FL CDR EXAM 2025 QUESTIONS AND
ANSWERS
Active pharmaceutical ingredient - ANS includes 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" - ANS any 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"* - ANS a 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) - ANS means: (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.
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, "Applicant" - ANS means a person applying for a permit or certification under this part.
"Certificate of free sale" - ANS means 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" - ANS means 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" - ANS means 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" - ANS includes black, white, and intermediate grays.
"Color additive" - ANS means, 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" - ANS means 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"* - ANS means the Department of Business and Professional Regulation.(DBPR)
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"Device" - ANS means any instrument, apparatus, implement, machine, contrivance, implant,
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in vitro reagent, or other similar or related article, including its components, parts, or
@COPYRIGHT BRAINBARTER 2025/2026
ANSWERS
Active pharmaceutical ingredient - ANS includes 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" - ANS any 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"* - ANS a 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) - ANS means: (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.
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, "Applicant" - ANS means a person applying for a permit or certification under this part.
"Certificate of free sale" - ANS means 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" - ANS means 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" - ANS means 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" - ANS includes black, white, and intermediate grays.
"Color additive" - ANS means, 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" - ANS means 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"* - ANS means the Department of Business and Professional Regulation.(DBPR)
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"Device" - ANS means any instrument, apparatus, implement, machine, contrivance, implant,
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in vitro reagent, or other similar or related article, including its components, parts, or
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