2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 3 - TENNESSEE PRESCRIPTION SAFETY ACT OF 2016 (§§ 53-10-301 — 53-10-312) › Section 53-10-304 - Controlled substance database - Director - Administration - Requirements

(a)
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.
(b)
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.
(c)
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.
(d)
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:
(1)
[Deleted by 2022 amendment.]
(2)
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;
(3)
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;
(4)
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; or
(5)
[Deleted by 2022 amendment.]
(6)
[Deleted by 2022 amendment.]
(7)
Any drug prescribed for administration directly to a patient during the course of inpatient or residential treatment in a hospital or nursing home licensed under title 68 or during the course of inpatient treatment in a hospital licensed under title 33.
(e)
Notwithstanding subsection (c) or (d), a healthcare practitioner whose practice is a Part 2 Program shall submit the dispensing and administration of all controlled substances in accordance with this part. However, reporting of dispensing or administration by a Part 2 Program is not required by this subsection (e) until the commissioner promulgates rules regulating the reporting of such dispensing and administration, and access to that reported information in a manner consistent with the confidentiality provisions of 42 CFR Part 2.
Amended by 2022 Tenn. Acts, ch. 825, Secs.s3, s4, s5 eff. 4/14/2022.
Amended by 2018 Tenn. Acts, ch. 978, s 6, eff. 7/1/2018.
Acts 2002, ch. 840, § 1; 2004, ch. 673, §§ 24, 25; 2007 , ch. 518, § 3; 2011 , ch. 310, § 2; 2012 , ch. 880, § 5.