2020 Tennessee Code
Title 53 - Food, Drugs and Cosmetics
Chapter 10 - Legend Drugs
Part 3 - Tennessee Prescription Safety Act of 2016
§ 53-10-310. Practice Sites Where a Controlled Substance Dispensed Required to Provide for Electronic Access to the Controlled Substance Database — Exceptions — Violations and Penalties

Universal Citation: TN Code § 53-10-310 (2020)

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Each person or entity operating a practice site where a controlled substance is prescribed or dispensed to a human patient shall provide for electronic access to the database at all times when a healthcare practitioner provides healthcare services to a human patient potentially receiving a controlled substance.
This section shall not apply to any person or entity that is not required to report pursuant to § 53-10-304(d) or § 53-10-305(g).
A violation of subsection (a) is punishable by a civil penalty not to exceed one hundred dollars ($100) per day assessed against the person or entity operating the practice site; provided, however, that the penalty shall only be imposed when there is a continued pattern or practice of not providing electronic access to the database.
Any healthcare practitioner, individual, or entity who is authorized to access the database by this part shall not be subject to a suit for civil damages or held civilly liable for the failure to register in, report to, or check the database, or for actions taken after reasonable reliance on information in the database, or for accessing the database to determine whether or not the healthcare practitioner's professional credentials are being inappropriately used, or for reporting the same to the appropriate authorities, except as otherwise provided in this part.
1. When prescribing a controlled substance, all healthcare practitioners, unless otherwise exempted under this part, shall check the controlled substance database prior to prescribing one (1) of the controlled substances identified in subdivision (e)(4) to a human patient at the beginning of a new episode of treatment, prior to the issuance of each new prescription for the controlled substance for the first ninety (90) days of a new episode of treatment, and shall check the controlled substance database for that human patient at least every six (6) months when that prescribed controlled substance remains part of the treatment. An authorized healthcare practitioner's delegate may check the controlled substance database on behalf of the healthcare practitioner. A “new episode of treatment” means a prescription for a controlled substance that has not been prescribed by that healthcare practitioner within the previous six (6) months.
2. When dispensing a controlled substance, all healthcare practitioners, unless otherwise exempted under this part, shall check the controlled substance database prior to dispensing one (1) of the controlled substances identified in subdivision (e)(4) to a human patient the first time that patient is dispensed a controlled substance at that practice site. The dispenser shall check the controlled substance database again at least once every six (6) months for that human patient after the initial dispensing for the duration of time the controlled substance is dispensed to that patient. The initial dispensing check fulfills the check requirement for the first six-month period. An authorized healthcare practitioner's delegate may check the controlled substance database on behalf of the healthcare practitioner.
3. Before prescribing or dispensing, a healthcare practitioner shall have the professional responsibility to check the database or have a healthcare practitioner delegate check the database if the healthcare practitioner is aware or reasonably certain that a person is attempting to obtain a Schedule II-V controlled substance, identified by the committee or commissioner as demonstrating a potential for abuse for fraudulent, illegal, or medically inappropriate purposes, in violation of § 53-11-402.
4. The controlled substances that trigger a check of the controlled substance database pursuant to subdivisions (e)(1) and (2) include, but are not limited to, all opioids and benzodiazepines. By rule, the commissioner, pursuant to § 53-10-311, may require a check of the database for additional Schedule II-V controlled substances that are identified by the committee or commissioner as demonstrating a potential for abuse.
5. The commissioner, pursuant to § 53-10-311, shall adopt rules in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, that establish standards and procedures to be followed by a healthcare practitioner regarding the review of patient information available through the database.
6. Healthcare practitioners are not required to check the controlled substance database before prescribing or dispensing one (1) of the controlled substances identified in subdivision (e)(4) or added to that list by the committee or commissioner if one (1) or more of the following conditions are met:
  1. The controlled substance is prescribed or dispensed for a patient who is currently receiving hospice care;
  2. [Deleted by 2018 amendment.]
  3. The quantity of the controlled substance which is prescribed or dispensed does not exceed an amount which is adequate for a single, three-day treatment period and does not allow a refill; or
  4. The controlled substance is 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.
Each appropriate licensure board may promulgate rules pursuant to the Uniform Administrative Procedures Act, to establish procedures, notice requirements, and penalties for healthcare practitioners who fail to register in, report to, or check the controlled substance database as required.
Notwithstanding this part to the contrary, a healthcare practitioner or healthcare practitioner delegate shall not be in violation of this part during any time period in which the controlled substance database is suspended or not operational or the Internet is not operational or available as defined by rules promulgated by the commissioner.

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