53-1-301. Part definitions. [Effective until June 30, 2021.]

As used in this part:

1. “Administration” means the United States food and drug administration;
2. “Department” means the department of agriculture; and
3. “Standards” means the standards for the growing, harvesting, packing, and holding of produce for human consumption (21 CFR Part 112).

Acts 2018, ch. 854, § 1.

Effective Dates. Acts 2018, ch. 854 § 2. May 3, 2018.

Cross-References. Repealer, § 53-1-304.

53-1-302. State cooperation with United States food and drug administration. [Effective until June 30, 2021.]

1. The department is authorized to cooperate with the administration under the standards.
2. In furtherance of its responsibilities under this part the department may:
   1. Conduct inspections and take other actions reasonably necessary to assist the administration in enforcing the standards;
   2. Enter into cooperative agreements with the administration to implement provisions of the standards; and
   3. Promulgate rules to effectuate the purposes of this part, in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.

Acts 2018, ch. 854, § 1.

Effective Dates. Acts 2018, ch. 854 § 2. May 3, 2018.

Cross-References. Repealer, § 53-1-304.

53-1-303. Use of state funds — Funds limited to those provided to state by federal government. [Effective until June 30, 2021.]

1. No state funds shall be expended for the purposes of enforcing the standards against agricultural producers that only make sales of produce to:
   1. The consumer of the produce; or
   2. A restaurant or retail food establishment that is located in this state or not more than two hundred seventy-five (275) miles away from the farm where the produce was produced.
2. The department shall not expend more funds to cooperate with the administration under the standards than the amount of funds that are provided to this state by the federal government for such purposes.

Acts 2018, ch. 854, § 1.

Effective Dates. Acts 2018, ch. 854 § 2. May 3, 2018.

Cross-References. Repealer, § 53-1-304.

53-1-304. Repealer. [Effective until June 30, 2021.]

This part shall cease to be effective on June 30, 2021.

Acts 2018, ch. 854, § 1.

Effective Dates. Acts 2018, ch. 854 § 2. May 3, 2018.

NOTES TO DECISIONS

1. Constitutionality.

The Unfair Milk Sales Act, compiled in title 53, ch. 3, part 2, meets the standards or criteria set by the United States supreme court to prevent its conflicting with the Sherman Act. Walker v. Bruno's, Inc., 650 S.W.2d 357, 1983 Tenn. LEXIS 775 (Tenn. 1983).

2. Cost to Retailer.

It was the legislative intent to include in the cost to the retailer the cost of trading stamps. Hogue v. Kroger Co., 210 Tenn. 1, 356 S.W.2d 267, 1962 Tenn. LEXIS 406 (1962).

3. Meeting Competition.

Retailer who did not give trading stamps would not be enjoined from meeting price of his competitors who gave trading stamps and reducing his price further in an amount equal to the value of the trading stamps. Hogue v. Kroger Co., 210 Tenn. 1, 356 S.W.2d 267, 1962 Tenn. LEXIS 406 (1962).

4. Presumption.

Provision that proof of commission of any act prohibited by the statute shall be prima facie evidence of unlawful intent fixes a presumption that attaches to certain facts, but where evidence to the contrary of the presumption is offered, the presumption disappears and the case stands on the facts and whatever inferences may be drawn therefrom. Hogue v. Kroger Co., 210 Tenn. 1, 356 S.W.2d 267, 1962 Tenn. LEXIS 406 (1962).

5. Purpose of Act.

The Unfair Milk Sales Act, compiled in title 53, ch. 3, part 2,must be construed to give effect to the legislative purpose, not to foster the very evils it was intended to prohibit. Hogue v. Kroger Co., 213 Tenn. 365, 373 S.W.2d 714, 1964 Tenn. LEXIS 393 (1964).

The Unfair Milk Sales Act, compiled in title 53, ch. 3, part 2, was designed to prevent destruction of the small retailer by financially strong competitors who are able to sell below their costs for extended periods of time. Hogue v. Kroger Co., 213 Tenn. 365, 373 S.W.2d 714, 1964 Tenn. LEXIS 393 (1964).

