The Board proposes the rule amendment to update language regarding security requirements.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.607Automated Pharmacy System – Long-Term Care, Hospice, and Prison

PURPOSE AND EFFECT: The Board proposes the rule amendment to update language regarding security requirements.

SUMMARY: Language regarding security requirements will be updated

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: 465.019, 465.022, 465.0235 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: Jennifer Wenhold, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.607 Automated Pharmacy System – Long Term Care, Hospice, and Prison.

(1) through (4) No change.

(5) Security Requirements.

(a) If a provider pharmacy intends to store a controlled substance in an automated pharmacy system:

1. It shall maintain a separate DEA registration for each remote site at which a controlled substance is stored, unless the automated pharmacy system is solely used as an emergency kit pursuant to Rule 59A-4.112, F.A.C.

2. No change.

(b) through (d) No change.

(6) through (7) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.019, 465.022, 465.0235 FS. History–New 4-22-07, Amended 1-1-10, 7-14-14,                                      .

 

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 18, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 3, 2019