Source: http://regulations.delaware.gov/register/june2011/proposed/14%20DE%20Reg%201311%2006-01-11.htm
Timestamp: 2018-08-16 06:52:14
Document Index: 586196264

Matched Legal Cases: ['§ 4797', '§4701', '§ 2502', '§ 2502', '§ 2502', '§ 4797', '§ 4797', 'art 2', 'art 1', 'art 2', 'art 1', 'art 2']

The Delaware Department of Homeland Security is promulgating rules and regulations pursuant to 16 Del. C. § 4797(c) of the Delaware Code affecting professionals licensed or registered under Title 24 and Title 16 of the Delaware Code having prescriptive authority. The proposed rules and regulations establish security requirements for a blank prescription form used by a prescriber or practitioner in this State. The primary objective of these rules and regulations is to reduce prescription fraud by decreasing the potential for forgery or alteration of a prescription form. The regulations shall be known as "Regulations Governing the Statewide Authorized Tamper Resistant Prescription Forms".
A public hearing will be held on July 13, 2011 at 9:00 a.m. in the second floor conference room B of the Cannon Building, 861 Silver Lake Boulevard, Dover before James L. Collins, Director of the Division of Professional Regulation, where members of the public can offer comments. The Director will also receive and consider input in writing from any person concerning the proposed regulations. Written comments should be submitted to James Collins, Director, Division of Professional Regulation, at the above address. The final date to submit written comments shall be at the public hearing. Anyone wishing to obtain a copy of the proposed regulations or to make comments at the public hearing should contact Shauna Slaughter, Administrative Specialist, at the above address or by calling (302) 744-4502.
The Department through the Director may consider promulgating the proposed regulations immediately following the public hearing.
2.2	Applicability. These regulations apply to any individual who is authorized by law to prescribe drugs in the course of professional practice and to any vendor in the business of manufacturing and selling tamper proof prescription forms to a Delaware practitioner or prescriber.
"Controlled Substance" shall mean a drug substance or immediate precursor in Schedules I through V as defined in 16 Del. C. Chap.47, Subchapter 2. There shall only be one controlled substance listed on each prescription form.
"Drugs" shall mean drugs as defined in 16 Del. C. §4701(14) or 24 Del.C. § 2502(14).
"Practitioner" or "Prescriber" shall mean prescriber as defined in 24 Del. C. § 2502(20). It shall not include any practitioner or prescriber generating prescriptions within a licensed medical facility that results in the internal dispensing of prescription drugs or devices to any patient receiving treatment in that facility.
"Provider ID #" shall mean the unique identification number assigned by a vendor to any individual, group or organization authorized to purchase tamper resistant prescription forms pursuant to 24 Del. C. § 2502(20) and these rules and regulations. The Provider ID # shall be a suffix to the serial number on the prescription forms as described in section 6.11.
"Tamper Resistant Prescription Form" or “Prescription Form” shall mean a prescription form which has been authorized pursuant to 16 Del. C. § 4797 and meets the criteria established in these rules and regulations.
"Vendor ID #" shall mean the unique identification number assigned by DPR to a registered vendor. Pursuant to 6.11, the Vendor ID # shall be displayed as a prefix to the serial number on the prescription form.
4.2	The Director shall establish and implement standards governing the production and issuance of authorized tamper resistant prescription forms pursuant to 16 Del. C. § 4797.
4.3	DPR may inspect facilities or records of vendors or require submission of information to demonstrate compliance with these rules.
5.1	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, and not readily available on the open market(unavailable in retail stores or stored in unsecured print facilities).
5.3	General Composition. A safety hollow VOID pantograph background is required on each design (a solid void pantograph is not acceptable). 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 that penetrates the paper fibers as a prescription fraud prevention requirement (Toner based imprinting is not permitted).
5.5.1	Size: 4-1/4 "x 5-1/2" overall, no bleeds.
5.5.2	Stock. The stock must be 24# white controlled safety paper. The paper must contain an invisible eradicator sensitive ink that shows the word "VOID" when tampering is attempted. A simple stain is not sufficient. 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.
5.5.3.1	FRONT: Prints 3 colors (black and other colors to be specified by DPR including a friction activated ink). The friction activated (thermochromic) ink on the face should be printed in blue and should change color or disappear when warmed (reacts to body heat). It should return to its original color (blue) when cooled. Must also contain color copy hollow VOID Pantograph as described under section 6.3, 6.5.2., and 7.1. There shall also be a tamper evident coating containing a hidden void feature. Under normal conditions, the feature is invisible. An erasure/abrasion attempt will activate the coating and the word VOID will appear.
