Business & Professional Regulation › Water and Wastewater Treatment Plant Operators › Chapter 61N-1 · Regulations For Drugs, Devices And Cosmetics

Rule 61N-1.024. Administrative Enforcement

Amended March 16, 2025 (current)

(1) In addition to any other action authorized by law, the department will issue a notice of violation, warning letter, or notice of inspection results to any person that violates Chapter 499, Part I, F.S., and this rule chapter if the documented facts of the case so warrant.

(2) The department sets forth below a summary listing of prohibited acts or other actions which constitute a violation of Chapter 499, F.S., or the rules adopted thereunder. The purpose of this listing is to give notice to permittees, registrants and other persons of the range of penalties which will normally be imposed for violation of particular provisions of Chapter 499, F.S., or rules adopted thereunder in a case where a person is adjudged by the department by final order incorporating an Administrative Complaint to have violated a provision of Chapter 499, F.S., or Chapter 61N-1, F.A.C. Whenever a violation of a particular provision of Chapter 499, F.S., or Chapter 61N-1, F.A.C., is addressed by more than one guideline penalty provision below, the more severe applicable penalty provision will apply. The descriptions of the violations below are only intended to be generally descriptive. The reader should look to the actual statutory and rule provisions cited below to determine the conduct the law actually requires or prohibits.

(3) The guidelines are based upon a single count violation of each provision listed. Each separate violation of a provision of Chapter 499, F.S., or Chapter 61N-1, F.A.C., is subject to a separate fine. Each day a violation continues constitutes a separate violation.

(4) These guidelines generally reflect the Department’s position as to the severity of a given violation. In determining the applicable penalty within a given guideline range, for a violation of a provision of Chapter 499, Part I, F.S., or a rule adopted thereunder, the Department will also consider any previous violations of those provisions by a person as well as any actions taken to correct a violation or remedy complaints.

(6) Administrative fines due the department may be paid by personal check, corporate check, cashier’s check, certified check, money order, or other guaranteed funds, payable to the Department of Business and Professional Regulation, Drugs, Devices and Cosmetics Program, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047. The department will take further legal action, including but not limited to, enforcing the underlying agreement if payment of an administrative fine by means of non-guaranteed funds does not result in the full payment of the fine.

(7) If a limited prescription drug veterinary wholesale distributor, prescription drug wholesale distributor or out-of-state prescription drug wholesale distributor fails to pay an administrative fine or costs within 30 days after the fine or costs become final, the department may make a claim against the bond or other security as authorized by Chapter 499, F.S., and this rule chapter.

(8) For any alleged violation of Chapter 499, F.S., or Chapter 61N-1, F.A.C., the Department may elect to provide the alleged violator with a notice of violation, in order to facilitate the uncontested settlement of all issues related to a complaint or investigation. Generally, this will be done at the completion of an investigation and prior to the filing of an Administrative Complaint. The notice of violation will advise the alleged violator of the statutory violations and provide a proposed penalty for settlement of the disciplinary matters related to a complaint. Upon issuing the notice of violation to an alleged violator, the Department will provide instructions on when and how the alleged violator can settle the disciplinary matter by accepting the notice of violation.

(9) No provision in this section will prevent or restrict the Department from denying a permit, registration or certification based on any provision of Chapter 499, F.S., that authorizes such action.

(10) No provision of this section will prevent or restrict the Department’s authority to enter into any settlement agreement concerning violations of Chapter 499, F.S., or this rule chapter, pursuant to the authority of Section 120.57(4), F.S. Rulemaking Authority 499.039, 499.05, 499.701 FS. Law Implemented 499.012, 499.039, 499.05, 499.066, 499.067, 499.701, 499.72, 499.91 FS. History–New 7-1-96, Formerly 10D-45.0595, Amended 1-26-99, 4-17-01, 1-1-04, 2-24-05, 9-22-09, Formerly 64F-12.024, Amended 3-16-25.