Florida Certified Designated
Representative
Active Pharmaceutical Ingredient (API) - ANS-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
\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
b. A third-party controls, or has the power to control, both business entities.
\Affiliated party - ANS-Any person who directs or participates in the conduct of ... the company.
\Common carriers - ANS-(i.e. FedEx, USP)
not required to obtain this permit
does not take ownership
\Contraband prescription drug - ANS-any adulterated drug (tracking, content, and/or labels)
\Counterfeit drug - ANS-A drug which, or the container or labeling of which, without
authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or
any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the
person or persons who in fact manufactured, processed, packed, or distributed such drug and
which thereby falsely purports or is represented to be the product of, or to have been packed or
distributed by, such other drug manufacturer, processor, packer or distributor.
\Department - ANS-means the Department of Business and Professional Regulation (DBPR)
\Distribute - ANS-to sell, purchase, trade, deliver, handle, store, or receive (MONEY NOT
REQUIRED)
\Drug - ANS-Recognized in the current edition of the United States Pharmacopoeia and
National Formulary ... but does not include devices or their nondrug components, parts, or
accessories
\Establishment - ANS-a place of business which is at one general physical location and may
extend to one or more contiguous suites, units, floors, or buildings operated and controlled
exclusively by entities under common operation and control.
\Freight forwarder - ANS-a person who receives prescription drugs which are owned by another
person and designated by that person for export and exports those prescription drugs. Must
obtain a permit to transport prescription drugs.
\Label - ANS-a display of written, printed, or graphic matter upon the immediate container of any
drug, device, or cosmetic
\Labeling - ANS-all labels and other written, printed, or graphic matters. [Wholesalers cannot
alter labels. Repackagers can, with an additional permit.]
\Manufacturer - ANS-A person who holds a New Drug Application, A co-licensed partner, An
affiliate, and/or A person who manufactures a device or a cosmetic. [Entities that do not qualify
Representative
Active Pharmaceutical Ingredient (API) - ANS-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
\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
b. A third-party controls, or has the power to control, both business entities.
\Affiliated party - ANS-Any person who directs or participates in the conduct of ... the company.
\Common carriers - ANS-(i.e. FedEx, USP)
not required to obtain this permit
does not take ownership
\Contraband prescription drug - ANS-any adulterated drug (tracking, content, and/or labels)
\Counterfeit drug - ANS-A drug which, or the container or labeling of which, without
authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or
any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the
person or persons who in fact manufactured, processed, packed, or distributed such drug and
which thereby falsely purports or is represented to be the product of, or to have been packed or
distributed by, such other drug manufacturer, processor, packer or distributor.
\Department - ANS-means the Department of Business and Professional Regulation (DBPR)
\Distribute - ANS-to sell, purchase, trade, deliver, handle, store, or receive (MONEY NOT
REQUIRED)
\Drug - ANS-Recognized in the current edition of the United States Pharmacopoeia and
National Formulary ... but does not include devices or their nondrug components, parts, or
accessories
\Establishment - ANS-a place of business which is at one general physical location and may
extend to one or more contiguous suites, units, floors, or buildings operated and controlled
exclusively by entities under common operation and control.
\Freight forwarder - ANS-a person who receives prescription drugs which are owned by another
person and designated by that person for export and exports those prescription drugs. Must
obtain a permit to transport prescription drugs.
\Label - ANS-a display of written, printed, or graphic matter upon the immediate container of any
drug, device, or cosmetic
\Labeling - ANS-all labels and other written, printed, or graphic matters. [Wholesalers cannot
alter labels. Repackagers can, with an additional permit.]
\Manufacturer - ANS-A person who holds a New Drug Application, A co-licensed partner, An
affiliate, and/or A person who manufactures a device or a cosmetic. [Entities that do not qualify
