To provide additional information to licensees who register as Dispensing Practitioners regarding statutory and legal obligations associated with dispensing prescription medications for a fee.

Notice of Proposed Rule

 

DEPARTMENT OF HEALTH

Board of Optometry

RULE NO.:RULE TITLE:

64B13-4.009Dispensing Practitioner Registration

PURPOSE AND EFFECT: To provide additional information to licensees who register as Dispensing Practitioners regarding statutory and legal obligations associated with dispensing prescription medications for a fee.

SUMMARY: Provide additional information regarding statutory and legal obligations with which all dispensing practitioners must comply.

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: The proposed rule amendments incorporate existing statutory requirements. Because the rule amendments do not impose new or additional requirements on licensees, small businesses or government, the Board does not foresee any cost increases. To the contrary, the Board anticipates this clarification of statutory requirements will reduce time, effort, delay and regulatory burdens associated with licensees attempting to locate statutory provisions on their own.

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: 463.005 FS.

LAW IMPLEMENTED: 465.0276 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE ANNOUNCED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE REGISTER.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Adrienne Rodgers, Executive Director, Board of Optometry, 4052 Bald Cypress Way, Bin #C07, Tallahassee, Florida 32399-3257, [phone]

 

THE TEXT OF THE PROPOSED RULE IS:

 

64B13-4.009 Dispensing Practitioner Registration.

(1) Section 465.0276, Florida Statutes, requires that licensees, who dispense medicinal drugs for a fee or remuneration of any kind, whether direct or indirect in the State of Florida, shall be required to register with the Board and pay a fee of $100. Dispensing Practitioners are required to comply with all laws and rules applicable to pharmacists and pharmacies, including, but not limited to Chapter 465, Florida Statutes (Pharmacy Practice Act), Chapter 499, Florida Statutes (Florida Drug and Cosmetic Act), and Chapter 893, Florida Statutes (Controlled Substance Act), and all federal laws and federal regulations. Before dispensing any drug, the dispensing practitioner is required by Section 465.0276(2)(c), Florida Statutes, to give the patient a written prescription and orally or in writing advise the patient that the prescription may be filled in the practitioner’s office or at any pharmacy. It is unlawful for any person to sell samples or complimentary packages of drug products. Practitioners who confine their activities to the dispensing of complimentary packages of medicinal drugs to their patients in the regular course of their practice shall not be required to register. Registered dispensing practitioners who choose to stop dispensing shall notify the Board that they are no longer dispensing. Renewal of dispensing registration runs concurrent with license renewal.

(2) A licensee may dispense medicinal drugs to his or her patients in the regular course of his or her practice provided that the licensee is registered as a dispensing practitioner with the Board. To register as a dispensing practitioner, the licensee must submit a Dispensing Practitioner Registration, form number DH-MQA 1137, (8/08), and the fees set forth in Rule 64B13-6.003, F.A.C. The form is incorporated by reference herein and can be obtained available from the Board office or at http://floridasoptometry.gov or http://www.flrules.org/Gateway/zzz. website: http://www.doh.state.fl.us/mqa/optometry/index.html. Dispensing practitioners must comply with all provisions of Section 465.0276, F.S.

Rulemaking Authority 463.005 FS. Law Implemented 465.0276 FS. History–New 3-31-09, Amended___________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Optometry

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 23, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 27, 2014