FL CDR Sample questions module 1-8: 55 Verified
Questions & Answers
Active pharmaceutical ingredient - ANSWERincludes any substance or mixture of
substances intended, represented, or labeled for use in drug manufacturing that
furnishes or is intended to furnish, in a finished dosage form, any pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment, therapy,
or prevention of disease in humans or other animals, or to affect the structure or any
function of the body of humans or animals.
"Advertisement" - ANSWERany representation disseminated in any manner or by
any means, other than by labeling, for the purpose of inducing, or which is likely to
induce, directly or indirectly, the purchase of drugs, devices, or cosmetics.
"Affiliate"* - ANSWERa business entity that has a relationship with another business
entity in which, directly or indirectly: (a) The business entity controls, or has the
power to control, the other business entity; or (b) A third party controls, or has the
power to control, both business entities.
"Affiliated party"** (KNOW THIS) - ANSWERmeans: (a) A director, officer, trustee,
partner, or committee member of a permittee or applicant or a subsidiary or service
corporation of the permittee or applicant; (b) A person who, directly or indirectly,
manages, controls, or oversees the operation of a permittee or applicant, regardless
of whether such person is a partner, shareholder, manager, member, officer,
director, independent contractor, or employee of the permittee or applicant; (c) A
person who has filed or is required to file a personal information statement pursuant
to s. 499.012(9) or is required to be identified in an application for a permit or to
renew a permit pursuant to s. 499.012(8); or (d) The five largest natural shareholders
that own at least 5 percent of the permittee or applicant.
"Applicant" - ANSWERmeans a person applying for a permit or certification under
this part.
"Certificate of free sale" - ANSWERmeans a document prepared by the department
which certifies a drug, device, or cosmetic, that is registered with the department, as
one that can be legally sold in the state.
"Chain pharmacy warehouse" - ANSWERmeans a distributor permitted pursuant to s.
499.01 that maintains a physical location for prescription drugs that functions solely
as a central warehouse to perform intracompany transfers of such drugs between
members of an affiliate.
"Closed pharmacy" - ANSWERmeans a pharmacy that is licensed under chapter 465
and purchases prescription drugs for use by a limited patient population and not for
wholesale distribution or sale to the public. The term does not include retail
pharmacies.
, "Color" - ANSWERincludes black, white, and intermediate grays.
"Color additive" - ANSWERmeans, with the exception of any material that has been
or hereafter is exempt under the federal act, a material that: (a) Is a dye pigment, or
other substance, made by a process of synthesis or similar artifice, or extracted,
isolated, or otherwise derived, with or without intermediate or final change of
identity from a vegetable, animal, mineral, or other source; or (b) When added or
applied to a drug or cosmetic or to the human body, or any part thereof, is capable
alone, or through reaction with other substances, of imparting color thereto.
"Cosmetic" - ANSWERmeans an article, with the exception of soap, that is: (a)
Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or
otherwise applied to the human body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance; or (b) Intended for use as a
component of any such article.
"Department"* - ANSWERmeans the Department of Business and Professional
Regulation.(DBPR)
"Device" - ANSWERmeans any instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article, including its
components, parts, or accessories, which is: (a) Recognized in the current edition of
the United States Pharmacopoeia and National Formulary, or any supplement
thereof, (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy,
or prevention of disease in humans or other animals, or (c) Intended to affect the
structure or any function of the body of humans or other animals, and that does not
achieve any of its principal intended purposes through chemical action within or on
the body of humans or other animals and which is not dependent upon being
metabolized for the achievement of any of its principal intended purposes.
"Distribute" or "distribution"** - ANSWERmeans to sell, purchase, trade, deliver,
handle, store, or receive. The term does not mean to administer or dispense.
REMEMBER THAT DISTRIBUTION DOES NOT REQUIRE MONEY TO CHANGE HANDS
NOR DOES IT REQUIRE TOUCHING THE DRUG. THEREFORE, VIRTUAL ENTITIES OR
BROKERS STILL DISTRIBUTE AS DEFINED HERE
"Drug" - ANSWERmeans an article that is: (a) Recognized in the current edition of the
United States Pharmacopoeia and National Formulary, official Homeopathic
Pharmacopoeia of the United States, or any supplement to any of those publications;
(b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or
prevention of disease in humans or other animals; (c) Intended to affect the
structure or any function of the body of humans or other animals; or (d) Intended for
use as a component of any article specified in paragraph (a), paragraph (b), or
paragraph (c), and includes active pharmaceutical ingredients, but does not include
devices or their nondrug components, parts, or accessories.
