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FL CDR Questions and Answers (100%
Correct Answers) Already Graded A+
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
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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
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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.
, 2
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499.012(8); or (d) The five largest natural shareholders that own at
least 5 percent of the permittee or applicant.
"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.
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"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
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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.
For Expert help and assignment solutions, +254707240657
FL CDR Questions and Answers (100%
Correct Answers) Already Graded A+
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
© 2025 Assignment Expert
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
Guru01 - Stuvia
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.
, 2
For Expert help and assignment solutions, +254707240657
499.012(8); or (d) The five largest natural shareholders that own at
least 5 percent of the permittee or applicant.
"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.
© 2025 Assignment Expert
"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
Guru01 - Stuvia
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.
