prescription drug if they pass Transaction History, Information and Statement (T3).
B) Only prescription drugs they qualify as the manufacturer for, if they pass the proper T3.*
C) Only prescription drugs they manufacture but no T3 is required by a manufacturer.
D) A Manufacturer is not permitted to wholesale distribute any drugs.
\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. - ANS-True
False*
\A Non-resident prescription drug manufacturer permit is NOT required for the manufacturer to
ship/sell Active Pharmaceutical Ingredients (API) into the State of FL under the following
circumstances: - ANS-A) If the non-resident manufacturer ships into FL what it manufactured to
a permitted manufacturer in this State.
B) If the API quantities are "limited."
C) If the API is only being used for research and development.
D) If all record keeping requirements, required under Chapter 499 are met.
E) All of the above*
\A prescription drug could be considered ___________ if it has ANY of the following
characteristics: Adulterated, counterfeit, Transaction information, history or statement (T3) does
not exist or T3 is false. - ANS-A) Contaminated
B) Contraband
C) Subject to seizure
D) Subject to stop sale
E) All of the above
\A prescription drug wholesale distributor must notify the Department within ______ days after
the last day of the CDR's employment with the wholesale permittee? - ANS-A) 5
B) 10*
C) 15
