Change of Ownership, Centralized Prescription Filling, Delivering and Returning, Transmission of Starter Dose Prescriptions for Patients in Class I Institutional or Modified II B Facilities, Class II Institutional Pharmacies – Automated Distribution ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NOS.:RULE TITLES:

64B16-28.2021Change of Ownership

64B16-28.450Centralized Prescription Filling, Delivering and Returning

64B16-28.503Transmission of Starter Dose Prescriptions for Patients in Class I Institutional or Modified II B Facilities

64B16-28.605Class II Institutional Pharmacies – Automated Distribution and Packaging

64B16-28.606Remote Medication Order Processing for Class II Institutional Pharmacies

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

64B16-28.702Modified Class II Institutional Pharmacies

NOTICE OF CORRECTION

Notice is hereby given that the following correction has been made to the proposed rule in Vol. 40, No. 59, March 26, 2014 issue of the Florida Administrative Register.

The correction is as follows:

The Summary of Statement of Estimated Regulatory Costs and Legislative Ratification should have read: SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST 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 proposed rule at its Board meeting, the Board, with input from the public, determined that record maintenance for 4 years would not have an adverse effect on small business, and that there would not be a regulatory cost of $200,000 in the aggregate to any entity. Change of ownership documentation and quality assurance program reports and analyses are not high volume records and would not pose a burden to maintain an additional two years. The 4 year maintenance of prescription records is required by Section 465.022(12)(b), F.S.

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.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Patrick Kennedy, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254