Tennessee § 53-10-304 - Controlled substance database — Director — Administration — Requirements.

§ 53-10-304. Controlled substance database — Director — Administration — Requirements.

There is created within the department a controlled substance database. The director of the controlled substance database shall be responsible for determining staffing in consultation with the executive director of the board of pharmacy. The director shall administer, maintain, and direct the functioning of the database in accordance with this part. The department in consultation with the committee and board may, under state procurement laws, contract with another state agency or private entity to establish, operate, or maintain the database. Additionally, the department, in consultation with the committee and board, shall determine whether to operate the database within the department or contract with another entity to operate the database, based on an analysis of costs and benefits. The purpose of the database is to increase the quality of patient care by equipping healthcare practitioners with accurate, timely information that the practitioners can use to determine when patients acquiring controlled substances may require counseling or intervention for substance abuse, by collecting and maintaining data as described in this part regarding all controlled substances in Schedules II, III, and IV dispensed in this state, and Schedule V controlled substances identified by the controlled substance database committee as demonstrating a potential for abuse. Further, the database is to be used to assist in research, statistical analysis, criminal investigations, enforcement of standards of health professional practice, and state or federal laws involving controlled substances. The data required by this part shall be submitted in compliance with this part to the database by any healthcare practitioner who dispenses a controlled substance contained in Schedules II, III, and IV, and Schedule V controlled substances identified by the committee as demonstrating a potential for abuse, or by any healthcare practitioner delegate who is designated to submit data on a healthcare practitioner's behalf. The reporting requirement shall not apply for the following: A drug administered directly to a patient; Complimentary packages of medicinal drugs that are labeled as a drug sample or complimentary drug dispersed to the practitioner's own patients adequate to treat the patient for a maximum of forty-eight (48) hours in the regular course of practice without the payment of a fee or remuneration of any kind; A sample of a schedule IV or schedule V controlled substance in a quantity limited to an amount that is adequate to treat a patient for a maximum of seventy-two (72) hours or a sample of a non-narcotic schedule V controlled substance in a quantity limited to an amount that is adequate to treat a patient for a maximum of fourteen (14) days, provided without charge by a medical doctor, osteopathic physician, advanced practice nurse with certificates of fitness to prescribe, or physician assistant working at a pain management clinic from providing to that practitioner's patient; Any drug dispensed by a licensed veterinarian; provided, that the quantity dispensed is limited to an amount adequate to treat the nonhuman patient for a maximum of five (5) days; Any entity that is registered by the United States drug enforcement administration (DEA) as a narcotic treatment program and is subject to the recordkeeping provisions of 21 CFR 1304.24; or Any drug dispensed or distributed by a facility; provided, that the quantity dispensed or distributed is limited to an amount that is adequate to treat the patient for a maximum of forty-eight (48) hours. Notwithstanding subsection (c) or (d), a healthcare practitioner shall submit the dispensing of buprenorphine products in accordance with this part. However, this subsection (e) does not apply to a practitioner when reporting the dispensing of buprenorphine products would conflict with 42 CFR part 2. Acts 2016, ch. 1002, § 4; 2018, ch. 978, § 6. Compiler's Notes. Former part 3, §§ 53-10-301 — 53-10-312 (Acts 2002, ch. 840, § 1; 2004, ch. 673, §§ 24-27; 2005, ch. 474, § 7; 2007, ch. 498, §§ 1-3; 2007, ch. 518, §§ 1-4; 2008, ch. 914, § 1; Acts 2009, ch. 228, § 1; 2011, ch. 310, §§ 1-5; 2012, ch. 575, § 1; 2012, ch. 880, §§ 1-21; 2012, ch. 915, § 1; 2012, ch. 924, §§ 1-5; 2013, ch. 236, § 50; 2013, ch. 430, §§ 3, 5, 6, 15; 2014, ch. 622, §§ 1, 2; 2014, ch. 791, §§ 1-6; 2014, ch. 983, § 2; 2014, ch. 1011, §§ 1, 2), concerning the Tennessee Prescription Safety Act of 2012, was repealed and reenacted by Acts 2016, ch. 1002, §§ 1-12, effective April 27, 2016. Acts 2016, ch. 1002, § 16 provided that notwithstanding this act or the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, any rule promulgated to implement the provisions of this act shall be provided to the chairs of the health committee of the house of representatives and the health and welfare committee of the senate by the secretary of state, after approval by the attorney general and reporter, at the same time the text of the rule is made available to the government operations committees of the senate and the house of representatives for purposes of conducting the review required by § 4-5-226 in order for the health committee of the house of representatives and the health and welfare committee of the senate to be afforded the opportunity to comment on the rule. Amendments. The 2018 amendment added (e). Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016. Acts 2018, ch. 978, § 15. July 1, 2018; provided that for rulemaking purposes, the act took effect on May 21, 2018. Law Reviews. The Right Hammer for the Right Nail: Public Health Tools in the Struggle Between Pain and Addiction, 48 U. Mem. L. Rev. 1300 (Summer 2018). Defining the Opioid Crisis and the Limited Role of the Criminal Justice System Resolving It, 48 U. Mem. L. Rev. 1206 (Summer 2018).