RULE NO.: RULE TITLE:
64B-3.005: Counterfeit-resistant Prescription Blanks for Controlled Sustance Prescribing

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 38 No. 3, January 20, 2012 issue of the Florida Administrative Weekly.

(1) No change.

(2)(4) Any person or entity desiring to produce counterfeit-proof prescription pads or blanks for use by prescribing practitioners shall apply to the department for approval. The application shall be made on incorporated by reference form DH-MQA 1250 (03/12), Application for Counterfeit-Proof Prescription Pad Vendor, which can be obtained at ________ or from the department at Department of Health, 4052 Bald Cypress Way, Bin BCO-01, Tallahassee, Florida 32399-3260, or online at http://www.doh.state.fl.us/mqa/counterfeit-proof.html. To obtain approval, the counterfeit-proof prescription pad or blank must contain the following security features:

(a) The background color must be blue or green and resist reproduction;

(b) The pad or blank must be printed on artificial watermarked paper;

(c) The pad or blank must resist erasures and alterations and;

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

(3) The counterfeit-proof prescription pad or blank must contain the following information:

(a) through (b) No change.

(5)(c) Print A unique tracking identification number for each order on the front of the counterfeit-proof prescription pad or blank. The number must consist of three subsets: (1) a unique alphabetic prefix that readily identifies the vendor, (2) the date of printing, and (3) a batch number. The alpha prefix used to identify the vendor will be assigned by the department and must appear in upper case. The date of printing must immediately follow the vendors’s unique alpha identifier and must be presented in six character numerical field using the format YRMODY. The batch number assigned by the vendor must immediately follow the print date and consist of numerical characters and must not contain spaces or special characters (e.g., dashes, periods, commas, slashes, alpha characters). From left to right, the tracking identification number must appear as alpha prefix, print date, and then batch number, with no blank spaces between subsets.

(4)(5) Vendors approved to produce counterfeit-proof prescription pads or blanks are responsible for the secure production and distribution of the counterfeit-proof prescription pads or blanks to prescribing practitioners. Approved vendors must:

(a)(b) Receive orders in writing signed by an authorized prescribing practitioner or healthcare facility;

(b)(e) Maintain records and information about the production and distribution of counterfeit-proof prescription pads or blanks. A unique tracking identification number and the name of the authorized presciber or healthcare facility that purchased the prescription pad or blank must be maintained and made available to the department upon request. The department may request random inspections of the counterfeit-proof prescription pads or blanks produced by the vendor;

(c)(f) Destroy counterfeit-proof prescription pads or blanks unused by the prescriber or healthcare facility for which they were produced and returned to the vendor; and

(d)(g) Submit a monthly report to the department documenting the name of the prescribing practitioner or healthcare facility who purchased counterfeit-proof prescription pads or blanks, the batch number assigned to the counterfeit-proof prescription pad or blank order, and the number of pads or blanks sold. This report must be submitted to the department within 15 business days after the end of the reporting month.

(5)(6) No change.

With regard to the form incorporated by reference in the rule, clerical errors were corrected, the rule text was inserted in lieu of certain statements, and changes were made to reflect that certain information is optional and not used to determine whether the application is approved.