24 Del. Admin. Code § 2501-8.0
Current through Register Vol. 28, No. 5, November 1, 2024
Section 2501-8.0 - Requirements for Vendors8.1 Secure Stock: All controlled paper utilized in the production of the Prescription Forms must be manufactured under tightly controlled security conditions, restricted in its use and distribution8.2 Document Security: Vendors must guard against the loss of forms during the process of manufacture, storage, imprinting and delivery to designated recipients. Vendors must provide document security measures including but not limited to: 8.2.1 Security of the area where prescriptions pads and paper are stored.8.2.2 Destruction of sensitive material waste including but not limited to all samples and test documents.8.2.3 Accessibility of the printing, handling, imprinting, packaging and distribution area.8.2.4 Storage of all printing and imprinting plates including the maintenance of a plate log and destruction record of places.8.2.5 Building security including but not limited to surveillance within and around the facility.8.3 Technical Environment/Computer.8.3.1 Vendors must provide system security including but not limited to: 8.3.1.1 Robust encryption management process for managing data transfers both internally and eternally.8.3.1.2 Back up data process and recoverability.8.4 Vendors shall guarantee that only one copy of each serially numbered set will be produced. NO DUPLICATE OR MISSING NUMBERS ARE ACCEPTABLE.8.5 State of Delaware reserves the right to have 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 resistant prescription forms to a Delaware licensed practitioner or prescriber shall: 8.6.1 Register the vendor's company, representatives' contact information with the Division of Professional Regulation;8.6.2 Verify, by means of an online service provided by the Division of Professional Regulation, that each person or organization placing an order for tamper resistant prescription forms is authorized to purchase the forms;8.7 Vendors must provide for the immediate disposal of all damaged or mutilated forms.8.8 Vendor staff and equipment must be capable of receiving and servicing all calls received daily.8.9 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. 8.10 Vendors must have a contingency plan for equipment or service failure.8.11 Vendor staff must have computer equipment capable of accessing the web-based ordering system, so that customer calls can be adequately serviced.8.10 PAYMENT: Vendors must accept full payment by procurement (credit) card and/or conventional check and/or other electronic means.8.11 Quality Assurance: Vendors must notify the Division of Professional Regulation of any quality control problems as they occur.8.12 Certified vendors must notify Division of Professional Regulation in writing within 30 days of any material changes to its business, systems or processes related to compliance with these rules.24 Del. Admin. Code § 2501-8.0