64B-3.005: Counterfeit-resistant Prescription Blanks for Controlled Sustance Prescribing
PURPOSE AND EFFECT: Due to statutory changes, the rule must be amended to reflect that use of counterfeit-proof prescription blanks or pads is mandatory. Due to statutory changes, the Department also must impose additional requirements and approve vendors of counterfeit-proof prescription pads.
SUMMARY: This rule specifies the security features that must be included to obtain approval for use as a counterfeit-proof prescription pad. The rule incorporates an application for the approval of counterfeit-proof prescription pad vendors and describes the responsibilities of approved vendors including submission of a monthly report.
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 been prepared by the agency.
The SERC estimates the number of entities likely to be affected by the rule, and reflects that most of the costs were imposed by the existing rule and are as mandated by the statute. It also reflects that there will be no impact on state or local revenues.
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 agency does not anticipate the need for ratification as the amendment of this rule will not have the adverse impact or regulatory costs in excess of $1 million in five years as established in Section 120.541(2)(a)1., 2. and 3., F.S.
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: 456.42, 893.065 FS.
LAW IMPLEMENTED: 456.42, 893.065 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Lola Pouncey, Bureau Chief, Division of Medical Quality Assurance, Bureau of Operations, 4052 Bald Cypress Way, Bin #BCO-01, Tallahassee, Florida 32399-3260 or by e-mail at lola_pouncey@doh.state.fl.us
THE FULL TEXT OF THE PROPOSED RULE IS:
64B-3.005 Counterfeit-Proof Resistant Prescription Pads or Blanks for Controlled Substance Prescribing.
(1) A practitioner authorized in this state to prescribe prescription drugs (hereinafter referred to as “prescribing practitioner”) must may use a counterfeit-proof resistant prescription pad or blank produced by a vendor approved by the department when writing hard copy prescription(s) for controlled substances listed in Chapter 893, Schedule II, Schedule III, or Schedule IV of Section 893.03, F.S.
(2) The counterfeit-proof resistant prescription pad or blank must may contain the following security features which must be present on the blank:
(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 resistant prescription pad or blank must contain the following information:
(a) The preprinted name, address and category of professional licensure of the prescribing practitioner or the name and address of the healthcare facility and;
(b) A space for the prescribing practitioner’s name if not preprinted and federal Drug Enforcement Administration registration number for controlled substances;
(c) The vendor’s unique tracking number, as described in (5)(c), printed on the front and readily visible; and
(d) A description of the security features.
(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 (07/11), 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.
(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) Maintain a secure facility and safeguards for operational processes that ensure the integrity of receiving, verifying, manufacturing, storing, distributing to intended parties, and recalling or voiding counterfeit-proof prescription pad or blank orders received from prescribing practitioners or healthcare facilities;
(b) Receive orders in writing signed by an authorized prescribing practitioner or healthcare facility;
(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;
(d) Ship counterfeit-proof prescription pads or blanks in sturdy containers that resist loss or damage to the prescription pads or blanks. The product must be shipped by the vendor or a reliable shipping firm that uses tracking numbers to locate missing shipments or verifies delivery to the authorized prescribing practitioner or healthcare facility;
(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 prescriber 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;
(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
(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.
(6) The counterfeit-proof resistant prescription pad or blank is not transferable and shall not be used by any person other than the prescribing practitioner whose name appears on the pad or blank or who is authorized to use the pad or blank by the healthcare facility.
Rulemaking Specific Authority 456.42, 893.065 FS. Law Implemented 456.42, 893.065 FS. History–New 6-26-08, Amended ________.