24 Del. Admin. Code § 2501-5.0
Current through Register Vol. 28, No. 5, November 1, 2024
Section 2501-5.0 - Tamper Resistant Form Requirements5.1 Secure Stock. All paper utilized in the production of tamper resistant prescription forms must be manufactured under tightly controlled security conditions, restricted in its use and distribution.5.2 Vendors will be required to set all new copy on each prescription design. There are multiple versions that require design. Placement of design elements and security features must be consistent across all versions.5.3 General Composition. A safety VOID pantograph background is required on each design. The document shall include substantial protection against reproduction by color copiers. Preferred methods include darker and lighter gradually changing tones that provide significant color copy protection across a full range of copier settings. The word "VOID" shall appear on all copies made across a wide variety of copier settings. Areas intended for data entry shall be in lighter tones to permit easy reading of information without compromising copy protection.5.4 Custom Imprinting. Custom imprinting of the Prescription Forms will be required for each practitioner, group practice or institution. Printing will include name, street, city, state zip code, telephone number, State of Delaware license number, and the United States Drug Enforcement Agency (DEA) number (at the practitioner's option) of the practitioner(s) or institution as requested. All custom imprinting must be printed in black ink.5.5 Prescription Forms (Two Types - Practitioner and Institution).5.5.1 Size: Approximately 4-1/4 "x 5-1/2" overall.5.5.2 Stock. The stock must be a minimum 20# white controlled safety paper. The paper must react when alteration is attempted using the following list of chemicals: Acetone, Methyl Ethyl Ketone, Ethyl Acetate, Nail Polish Remover, Paint Remover, Benzyl Alcohol, Methyl Alcohol, N-Butyl Alcohol, Iso Propyl Alcohol, Ethyl Alcohol, Rubbing Alcohol, Hair Spray, 1-Methoxy-2-Propanol, Carbon Tetrachloride, Bleach, Tetrahydrofurane, Butyl Cellulose, 5% Hydrochloric Acid & Trichloroethylene.5.5.3 Presswork/Ink.5.5.3.1 FRONT: Blue or green background.5.5.3.2 BACK: The back shall contain an artificial watermark reading "Delaware Security Prescription" horizontally in a step-and -repeated pattern in 5 lines, using 12-point Helvetica bold type style, printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription and should change color or disappear when heated (reacts to body heat). It should return to its original color when cooled. The back shall also contain a chart listing all security features.5.5.3 Construction/Bindery. Pads are in sets of 100 prescriptions for shipment to practitioners and institutions across Delaware. A chipboard backer is required for each pad.5.6 Laser Sheets (1-Up Version). 5.6.1 Size: Approximately 8-1/2" x 11".5.6.2 Stock. the stock must be a minimum of 20# white controlled safety paper. The paper must react when alteration is attempted using the following list of chemicals: (Acetone, Methyl Ethyl Ketone, Ethyl Acetate, Nail Polish Remover, Paint Remover, Benzyl Alcohol, Methyl Alcohol, N-Butyl Alcohol, Iso Propyl Alcohol, Ethyl Alcohol, Rubbing Alcohol, Hair Spray, 1- Methoxy-2-Propanol, Carbon Tetrachloride, Bleach, Tetrahydrofurane, Butyl Cellulose, 5% Hydrochloric Acid & Trichloroethylene).5.6.3 Presswork/Ink:5.6.3.1 FRONT: Blue or green background. All text, not including logos, must be black. Must also contain color copy VOID Pantograph5.6.3.2 BACK: The back shall contain an artificial watermark reading "Delaware Security Prescription" horizontally in a step-and -repeated pattern in 5 lines, using 12-point Helvetica bold type style, printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription and should change color or disappear when heated (reacts to body heat). It should return to its original color when cooled. The back shall also contain a chart listing all security features.5.7 Laser Sheets (4-Up Version):5.7.1 Size: Approximately Four individual 4-1/4" x 5-1/2" forms up on an approximately 8-1/2" x 11" sheet.5.7.2 Stock. the stock must be a minimum of 20# white controlled safety paper. The stock utilized must be unavailable on the consumer market (unavailable in retail stores or stored in