Statutes, codes, and regulations
Florida Administrative Code
Department 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATIONDivision 61N - Drugs, Devices and Cosmetics
Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS
Section 61N-1.024 - Administrative Enforcement

Fla. Admin. Code R. 61N-1.024

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Current through Reg. 51, No. 009; January 14, 2025
Section 61N-1.024 - Administrative Enforcement
(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.
(5) The following codes outline department policy under section 499.066, F.S., and are used to designate the general severity in terms of the threat to the public health for a violation.

3 = Administrative Complaint with a fine ranging from $250.00 to $1,000.00 per violation and up to suspension of permits for one year.

2 = Administrative Complaint with a fine ranging from $1,000.00 to $3,000.00 per violation, and up to permanent suspension or revocation of permits.

1 = Administrative Complaint with a fine ranging from $3,000.00 to $5,000.00 per violation; and up to permanent suspension or revocation of permits.

CITE

VIOLATION

GENERAL

SEVERITY

499 refers to chapter 499, F.S.

1 refers to chapter 61N-1, F.A.C.

FACILITY, STORAGE:

Section 499.0121(a), F.S.;

Subsection 61N-1.014(4), F.A.C.

Inadequate facility.

3

Section 499.0121(1)(b), F.S.

Inadequate security.

3

Section 499.0121(1)(a), F.S.

Unrestricted access to prescription drugs.

3

Subsection 61N-1.022(4), F.A.C.

Unrestricted access to ether.

3

Section 499.0121(3), F.S.

Inadequate storage.

3

Subsections 61N-1.013(3), and 61N-1.014(1), F.A.C.

Improper temperature conditions.

2

Section 499.0121(1)(b) F.S.

Improper ventilation/physical access.

3

Section 499.0121(1)(c) F.S.; subsection 61N-1.013(4), F.A.C., and Section 499.05355(2), F.S.

No quarantine area.

3

MISCELLANEOUS:

Section 499.012(6), F.S.

Failure to comply with section 499.012(6), F.S.

2

Section 499.005(4), F.S.

Activity in violation of law or rules.

3

Section 499.005(20), F.S.

Import prescription drug contrary to Federal Food Drug and Cosmetic Act.

1

Section 499.005(21), F.S.

Wholesaling health care entity Rx drugs.

1

Sections 499.01(2)(j), and (2)(m), F.S.

Returning sold drug to inventory.

2

Subsection 61N-1.023(5), F.A.C.

Failure to monitor.

2

Section 499.005(7), F.S.

Using currency for Rx drug transaction.

2-1

OPERATING:

Sections 499.005(6), and 499.67(5), F.S.

Refusing entry, inspection, taking evidence.

1

Paragraph 61N-1.015(2)(c), F.A.C.

Inaccessible during business hours.

2

Sections 499.005(22), 499.62, F.S., and rule 61N-12.015, F.A.C.

Failure to obtain proper permit.

2

Section 499.015, F.S., and Rule 61N-12.016, F.A.C.

Failure to register products ($50 per product per year).

3

Section 499.01(4)(a), F.S., and subsection 61N-12.016(4), F.A.C.

Failure to notify dept. of address change.

2

Section 499.012(16), F.S.

Violation by or related to certified representative.

2

Section 499.039, F.S.

Transfer of harmful substance.

3

Section 499.039, F.S.

Tranfer violation causing injury.

1

RECORDKEEPING:

Sections 499.005(18), 499.0121(6), 499.028, 499.052, 499.66, 499.67, F.S., and rule 61N-1.012, subsection 61N-1.022(3), F.A.C.

Failing to maintain records, inventories.

2

Sections 499.66, 499.67, F.S., and rule 61N-1.012, F.A.C.

Failing to make records available.

2

Section 499.005(28), F.S.

Absence of/not providing pedigree papers.

1

Subsection 61N-1.012(1), F.A.C.

Not maintaining a complete audit trail.

2

Subsection 61N-1.012(12), F.A.C.

Separate records, multiple businesses.

Subsection 61N-1.007(2), F.A.C.

No written procedures for medical oxygen.

2

SAMPLES:

Section 499.005(17), F.S.

Sample drug distribution - activity with.

1

Section 499.005(25), F.S.

Charging a dispensing fee for a prescription sample.

