The Board proposes the rule amendment to add additional violations which may be resolved through issuance of a citation.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-30.003Citations

PURPOSE AND EFFECT: The Board proposes the rule amendment to add additional violations which may be resolved through issuance of a citation.

SUMMARY: The rule will be updated to add additional violations which may be resolved through issuance of a citation.

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.

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: 456.077, 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: Jennifer Wenhold, Acting 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) No change.

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

(a) through (o) No change.

(p) Failure to comply with pharmacist to registered pharmacist technician ratio for activities not involving sterile compounding; no injury to patient/customer. (Rule 64B16-27.410(5) or (6), F.A.C.)	$250
(q) Failure to remove from active stock and properly quarantine outdated prescription drugs. (Section 499.006(9) through 499.005(2), F.S.) (Section 499.121(5)(a)2., F.S.) (Rule 64B16-28.110, F.A.C.)	$250

(3) through (4) 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, 9-27-18, 1-16-19,              .

 

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: December 12, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 14, 2019