5.5.3.2	BACK: Prints 3 colors (gray, white fluorescent & a friction activated ink). "Enhanced" Laid lines - unevenly spaced and sized diagonal lines printed in gray ink across the back of each prescription. The back shall also contain an artificial watermark identifying the vendor responsible for manufacturing the prescriptions forms printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. This feature must also appear fluorescent green under a black light. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription. The ink shall be printed in orange and should change color or disappear when warmed (reacts to body heat). It should return to its original color (orange) when cooled.
5.5.3	Construction/Bindery. Pads are edge glued in sets of 100 prescriptions for shipment to practitioners and institutions across Delaware. A chipboard backer is required for each pad.
5.6.1	Size: 8-1/2" x 11", no bleeds.
5.6.2	Stock. 24# 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 contain an invisible eradicator sensitive ink that shows the word "VOID", as defined under section 6.3 and 7.1, when tampering is attempted. A simple stain is not sufficient. 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).
5.6.3.1	FRONT: Prints 3 colors (black and other colors to be specified by DPR including a friction activated ink). The friction activated (thermochromic) ink on the face should be printed in blue and should change color or disappear when warmed (reacts to body heat). It should return to its original color (blue) when cooled. Must also contain color copy hollow VOID Pantograph as described under section 6.3, 6.6.2 and 7.1. An additional coating is required on the face to insure toner adhesion to the paper. This feature is commonly referred to as "toner grip" or "laser lock".
5.6.3.2	BACK: Prints 3 colors (gray, white fluorescent & a friction activated ink). "Enhanced" Laid lines - unevenly spaced and sized diagonal lines printed in gray ink across the back of each prescription. The back shall also contain an artificial watermark identifying the vendor responsible for manufacturing the prescription forms printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. This feature must also appear fluorescent green under a black light. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription. The ink shall be printed in orange and should change color or disappear when warmed (reacts to body heat). It should return to its original color (orange) when cooled.
5.7.1	Size: Four individual 4-1/4" x 5-1/2" forms up on an 8-1/2" x 11" sheet, no bleeds.
5.7.2	Stock. 24# 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 contain an invisible eradicator sensitive ink that shows the word "VOID", as defined under section 6.3 and 7.1, when tampering is attempted. A simple stain is not sufficient. 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).
5.7.3.1	FRONT: Prints 3 colors (black plus colors to be specified by DPR including a friction activated ink). The friction activated (thermochromic) ink on the face should be printed in blue and should change color or disappear when warmed (reacts to body heat). It should return to its original color (blue) when cooled. Must also contain color copy hollow VOID Pantograph as described under section 6.3 and 7.1. An additional coating is required on the face to insure toner adhesion to the paper. This feature is commonly referred to as "toner grip" or "laser lock".
5.7.3.2	BACK: Prints 3 colors (gray, white fluorescent & a friction activated ink). "Enhanced" Laid lines - unevenly spaced and sized diagonal lines printed in gray ink across the back of each prescription. The back shall also contain an artificial watermark identifying the vendor responsible for manufacturing the prescription forms printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. This feature must also appear fluorescent green under a black light. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription. The ink shall be printed in orange and should change color or disappear when warmed (reacts to body heat). It should return to its original color (orange) when cooled.
5.7.4	Perforations: Laser cross perforations (full horizontal & full vertical) divide each sheet into 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.
5.8.1	Size: Individual form size is 4-1/4 "x 5-1/2", no bleeds.
5.8.3.1	FRONT: Prints 3 colors (black and other colors to be specified by DPR including a friction activated ink.). The friction activated (thermochromic) ink on the face should be printed in blue and should change color or disappear when warmed (reacts to body heat). It should return to its original color (blue) when cooled. Must also contain color copy hollow VOID Pantograph as described under section 6.3 and 7.1.
5.8.3.2	BACK: Prints 4 colors (gray, black, white fluorescent & a friction activated ink). "Enhanced" Laid lines - unevenly spaced and sized diagonal lines printed in gray ink across the back of each prescription. The back shall also contain an artificial watermark identifying the vendor responsible for manufacturing the prescription forms printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. This feature must also appear fluorescent green under a black light. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription. The ink shall be printed in orange and should change color or disappear when warmed (reacts to body heat). It should return to its original color (orange) when cooled. Two timing marks must also be printed in black ink on the back of each individual prescription.
