§ 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 […]
§ 53-14-101. Short Title
This chapter shall be known and may be cited as the “Tennessee Legend Drug and Controlled Substance Research Act of 1984.”
§ 53-14-102. Exemption From Chapter
This chapter shall not apply to: A licensed physician, dentist or veterinarian lawfully administering, dispensing or prescribing a legend drug or controlled substance in the course of the individual’s professional practice to an ultimate user for a recognized medical purpose; or A manufacturer or distributor whose research protocol has been approved by the federal food […]
§ 53-14-103. Chapter Definitions
As used in this chapter, unless the context otherwise requires: “Board” means the board of pharmacy created by § 63-10-301; “Commissioner” means the commissioner of health; “Controlled substance analogues” is defined as in § 39-17-454; “Controlled substances” is defined as in § 39-17-402; “Director” means the director of the board of pharmacy elected pursuant to […]
§ 53-14-104. License — Required — Application — Fees
No person shall manufacture, obtain, possess, administer or dispense a legend drug, controlled substance or controlled substance analogue for the purpose of scientific research, chemical analysis, instruction or training of detection animals without having first secured a license to do so from the director. An application for the license shall be submitted on the prescribed […]
§ 53-14-105. License — Issuance
Upon approval by the commissioner, the director shall issue a license authorizing the holder to manufacture, obtain, possess, dispense, or administer legend drugs, controlled substances or controlled substance analogues, or any combination thereof, for the purpose of scientific research, instruction or chemical analysis. The commissioner shall not grant approval unless the commissioner determines that the […]