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 to $1,000 per violation and up to suspension of permits for one year.

2 = Administrative Complaint with a fine ranging from $1,000 to $3,000 per violation, and up to permanent suspension or revocation of permits.

1 = Administrative Complaint with a fine ranging from $3,000 to $5,000 per violation; and up to permanent suspension or revocation of permits.

	CITE	VIOLATION	GENERAL SEVERITY
	499 refers to Chapter 499, F.S.
	1refers to Chapter 61N-1, F.A.C.
	FACILITY, STORAGE:
	499.0121(a);
	1.014(4)	Inadequate facility	3
	499.0121(1)(b)	Inadequate security	3
	499.0121(1)(a)	Unrestricted access to prescription drugs	3
	1.022(4)	Unrestricted access to ether	3
	499.0121(3)	Inadequate storage	3
	1.013(3) & 1.014(1)	Improper temperature conditions	2
	499.0121(1)(b)	Improper ventilation/physical access	3
	499.0121(1)(c);	No quarantine area	3
	1.013(4) & 499.05355(2)
	MISCELLANEOUS:
	499.012(6)	Failure to comply with 499.012(6)	2
	499.005(4)	Activity in violation of law or rules	3
	499.005(20)	Import prescription drug contrary to Federal Food Drug and Cosmetic Act	1
	499.005(21)	Wholesaling health care entity Rx drugs	1
	499.01(2)(j) and (2)(m)	Returning sold drug to inventory	2
	1.023(5)	Failure to monitor	2
	499.005(7)	Using currency for Rx drug transaction	2-1
	OPERATING:
	499.005(6) & 499.67(5)	Refusing entry, inspection, taking evidence	1
	1.015(2)(c)	Inaccessible during business hours	2
	499.005(22);	Failure to obtain proper permit	2
	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	2
	499.012(16)	Violation by or related to certified representative	2
	499.039	Transfer of harmful substance	3
	499.039	Tranfer violation causing injury	1
	RECORDKEEPING:
	499.005(18);	Failing to maintain records, inventories	2
	499.0121(6);
	499.028; 499.052;
	499.66; 499.67;
	1.012 & 1.022(3);
	499.66; 499.67 & 1.012	Failing to make records available	2
	499.005(28)	Absence of/not providing pedigree papers	1
	1.012(1)	Not maintaining a complete audit trail	2
	1.012(12)	Separate records, multiple businesses
	1.007(2)	No written procedures for medical oxygen	2
	SAMPLES:
	499.005(17)	Sample drug distribution – activity with	1
	499.005(25)	Charging a dispensing fee for a prescription sample	1
	ADULTERATED & MISBRANDED:
	499.005(1)	Activity with adulterated or misbranded product	2
	499.005(2)	Adulterating or misbranding a product	2
	499.005(3)	Receiving adulterated/misbranded product	2
	499.005(9)	Making a product misbranded	2
	1.007(3)	Improper labeling on medical oxygen	2
	499.013(2)(a)	Prescription Drug Manufacturer not following GMP	2
	499.013(2)(b)	OTC Drug Manufacturer not following GMP	2
	499.013(2)(c) & 1.007(1)	Comp. Med. Gas Manufacturer not following GMP	2
	499.013(2)(d)	Device Manufacturer not following GMP	2
	1.010	Cosmetic Manufacturer not following GMP/guidelines	2
	499.005(1)	Activity with drug which left regulatory control, GMP	2
	499.005(26)	Removing pharmacy dispensing label	1
	499.005(27)	Distributing previously dispensed Rx drug	1
	499.005(28), (29)	Pedigree paper violation	1
	499.0121(4)(d)	Failure to authenticate pedigree	1
	COUNTERFEIT:
	499.005(8)	Making/dealing in a counterfeit product	1
	FALSE & MISLEADING:
	499.005(5) & 1.002	Disseminating false/misleading ad	3
	499.005(10)	Forging, counterfeiting, falsely representing a product	1
	499.005(11)	Labeling or advertisement of effectiveness when not	3
	499.005(19);	Making false or fraudulent statements	1
	499.005(23);
	499.66 & 499.67
	499.005(19);	Providing department with false/fraudulent	1
	499.64(4) & 499.67	records/statements
	499.0054	Advertising Violations	3
	499.005(23)	Obtaining/attempting to obtain by fraud, deceit,	1
		misrepresentation, subterfuge
	499.005(13)	Activity w/self-testing HIV/AIDS products	2
	UNAUTHORIZED SOURCE OR RECIPIENT:
	499.005(14)	Purchase or receipt of prescription drug from	2
		unauthorized source
	499.005(16)	Purchase or receipt of Comp. Med. Gas from	2
		unauthorized source
	499.005(15)	Sale or transfer of prescription drug to unauthorized	2
		person
	499.005(24)	Sale or transfer of legend device to unauthorized person
	499.01(2)(j) & 1.012(4)	Improper sale of veterinary Rx drug	2
	1.012(4)	Distribution of medical oxygen by medical oxygen
		retailer without a prescription (order)
	499.66	Sale or transfer of ether to unauthorized person	2
	POSSESSION:
	499.01(2)(j)	Activity relating to human Rx drug by Vet. Retailer	2
	499.01(2)(p)1.	Possession of prescription drug by OTC Mfgr	2
	499.01(2)(o)1.	Possession or manufacture of other Rx drug by Comp. Med. Gas Manufacturer	2
	499.01(2)(m)	Possession of other Rx drugs by medical oxygen retailer	2
	499.023	Activity with unapproved new drug	2
	499.03(1)	Illegal possession, etc. of habit forming toxic, etc. new drug	2
	499.005(12)	Possession in violation of 499.001-499.081	2
	499.028(15)	Illegal possession of a sample drug	2
	499.65	Illegal possession of ether >2.5 gallons	2
	499.69	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 Florida Drugs, Devices and Cosmetics Trust Fund, at 1940 N. Monroe Street, 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 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.