The Board proposes the rule amendments to implement HB 675 which created a new permit, Class III Institutional Pharmacies.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NOS.:RULE TITLES:

64B16-28.501Consultant Pharmacist of Record; Initial Designation; Change

64B16-28.502Class I Institutional Permit and Class II Institutional Permit - Labels and Labeling of Medicinal Drugs for Inpatients of a Nursing Home

64B16-28.602Institutional Class II Dispensing

64B16-28.6021Institutional Class II Pharmacy - Emergency Department Dispensing

64B16-28.603Class II Institutional Pharmacy Operating Hours

64B16-28.606Remote Medication Order Processing for Class II Institutional Pharmacies or Special Pharmacy Permits Servicing Class I, Class II, Modified Class II, and Special ALF Permitted Facilities

64B16-28.810Special Pharmacy - Limited Community Permit

PURPOSE AND EFFECT: The Board proposes the rule amendments to implement HB 675 which created a new permit, Class III Institutional Pharmacies.

SUMMARY: Class III Institutional pharmacy permits will be added to the rules.

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, 465.0125, 465.022 465.005, 465.022 , 465.019(4) FS.

LAW IMPLEMENTED: 465.0125, 465.019, 465.022, 465.0266, 465.022(1), 465.019(2)(b), (4), 465.0196, 465.026 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:

 

64B16-28.501 Consultant Pharmacist of Record; Initial Designation; Change.

(1) through (2) No change.

(3) Drug Regimen Reviews. The consultant pharmacist of record for a Class I, Class II, or Modified Class II, or Class III Iinstitutional permit shall conduct Drug Regimen Reviews as required by Federal or State law, inspect the facility and prepare a written report to be filed at the permitted facility at least monthly. In addition, the consultant pharmacist of record must monitor the facility system for providing medication administration records and physician order sheets to ensure that the most current record of medications is available for the monthly drug regimen review. The consultant pharmacist of record may utilize additional consultant pharmacists to assist in this review and in the monthly facility inspection.

(4) No change.

Rulemaking Authority 465.005, 465.0125, 465.022 FS. Law Implemented 465.0125, 465.019, 465.022, 465.0266 FS. History–New 7-18-94, Formerly 61F10-28.501, 59X-28.501, Amended 1-2-02, 12-30-07, 11-5-17, 6-5-18,                             .

 

64B16-28.502 Class I, Class II and Class III Institutional Permit and Class II Institutional Permit – Labels and Labeling of Medicinal Drugs for Inpatients of a Nursing Home.

(1) The label affixed to a container used in conventional dispensing to a Class I Institutional permit or a Class II or Class III Institutional permit which, within the scope of its practice, services only the inpatients of a nursing home as defined by subsection 400.021(5), F.S., shall contain at least the following information:

(a) through (h) No change.

(2) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022(1) FS. History–New 7-31-91, Amended 10-1-92, Formerly 21S-28.502, 61F10-28.502, 59X-28.502, Amended 8-16-10,                                         .

 

64B16-28.602 Institutional Class II and Class III Dispensing.

(1) No change.

(2) A Class II or Class III Iinstitutional pharmacy may contract with a Special Parenteral/Enteral Extended Scope pharmacy for the pharmacy services provided for by rule 64B16-28.860, F.A.C.

(a) through (c) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.019(2)(b), 465.0196, 465.022(1) FS. History–Amended 5-19-72, Repromulgated 12-18-74, Amended 10-10-78, Formerly 21S-1.11, 21S-1.011, Amended 7-31-91, Formerly 21S-28.602, 61F10-28.602, Amended 9-4-96, Formerly 59X-28.602, Amended 8-16-10,                                        .

 

64B16-28.6021 Institutional Class II and Class III Pharmacy – Emergency Department Dispensing.

(1) Individuals licensed to prescribe medicinal drugs in this state may dispense from the emergency department of a hospital holding a Cclass II or Class III Iinstitutional pharmacy permit. Such dispensing must meet the requirements provided in subsection 465.019(4), F.S., and this section.

(2) through (4) No change.

Rulemaking Authority 465.005, 465.019(4), 465.022 FS. Law Implemented 465.019(2)(b), (4), 465.0196, 465.022(1) FS. History–New 9-20-99, Amended 8-16-10,                                 .

 

64B16-28.603 Class II and Class III Institutional Pharmacy Operating Hours.

Any person who receives a Class II or Class III Institutional permit pursuant to section 465.019, F.S., and commences to operate such a pharmacy shall, for the benefit of the institutions’ patients’ health and welfare, keep the pharmacy of the establishment open for a sufficient number of daily operating hours required to provide adequate and quality pharmaceutical services to the patients of said institution.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022(1) FS. History–New 7-31-91, Formerly 21S-28.603, 61F10-28.603, 59X-28.603, Amended                             .

 

64B16-28.606 Remote Medication Order Processing for Class II or Class III Institutional Pharmacies or Special Pharmacy Permits Servicing Class I, Class II, Modified Class II, Class III, and Special ALF Permitted Facilities.

(1) Definitions.

(a) “Remote Medication Order Processing” includes any of the following activities performed for a Class II or Class III Institutional Pharmacy or for Special Pharmacy Permits servicing Class I, Class II, Modified Class II, Class III, and Special ALF permitted facilities from a remote location:

1. through 8. No change.

(b) through (c) No change.

(2) General requirements.

(a) No change.

(b) A Class II or Class III Institutional pharmacy or Special Pharmacy servicing Class I, Class II, Modified Class II, Class III, and Special ALF permitted facilities may utilize remote medication order processing if the pharmacist performing the remote medication order processing has access to sufficient patient information necessary for prospective drug use review and approval of medication orders.

(c) No change.

(d) If the pharmacist performing remote medication order processing is not an employee of the pharmacy, the Class II or Class III Institutional pharmacy or Special Pharmacy servicing Class I, Class II, Modified Class II, Class III, and Special ALF permitted facilities must have a written agreement or contract with the pharmacist or entity employing the pharmacist. The written agreement or contract shall:

1. through 4. No change.

(3) No change.

(4) Records.

(a) A Class II or Class III Institutional Pharmacy or Special Pharmacy Permits servicing Class I, Class II, Modified Class II, Class III, and Special ALF permitted facilities involved in remote medication order processing shall maintain a record that identifies the name, initials, or identification code of each person who performed a processing function for every medication order. The record shall be available by medication order or by patient name.

(b) through (d) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.019, 465.022, 465.026, 465.0266 FS. History–New 11-29-04, Amended 7-14-14, 7-19-17,                                            .

 

64B16-28.810 Special Pharmacy – Limited Community Permit.

A Special-Limited Community Permit shall be obtained by a Class II or Class III Institutional Pharmacy that dispenses medicinal drugs, including controlled substances to:

(1) through (4) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.0196 FS. History–New 7-31-91, Formerly 21S-28.810, 61F10-28.810, 59X-28.810, Amended 7-17-05, 2-10-14,                          .

 

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: June 12, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 6, 2018