The Department proposes to make changes to this chapter to clarify and update the penalties that may be imposed against persons who are adjudged to have violated Chapter 499, F.S. or Chapter 64F-12, F.A.C., as well as updating the citations to and ...
DEPARTMENT OF HEALTH
Division of Family Health ServicesRULE NO: RULE TITLE
64F-12.024: Administrative Enforcement
PURPOSE AND EFFECT: The Department proposes to make changes to this chapter to clarify and update the penalties that may be imposed against persons who are adjudged to have violated Chapter 499, F.S. or Chapter 64F-12, F.A.C., as well as updating the citations to and descriptions of applicable provisions of law and permits. The Department proposes to describe and set forth a procedure for settling disciplinary cases through a notice of violation. The Department proposes to clarify that no provision of this section will prevent the Department from denying a permit application or from settling a disciplinary or other matter through authority of Section 120.57(4), F.S.
SUMMARY: The rule revises and updates the penalties applicable to adjudged violations of Chapter 499, F.S. or Chapter 64F-12, F.A.C., as well as clarifies citations to and descriptions of offenses, for which disciplinary actions can be taken. The rule provides a procedure for uncontested settlement of cases and complaints through notices of violation and provides that no provision of the rule section prohibits the Department from denying a permit application, or from settling a case under authority of Section 120.57(4), F.S.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: The proposed changes will not impact small businesses, small counties, or small cities. There should be no transactional costs for any individual or entity related to this rule revision. There is no change to any fees, costs, monitoring or reporting currently required.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 499.05, 499.701 FS
LAW IMPLEMENTED: 499.012, 499.05, 499.066, 499.701, 499.72 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca Poston, R. Ph., Director, Drugs Devices and Cosmetics Program, 4052 Bald Cypress Way, Mail Bin #C-04, Tallahassee, Florida 32399
THE FULL TEXT OF THE PROPOSED RULE IS:64F-12.024 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, and 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 64F-12, F.A.C. Whenever a violation of a particular provision of Chapter 499, F.S. or Chapter 64F-12, 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 64F-12, 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. Multiple counts of violations of the same provision, other violations contained in the same enforcement action, or prior activities are grounds for enhancement of penalties. Aggravating or mitigating circumstances will affect the penalty imposed and can cause the penalty to exceed or be less than the range indicated in these guidelines.
(5)(4) The following codes outline department policy under Section 499.066(3)(a), F.S., and are used to designate the general severity in terms of the threat to the public health for a violation and the range of action which the department will initiate.
3 = Warning Letter, Letter of Violation with no fine or Notice of Violation or Administrative Complaint with a fine ranging from $250* to $1,000 per violation and up to suspension of permits for one year per day.
(*) If medical oxygen is the prescription drug involved, the range of the fine is $50 to $1,000.
2 = Notice of Violation or Administrative Complaint with a fine ranging from $1,000 $500 to $3,000 $2,500 per violation, and up to permanent suspension or revocation of permits per day.
1 = Notice of Violation or Administrative Complaint with a fine ranging from $3,000 to $1,000-$5,000 per violation per day; and up to permanent suspension or revocation of permits. Suspension of the permit with a fine; or Revocation of the permit with a fine.
CITE
VIOLATION
GENERAL SEVERITY
499 refers to Chapter 499, F.S.
12 refers to Rule 64F-12
FACILITY, STORAGE:
12.014(4)
Inadequate facility
3
Inadequate security
3
Unrestricted access to prescription drugs
3*
12.022(4)
Unrestricted access to ether
3
Inadequate storage
3*
12.013(3) & 12.014(1)
Improper temperature conditions
2
Improper ventilation/physical access
3*
No quarantine area
3
12.013(4) & 499.05355(2)
MISCELLANEOUS:
Failure to comply with 499.012(6)
2
Activity in violation of law or rules
3
Importing a prescription drug contrary to Federal Food
Drug and Cosmetic Act
2-1
Wholesaling by health care entity Rx drugs
2-1
499.01(2)(j) and (2)(m)
499.0122(2)(d)
Returning sold dispensed drug to inventory
2
12.023(5)
Failure to monitor
2 3-1
Using currency for Rx drug transaction
2-1
OPERATING:
Refusing entry, inspection, taking evidence
2-1
12.015(2)(c)
Inaccessible during business hours
3-2
Failure to obtain proper permit (cost of permit plus fine)
2 3-1
499.62 & 12.015
499.015 & 12.016
Failure to register products ($50 per product per year)
3
499.01(4)(a) & 12.016(4)
Failure to notify dept. of address change
Violation by or related to certified representative
Transfer of harmful substance
Transfer violation causing injury
2 3
2
3
1
RECORDKEEPING:
Failing to maintain records, inventories
2 3-1
12.012 & 12.022(3);
Failing to make records available
2 3-1