The Unfair Milk Sales Act, compiled in title 53, ch. 3, part 2, is not a resale price maintenance or “fair trade” statute, but is designed to prevent “loss-leader” sales and other unfair sales practices. Walker v. Bruno's, Inc., 650 S.W.2d 357, 1983 Tenn. LEXIS 775 (Tenn. 1983).

NOTES TO DECISIONS

1. Trading Stamps.

Whether called advertising gimmicks or discounts for cash, the giving of trading stamps along with milk violates the Unfair Milk Sales Act, compiled in title 53, ch. 3, part 2, if the milk is priced at the statutory minimum of the invoiced price, plus eight percent cost of doing business. Hogue v. Kroger Co., 213 Tenn. 365, 373 S.W.2d 714, 1964 Tenn. LEXIS 393 (1964).

There was an affirmative duty to state in the advertisement of discount coupons, bonus trading stamps, cash rebates or any other sales promotion practice, requiring the purchase of merchandise, that designated controlled items sold at the statutory minimum were excluded from the sales total required for the advertised discount. Hogue & Knott v. Kroger Co., 481 S.W.2d 784, 1971 Tenn. App. LEXIS 249 (Tenn. Ct. App. 1972).

2. Discount Coupons.

The giving of discount coupons or bonus trading stamps on an amount that included the purchase of controlled items at the statutory minimum price was a violation of the statute. Hogue & Knott v. Kroger Co., 481 S.W.2d 784, 1971 Tenn. App. LEXIS 249 (Tenn. Ct. App. 1972).

Collateral References.

Validity and construction of state statutes prohibiting area price discrimination. 67 A.L.R.3d 26.

NOTES TO DECISIONS

1. Declaratory Judgment.

Where appellants sold milk at their invoiced price, plus eight percent cost, and gave trading stamps in addition, appellee properly sought a declaratory judgment of his right under the “Unfair Milk Sales Act”, compiled in title 53, ch. 3, part 2, to sell milk at the posted price less an amount equal to the cost of the trading stamps. Hogue v. Kroger Co., 213 Tenn. 365, 373 S.W.2d 714, 1964 Tenn. LEXIS 393 (1964).

2. Due Process.

On rehearing, a retail milk dealer, who was denied the right to meet unlawful prices set by a competitor, contended that due process clauses were violated because a retailer has no way of knowing whether the competitor's prices are lawful, and can be prosecuted if he meets such price and it turns out to be unlawful; however, such contention is without merit, as this section sets out the proper procedures. Hogue v. Kroger Co., 213 Tenn. 365, 373 S.W.2d 714, 1964 Tenn. LEXIS 393 (1964).

3. Right of Action.

The “clean hands” rule does not necessarily apply in a declaratory judgment suit, and the fact that appellee had at times given redeemable coupons did not preclude his declaratory judgment action to determine his right under this section to sell milk at the appellant's posted price less an amount equal to the cost of the trading stamps. Hogue v. Kroger Co., 213 Tenn. 365, 373 S.W.2d 714, 1964 Tenn. LEXIS 393 (1964).

Complainants who deliberately violated Unfair Sales Law, compiled in title 53, ch. 25, part 2, and Fair Trade Law (repealed) did not have standing to enjoin competitors from violating Unfair Milk Sales Law, compiled in title 53, ch. 3, pt. 2, and Unfair Frozen Dessert Law, compiled in title 53, ch. 3, part 3 (repealed). Hogue & Knott v. Kroger Co., 481 S.W.2d 784, 1971 Tenn. App. LEXIS 249 (Tenn. Ct. App. 1972).

4. Out of Business.

Where retail grocery chain had ceased to do business in Tennessee after commencement of suit for injunction and damages for alleged violation of this statute, injunction would not lie but defendant remained in court on question of damages. Hogue & Knott v. Kroger Co., 481 S.W.2d 784, 1971 Tenn. App. LEXIS 249 (Tenn. Ct. App. 1972).

NOTES TO DECISIONS

1. Meeting Competition.

Retailer who did not give trading stamps would not be enjoined from meeting the price of his competitors who gave trading stamps and reducing his price further in an amount equal to the value of the trading stamps. Hogue v. Kroger Co., 210 Tenn. 1, 356 S.W.2d 267, 1962 Tenn. LEXIS 406 (1962).

