The amendment updates those violations which may be considered by the Department to be minor violations and for which a notice of noncompliance may be issued for a first-time offense.

 

DEPARTMENT OF HEALTH

Board of Podiatric Medicine

RULE NO.:RULE TITLE:

64B18-14.009Minor Violations; Notices of Compliance

PURPOSE AND EFFECT: The amendment updates those violations which may be considered by the Department to be minor violations and for which a notice of noncompliance may be issued for a first-time offense.

SUMMARY: The proposed amendment modifies the rule to be consistent with the language of the laws implemented and to include the failure of podiatric x-ray assistants to report a change in certification status to the supervising podiatric physician.

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: During discussion of the economic impact of this rule at its Board meeting, the Board concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

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: 456.072(3), 456.073, 461.005 FS.

LAW IMPLEMENTED: 456.073 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: Janet Hartman, Executive Director, Board of Podiatric Medicine, 4052 Bald Cypress Way, Bin # C08, Tallahassee, Florida 32399-1708.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B18-14.009 Minor Violations; Notices of Noncompliance.

(1) Through (2) No Change.

(3) A notice of noncompliance in lieu of other actions is authorized only if the violation is not a repeat violation and only if there is only one violation. If there are multiple violations, then the Department may not issue a notice of noncompliance, but must prosecute the violation under the other provisions of Section 456.073, F.S. There is only one exception to the prohibition against use of a notice of noncompliance when there is more than one violation. A notice of noncompliance may be issued to a registered dispensing practitioner for a first time violation of one or more of the violations listed in subsection (4), paragraphs (k), (f), (g), (l), (m), and (n), (o), and (p), if there is not evidence of diversion.

(4) The Board hereby establishes the following as minor violations which the Department may act upon by issuing notices of noncompliance for an initial offense:

(a) Through (e) No Change.

(f) Failure of a certified x-ray assistant to notify the supervising podiatric physician(s) of any changes to their certification status prior to continuing to perform the duties of a certified podiatric x-ray assistant, contrary to Rule 64B18-24.003, F.A.C. Failing to, before dispensing any drug, give the patient a written prescription and orally or in writing advise the patient that the prescription may be filled in the practitioner’s office or at any pharmacy, in violation of Section 465.027(2)(c), F.S. This applies to dispensing practitioners only.

(g) Dispensing medication without proper labeling, contrary to the provisions of Section 893.05(2), F.S., and Rule 64B16.28.108, F.A.C. This applies to dispensing practitioners only.

(g)(h) For a practitioner who is not required to register as a dispensing practitioner, failing to dispense drugs in the manufacturer’s labeled packaged with the practitioner’s name, patient’s name, and the date dispensed or, if such drugs are not dispensed in the manufacturer’s labeled package, failing to dispense the medication in a container which bears the following information: practitioner’s name; patient’s name; date dispensed; name and strength of the drug; and directions for use, contrary to Section 465.0276, F.S.

(h)(i) Failing to properly store medications which require refrigeration, contrary to Rule 64B16-28.104, F.A.C.

(i)(j) Failing to remove outdated medications from stock, contrary to Rule 64B16-28.110, F.A.C.

(j)(k) Failing to have proper labeling on all stock medications, contrary to Section 499.007, F.S.

(k)(l) Failing to post the generic drug sign, contrary to Section 465.025(7), F.S. This applies to dispensing practitioners only.

(l)(m) Failing to initial and date all controlled substances dispensed and all refills thereof, contrary to Section 893.04(1)(c)6., F.S. This applies to dispensing practitioners only.

(m)(n) Filling controlled substance prescriptions which do not have the patient’s address on them, contrary to Section 893.04(1)(c)1., F.S. This applies to dispensing practitioners only.

(n)(o) Filling controlled substance prescriptions which do not have the practitioner’s DEA number on them, contrary to Section 893.04(1)(c)2., F.S. This applies to dispensing practitioners only.

(p) Using a computer system, but failing to maintain a daily hard copy printout of controlled substances initialed and dated by the practitioner and failing to assure that the computer information is readily retrievable, contrary to subsection 64B16-28.119(5), F.A.C. This applies to dispensing practitioners only.

(o)(q) Failing to maintain records relating to controlled substances in a readily retrievable form, contrary to Section 893.07(4), F.S., and 21 C.F.R. §1304.04.

(p)(r) Failing to dispense medication in a childproof container, contrary to 16 C.F.R. §1700.14a(10).

(5) No change.

Rulemaking Authority 456.072(3), 456.073, 461.005 FS. Law Implemented 120.695, 456.073 FS. History–New 4-1-91, Formerly 21T-14.009, 61F12-14.009, Amended 2-25-96, 6-17-97, Formerly 59Z-14.009, Amended 8-8-99, 10-7-07,_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Podiatric Medicine

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Podiatric Medicine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 19, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 4, 2019