2015 Tennessee Code
Title 53 - Food, Drugs And Cosmetics
Chapter 10 - Legend Drugs
Part-1 3 - Controlled Substance Monitoring Act of 2002 [Effective on July 1, 2016. See the version effective until July 1, 2016]
§ 53-10-303 - Creation -- Membership -- Elections -- Meetings -- Per diem and travel reimbursement -- Public meetings -- Rules and regulations. [Effective on July 1, 2016. See the version effective until July 1, 2016.]

(a) There is created the controlled substance database advisory committee. The committee members shall be:

(1) The executive director of the board of pharmacy, who shall serve as database manager;

(2) The director of the department of health's division of health-related boards;

(3) The executive director of the board of medical examiners;

(4) One (1) of the governor-appointed and licensed members of each of the following health care professional licensure boards or committees to be chosen by the licensing board or committee:

(A) The board of medical examiners;

(B) The board of osteopathic examination;

(C) The board of dentistry;

(D) The board of registration in podiatry;

(E) The optometry board;

(F) The board of veterinary medical examiners;

(G) The board of nursing;

(H) The board of medical examiners' committee for physician assistants; and

(I) The board of pharmacy; and

(5) One (1) of the members of the board of pharmacy and one (1) of the members of the board of medical examiners who were appointed to those boards to represent the general public. The boards shall choose those representatives.

(b) The committee shall have a chair and vice-chair, who shall be elected annually from its members.

(c) The committee shall meet at least annually and as often as deemed necessary either at the call of the chair or upon request of at least three (3) members of the committee. A quorum for purposes of official actions by the committee shall be seven (7) members.

(d) The members of the committee chosen to serve by the individual licensure boards and committees, while serving on this committee, shall be deemed to be performing official duties as members of their original board or committee and shall be entitled to the same per diem and travel reimbursements as they would receive for performing their duties for their original board or committee. The member's original board or committee shall pay those per diems and travel reimbursements.

(e) At all times, except when considering, reviewing, discussing, advising or taking action in reference to specifically named individuals or dispensers identified from information contained in, or reported to the database, the committee shall be subject to title 8, chapter 44, part 1, regarding public meetings.

(f) The commissioner of health shall have the authority to promulgate all rules and regulations, pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, necessary for implementation of this part. The commissioner of health shall promulgate rules regarding:

(1) Establishing, maintaining, and operating the database;

(2) Access to the database and how access is obtained; and

(3) Control and dissemination of information contained in the database.

(g) The committee shall advise the commissioner of health with respect to any contemplated rulemaking under this part. The committee may make formal recommendations to the commissioner of health.

(h) (1) The committee shall have the duty to examine database information to identify unusual patterns of prescribing and dispensing controlled substances that appear to be higher than normal, taking into account the particular specialty, circumstances, patient-type or location of the prescriber or dispenser.

(2) (A) If the committee determines that a pharmacist or pharmacy has an unusually high pattern of dispensing controlled substances that is not explained by other factors, it shall refer the pharmacist or pharmacy to the chief board of pharmacy investigator.

(B) When the pharmacy investigator completes the investigation of any pharmacy or pharmacist referred to it by the committee pursuant to this subsection (h), the investigator shall report the results of the investigation back to the committee as follows:

(i) The investigator shall report that the investigation was dismissed if the results of the investigation indicate that the pharmacist or pharmacy had an unusually high dispensing pattern for explainable, legitimate and lawful reasons; or

(ii) The investigator shall report that the investigation was referred to the pharmacy board if the results indicate that a prescriber has an unusually high pattern of prescribing or dispensing controlled substances that are not explained by other factors.

(C) If the action taken by the board indicates that the pharmacist or pharmacy had an unusually high dispensing pattern for explainable, legitimate and lawful reasons, the committee shall take that finding into consideration before it again refers the same pharmacist or pharmacy to the investigator based upon similar conduct.

(3) (A) If the committee determines that a prescriber has an unusually high pattern of prescribing or dispensing controlled substances that are not explained by other factors, it shall refer the prescriber to the health related boards' investigation unit.

(B) When the boards' investigator completes the investigation of any prescriber referred to it by the committee pursuant to this subsection (h), the investigator shall report the results of the investigation back to the committee as follows:

(i) The investigator shall report that the investigation was dismissed if the results of the investigation indicate that the prescriber had an unusually high dispensing pattern for explainable, legitimate and lawful reasons; or

(ii) The investigator shall report that the investigation was referred to the health related boards if the results indicate that a prescriber has an unusually high pattern of prescribing or dispensing controlled substances that are not explained by other factors.

(C) If the action taken by the board indicate that the prescriber had an unusually high dispensing or prescribing pattern for explainable, legitimate and lawful reasons, the committee shall take that finding into consideration before it again refers the same prescriber to the health related boards' investigation unit based upon similar conduct.

(4) If a pharmacy investigator or a member of the health related boards' investigation unit has reason to believe during any part of an investigation that a prescriber or dispenser is in violation of a criminal law, the investigator is authorized to report the conduct to the appropriate district attorney general.