The Board proposes the rule promulgation to provide instructions regarding delivery of medicinal drugs.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.10801All Permits -- Delivery of Medicinal Drugs.

PURPOSE AND EFFECT: The Board proposes the rule promulgation to provide instructions regarding delivery of medicinal drugs.

SUMMARY: Instructions will be provided regarding the delivery of medicinal drugs.

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(1) FS.

LAW IMPLEMENTED: 465.022(1)(a) 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 C08, Tallahassee, Florida 32399-3258.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.10801 All Permits – Delivery of Medicinal Drugs.

(1) Neither a pharmacy nor a pharmacist shall dispense or deliver any adulterated medicinal drugs. 

(2) All pharmacies regulated under chapter 465, F.S., must have and follow policies and procedures to ensure medicinal drugs are not adulaterated as defined in s. 499.006, F.S, at the time of reciept by the patient or their agent.

(3) The policies and procedures must include providing instructions to the patient on reporting concerns with delivery and storage of medicinal drugs.

Rulemaking Authority 465.005, 465.022(1) FS. Law Implemented 465.022(1)(a) FS. History–New _____________.

 

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: August 5, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 23, 2019