The Board proposes the rule amendment to include additional minor violations in the rule.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-30.002Minor Violations

PURPOSE AND EFFECT: The Board proposes the rule amendment to include additional minor violations in the rule.

SUMMARY: Additional minor violations will be included in the rule.

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(3), 465.005 FS.

LAW IMPLEMENTED: 456.073(3) 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:

 

64B16-30.002 Minor Violations.

(1) The Board sets forth the following guidelines for use by Department investigators when a licensee is in noncompliance of an initial offense of a minor violation. The Board deems the following violations, depending upon severity, to be consistent with Section 456.073(3), F.S.

(a) through (m) No change.

(n) Failure to have a continuously designated Prescription Department Manager or Consultant Pharamcist of Record, if the gap between designations is less than fifteen (15) business days – Rules 64B16-27.450 and 64B16-28.501, F.A.C.

(2) No change.

Rulemaking Authority 456.073(3), 465.005 FS. Law Implemented 456.073(3) FS. History–New 11-12-90, Formerly 21S-17.002, 21S-30.002, 61F10-30.002, 59X-30.002, Amended 12-9-98, 8-26-02, 11-7-17,             .

 

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: February 4, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 19, 2018