Under subdivision (b)(7) a retailer may reduce his price once for each price reduction of his competitor. Hogue v. Kroger Co., 210 Tenn. 1, 356 S.W.2d 267, 1962 Tenn. LEXIS 406 (1962).

A retailer is not authorized by subdivision (b)(7) to reduce the price of milk below the statutory minimum in order to meet the unlawful price of a competitor who is selling milk at a posted price that is the statutory minimum and giving trading stamps in addition, thereby violating the act. Hogue v. Kroger Co., 213 Tenn. 365, 373 S.W.2d 714, 1964 Tenn. LEXIS 393 (1964).

Subdivision (b)(7) must be construed to allow a retailer of milk to reduce prices to meet those of a competitor, but only if the competitor's prices are lawful. Hogue v. Kroger Co., 213 Tenn. 365, 373 S.W.2d 714, 1964 Tenn. LEXIS 393 (1964).

53-3-301. Short title.

This part shall be known and may be cited as the “Dairy Farmers Prosperity Act.”

Acts 2010, ch. 627, § 2.

Effective Dates. Acts 2010, ch. 627, § 12. March 3, 2010.

Cross-References. Milk as the official state beverage, § 4-1-331.

Southern Dairy Compact, § 43-35-101 et seq.

53-3-302. Category Tennessee prime milk established.

Notwithstanding any provision of law to the contrary, there is established a category of milk to be known as Tennessee prime milk and to be certified as such by the department for sale at retail.

Acts 2010, ch. 627, § 3.

Effective Dates. Acts 2010, ch. 627, § 12. March 3, 2010.

53-3-303. “Tennessee prime milk” — Defined.

For the purposes of this part, “Tennessee prime milk” means a quantity of milk obtained by the milking of one (1) or more healthy cows, not less than eighty percent (80%) of which quantity of milk is produced in Tennessee.

Acts 2010, ch. 627, § 4

Effective Dates. Acts 2010, ch. 627, § 12. March 3, 2010.

53-3-304. Certification.

Processors electing to have their milk certified as Tennessee prime milk shall make application to the department for such purpose and submit to all inspections deemed necessary by the department to attain such certification.

Acts 2010, ch. 627, § 5.

Effective Dates. Acts 2010, ch. 627, § 12. March 3, 2010.

53-3-305. Standards.

Tennessee prime milk sold at retail shall meet the following standards:

1. Reduced fat milk shall contain at least ten percent (10%) milk solids not fat (SNF);
2. Non-fat or skim milk shall contain at least nine percent (9%) milk solids not fat (SNF);
3. Whole milk shall contain at least eight and one-half percent (8.5%) milk solids not fat (SNF);
4. Milk set out in subdivisions (1)-(3) shall only contain milk or any other product that is produced in the United States; and
5. Milk set out in subdivisions (1)-(3) shall only be packaged, bottled or processed in the United States.

Acts 2010, ch. 627, § 6.

Effective Dates. Acts 2010, ch. 627, § 12. March 3, 2010.

53-3-306. Labeling.

The milk solids not fat (SNF) content and butterfat content shall be included on the labeling of all quantities and containers of Tennessee prime milk sold at retail.

Acts 2010, ch. 627, § 7.

Effective Dates. Acts 2010, ch. 627, § 12. March 3, 2010.

53-3-307. Documentation — Monthly analysis — Product samples — Costs.

1. Only those products meeting the standards established in § 53-3-305 shall be labeled and sold as Tennessee prime milk.
2. Dairy processors certified by the department to offer for sale Tennessee prime milk shall maintain documentation from a qualified laboratory acceptable to the department, such documentation to reflect monthly analyses of each product labeled Tennessee prime milk to ensure compliance with the standards established in § 53-3-305.
3. All such documentary records, as well as all milk procurement and milk processing records, shall be made available to the commissioner upon request.
4. 1. In addition to the monthly analyses required by subsection (b), the commissioner may obtain samples of products for analyses to ensure compliance with the standards established in § 53-3-305, at the commissioner's discretion.
   2. The cost of performing such analyses and shipment to a qualified laboratory of such samples shall be borne by the appropriate processor.

