Controlled Substances Licensure
Authorizations are required prior to the use of controlled substances in animals. To obtain and use controlled substances such as certain common analgesics or anesthetics (e.g., buprenorphine, ketamine, pentobarbital) it is necessary to have appropriate federal Drug Enforcement Agency (DEA) registration, which in turn requires prior licensure by the Tennessee State Board of Pharmacy.
To initiate the process, download and complete the state form (available at http://health.state.tn.us/Downloads/Pharm_9905_ResearcherApp.pdf). This will require a concise description of the planned research use of the drug, a plan for secure storage, as well as payment of a fee. Once a state license number has been obtained the federal registration can be initiated (http://www.deadiversion.usdoj.gov/drugreg/reg_apps/index.html).
The federal fee is waived for academic institutions, requiring identification of Associate Vice Chancellor for Research Randall J. Nelson (901-448-3533) as the institutional contact and Fee Exempt Certifier.
In the Tennessee Legend Drug and Controlled Substance Research Act of 1984 (See 53-14-104 License/Required/Application/Fees) it states:(a) No person shall manufacture, obtain, possess, administer or dispense a legend drug or controlled substance 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. This means that even if a physician investigator maintains appropriate licensure for controlled substances used in his/her medical practice, (s)he must obtain research licensure from the Tennessee State Board of Pharmacy to use these substances in research involving animals and/or must modify his/her state license to include the use of controlled substances in the research setting.
Clinical Researchers Obtaining Controlled Substance for Use in Research
Some clinicians may be using their practice license to secure controlled substances for research purposes. By a memorandum issued by the Executive Vice Chancellor and the previous Vice Chancellor for Research, effective July 1, 2010 all personnel responsible for procuring control substances for research purposes must obtain researcher licensure from the State Board of Pharmacy. Non-clinical research personnel are already required to obtain State licensure before obtaining controlled substances for use in research.
Below are excerpts from Tennessee Code Annotated pertaining to this issue. From these we conclude that it is unlawful for a clinician to obtain research drugs using his/her clinical license because he/she has not completed and filed those things described in 53-14-104 part b3. It is not appropriate for a licensed physician or dentist to dispense or prescribe drugs other than in the course of his/her professional practice.
We urge all affected by this policy to obtain researcher licensure from the Tennessee State Board of Pharmacy at your earliest convenience. The URL for information is: http://health.state.tn.us/boards/Pharmacy/applications.shtml. The Research license application is found in the section entitled "Other Applications/Forms"
53-14-104. License - Required - Application - Fees. -
(a) No person shall manufacture, obtain, possess, administer or dispense a legend drug or controlled substance 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.
[Acts 1984, ch. 717, § 4; 1990, ch. 1026, § 14.]
53-14-102. Exemption from chapter. -
This chapter shall not apply to:
(1) 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
(2) A manufacturer or distributor whose research protocol has been approved by the federal food and drug administration under that agency's auspices, or otherwise subject to jurisdiction of the federal food and drug administration and if lawful under that jurisdiction.
[Acts 1984, ch. 717, § 2.]
Randall J. Nelson, Ph.D.
Professor and Associate Vice Chancellor for Research
Memphis, TN 38163
Phone: (901) 448-3533
Fax: (901) 448-5222