64B-7.003: Counterfeit-Resistant Prescription Blanks
PURPOSE AND EFFECT: This rule will implement new provisions in the law regarding pain-management clinic controlled substance prescriptions.
SUMMARY: Considering that physicians who write scripts to prescribe controlled substances at pain-management clinics must use counterfeit-resistant prescription blanks, this rule specifies the security features that a counterfeit-resistant prescription must include for compliance with the statute.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: The agency has determined that this rule will have an impact on small business. A SERC has been prepared by the agency. The Statement of Estimated Regulatory Costs provides the number of clinics with physicians likely to be affected by the rule, indicates that only enforcement costs may impact the agency, but there will be no impact on state or local revenues. It indicates that there will be some transactional costs for those physicians not already complying relating to the high quality of the paper and the number of prescriptions written. The rule is anticipated to have a minor impact on small business, but no impact on small counties and cities, and no alternatives have been proposed.
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: 456.004, 458.3265(4), 459.0137(4) FS.
LAW IMPLEMENTED: 458.3265, 459.0137, 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: Larry McPherson, Executive Director, Division of Medical Quality Assurance, 4052 Bald Cypress Way, Bin #C03, Tallahassee, Florida 32399-3253
THE FULL TEXT OF THE PROPOSED RULE IS:
64B-7.003 Counterfeit-Resistant Prescription Blanks.
(1) A physician who prescribes on the premises of a registered pain-management clinic must use a counterfeit-resistant prescription blank when writing a hard copy prescription for a controlled substance listed in Section 893.03, F.S.
(2) The counterfeit-resistant prescription blank must contain the following security features:
(a) The background color must be blue or green and resist reproduction;
(b) The blank must be printed on watermarked paper;
(c) The blank must resist erasures and alterations and;
(d) 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:
(a) The preprinted name of the prescribing physician and the address of the clinic;
(b) A space for the prescribing physicians 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 physician.
(5) Within 24 hours following the theft or loss of a prescription blank or the discovery of a breach with regard to the prescribing of controlled substances, the physician must notify the department in writing at e-mail address MQA_Medicine@doh.state.fl.us or by letter to Department of Health, Pain Clinic Registration Program, 4052 Bald Cypress Way, Bin #C03, Tallahassee, FL 32399-3253.
Rulemaking Authority 456.004, 458.3265(4), 459 0137(4) FS. Law Implemented 458.3265, 459.0137, 893.065 FS. History New________.
