Rule 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 |$100,000.00 | |$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. | | |(d) Bond/Security: Prescription Drug Wholesale Distributor or Out-of-State Prescription Drug Wholesale Distributor with $10,000,000.00 |$25,000.00 | |million or less in annual gross receipts during the previous tax year, as set forth in section 499.012(8)(m), F.S. | | |(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.