Acts 2010, ch. 627, § 8.

Effective Dates. Acts 2010, ch. 627, § 12. March 3, 2010.

53-3-308. Sale of milk to dairy or trade products plant.

In order to facilitate the production and sale of Tennessee prime milk, dairy cooperatives doing business in Tennessee shall sell any reasonable quantity of milk to a dairy products plant or trade products plant that processes or packages Tennessee prime milk at the request of any such plant.

Acts 2010, ch. 627, § 9.

Effective Dates. Acts 2010, ch. 627, § 12. March 3, 2010.

53-3-309. Rules and regulations.

The commissioner of agriculture shall promulgate rules and regulations to effectuate the purposes of this part. All such rules and regulations shall be promulgated in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.

Acts 2010, ch. 627, § 10.

Effective Dates. Acts 2010, ch. 627, § 12. March 3, 2010.

Part 1
Horsemeat

53-10-301. Short title.

This part shall be known and may be cited as the “Tennessee Prescription Safety Act of 2016”.

Acts 2016, ch. 1002, § 1.

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.

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

53-10-302. Part definitions.

As used in this part, unless the context requires otherwise:

1. “Board” means the board of pharmacy created by title 63, chapter 10, part 3;
2. “Commissioner” means the commissioner of health;
3. “Committee” means the controlled substance database committee created by § 53-10-303;
4. “Controlled substances” means a drug, substance, or immediate precursor in Schedules I through VI defined or listed in the Tennessee Drug Control Act of 1989, compiled in title 39, chapter 17, part 4;
5. “Database” means the controlled substance database created by § 53-10-304;
6. “Department” means the department of health;
7. “Director” means the director of the controlled substance database, who shall be a Tennessee licensed pharmacist designated by the commissioner, in consultation with the executive director of the board of pharmacy and with the committee, to administer, maintain, and direct the operation and function of the controlled substance database;
8. “Dispense” means to physically deliver a controlled substance covered by this part to any person, institution, or entity with the intent that it be consumed away from the premises on which it is dispensed. “Dispense” does not include the act of writing a prescription by a practitioner to be filled at a pharmacy licensed by the board. For purposes of this part, physical delivery includes mailing controlled substances into this state;
9. “Healthcare practitioner,” for the purposes of this part only, means:
   1. A person licensed, registered, or otherwise permitted to prescribe, distribute, or dispense a controlled substance in the course of professional practice;
   2. A pharmacy, hospital, or other institution licensed, registered, or otherwise permitted to distribute, or dispense, or administer a controlled substance in the course of professional practice; or
   3. A certified registered nurse anesthetist (CRNA) as described in § 63-7-103;
10. “Healthcare practitioner delegate” means any person authorized to practice pursuant to title 63, and up to two (2) unlicensed persons per healthcare practitioner designated by the healthcare practitioner to act as agents of the healthcare practitioner, upon registering the delegates and providing any information required by the department. A healthcare practitioner shall have the ability to authorize a healthcare practitioner delegate to check the controlled substance database as stipulated in this part. The healthcare practitioner shall be responsible for actions taken by their healthcare practitioner delegates pursuant to this part;
11. “Law enforcement personnel” means agents of the Tennessee bureau of investigation, agents of a judicial district drug task force, drug enforcement administration agents, and certified law enforcement officers certified pursuant to § 38-8-107, and certified law enforcement officers by other states;
12. “Manufacturer” means any person, except a pharmacist compounding in the normal course of professional practice, engaged in the commercial production, preparation, propagation, conversion, or processing of a drug, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis, or both, and includes any packaging or repackaging of a drug or the labeling or relabeling of its container and the promotion and marketing of such drugs or devices;
13. “Operations committee” means the operations committee created by this part to consult with and confirm or deny decisions made by the commissioner within the authority granted to the commissioner by this part; and
14. “Wholesaler” or “wholesale distributor” means a person primarily engaged in the wholesale distribution of drugs or devices; provided, that “wholesaler” or “wholesale distributor” does not include licensed third-party logistics providers. For the purposes of this part, transfers and sales of drugs or devices from one (1) licensed pharmacy to another shall not constitute wholesale distribution of drugs or devices.

