To designate and adopt by rule those rules the violation of which would be a minor violation as required by section 120.695, F.S., for which a notice of non-compliance could be issued for those minor violations.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.0245Notice of Non Compliance; Minor Violations

PURPOSE AND EFFECT: To designate and adopt by rule those rules the violation of which would be a minor violation as required by section 120.695, F.S., for which a notice of non-compliance could be issued for those minor violations.

SUMMARY: Designation of minor violations and issuance of Notice of Non-compliance.

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: the economic review conducted by the agency.

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: 499.05, 499.701, 120.695 FS.

LAW IMPLEMENTED: 499.05, 120.695 FS.

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: Dinah Greene, Operations Review Specialist, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 2601 Blair Stone, Tallahassee, Florida 32399-1047; 850-717-1802; [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.0245  Notification of Noncompliance; Minor Violations.

(1) In accordance with Section 120.695, F.S., the Division of Drugs, Devices, and Cosmetics (hereinafter the “Division”) may issue a notice of noncompliance to a licensee, registrant or permitholder for an initial offense of a minor violation.

(2) The Division designates the following minor violations for which a notice of noncompliance may be issued:

(a) Subsection 61N-1.012(5), F.A.C. – Failure to maintain a copy of the Florida Drug and Cosmetic Act, Chapter 499, Part I, F.S., and Chapter 61N-1, F.A.C., Regulations for Drugs, Devices and Cosmetics, at the permitted establishment.

(3) The designation of a minor violation for purposes of Section 120.695, F.S., is limited to only initial violations in which corrective action is commenced within 14 days after the licensee, registrant or permitholder’s receipt of the Division’s issuance of a notice of noncompliance.  The failure of a licensee, registrant or permitholder to comply with the notice of noncompliance within the prescribed period of time shall no longer be deemed a minor violation and shall be treated as a disciplinary violation pursuant to Section 499.066, F.S., and/or Subsection 61N-1.024, F.A.C.  Violations of this section shall be handled in accordance with the standard disciplinary guidelines of the Division.  Nothing provided in this section shall restrict the Division from seeking full administrative action in such instances where aggravating circumstances are present which would preclude a minor violation dismissal.

(4) The notice of noncompliance may be delivered to the licensee, registrant or permit holder’s current mailing address by certified mail, by restricted delivery or by personal service. The notice of noncompliance may also be issued by an authorized representative of the Division.

Rulemaking Authority 120.695(2)(c), 499.05FS. Law Implemented 120.695,499.05, 499.066 FS. History–New____.          

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Drew Winters, Division Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Jonathan Zachem, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 24, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 6, 2017