5.8.4	This is a direct thermal roll product that requires winding 500 prescriptions on each roll. Scripts are wound on a roll that utilizes a 1" plastic core. A core made of cardboard or other material is not acceptable.
5.9.1	Size: Individual form size is 4-1/4" x 5-1/2", no bleeds.
5.9.3.1	FRONT: Prints 3 colors (black plus colors to be specified by DPR including a friction activated ink). The friction activated (thermochromic) ink on the face should be printed in blue and should change color or disappear when warmed (reacts to body heat). It should return to its original color (blue) when cooled. Must also contain color copy hollow VOID Pantograph as described under section 6.3 and 7.1.
5.9.3.2	BACK: Prints 4 colors (gray, black, white fluorescent & a friction activated ink). "Enhanced" Laid lines - unevenly spaced and sized diagonal lines printed in gray ink across the back of each prescription. The back shall also contain an artificial watermark identifying the vendor responsible for manufacturing the prescription forms printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. This feature must also appear fluorescent green under a black light. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription. The ink shall be printed in orange and should change color or disappear when warmed (reacts to body heat). It should return to its original color (orange) when cooled. A timing mark that extends horizontally across the back of each script shall be printed in black ink.
5.9.4	This is a direct thermal roll product that requires winding 500 prescriptions on each roll. Prescriptions are wound on a roll that utilizes a 1" plastic core. A core made of cardboard or other material is not acceptable. A full horizontal perforation is required between each prescription (every 5-1/2").
6.1	Size: 4-1/4" x 5-1/2", no bleeds.
6.2.2	Part 2 - Minimum of 20# Canary CF carbonless bond.
6.3.1	FRONT: Part 1 prints 3 colors (black plus colors to be specified by DPR including a friction activated ink). The friction activated (thermochromic) ink on the face should be printed in blue and should change color or disappear when warmed (reacts to body heat). It should return to its original color (blue) when cooled. Must also contain color copy hollow VOID Pantograph as described under section 6.3 and 7.1. An additional coating is required on the face to insure toner adhesion to the paper. This feature is commonly referred to as "toner grip" or "laser lock". Part 2 prints one color to be specified by DPR.
6.3.2	BACK: Part 1 prints 3 colors (gray, white fluorescent & a friction activated ink). "Enhanced" Laid lines - unevenly spaced and sized diagonal lines printed in gray ink across the back of each prescription. The back shall also contain an artificial watermark identifying the vendor responsible for manufacturing the prescription forms printed in white or transparent non-penetrating ink, which is visible to the human eye when viewed only at a 45 degree angle. This feature must also appear fluorescent green under a black light. A friction activated (thermochromic) ink must be present in several locations on the back of each prescription. The ink shall be printed in orange and should change color or disappear when warmed (reacts to body heat). It should return to its original color (orange) when cooled. The back of Part 2 is unprinted.
6.5	Construction and Bindery: Pads are edge glued in sets of 50 two-part prescriptions for shipment to practitioners and institutions across Delaware. A chipboard backer is required for each pad. An additional chipboard insert (size 4-1/4" x 5-1/2") is shipped with each pad. Since these are carbonless 2-part pads, the chipboard insert will be used to prevent writing through to other ply(s). An instruction sheet describing how to use the chipboard insert must also accompany STATE each shipment.
7.1	Hollow Void Pantograph: Outlined open letters spelling the word "VOID" when form is photocopied. A safety hollow VOID pantograph background is required on each design (a solid void pantograph is not acceptable) pursuant to Section 4.2 of these regulations.
7.3	Micro-printing: Very small font that is legible when viewed at 5 times magnification or greater, but illegible when copied;
7.4	Reverse "Rx": Visible "Rx" watermark that disappears when copied;
7.5	Watermarking: The back of the form shall contain an artificial watermark identifying the vendor responsible for manufacturing the prescription forms printed on the back of the prescription that can only be seen when viewed at an angle;
7.6	Solid colored background;
7.7	Quantity Check Boxes;
7.8	Refill Indicator;
7.9	Chemical Reactive Paper: The paper must react when alteration is attempted using the following list of chemicals: Acetone, Methyl Ethyl Ketone, Nail Polish Remover, Paint Remover, Benzyl Alcohol, Methyl Alcohol, Rubbing Alcohol, Hair Spray, 1-Methoxy-2-Propanol, Carbon Tetrachloride, Bleach;
7.10	List all Security Features on Back;
7.11	Serial Numbered: The serial number shall be prefaced by the Vendor ID # and the Provider ID # shall follow as a suffix to the serial number. The Vendor Id #, serial number and Provider ID # must also be displayed as a bar code pursuant to Section 6.13.2 of these regulations; and,
7.12	Heat Sensing (Thermochromic Ink) Imprint.
7.13	Serial Numbering/Bar Coding:
7.13.4	The Vendor ID # shall appear as a prefix to the serial number and the Provider ID # shall appear as a suffix to the serial number. The Vendor ID # and Provider ID # shall also be included as part of the matching 39 barcode.
