2016 Tennessee Code
Title 53 - Food, Drugs and Cosmetics
Chapter 14 - Legend Drug and Controlled Substance Research Act of 1984
§ 53-14-104. License -- Required -- Application -- Fees.

(a) 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.

(b) An application for the license shall be submitted on the prescribed form, and shall be accompanied by:

(1) A nonrefundable fee of thirty dollars ($30.00), or in an amount set by the board;

(2) Copies of all papers and materials filed with any state or federal governmental agency in connection with the applicant's proposed project; and

(3) A detailed protocol, in triplicate, setting forth:

(A) The nature of the proposed project;

(B) The qualifications of the applicant to engage in the project;

(C) The proposed quantity of each drug involved;

(D) The measures proposed to provide for security and proper record-keeping of the drugs;

(E) Specific provisions for the safe administration or dispensing of drugs to humans, if contemplated, and the proposed method for selecting the humans; and

(F) Other information the commissioner may require.