61N-1.018. Fees

(1) Biennial fees for a Manufacturer or Repackager permit are as follows: Biennial Fee Prescription Drug Manufacturer (including virtual) $1,500.00 Prescription Drug Repackager $1,500.00 Device Manufacturer $1,200.00 Cosmetic Manufacturer $800.00 Over-the Counter Drug Manufacturer $800.00 Medical Gas Manufacturer $1,000.00 Non-resident Prescription Drug Manufacturer (including virtual) $1,000.00 Non-resident Prescription Drug Repackager $1,500.00 No manufacturer shall be required to pay more than one fee per establishment to obtain an additional manufacturing permit; but the manufacturer must pay the highest fee applicable to the operations in each establishment. (2)(a) Biennial fees for a Wholesale Distributor or Freight Forwarder permit that is issued on a Biennial basis are as follows: Biennial Fee Medical Gas Wholesale Distributor $600.00 Retail Pharmacy Drug Wholesale Distributor $100.00 Freight Forwarder $600.00 Veterinary Prescription Drug Wholesale Distributor $1,000.00 Limited Prescription Drug Veterinary Wholesale Distributor $1,000.00 Prescription Drug Wholesale Distributor (including Broker Only) $1,600.00 Out-of-State Prescription Drug Wholesale Distributor $1,600.00 (3) Biennial fees for Other permits are as follows: Biennial Fee Complimentary Drug Distributor $500.00 Veterinary Prescription Drug Retail Establishment $600.00 Medical Oxygen Retail Establishment $600.00 Restricted Prescription Drug Distributor – Blood Establishment $600.00 Restricted Prescription Drug Distributor – Health Care Entity $600.00 Restricted Prescription Drug Distributor – Charitable Organization $600.00 Restricted Prescription Drug Distributor – Reverse Distributor $600.00 Restricted Prescription Drug Distributor – Destruction $600.00 Restricted Prescription Drug Distributor – Government Programs $600.00 Restricted Prescription Drug Distributor – Institutional Research $600.00 Third Party Logistics Provider $600.00 Health Care Clinic Establishment $255.00 (4) Miscellaneous Other fees are as follows: Fee (a) Certification as Designated Representative $150.00 (b) Initial Application/Onsite Inspection $150.00 Non-Refundable The initial application/onsite inspection fee is non-refundable. If the department determines it must re-inspect for an initial application because the applicant does not have security, climate control, a quarantine area, or written policies and procedures, as required by the particular permit for which the applicant is applying; fails to appear for a scheduled inspection; or is otherwise not ready or available for inspection or available to schedule an inspection on or after the date indicated on the application form, an additional onsite inspection fee of $150.00 is required for each reinspection. (c) Bond/Security: Prescription Drug Wholesale Distributor or Out-of-State Prescription Drug Wholesale Distributor with more than $10,000,000.00 million in annual gross receipts during the previous tax year, as set forth in section 499.012(8)(m), F.S. $100,000.00 (d) Bond/Security: Prescription Drug Wholesale Distributor or Out-of-State Prescription Drug Wholesale Distributor with $10,000,000.00 million or less in annual gross receipts during the previous tax year, as set forth in section 499.012(8)(m), F.S. $25,000.00 (e) Bond/Security: Limited Prescription Drug Veterinary Wholesale, as set forth in section 499.01(2)(m), F.S. $20,000.00 (f) Change of Address: A relocation fee of $100.00 must be paid for each permitted person or establishment relocating for which an onsite inspection is required. If no onsite inspection is required, the relocation fee is $25.00 per permit. If a permitted person has multiple permits under the same permitted name and address and relocates any or all permitted activities concurrently to the new location, then only one $100.00 fee is required plus $25.00 for each additional permit. (g) Product Registration (for each drug product registered) $30.00* *The registration fee for a prescription drug product being amended to an existing product registration that has 12 months or less until it expires is $15.00. (h) Listed Identical Products $15.00 (i) Free Sale Certificate $25.00 Signature of Free Sale Certificate copy (requested concurrently) $2.00 (j) Delinquent Establishment Permit Renewal (per permit) $100.00 Rulemaking Authority 499.01, 499.04, 499.05, 499.831, 499.832 FS. Law Implemented 499.01, 499.012, 499.015, 499.04, 499.041, 499.05, 499.028, 499.831, 499.832 FS. History–New 7-1-96, Formerly 10D-45.0544, Amended 4-17-01, 7-6-03, 1-1-04, 9-13-04, 2-14-06, 9-5-07, 3-10-09, Formerly 64F-12.018, Amended 6-3-15, 11-2-17.