The Department proposes to promulgate a new rule to address the creation and content of counterfeit-resistant prescription blanks in accordance with Section 893.065, Florida Statutes (2007).  


  • RULE NO: RULE TITLE
    64B-3.005: Counterfeit-Resistant Prescription Pads
    PURPOSE AND EFFECT: The Department proposes to promulgate a new rule to address the creation and content of counterfeit-resistant prescription blanks in accordance with Section 893.065, Florida Statutes (2007).
    SUMMARY: The proposed rule will provide the form and content for a counterfeit-resistant prescription blank which may be used by practitioners for the purpose of prescribing a controlled substance listed in Schedule II, Schedule III, or Schedule IV of Section 893.03, Florida Statutes. The rule provides for security features that must be present on the blanks, limits the transfer of the blanks and prohibits their use by someone other than the prescribing practitioner.
    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
    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.
    SPECIFIC AUTHORITY: 893.065 FS.
    LAW IMPLEMENTED: 893.065 FS.
    IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca Poston, R.Ph., Executive Director, Drugs Devices and Cosmetics Program, 4052 Bald Cypress Way, Mail Bin C-04, Tallahassee, Florida 32399, (850)245-4292

    THE FULL TEXT OF THE PROPOSED RULE IS:

    64B-3.005 Counterfeit-Resistant Prescription Blanks For Controlled Substance Prescribing.

    (1) A practitioner authorized in this state to prescribe prescription drugs (hereinafter referred to as “prescribing practitioner” may use a counterfeit-resistant prescription blank when writing hard copy prescription(s) for controlled substances listed in Schedule II, Schedule III, or Schedule IV of Section 893.03, Florida Statutes.

    (2) The counterfeit-resistant prescription blank must contain the following security features which must be present on the blank:

    1. The background color must be blue or green and resist reproduction;

    2. The blank must be printed on watermarked paper;

    3. The blank must resist erasures and alterations and;

    4. The word “void” or “illegal” must appear on any photocopy or other reproduction of the blank. This language shall not obstruct or render illegible any portion of the drug name, quantity or directions for use.

    (3) The counterfeit-resistant prescription blank must contain the following information:

    1. The preprinted name, address and category of professional licensure of the prescribing practitioner and;

    2. A space for the prescribing practitioner’s federal Drug Enforcement Administration registration number for controlled substances.

    (4) The counterfeit-resistant prescription blank is not transferable and shall not be used by any person other than the prescribing practitioner.

    Specific Authority 893.065 FS. Law Implemented 893.065 FS. History–New_________.


    NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca Poston
    NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Rebecca Poston
    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 24, 2008
    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: September 21, 2007

Document Information

Comments Open:
4/25/2008
Summary:
The proposed rule will provide the form and content for a counterfeit-resistant prescription blank which may be used by practitioners for the purpose of prescribing a controlled substance listed in Schedule II, Schedule III, or Schedule IV of Section 893.03, Florida Statutes. The rule provides for security features that must be present on the blanks, limits the transfer of the blanks and prohibits their use by someone other than the prescribing practitioner.
Purpose:
The Department proposes to promulgate a new rule to address the creation and content of counterfeit-resistant prescription blanks in accordance with Section 893.065, Florida Statutes (2007).
Rulemaking Authority:
893.065 FS.
Law:
893.065 FS.
Contact:
Rebecca Poston, R.Ph., Executive Director, Drugs Devices and Cosmetics Program, 4052 Bald Cypress Way, Mail Bin C-04, Tallahassee, Florida 32399, (850)245-4292
Related Rules: (1)
64B-3.005. Counterfeit-resistant Prescription Blanks for Controlled Sustance Prescribing