Acts 2016, ch. 1002, § 2.

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.

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

53-10-303. Controlled substance database committee. [Effective until July 1, 2023. See version effective on July 1, 2023.]

1. There is created the controlled substance database committee. The committee members shall be:
   1. One (1) of the governor-appointed licensed members of each of the following healthcare professional licensure boards or committees to be chosen by the licensing board or committee:
      1. The board of medical examiners;
      2. The board of osteopathic examination;
      3. The board of dentistry;
      4. The board of podiatric medical examiners;
      5. The board of optometry;
      6. The board of veterinary medical examiners;
      7. The board of nursing;
      8. The board of medical examiners' committee on physician assistants; and
      9. The board of pharmacy; and
   2. 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.
2. The committee shall have a chair and vice chair, who shall be elected annually from its members.
3. 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.
4. The members of the committee chosen to serve by the respective licensure boards and committees, while serving on this committee, shall be deemed to be performing official duties as members of their respective 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 respective board or committee. The respective board or committee of each member shall pay such per diem and travel reimbursement.
5. At all times, except when considering, reviewing, discussing, advising, or taking action in reference to specifically named individuals or healthcare practitioners 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.
6. Pursuant to § 53-10-311 and the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, the commissioner shall have the authority to promulgate rules as necessary for implementation of this part regarding:
   1. Establishing, maintaining, and operating the database;
   2. Access to the database and how access is obtained;
   3. Control and dissemination of data and information in the database;
   4. The control, sharing, and dissemination of data and information in the database with other states or other entities acting on behalf of a state; and
   5. Establishing the morphine milligram equivalent calculation for an opioid drug contained in Schedules II-V for purposes of § 63-1-164; provided, that if no such rule is promulgated for an opioid drug, the morphine milligram equivalent calculation established by the federal centers for disease control and prevention for that drug shall be used.
7. The committee shall advise the commissioner with respect to any contemplated rulemaking under this part. The committee may make formal recommendations to the commissioner.
8. 1. The committee and the commissioner shall have the right to examine database information to identify unusual patterns of prescribing, distributing, or dispensing controlled substances that appear to be higher than normal, taking into account the particular specialty, circumstances, patient type, or location of the healthcare practitioner.
   2. If the committee or the commissioner determines that a healthcare practitioner has an unusually high pattern of prescribing, distributing, or dispensing controlled substances that is not explained by other factors, the committee or the commissioner shall refer the healthcare practitioner to the appropriate licensing board.
   3. If an investigator in service of a health-related board as licensed under title 63 or title 68 has reason to believe during any part of an investigation that a healthcare practitioner is in violation of a criminal law, the investigator is authorized to report the conduct to the appropriate law enforcement personnel.

Acts 2016, ch. 1002, § 3; 2018, ch. 1039, § 1.

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.

The controlled substance database advisory committee, created by this section, terminates June 30, 2023. See §§ 4-29-112, 4-29-244.

Acts 2016, ch. 546, § 3 provided that the representatives of the controlled substance database advisory committee shall appear before the government operations joint evaluation committee on education, health and general welfare no later than November 18, 2016, to update the joint evaluation committee on the advisory committee's progress in addressing the findings set forth in the October 2015 performance audit report issued by the division of state audit.

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.

Acts 2018, ch. 1039, § 9 provided that sections 1 and 6 of the act, which amended this section and enacted § 63-1-164, shall terminate on July 1, 2023, and the law in effect prior to July 1, 2018 shall be restored.

Amendments. The 2018 amendment, effective July 1, 2018 until July 1, 2023, added (f)(5); and rewrote the introductory language of (f) which read: “The commissioner shall have the authority to promulgate rules, pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, necessary for implementation of this part. Pursuant to § 53-10-311 the commissioner may promulgate rules regarding:”

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

Acts 2018, ch. 1039, § 10. July 1, 2018; provided that for the purposes of rulemaking, the act took effect May 21, 2018.

