The Board proposes the rule amendment to update violations and citations.

 

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO.: RULE TITLE:
64B16-30.003: Citations

PURPOSE AND EFFECT: The Board proposes the rule amendment to update violations and citations.

SUMMARY: Violations and citations will be updated.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST AND LEGISLATIVE RATIFICATION:

During discussion of the economic impact of the rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Cost (SERC) was not necessary and that the rule amendment will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time. The Board has determined that this rule will not have an adverse impact on small business, or likely increase regulatory costs in excess of $200,000 in the aggregate within 1 year after implementation of the rule.

Any person who wishes to provide information regarding the statement of estimated costs, or to provide a proposal for a lower regulatory cost 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 FAW.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Mark Whitten, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64B16-30.003 Citations.

(1) through (2) No change.

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

(a) through (g) No change.

(h) Using in the compounding of$250 fine, Completion

a prescription, or furnishing uponof an approved CE

prescription, an ingredient orcourse in the

article different in any mannerprevention of

from the ingredient or articlemedication errors or no

prescribed, except as authorizedless than 8 hours.

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.

1. No allegation of harm or ill effects is present;

2. The licensee has no prior disciplinary history; and

3. The event did not result in or pose a significant threat to the health and safety of the patient or the public.

The penalty shall be a letter of concern, payment of costs, and completion of an approved continuing education course in the prevention of medication dispensing errors, of no less than eight (8) hours.

(i) Tendering a check payable to$100 fine plus

the Board of Pharmacy or to thepayment of the

Department of Health that ischeck within 30 days.

dishonored by the Institution upon

which it is drawn

(j) Failing to comply with the$500

Educational course requirements for

Human immunodeficiency virus and

Acquired immune deficiency

syndrome (HIV/AIDS), or medical errors

(k) Failure to correct$250

Minor violation as listed in

Rule 64B16-30.002, F.A.C.

(l) Failure to retain continuing

education records$250

(4) No change.

(5) The procedures described herein apply only for an initial offense of the alleged violation. Subsequent violation(s) of the same rule or statute shall require the procedures of Section 456.073, F.S., to be applied. In addition, should an initial offense for which a citation could be issued occur in conjunction with violations not described herein, then the procedures of Section 456.073 455.225, F.S., shall apply.

Rulemaking Specific 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,________.

 

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 8, 2010

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: September 30, 2011