The purpose and effect of the proposed rule amendment is to add penalty guidelines for certain violations relating to the Florida Drug and Cosmetic Act, primarily as to medical gas; but in particular, sections 499.005(24), ....
DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION
RULE NO.:RULE TITLE:
61N-1.024Administrative Enforcement
PURPOSE AND EFFECT: The purpose and effect of the proposed rule amendment is to add penalty guidelines for certain violations relating to the Florida Drug and Cosmetic Act, primarily as to medical gas; but in particular, sections 499.005(24), 499.005(29), 499.91, Fla. Stat., and 61N-1.012(4), F.A.C.; and amend the penalty guideline for violation of 499.005(7), Fla. Stat.
SUMMARY: The proposed rulemaking adds penalty guidelines for certain violations relating to the Florida Drug and Cosmetic Act; in particular, sections 499.005(24), 499.005(29), 499.91, Fla. Stat., and 61N-1.012(4), F.A.C.; and amends the penalty guideline for violation of 499.005(7), Fla. Stat.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:
The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.
The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein:
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.
RULEMAKING AUTHORITY: 499.039, 499.05, 499.701, F.S.
LAW IMPLEMENTED: 499.012, 499.039, 499.05, 499.066, 499.067, 499.701, 499.72, 499.91, F.S.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Susan Hartmann Swartz, Rules Attorney, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, Florida 32399-2202, Tel. (850)717-1252, Email susan.swartz@myfloridalicense.com.
THE FULL TEXT OF THE PROPOSED RULE IS:
61N-1.024 Administrative Enforcement.
(1) through (4) No change.
(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(1) 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(2)(a) 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.
Transfer 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
Section 499.005(29), F.S.
Failure to accurately complete and timely submit reportable drug price increase forms, reports, and documents as required by s. 499.026 and rules adopted thereunder.
2
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.
2
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)
2
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
MEDICAL GAS:
Section 499.91(1), F.S.
Manufacture, sale, or delivery, or the holding or offering for sale, of a medical gas that is adulterated, misbranded, or is otherwise unfit for distribution.
2
Section 499.91(2), F.S.
Adulteration or misbranding of a medical gas.
2
Section 499.91(3), F.S.
Receipt of a medical gas that is adulterated, misbranded, stolen, or obtained by fraud or deceit, and the delivery or proffered delivery of such medical gas for pay or otherwise.
2
Section 499.91(4), F.S.
Alteration, mutilation, destruction, obliteration, or removal of all or any part of the product labeling of a medical gas, or the willful commission of any other act with respect to a medical gas that results in its being misbranded.
2
Section 499.91(5), F.S.
Purchase or receipt of a medical gas from a person not authorized to distribute or dispense medical gas or who is not exempted from permitting requirements to wholesale distribute medical gas to such purchaser or recipient.
2
Section 499.91(6), F.S.
Knowing and willful sale or transfer of a medical gas to a recipient who is not legally authorized to receive a medical gas, except that a violation does not exist if a permitted wholesale distributor provides oxygen to a permitted medical oxygen retail establishment that is out of compliance with the notice of location change requirements of s. 499.833(3)(a), provided that the wholesale distributor with knowledge of the violation notifies the department of the transaction by the next business day.
2
Section 499.91(7), F.S.
Failure to maintain or provide records required under Part III and the rules adopted under Part III.
3
Section 499.91(8), F.S.
Providing the department or any of its representatives or any state or federal official with false or fraudulent records or making false or fraudulent statements regarding Part III or the rules adopted under Part III.
1
Section 499.91(9), F.S.
Distribution of a medical gas that was:
(a) Purchased by a public or private hospital or other health care entity, except for the physical distribution of such medical gas to an authorized recipient at the direction of a hospital or other health care entity;
(b) Donated or supplied at a reduced price to a charitable organization; or
(c) Stolen or obtained by fraud or deceit.
2
Section 499.91(10), F.S.
Failure to obtain a license or permit or operating without a valid license or permit, if one is required.
2
Section 499.91(11), F.S.
The obtaining of, or attempt to obtain, a medical gas by fraud, deceit, or misrepresentation or engaging in misrepresentation or fraud in the distribution of a medical gas.
1
Section 499.91(12), F.S.
Except for emergency use oxygen, the distribution of a medical gas to a patient without a prescription from a practitioner authorized by law to prescribe a medical gas.
2
Section 499.91(13), F.S.
Distribution or dispensing of a medical gas that was previously dispensed by a pharmacy or a practitioner authorized by law to prescribe.
2
Section 499.91(14), F.S.
Distribution or dispensing of a medical gas or medical gas-related equipment to a patient, unless the patient has been provided with the appropriate information and counseling on the use, storage, and disposal of the medical gas.
2
Section 499.91(15), F.S.
Failure to report an act prohibited under Part III or the rules adopted under Part III.
3
Section 499.91(16), F.S.
Failure to exercise due diligence as provided in s. 499.88.
3
(6) through (10) No change.
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.
NAME OF PERSON ORIGINATING PROPOSED RULE: Susan Hartmann Swartz
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Melanie S. Griffin
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 16, 2024
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 8, 2024
Document Information
- Comments Open:
- 12/27/2024
- Summary:
- The proposed rulemaking adds penalty guidelines for certain violations relating to the Florida Drug and Cosmetic Act; in particular, sections 499.005(24), 499.005(29), 499.91, Fla. Stat., and 61N-1.012(4), F.A.C.; and amends the penalty guideline for violation of 499.005(7), Fla. Stat.
- Purpose:
- The purpose and effect of the proposed rule amendment is to add penalty guidelines for certain violations relating to the Florida Drug and Cosmetic Act, primarily as to medical gas; but in particular, sections 499.005(24), 499.005(29), 499.91, Fla. Stat., and 61N-1.012(4), F.A.C.; and amend the penalty guideline for violation of 499.005(7), Fla. Stat.
- Rulemaking Authority:
- 499.039, 499.05, 499.701, F.S.
- Law:
- 499.012, 499.039, 499.05, 499.066, 499.067, 499.701, 499.72, 499.91, F.S.
- Related Rules: (1)
- 61N-1.024. Administrative Enforcement