Section 456.42(2), Florida Statutes, requires approved vendors submit a monthly report to the Florida Department of Health that documents the number of prescription pads sold and identifies the purchasers.
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Pad Specifications
To ensure the quality and 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:
Prescription Pads
To ensure the quality and security of counterfeit-proof prescription pads, a vendor must agree to produce a counterfeit-proof prescription pad or blank that meets minimum specifications as required by Florida law.
- Background color must be blue or green and resist reproduction.
- Pad or blank must be printed on artificial watermarked paper.
- Pad or blank must resist erasures and alterations.
- The word โvoidโ or โillegalโ 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.
Vendor Application
A prospective vendor must submit a complete a counterfeit-proof prescription pad vendor application for review and approval before the vendor will be added to the
Florida Department of Healthโs approved vendor list.
Counterfeit-proof prescription pad or blank must contain the following information:
- Preprinted name, address, and category of professional licensure of the prescribing practitioner or the name and address of the health care facility.
- Space for the prescribing practitioners name if not preprinted and U.S. Drug Enforcement Administration registration number for controlled substances.
- Place to indicate if โNONACUTE PAINโ if the prescription is for the treatment of pain other than acute pain.
- Place to indicate โACUTE PAIN EXCEPTIONโ if the prescription is for the treatment of acute pain with exception as specified in section 456.44, F.S.
- 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 vendorโs 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.
Production & Distribution
An approved vendor must agree to take responsibility for the secure production and distribution of the prescription blanks to licensed health care 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 health care 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 health care practitioner or health care facilities.
- Collect payment for prescription pads from the licensed healthcare practitioner or health care 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 health care practitioners.
- Submit a monthly report to the Department which, at a minimum, documents the number of prescription pads sold and identifies the purchasers.ย This report must be received in by the Florida Department of Health 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.
