§ 53-14-110. Records and Documents
All licensees under this chapter shall maintain in a readily retrievable manner for a period of two (2) years: Records showing the receipt, administration, dispensing or destruction of all legend drugs, controlled substances and controlled substance analogues; and Copies of any protocols, including revisions of the protocols, progress reports, evaluations and other project documents.
§ 53-14-111. Inspections
The board, or its officers, agents or employees, shall periodically inspect the premises of licensees under this chapter for compliance with the submitted protocol, record-keeping and security requirements, and other state and federal laws or regulations relating to legend drugs, controlled substances and controlled substance analogues. Any applicant for a license under this chapter shall […]
§ 53-14-112. Suspension or Revocation of License — Probation
The board may, in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, suspend or revoke any license issued pursuant to this chapter or place on probation any licensee, if the licensee is found to have: Falsified any application, record, report or information required by this chapter; Failed to comply with […]
§ 53-14-113. Restraining or Enjoining Violations — Jurisdiction
The board may seek relief at law or equity to restrain or enjoin any act or practice in violation of this chapter. Jurisdiction is conferred upon the chancery and circuit courts of this state to hear and determine a suit to restrain or enjoin. No bond shall be required for the prosecution of the suit […]
§ 53-14-114. Restricted Access to Information
Only the following persons shall have a right of access to the names and other identifying characteristics of individuals who are the subjects of research on the use and effects of legend drugs, controlled substances or controlled substance analogues: The board; The director; The commissioner; The attorney general and reporter or the attorney general and […]
§ 53-14-106. License — Contents — Expiration — Nontransferable
All licenses issued pursuant to § 53-14-105 shall specify: The name and address of the licensees; The nature of the authorized project or projects; The nature of legend drugs, controlled substances or controlled substance analogues to be used in the project; and Whether dispensing to human subjects is permitted. A license shall expire one (1) […]
§ 53-14-107. Modification of License
If any licensee under this chapter wishes to amend the terms or conditions of the licensee’s license, the licensee shall make application to the director. The application shall be accompanied by a nonrefundable fee of five dollars ($5.00), or other amount set by the board. The director shall grant the requested amendment upon approval by […]
§ 53-14-108. Denial of Application for License
If an application for a license or amendment under this chapter is denied, the director shall notify the applicant in writing of the reason or reasons for the denial. The applicant may, within thirty (30) days of the date of the notification, submit responsive materials for consideration by the commissioner.
§ 53-14-109. Institutional Applicants for Licenses
Any institution that regularly engages in research, instruction or chemical analysis may apply for a license authorizing internal approval of specific projects conducted under the institution’s immediate auspices. The application shall be accompanied by the fee and materials specified in § 53-14-104; provided, that in lieu of a detailed protocol, the institutional applicant may submit […]
§ 53-14-101. Short Title
This chapter shall be known and may be cited as the “Tennessee Legend Drug and Controlled Substance Research Act of 1984.”