Section 456.42(2), Florida Statutes, requires licensed health-care practitioners purchase counterfeit-proof prescription pads or blanks from vendors approved by the Department of Health. A prospective vendor must submit a complete and legible Counterfeit-Proof Prescription Pad Vendor application and received approval from the Department before being added to the approved vendor list. Vendors must agree to produce a counterfeit-proof prescription pad or blank that meets the minimum specifications and take responsibility for the secure production and distribution of the prescription blanks to licensed healthcare practitioners.
If you are currently approved by the Agency for Health Care Administration to manufacture and distribute counterfeit-proof prescription blanks to Medicaid providers, please contact the Division of Medical Quality Assurance, Board of Pharmacy, at (850) 245-4292 for information about becoming an approved vendor for the Department of Health.
To ensure the quality and security of counterfeit-proof prescription pads provided by the vendor, the vendor must agree to produce a counterfeit-proof prescription pad or blank that meets the minimum specifications listed below:
- The background color must be blue or green and resist reproduction;
- The pad or blank must be printed on artificial watermarked paper;
- The pad or blank must resist erasures and alterations and;
- 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.
- The counterfeit-proof prescription pad or blank must contain the following information:
- The preprinted name, address and category of professional licensure of the prescribing practitioner or the name and address of the healthcare facility;
- A space for the prescribing practitioners name if not preprinted and federal Drug Enforcement Administration registration number for controlled substances;
- 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:
- a unique alphabetic prefix that readily identifies the vendor
- the date of printing
- 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.
An approved vendor must agree to take responsibility for the secure production and distribution of the prescription blanks to licensed healthcare practitioners to include:
- Maintain a secure facility and safeguards for the operational processes that ensure the integrity of receiving, verifying, manufacturing, storing, distributing to intended parties, and recalling or voiding counterfeit-proof prescription pad orders from licensed healthcare practitioners or healthcare facilities.
- Receive orders in writing signed by a licensed healthcare practitioner or health-care facility.
- Ship prescription pads in sturdy containers that resist loss or damage to the pads. The product must be shipped by the vendor or by a reliable shipping firm that uses tracking numbers to locate missing shipments or verifies delivery to licensed healthcare practitioner or healthcare facilities.
- Collect payment for prescription pads from the licensed healthcare practitioner or healthcare facility. The State of Florida is not responsible for any payments to the vendor for services or products.
- Maintain records and information about the production and distribution of counterfeit-proof prescription blanks for use by licensed healthcare practitioners.
- Submit a monthly report to the Department which, at a minimum, documents the number of prescription pads sold and identifies the purchasers. This report must be received in the Department by the 15th day of the following month upon which the generated report is based on.
- Comply with local, state, and federal statutes regulating the use of counterfeit-proof prescription pads.
- Allow the Department to inspect any facilities where the blanks are printed, produced, stored, or mailed. The Department may conduct random examinations of the blanks produced by the vendor.