unsecured print facilities). The paper utilized must be designed and function effectively across a wide range of laser printing devices. The paper must react when alteration is attempted using the following list of chemicals: (Acetone, Methyl Ethyl Ketone, Ethyl Acetate, Nail Polish Remover, Paint Remover, Benzyl Alcohol, Methyl Alcohol, N-Butyl Alcohol, Iso Propyl Alcohol, Ethyl Alcohol, Rubbing Alcohol, Hair Spray, 1- Methoxy-2-Propanol, Carbon Tetrachloride, Bleach, Tetrahydrofurane, Butyl Cellulose, 5% Hydrochloric Acid & Trichloroethylene).5.7.3 Presswork/Ink: 5.7.3.1 FRONT: Blue or green background. All text, not including logos, must be black Must also contain color copy VOID Pantograph5.7.3.2 BACK: The back shall contain an artificial watermark reading "Delaware Security Prescription" horizontally in a step-and -repeated pattern in 5 lines, using 12-point Helvetica bold type style, printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription and should change color or disappear when heated (reacts to body heat). It should return to its original color when cooled. The back shall also contain a chart listing all security features.5.7.4 Perforations: Laser cross perforations (full horizontal & full vertical) divide each sheet into approximately 4 equal sections that measure 4-1/4"x 5-1/2". Perforations must be compatible with a laser printing environment the paper must feed effectively and operate trouble-free across a wide range of laser devices by various manufacturers.5.8 Thermal Rolls:5.8.1 Size: Individual form size is approximately 4-1/4 "x 5-1/2".5.8.2 Stock. A heavy weight, high sensitivity, direct thermal paper grade with an average basis weight of 20.4 lbs. (76.8 grams/m2). The thickness should be an average of 3.26 Mils (82.8 Microns). The grade should have an enhanced coating design with resistance to reasonable environmental conditions. The grade should provide a clear, dark image that is consistent and suitable for high quality bar code imaging. The optimum activation temperature at 194+/- 9 degrees F (90 +/- 5 degrees C) should result in a density reading of 1.3 ODU. The thermal grade should have an image stability or archivability rating such that after imaging with reasonable storage, the image will remain human readable for a minimum of 10 years.5.8.3 Presswork/Ink: 5.8.3.1 FRONT: Must also contain color copy VOID Pantograph.5.8.3.2 BACK: The back shall contain an artificial watermark reading "Delaware Security Prescription" horizontally in a step-and -repeated pattern in 5 lines, using 12-point Helvetica bold type style, printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription and should change color or disappear when heated (reacts to body heat). It should return to its original color when cooled. The back shall also contain a chart listing all security features.5.8.4 This is a direct thermal roll product.5.9 Intermic Thermal Rolls. 5.9.1 Size: Individual form size is approximately 4-1/4" x 5-1/2".5.9.2 Stock. A heavy weight, high sensitivity, direct thermal paper grade with an average basis weight of 20.4 lbs. (76.8 grams/m2). The thickness should be an average of 3.26 Mils (82.8 Microns). The grade should have an enhanced coating design with resistance to reasonable environmental conditions, such as 24 hour immersion in water. The grade should provide a clear, dark image that is consistent and suitable for high quality bar code imaging. The optimum activation temperature at 194+/- 9 degrees F (90 +/- 5 degrees C) should result in a density reading of 1.3 ODU. The thermal grade should have an image stability or archivability rating such that after imaging with reasonable storage, the image will remain human readable for a minimum of 10 years.5.9.3 Presswork/Ink: 5.9.3.1 FRONT: Blue or green background. All text, not including logos, must be black.5.9.3.2 BACK: The back shall contain an artificial watermark reading "Delaware Security Prescription" horizontally in a step-and -repeated pattern in 5 lines, using 12-point Helvetica bold type style, printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription and should change color or disappear when heated (reacts to body heat). It should return to its original color when cooled. The back shall also contain a chart listing all security features. ]
24 Del. Admin. Code § 2501-5.0