Fla. Admin. Code R. 61N-1.018
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.
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 |
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 |
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 |
Fla. Admin. Code Ann. R. 61N-1.018
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.
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.