1

ADULTERATED AND MISBRANDED:

Section 499.005(1), F.S.

Activity with adulterated or misbranded product.

2

Section 499.005(2), F.S.

Adulterating or misbranding a product.

2

Section 499.005(3), F.S.

Receiving adulterated/misbranded product.

2

Section 499.005(9), F.S.

Making a product misbranded.

2

Subsection 61N-1.007(3), F.A.C.

Improper labeling on medical oxygen.

2

Section 499.013(2)(a), F.S.

Prescription Drug Manufacturer not following GMP.

2

Section 499.013(2)(b), F.S.

OTC Drug Manufacturer not following GMP.

2

Section 499.013(2)(c), F.S., and subsection 61N-1.007(1), F.A.C.

Comp. Med. Gas Manufacturer not following GMP.

2

Section 499.013(2)(d), F.S.

Device Manufacturer not following GMP.

2

Rule 61N-1.010, F.A.C.

Cosmetic Manufacturer not following GMP/guidelines.

2

Section 499.005(1), F.S.

Activity with drug which left regulatory control, GMP.

2

Section 499.005(26), F.S.

Removing pharmacy dispensing label.

1

Section 499.005(27), F.S.

Distributing previously dispensed Rx drug.

1

Sections 499.005(28), and (29), F.S.

Pedigree paper violation.

1

Section 499.0121(4)(d), F.S.

Failure to authenticate pedigree.

1

COUNTERFEIT:

Section 499.005(8), F.S.

Making/dealing in a counterfeit product.

1

FALSE AND MISLEADING:

Section 499.005(5), F.S., and rule 61N-1.002, F.A.C.

Disseminating false/misleading ad.

3

Section 499.005(10), F.S.

Forging, counterfeiting, falsely representing a product.

1

Section 499.005(11), F.S.

Labeling or advertisement of effectiveness when not.

3

Sections 499.005(19), 499.005(23), 499.66 and 499.67, F.S.

Making false or fraudulent statements.

1

Section 499.005(19), 499.64(4), and 499.67, F.S.

Providing department with false/fraudulent records/statements.

1

Section 499.0054, F.S.

Advertising Violations.

3

Section 499.005(23), F.S.

Obtaining/attempting to obtain by fraud, deceit, misrepresentation, subterfuge.

1

Section 499.005(13), F.S.

Activity w/self-testing HIV/AIDS products.

2

UNAUTHORIZED SOURCE OR RECIPIENT:

Section 499.005(14), F.S.

Purchase or receipt of prescription drug from unauthorized source.

2

Section 499.005(16), F.S.

Purchase or receipt of Comp. Med. Gas from unauthorized source.

2

Section 499.005(15), F.S.

Sale or transfer of prescription drug to unauthorized person.

2

Section 499.005(24), F.S.

Sale or transfer of legend device to unauthorized person.

Section 499.01(2)(j), F.S. and subsection 61N-1.012(4), F.A.C.

Improper sale of veterinary Rx drug.

2

Subsection 61N-1.012(4), F.A.C.

Distribution of medical oxygen by medical oxygen retailer without a prescription (order)

Section 499.66, F.S.

Sale or transfer of ether to unauthorized person.

2

POSSESSION:

Section 499.01(2)(j), F.S.

Activity relating to human Rx drug by Vet. Retailer.

2

Section 499.01(2)(p)1., F.S.

Possession of prescription drug by OTC Mfgr.

2

Section 499.01(2)(o)1., F.S.

Possession or manufacture of other Rx drug by Comp. Med. Gas Manufacturer.

2

Section 499.01(2)(m), F.S.

Possession of other Rx drugs by medical oxygen retailer.

2

Section 499.023, F.S.

Activity with unapproved new drug.

2

Section 499.03(1), F.S.

Illegal possession, etc. of habit forming toxic, etc. new drug.

2

Section 499.005(12), F.S.

Possession in violation of sections 499.001 - 499.081, F.S.

2

Section 499.028(15), F.S.

Illegal possession of a sample drug.

2

Section 499.65, F.S.

Illegal possession of ether >2.5 gallons.

2

Section 499.69, F.S.

Possession of ether within 500' of residence.

2

(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.

Fla. Admin. Code Ann. R. 61N-1.024

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 FS.

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.

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.