License — Required — Application — Fees

1. Law
2. Tennessee Code
3. Food, Drugs and Cosmetics
4. Legend Drug and Controlled Substance Research Act of 1984
5. License — Required — Application — Fees

1. 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.
2. 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:
      1. The nature of the proposed project;
      2. The qualifications of the applicant to engage in the project;
      3. The proposed quantity of each drug involved;
      4. The measures proposed to provide for security and proper record-keeping of the drugs;
      5. Specific provisions for the safe administration or dispensing of drugs to humans, if contemplated, and the proposed method for selecting the humans; and
      6. Other information the commissioner may require.

Download our app to see the most-to-date content.