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.