The Board proposes the rule amendment to clarify the performance of pharmacy inspections.

 

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO.: RULE TITLE:
64B16-28.101: Prescription Area Accessible to Inspection

PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify the performance of pharmacy inspections.

SUMMARY: The performance of pharmacy inspections will be clarified.

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: 465.005, 465.022 FS.
LAW IMPLEMENTED: 465.017, 465.022 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:

64B16-28.101 Prescription Area Accessible to Inspection.

(1) The prescription department compounding room or any other place where prescriptions are compounded, filled, processed, accepted, dispensed, or stored in each pharmacy shall be so situated and located that authorized agents and employees of the Department or other persons authorized by law to enter and inspect, can observe and survey the confines of said department, room or area and can enter into said department, room or area after identifying themselves, for the purpose of inspection at a reasonable hour or when the practice of the profession of pharmacy is being carried on, as defined in Section 465.003, F.S., without having been previously detained or announced. Such inspection may be routinely conducted at any time by authorized agents of the Department to determine whether Chapter 465, F.S., or provisions of these rules have been violated or for other lawful purposes, and need not be in response to a complaint filed with the Department. There shall be a minimum of one (1) inspection per year except as otherwise provided herein or directed by the Board.

(a) A pharmacy shall be inspected twice during the first year of operation.

(b) A pharmacy which has had passing inspections for the most current three years, and no discipline during the most current three years shall be inspected every two years.

(c) A pharmacy which fails to obtain a passing inspection or which is disciplined during the two year inspection cycle will be inspected annually until it achieves passing inspections for the most current three years, and no discipline during the most current three years as setforth in this subsection.

(2) No change.

Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.017, 465.022 FS. History–Amended 5-19-72, 11-2-81, Formerly 21S-1.01, 21S-1.001, Amended 7-31-91, Formerly 21S-28.101, 61F10-28.101, 59X-28.101, Amended 5-4-05,________.

 

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 9, 2011

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