The Board proposes the rule amendment to update the rule due to statutory changes.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-30.003Citations

PURPOSE AND EFFECT: The Board proposes the rule amendment to update the rule due to statutory changes.

SUMMARY: The rule will be updated due to statutory changes.

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, based upon the expertise and experience of its members, 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: 456.073, 456.077, 465.005 FS.

LAW IMPLEMENTED: 456.077 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: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-30.003 Citations.

(1) Pursuant to Section 456.077, F.S., the Board sets forth in subsection (3) of this rule those violations for which there is no substantial threat to the public health, safety and welfare; or, if there is a substantial threat to the public health, safety and welfare, such potential for harm has been removed prior to the issuance of the citation. Next to each violation is the fine to be imposed.

(2) No change.

(3) The following violations with accompanying fines may be disposed of by citation:

 

(a) through (b) No change.
(c) First time failure to complete the required continuing education during the biennial licensure period. (Section 456.072(3)(a), F.S.)
Failure to complete less than 10 hours Failure to complete 10 or more hours	$500 $1,000

In addition, licensees shall take two additional hours of continuing education for each of the continuing education deficiencies. Said hours shall not count for continuing education renewal requirements for the next biennium.

 

(d) through (f) No change.
(g) Failure to notify the board of a change in a prescription department manager or consultant pharmacist. (64B16-27.450 or 28.501, F.A.C.)	Fine based on the length of time prior to notifying board. $200 a month to $5,000 maximum.

 

(h) Using in the compounding of a prescription, or furnishing upon prescription, an ingredient or article different in any manner from the ingredient or article prescribed, except as authorized in Section 465.019(6) or 465.025, F.S.; or dispensing a medication with dosage instructions different in any way than prescribed, provided that the medication was not used or ingested. (465.016(1)(g), F.S.)	$250 fine, Completion of an approved CE course in the prevention of medication errors of no less than 8 hours.
(i) No change.
(j) Failing to comply with the Educational course requirements for Human immunodeficiency virus and Acquired immune deficiency syndrome (HIV/AIDS), or medical errors. (456.033(1), F.S.)	$500
(k) No change.
(l) First time failure to report controlled substance dispensing information to the Prescription Drug Monitoring Program Controlled Substance Dispensing Information Electronic System.  (893.055(3)(a), F.S.) Failure to retain continuing education records.	$100         $250
(m) First time (initial) failure to consult the Prescription Drug Monitoring Program Controlled Substance Dispensing Information Electronic System prior to dispensing a controlled substance. (893.055(8), F.S.)	$100
(n) Failure to request photo of other verification of identity prior to dispensing a controlled substance to a person not known. (465.0155(2),	$100
(o)  Failure to inform customers of less expensive drug when cost sharing obligation to customer exceeds retail price. (465.0244(2), F.S.)	$100

(4) through (5) No change.

Rulemaking Authority 456.073, 456.077, 465.005 FS. Law Implemented 456.077 FS. History–New 12-22-91, Formerly 21S-30.003, 61F10-30.003, 59X-30.003, Amended 4-3-00, 1-2-02, 8-26-02, 1-12-03, 2-1-12,                                      .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 12, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 6, 2018