The Board proposes the rule amendment to reduce required daily operating hours and define when a pharmacy commences to operate.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.1081Regulation of Daily Operating Hours

PURPOSE AND EFFECT: The Board proposes the rule amendment to reduce required daily operating hours and define when a pharmacy commences to operate.

SUMMARY: Required daily operating hours will be reduced and commencement of operations will be defined 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: 465.005, 465.022(1) FS.

LAW IMPLEMENTED: 465.022(1) 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: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.1081 Regulation of Daily Operating Hours; Commencement of Operations.

(1) Any person who receives a community pharmacy permit pursuant to Section 465.018, F.S., and commences to operate such an establishment, shall keep the prescription department of the establishment open for a minimum of twenty (20) forty (40) hours per week. The Board hereby approves exceptions to the requirements noted above and permits closing of the prescription department for the following holidays: New Year’s Day, Memorial Day, Fourth of July (Independence Day), Labor Day, Veterans’ Day, Thanksgiving, Christmas and any bona fide religious holiday provided that notice of such closing is given in a sign as set forth herein.

(a) “Commences to Operate” means the compounding, dispensing, storage, or sale of medicinal drugs or the filling or dispensing of prescriptions.

(b) The Board recognizes that a delay may exist between the time a pharmacy receives a Florida pharmacy permit and commences to operate. Accordingly, upon receipt of a Florida pharmacy permit, a community pharmacy may delay commencement of operations in compliance with the following:

1. Within fourteen (14) days of receipt of the Florida pharmacy permit, the permittee shall notify the Board office, in writing, of the permittee's election to delay commencement of operations and the reason(s) therefore;

2. The permittee shall display a sign in block letters not less than one inch in height at the main entrance of the establishment stating that the pharmacy is not yet open for business and that medicinal drugs may not be dispensed or sold nor prescriptions filled or dispensed;

3. Within two (2) business days of commencement of operations, the permittee shall notify the Board office in writing that the permittee has commenced to operate and the date of commencement.

(c) Any pharmacy permittee that does not commence to operate within six (6) months of the date of receipt of the Florida pharmacy permit shall provide a written statement to the Board office, which shall include the reason(s) the pharmacy has not yet commenced operations, the efforts the pharmacy has made to commence to operate, and the date the pharmacy expects to commence to operate.

(2) At the time a pharmacy commences to operate, a A sign in block letters not less than one inch in height stating the hours the prescription department is open each day shall be displayed either at the main entrance of the establishment or at or near the place where prescriptions are dispensed in a prominent place that is in clear and unobstructed view. The prescription department manager may petition the Board in writing to operate the prescription department for less than forty (40) hours per week, but no less than twenty (20) hours per week. Prior to approving reduced hours, the Board may require the prescription department manager to appear before the Board to explain in detail the services that will be performed. Any pharmacy open less than 40 hours shall have a policy and procedure that provides a mechanism for access to a pharmacist during the time the pharmacy is not open for the remainder of the forty hour week. Any pharmacy that is not open 40 hours a week, must post the days and hours that the pharmacy is open and the information for after-hours access and shall also have a written policy and procedure for transferring a prescription pursuant to Rule 64B16-27.105, F.A.C., or receiving an emergency dose pursuant to Section 465.0275, F.S. during the time the pharmacy is open less than 40 hours.

Rulemaking Authority 465.005, 465.022(1) FS.  Law Implemented 465.022(1) FS.  History–New 4-10-05, Amended 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: April 5, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 3, 2016