The Board proposes the rule amendment to clarify that pharmacies which only perform prescription drug processing for other pharmacies are not required to comply with certain Board rules, since these pharmacies do not directly engage with patients or ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.451Pharmacy Common Database

PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify that pharmacies which only perform prescription drug processing for other pharmacies are not required to comply with certain Board rules, since these pharmacies do not directly engage with patients or the public.

SUMMARY: Pharmacies which only perform prescription drug processing for other pharmacies are not required to comply with certain Board rules since these pharmacies do not directly engage with patients or the public will be clarified.

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 FS.

LAW IMPLEMENTED: 465.0266 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:

 

64B16-28.451 Pharmacy Common Database; Exceptions for Prescription Drug Processing Only Pharmacies.

(1) through (6) No change.

(7) Prescription drug processing only pharmacies. A pharmacy permittee which solely performs prescription drug processing for other pharmacies pursuant to this rule, and at which medicinal drugs are not compounded, dispensed, stored or sold, nor are prescriptions filled or dispensed, and which notifies the Board that its pharmacy practice is limited solely to prescription drug processing shall be exempt from the following rules:

(a) Rule 64B16-28.102, F.A.C., Sink and Running Water, Sufficient Space, Refrigeration, Sanitation, Equipment;

(b) Rule 64B16-28.1035, F.A.C., Patient Consultation Area;

(c) Rule 64B16-28.1081, F.A.C., Regulation of Daily Operating Hours; and,

(d) Subsection 64B16-28.109(1), F.A.C., relating to signage.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0266 FS. History–New 3-24-08, Amended 1-1-10,          .

 

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