Notice of Non Compliance; Minor Violations

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.0245Notice of Non Compliance; Minor Violations

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 43 No. 151, August 4, 2017 issue of the Florida Administrative Register.

61N-1.0245 Notification of Noncompliance; Minor Violations.

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

(2) The Department Division designates a violation of 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, as a the following minor violation 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 Department’s 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 Rule Subsection 61N-1.024, F.A.C.  Violations of this section shall be handled in accordance with the standard disciplinary guidelines of the Department Division.  Nothing provided in this section shall restrict the Department 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 permitholder’s 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 Department Division.

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

 

THE PERSON TO BE CONTACTED REGARDING THE NOTICE OF CHANGE 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].