(1) The department shall assess applicants requiring a manufacturing permit an annual fee within the ranges established in this section for the specific type of manufacturer.

(a) The fee for a prescription drug manufacturer permit may not be less than $500 or more than $750 annually.

Terms Used In Florida Statutes 499.041

  • Applicant: means a person applying for a permit or certification under this part. See Florida Statutes 499.003
  • Cosmetic: 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. See Florida Statutes 499.003
  • Department: means the Department of Business and Professional Regulation. See Florida Statutes 499.003
  • Device: means 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. See Florida Statutes 499.003

  • Drug: means 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. See Florida Statutes 499.003
  • Establishment: means 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. See Florida Statutes 499.003
  • Freight forwarder: means a person who receives prescription drugs which are owned by another person and designated by that person for export, and exports those prescription drugs. See Florida Statutes 499.003
  • Manufacturer: means :
    (a) A person who holds a New Drug Application, an Abbreviated New Drug Application, a Biologics License Application, or a New Animal Drug Application approved under the federal act or a license issued under…. See Florida Statutes 499.003
  • Permittee: means any person holding a permit issued under this chapter. See Florida Statutes 499.003
  • Person: means any individual, child, joint venture, syndicate, fiduciary, partnership, corporation, division of a corporation, firm, trust, business trust, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within this state, and any representative, agent, or agency of any of the foregoing, or any other group or combination of the foregoing. See Florida Statutes 499.003
  • Pharmacy: means an entity licensed under chapter 465. See Florida Statutes 499.003
  • Prescription drug: means a prescription, medicinal, or legend drug, including, but not limited to, finished dosage forms or active pharmaceutical ingredients subject to, defined by, or described by…. See Florida Statutes 499.003
  • Repackager: means a person who repackages. See Florida Statutes 499.003
  • Veterinary prescription drug: means a prescription drug intended solely for veterinary use. See Florida Statutes 499.003
  • Wholesale distributor: means a person, other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or a repackager, who is engaged in wholesale distribution. See Florida Statutes 499.003
(b) The fee for a device manufacturer permit may not be less than $500 or more than $600 annually.
(c) The fee for a cosmetic manufacturer permit shall be sufficient to cover the costs of administering the cosmetic manufacturer permit program.
(d) The fee for an over-the-counter drug manufacturer permit may not be less than $300 or more than $400 annually.
(e) The fee for a prescription drug repackager permit may not be less than $500 or more than $750 annually.
(f) A manufacturer may not be required to pay more than one fee per establishment to obtain an additional manufacturing permit, but each manufacturer must pay the highest fee applicable to his or her operation in each establishment.
(2) The department shall assess an applicant that is required to have a wholesaling permit an annual fee within the ranges established in this section for the specific type of wholesaling.

(a) The fee for a prescription drug wholesale distributor permit may not be less than $300 or more than $800 annually.
(b) The fee for an out-of-state prescription drug wholesale distributor permit may not be less than $300 or more than $800 annually.
(c) The fee for a nonresident prescription drug manufacturer permit may not be less than $300 or more than $500 annually.
(d) The fee for a retail pharmacy drug wholesale distributor permit may not be less than $35 or more than $50 annually.
(e) The fee for a freight forwarder permit may not be less than $200 or more than $300 annually.
(f) The fee for a veterinary prescription drug wholesale distributor permit may not be less than $300 or more than $500 annually.
(g) The fee for a limited prescription drug veterinary wholesale distributor permit may not be less than $300 or more than $500 annually.
(h) The fee for a third party logistics provider permit may not be less than $200 or more than $300 annually.
(3) The department shall assess an applicant that is required to have a retail establishment permit an annual fee within the ranges established in this section for the specific type of retail establishment.

(a) The fee for a veterinary prescription drug retail establishment permit may not be less than $200 or more than $300 annually.
(b) The fee for a health care clinic establishment permit may not be less than $125 or more than $250 annually.
(4) The department shall assess an applicant that is required to have a restricted prescription drug distributor permit an annual fee of not less than $200 or more than $300.
(5) In addition to the fee charged for a permit required by this part, the department shall assess applicants an initial application fee of $150 for each new permit issued by the department which requires an onsite inspection.
(6) A person that is required to register drugs or devices under s. 499.015 shall pay an annual product registration fee of not less than $5 or more than $15 for each separate and distinct product in package form. The registration fee is in addition to the fee charged for a free-sale certificate.
(7) The department shall assess an applicant that requests a free-sale certificate a fee of $25. A fee of $2 will be charged for each signature copy of a free-sale certificate that is obtained at the same time the free-sale certificate is issued.
(8) The department shall assess an out-of-state prescription drug wholesale distributor applicant or permittee an onsite inspection fee of not less than $1,000 or more than $3,000 annually, to be based on the actual cost of the inspection if an onsite inspection is performed by agents of the department.
(9) The department shall assess each person applying for certification as a designated representative a fee of $150, plus the cost of processing the criminal history record check.
(10) The department shall assess other fees as provided in this part.
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