Absence of/not providing pedigree papers
2-1
12.012(1)
Not maintaining a complete audit trail
2 3
12.012(12)
Separate records, multiple businesses
3
12.007(2)
No written procedures for medical oxygen
2 3
SAMPLES:
Sample drug distribution activity with
1
Charging a dispensing fee for a prescription sample
2-1
ADULTERATED & MISBRANDED:
Activity with adulterated or misbranded product
2 3-1
Adulterating or misbranding a product
2 3-1
Receiving adulterated/misbranded product
3-2
Making a product misbranded
2 3-1
12.007(3)
Improper labeling on medical oxygen
2 3
499.013(2)(a)
Prescription Drug Manufacturer not following GMP
2 3-1
499.013(2)(b)
OTC Drug Manufacturer not following GMP
2 3-1
499.013(2)(c) & 12.007(1)
Comp. Med. Gas Manufacturer not following GMP
2 3-1
499.013(2)(d)
Device Manufacturer not following GMP
2 3-1
12.010
Cosmetic Manufacturer not following GMP/guidelines
2 3-1
Activity with drug which left regulatory control, GMP
2-1
Removing pharmacy dispensing label
1
Distributing previously dispensed Rx drug
1
499.005(28), (29)
Receipt of Rx drug without pedigree paper violation
Failure to authenticate pedigree
2-1
1
COUNTERFEIT:
Making/dealing in a counterfeit product
1
FALSE & MISLEADING:
499.005(5) & 12.002
Disseminating false/misleading ad
3
Forging, counterfeiting, falsely representing a product
2-1
Labeling or advertisement of effectiveness when not
3
Making false or fraudulent statements
2-1
Providing department with false/fraudulent
2-1
records/statements
Advertising Violations
3
Obtaining/attempting to obtain by fraud, deceit,
2-1
misrepresentation, subterfuge
Activity w/self-testing HIV/AIDS products
2
UNAUTHORIZED SOURCE OR
RECIPIENT:
Purchase or receipt of prescription drug from
2-1
unauthorized source
Purchase or receipt of Comp. Med. Gas from
2 3*
unauthorized source
Sale or transfer of prescription drug to unauthorized
2 3*-1
person
Sale or transfer of legend device to unauthorized person
3
499.01(2)(j) 499.0122(1)(d) &
12.012(4)
Improper sale of veterinary Rx drug
2 3
12.012(4)
Distribution of medical oxygen by medical oxygen
3
retailer without a prescription (order)
Sale or transfer of ether to unauthorized person
3-2
POSSESSION:
499.01(2)(j) 499.0122(1)(d)
Activity relating to human Rx drug by Vet. Retailer
2 3
499.01(2)(p)1. 499.013(2)(b)
Possession of prescription drug by OTC Mfgr
2 3
499.01(2)(o)1. 499.013(2)(c)
Possession or of manufacture other Rx drug by Comp.
Med. Gas
2 3
Manufacturer
499.01(2)(m) 499.0122(1)
Possession of other Rx drugs by medical oxygen retailer
2 3
Activity with unapproved new drug
2-1
Illegal possession, etc. of habit forming toxic, etc.
new drug
2 3-1
Possession in violation of 499.001-499.081
2 3*
Illegal possession of a sample drug
2 3-1
Illegal possession of ether >2.5 gallons
2 3-1
Possession of ether within 500´ of residence
2
(6)(5) 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 Florida Drugs, Devices and Cosmetics Trust Fund, at 4052 Bald Cypress Way, Bin C-04, Tallahassee, Florida 32399-3254. 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)(6) If a limited prescription drug veterinary wholesale distributor, prescription drug wholesale distributor wholesaler, including a broker only, or out-of-state prescription drug wholesale distributor wholesaler 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 provided in Sections 499.012(2) (a) and (c), F.S.
(8) For any alleged violation of Chapter 499, F.S., or Chapter 64F-12, 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.
Specific 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. History–New 7-1-96, Formerly 10D-45.0595, Amended 1-26-99, 4-17-01, 1-1-04, 2-24-05,________.
NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca Poston
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Dr. Ana Viamonte Ros, State Surgeon General
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 19, 2009
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: May 15, 2009
Document Information
- Comments Open:
- 7/2/2009
- Summary:
- The rule revises and updates the penalties applicable to adjudged violations of Chapter 499, F.S. or Chapter 64F-12, F.A.C., as well as clarifies citations to and descriptions of offenses, for which disciplinary actions can be taken. The rule provides a procedure for uncontested settlement of cases and complaints through notices of violation and provides that no provision of the rule section prohibits the Department from denying a permit application, or from settling a case under authority of ...
- Purpose:
- The Department proposes to make changes to this chapter to clarify and update the penalties that may be imposed against persons who are adjudged to have violated Chapter 499, F.S. or Chapter 64F-12, F.A.C., as well as updating the citations to and descriptions of applicable provisions of law and permits. The Department proposes to describe and set forth a procedure for settling disciplinary cases through a notice of violation. The Department proposes to clarify that no provision of this section ...
- Rulemaking Authority:
- 499.05, 499.701 FS
- Law:
- 499.012, 499.05, 499.066, 499.701, 499.72 FS.
- Contact:
- Rebecca Poston, R. Ph., Director, Drugs Devices and Cosmetics Program, 4052 Bald Cypress Way, Mail Bin #C-04, Tallahassee, Florida 32399
- Related Rules: (1)
- 64F-12.024. Administrative Enforcement