Current through Register Vol. XLI, No. 50, December 13, 2024
Section 206-1-2 - DefinitionsTerms not defined in this rule have the meanings ascribed to them in West Virginia Code § 5A-3C-3. As used in this rule:
2.1. "Aggregate" or "aggregate data" means information which does not disclose personally-identifiable information about specific prescribers or otherwise identify specific individuals or companies.2.2. "Aggregate list" means the aggregate data included in the Council's report to the Joint Committee on Government and Finance, pursuant to West Virginia Code § 5A-3C-13(e).2.3. As used in West Virginia Code § 5A-3C-13(c)(2), "bona-fide clinical trial" means a clinical trial approved by an institutional review board in compliance with the statutory and regulatory requirements of the federal Food and Drug Administration, including Title 21 of the United States Code and 21 CFR, Part 56 and 45 C.F.R. § 46.101, and conducted in connection with a research study the principle purpose of which is scientific research.2.4. "Council means the West Virginia Pharmaceutical Cost Management Council established under the authority of West Virginia Code § 5A-3C-1et.seq.2.5. "Direct-to-consumer advertising" or "DTC advertising" means advertising prescription drugs directly to residents of this state through radio, television, magazines, newspapers, direct mail or telephone communications.2.6. "Dispensed" or "dispensing" means that aspect of the practice of pharmacy concerned with the preparation, verification of contents and delivery of a drug or device in an appropriately labeled and suitable container to a patient or a patient's representative pursuant to a lawful order of a practitioner for subsequent administration to, or use by, a patient. A drug or device has not been dispensed until it has been physically delivered to the patient or patient's representative.2.7. "National aggregate data" means all expenses associated with advertising and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail and telephone communications in the United States.2.8. "Prescription drugs" or "pharmaceutical drugs" means drugs for human use which may be legally dispensed only with a prescription.2.9. "Prescriber" means a physician or other health care professional licensed to prescribe drugs in the State of West Virginia. 2.10. "Reporting entity" means a drug manufacturer, pharmaceutical manufacturer or labeler.