§ 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 […]
§ 53-13-105. Compliance With Food, Drug and Cosmetic Act
The qualification of civil liability provided under this chapter shall apply only to food that meets the standards of the Tennessee Food, Drug and Cosmetic Act, compiled in chapter 1 of this title, or the regulations under that chapter, and shall not apply to food that was unfit for human consumption at the time of […]
§ 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 […]
§ 53-11-411. Administrative Decisions — Judicial Review
All final determinations, findings and conclusions of the department of safety, department of mental health and substance abuse services, department of health, or the board of pharmacy under part 3 of this chapter and this part, or title 39, chapter 17, part 4, are final and conclusive decisions of the matters involved. Any person aggrieved […]
§ 53-11-412. Research, Instruction or Chemical Analysis
No person shall manufacture, obtain, possess, administer or dispense any controlled substance or controlled substance analogue for the purpose of scientific research, instruction or chemical analysis except as provided in the Tennessee Legend Drug and Controlled Substance Research Act of 1984, compiled in chapter 14 of this title.