The proposed amendment ensures that pharmaceuticals and biologics, the efficacies of which are temperature sensitive, are stored in a fashion consistent with manufacturer's protocol when said items are utilized by Veterinarians whose practice ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Board of Veterinary Medicine

RULE NO.:RULE TITLE:

61G18-15.0025Minimum Standards for a Mobile Veterinary Practice for Agricultural Animals

PURPOSE AND EFFECT: The proposed amendment ensures that pharmaceuticals and biologics, the efficacies of which are temperature sensitive, are stored in a fashion consistent with manufacturer's protocol when said items are utilized by Veterinarians whose practice requires the administration of same in an agricultural venue away from an established veterinary premise.

SUMMARY: Storage of pharmaceuticals and biologics.

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: 474.206, 474.215(6) FS.

LAW IMPLEMENTED: 474.215(6) 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: Juanita Chastain, Executive Director, Division of Professions, Board of Veterinary Medicine, 1940 N. Monroe Street, Tallahassee, FL 32399-0783

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61G18-15.0025 Minimum Standards for a Mobile Veterinary Practice for Agricultural Animals.

The following minimum standards shall apply to mobile veterinary medical practices for agricultural animals:

(1) Mobile units utilized by veterinarians:

(a) Shall be clean and orderly.

(b) Shall contain the following:

1. Sterile syringes and needles.

2. All pharmaceuticals and biologics shall be maintained at the temperature recommended by the manufacturer in a refrigeration device that is powered by a stable energy source and is capable of maintaining a constant temperature. A thermometer shall be included where the biologics are being stored. Properly stored biologics.

3. through 7. No change.

(2) through (4) No change.

Rulemaking Authority 474.206, 474.215(6) FS. Law Implemented 474.215(6) FS. History–New 7-4-95, Amended 7-22-10, 9-26-12,_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Veterinary Medicine

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Veterinary Medicine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 4, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 9, 2014