8.1	Secure Stock: Pursuant to section 6.1, all controlled paper utilized in the production of the Prescription Forms must be manufactured under tightly controlled security conditions, restricted in its use and distribution, and not readily available on the open market. Vendors must supply a list of the built in security features contained in their proposed security paper.
8.5	State of Delaware reserves the right to have DPR representatives enter a Vendor's premises without advance notice during stated hours of daily operation to inspect methods of production, storage and handling of forms, and to determine full compliance with all provisions of these regulations.
8.6	Any vendor manufacturing and selling tamper proof prescription forms to a Delaware licensed practitioner or prescriber shall contact the Division of Professional Regulation to:
8.6.1	Obtain, for purposes of accurate delivery of tamper proof prescription forms, the registered name, address and telephone number of the practitioner or prescriber;,
8.6.2	Register the company, contact person, address and telephone number; and,
8.6.3	The Division of Professional Regulation shall assign a Vendor ID # to a registered vendor, which shall then be included as a prefix to the serial number pursuant to 6.11.
8.8	Vendors are required to furnish a toll free 800 number operated with the United States available to Practitioners for questions and order information.
8.8.1	Vendor staff and equipment must be capable of receiving and servicing all calls received daily.
8.8.2	Vendors must have the ability to track and report calls received, answered, abandoned, average speed of answer, average talk time, call reason, call resolution and call monitoring.
8.8.3	Vendors must have a contingency plan for equipment or service failure.
8.8.4	Vendor staff must have computer equipment capable of accessing the web-based ordering system, so that customer calls can be adequately serviced.
8.9	PAYMENT: Vendors must accept full payment by procurement (credit) card and/or conventional check and/or other electronic means.
8.10	Quality Assurance: Vendors must notify the DPR of any quality control problems as they occur.
8.11	Certified vendors must notify DPR in writing within 30 days of any material changes to its business, systems or processes related to compliance with these rules.
9.1	Vendors must establish a system to directly receive, verify and process all orders for Prescription forms. Vendors must ensure that Prescriptions Forms are only to be issued to authorized practitioners and institutions. Such authorization shall include a registration process by which DPR registers authorized practitioners/institutions. All such systems, including computer information, shall be housed and maintained in a secure environment.
9.6	Suspicious Orders: Vendors must maintain records of all suspicious orders which shall be made available for review and inspection by the DPR upon request.
9.9.2.2	Stock: 20# xerographic bond in colors specified by the DPR
9.9.2.3	Size: 8-1/2" x 11", no bleeds
9.9.2.5	Variable Information: Reorder forms to be personalized with individual practitioner's/institution's applicable contact information.
9.9.2.6	Perforation: a full horizontal perforation is required.
10.1	Data Transmission: Vendors shall provide authorized registered Practitioners with the order information in electronic format.
11.0	Data Interface Requirements.
Vendors must implement a technical solution for receiving and updating practitioner information from the DPR.
13.0	Delivery.
13.1	Forms shall be shipped via courier which provides a "protective signature service," or the vendor may make direct shipment from their factory by "For Hire" carrier or vendor's truck, provided shipment is made in locked vans and such vans are not left unlocked or unattended while making pickups and deliveries. Delivery may also be made by vendor's vehicles under similar security and delivery requirements. A printer's manifest must accompany the shipment.
13.2	Vendor Prescription Forms must be shipped within 3 days of receipt of order. Delivery must be made to the address approved by DPR. No deliveries will be made to a private residence unless a practitioner's office and business location are attached. A record of delivery must be maintained by the Vendor and shall consist of the name of the practitioner/institution, prescription serial numbers, date of delivery, and the name and signature of the person receiving the delivery. This information must be maintained for a period of at least 5 years. Orders which are not delivered shall be handled as detailed in the section titled "Returned Prescriptions".
14.0	Mandatory Insurance Requirements.
Vendors shall obtain at their own cost and expense and keep in force and effect comprehensive general liability insurance.
15.0	State of Delaware Business License Requirement.
14 DE Reg. 1311 (06/01/11) (Prop.)