20 FL X Certified Designated Representative Exam
(Florida Board of Pharmacy – Designated
Representative for Prescription Drug Distributors
ACTUAL QUESTIONS AND ANSWERS .pdf (2026/2027)
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.
(Florida Board of Pharmacy – Designated
Representative for Prescription Drug Distributors
ACTUAL QUESTIONS AND ANSWERS .pdf (2026/2027)
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.
