Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.024 - Administrative Enforcement

Current through Reg. 50, No. 138; July 16, 2024
(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.
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.