499.041 Schedule of fees for drug, device, and cosmetic applications and permits, product registrations, and free-sale certificates. - Florida Statutes

499.041 Schedule of fees for drug, device, and cosmetic applications and permits, product registrations, and free-sale certificates.

   (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.

   (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 may not be less than $250 or more than $400 annually.

   (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 compressed medical gas manufacturer permit may not be less than $400 or more than $500 annually.

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

   (g) 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 a compressed medical gas wholesale distributor permit may not be less than $200 or more than $300 annually.

   (c) The fee for an out-of-state prescription drug wholesale distributor permit may not be less than $300 or more than $800 annually.

   (d) The fee for a nonresident prescription drug manufacturer permit may not be less than $300 or more than $500 annually.

   (e) The fee for a retail pharmacy drug wholesale distributor permit may not be less than $35 or more than $50 annually.

   (f) The fee for a freight forwarder permit may not be less than $200 or more than $300 annually.

   (g) The fee for a veterinary prescription drug wholesale distributor permit may not be less than $300 or more than $500 annually.

   (h) The fee for a limited prescription drug veterinary wholesale distributor permit may not be less than $300 or more than $500 annually.

   (i) 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 medical oxygen retail establishment permit may not be less than $200 or more than $300 annually.

   (c) 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, devices, or cosmetic products 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.

History. s. 34, ch. 82-225; s. 116, ch. 83-218; s. 1, ch. 83-265; ss. 10, 14, ch. 88-159; s. 4, ch. 89-296; ss. 35, 52, ch. 92-69; s. 591, ch. 97-103; s. 16, ch. 2000-326; s. 20, ch. 2003-155; s. 5, ch. 2004-328; s. 5, ch. 2006-92; s. 27, ch. 2008-207.