The Board proposes the rule amendment to update/correct the name of a type of ICF and include the statutorily required language regarding preventing controlled substance dispensing based on fraudulent prescriptions.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.: RULE TITLE:

64B16-28.830 Special - Closed System Pharmacy

PURPOSE AND EFFECT: The Board proposes the rule amendment to update/correct the name of a type of ICF and include the statutorily required language regarding preventing controlled substance dispensing based on fraudulent prescriptions.

SUMMARY: The name of a type of ICF will be updated/corrected. The statutorily required language regarding preventing controlled substance dispensing based on fraudulent prescriptions will be added to 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: 456.013, 465.005, 465.0155, 465.009, 465.022(12) FS.

LAW IMPLEMENTED: 456.013, 456.42, 456.43, 465.0155, 465.003, 465.009, 465.016(1)(i), (s), 465.017, 465.022(12), 893.04 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:

64B16-28.830 Special – Closed System Pharmacy.

(1) A Special – Closed System Pharmacy permit is a type of special pharmacy as provided for by Section 465.0196, F.S., which dispenses medicinal drugs, utilizing closed delivery systems, to facilities where prescriptions are individually prepared for the ultimate consumer, including nursing homes, jails, ALF’s (Adult Congregate Living Facilities), ICF-IIDs (Intermediate Care Facilities – Developmentally Delayed, also known as ICF – Individuals with Intellectual Disabilities, ICF-MR’s (Intermediate Care Facility/Mentally Retarded) or other custodial care facilities when defined by AHCA rules and which the Board may approve.

(2) A special – closed system pharmacy permittee shall maintain a policy and procedure manual including drug procurement, storage, handling, compounding, dispensing, record keeping and disposition, as well as procedures for preventing the dispensing of controlled substances based upon fraudulent prescriptions.

(3) A special – closed system pharmacy permittee shall provide twenty-four-hour emergency and on-call service.

(4) through (5) No change.

(6) The utilization of registered pharmacy interns and registered pharmacy technicians is subject to the rules as provided by Rules 64B16-26.400, 27.4001, 27.410, and 27.420, F.A.C.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196, 465.022, FS. History–New 7-31-91, Amended 10-1-92, Formerly 21S-28.830, 61F10-28.830, 59X-28.830, 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: February 6, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: February 26, 2018