Questions & Answers
Active pharmaceutical ingredient - ANSWERincludes any substance or mixture of
substances intended, represented, or labeled for use in drug manufacturing that
furnishes or is intended to furnish, in a finished dosage form, any pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment, therapy,
or prevention of disease in humans or other animals, or to affect the structure or any
function of the body of humans or animals.
"Advertisement" - ANSWERany representation disseminated in any manner or by
any means, other than by labeling, for the purpose of inducing, or which is likely to
induce, directly or indirectly, the purchase of drugs, devices, or cosmetics.
"Affiliate"* - ANSWERa business entity that has a relationship with another business
entity in which, directly or indirectly: (a) The business entity controls, or has the
power to control, the other business entity; or (b) A third party controls, or has the
power to control, both business entities.
"Affiliated party"** (KNOW THIS) - ANSWERmeans: (a) A director, officer, trustee,
partner, or committee member of a permittee or applicant or a subsidiary or service
corporation of the permittee or applicant; (b) A person who, directly or indirectly,
manages, controls, or oversees the operation of a permittee or applicant, regardless
of whether such person is a partner, shareholder, manager, member, officer,
director, independent contractor, or employee of the permittee or applicant; (c) A
person who has filed or is required to file a personal information statement pursuant
to s. 499.012(9) or is required to be identified in an application for a permit or to
renew a permit pursuant to s. 499.012(8); or (d) The five largest natural shareholders
that own at least 5 percent of the permittee or applicant.
"Applicant" - ANSWERmeans a person applying for a permit or certification under
this part.
"Certificate of free sale" - ANSWERmeans a document prepared by the department
which certifies a drug, device, or cosmetic, that is registered with the department, as
one that can be legally sold in the state.
"Chain pharmacy warehouse" - ANSWERmeans a distributor permitted pursuant to s.
499.01 that maintains a physical location for prescription drugs that functions solely
as a central warehouse to perform intracompany transfers of such drugs between
members of an affiliate.
"Closed pharmacy" - ANSWERmeans a pharmacy that is licensed under chapter 465
and purchases prescription drugs for use by a limited patient population and not for
wholesale distribution or sale to the public. The term does not include retail
pharmacies.
, "Color" - ANSWERincludes black, white, and intermediate grays.
"Color additive" - ANSWERmeans, with the exception of any material that has been
or hereafter is exempt under the federal act, a material that: (a) Is a dye pigment, or
other substance, made by a process of synthesis or similar artifice, or extracted,
isolated, or otherwise derived, with or without intermediate or final change of
identity from a vegetable, animal, mineral, or other source; or (b) When added or
applied to a drug or cosmetic or to the human body, or any part thereof, is capable
alone, or through reaction with other substances, of imparting color thereto.
"Cosmetic" - ANSWERmeans an article, with the exception of soap, that is: (a)
Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or
otherwise applied to the human body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance; or (b) Intended for use as a
component of any such article.
"Department"* - ANSWERmeans the Department of Business and Professional
Regulation.(DBPR)
"Device" - ANSWERmeans any instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article, including its
components, parts, or accessories, which is: (a) Recognized in the current edition of
the United States Pharmacopoeia and National Formulary, or any supplement
thereof, (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy,
or prevention of disease in humans or other animals, or (c) Intended to affect the
structure or any function of the body of humans or other animals, and that does not
achieve any of its principal intended purposes through chemical action within or on
the body of humans or other animals and which is not dependent upon being
metabolized for the achievement of any of its principal intended purposes.
"Distribute" or "distribution"** - ANSWERmeans to sell, purchase, trade, deliver,
handle, store, or receive. The term does not mean to administer or dispense.
REMEMBER THAT DISTRIBUTION DOES NOT REQUIRE MONEY TO CHANGE HANDS
NOR DOES IT REQUIRE TOUCHING THE DRUG. THEREFORE, VIRTUAL ENTITIES OR
BROKERS STILL DISTRIBUTE AS DEFINED HERE
"Drug" - ANSWERmeans an article that is: (a) Recognized in the current edition of the
United States Pharmacopoeia and National Formulary, official Homeopathic
Pharmacopoeia of the United States, or any supplement to any of those publications;
(b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or
prevention of disease in humans or other animals; (c) Intended to affect the
structure or any function of the body of humans or other animals; or (d) Intended for
use as a component of any article specified in paragraph (a), paragraph (b), or
paragraph (c), and includes active pharmaceutical ingredients, but does not include
devices or their nondrug components, parts, or accessories.