53-10-303. Controlled substance database committee. [Effective on July 1, 2023. See version effective until July 1, 2023.]

1. There is created the controlled substance database committee. The committee members shall be:
   1. One (1) of the governor-appointed licensed members of each of the following healthcare professional licensure boards or committees to be chosen by the licensing board or committee:
      1. The board of medical examiners;
      2. The board of osteopathic examination;
      3. The board of dentistry;
      4. The board of podiatric medical examiners;
      5. The board of optometry;
      6. The board of veterinary medical examiners;
      7. The board of nursing;
      8. The board of medical examiners' committee on physician assistants; and
      9. The board of pharmacy; and
   2. 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.
2. The committee shall have a chair and vice chair, who shall be elected annually from its members.
3. 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.
4. The members of the committee chosen to serve by the respective licensure boards and committees, while serving on this committee, shall be deemed to be performing official duties as members of their respective 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 respective board or committee. The respective board or committee of each member shall pay such per diem and travel reimbursement.
5. At all times, except when considering, reviewing, discussing, advising, or taking action in reference to specifically named individuals or healthcare practitioners 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.
6. The commissioner shall have the authority to promulgate rules, pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, necessary for implementation of this part. Pursuant to § 53-10-311 the commissioner may promulgate rules regarding:
   1. Establishing, maintaining, and operating the database;
   2. Access to the database and how access is obtained;
   3. Control and dissemination of data and information in the database; and
   4. The control, sharing, and dissemination of data and information in the database with other states or other entities acting on behalf of a state.
7. The committee shall advise the commissioner with respect to any contemplated rulemaking under this part. The committee may make formal recommendations to the commissioner.
8. 1. The committee and the commissioner shall have the right to examine database information to identify unusual patterns of prescribing, distributing, or dispensing controlled substances that appear to be higher than normal, taking into account the particular specialty, circumstances, patient type, or location of the healthcare practitioner.
   2. If the committee or the commissioner determines that a healthcare practitioner has an unusually high pattern of prescribing, distributing, or dispensing controlled substances that is not explained by other factors, the committee or the commissioner shall refer the healthcare practitioner to the appropriate licensing board.
   3. If an investigator in service of a health-related board as licensed under title 63 or title 68 has reason to believe during any part of an investigation that a healthcare practitioner is in violation of a criminal law, the investigator is authorized to report the conduct to the appropriate law enforcement personnel.

Acts 2016, ch. 1002, § 3; 2018, ch. 1039, § 1.

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.

The controlled substance database advisory committee, created by this section, terminates June 30, 2023. See §§ 4-29-112, 4-29-244.

Acts 2016, ch. 546, § 3 provided that the representatives of the controlled substance database advisory committee shall appear before the government operations joint evaluation committee on education, health and general welfare no later than November 18, 2016, to update the joint evaluation committee on the advisory committee's progress in addressing the findings set forth in the October 2015 performance audit report issued by the division of state audit.

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.

Acts 2018, ch. 1039, § 9 provided that sections 1 and 6 of the act, which amended this section and enacted § 63-1-164,  shall terminate on July 1, 2023, and the law in effect prior to July 1, 2018 shall be restored.

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

Acts 2018, ch. 1039, § 10. July 1, 2018; provided that for the purposes of rulemaking, the act took effect May 21, 2018.

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

1. 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.
2. 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.
3. 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.
4. 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. A drug administered directly to a patient;
   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;
   5. 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
   6. 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.
5. 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).

53-10-305. Submission of information — Data format.

1. All healthcare practitioners who prescribe or dispense controlled substances in practice providing direct care to patients in this state by prescribing or dispensing on more than fifteen (15) days in a calendar year total and are required to have a federal drug enforcement administration (DEA) registration pursuant to federal law shall be registered in the controlled substance database. Healthcare practitioners or their agents shall have up to thirty (30) calendar days after receiving a DEA number to register in the database; such privilege shall apply equally to both prescribers and dispensers. Licensed veterinarians who never prescribe or dispense controlled substances in an amount intended to treat a nonhuman patient for more than five (5) days shall not be required to register in the database.
2. 1. Each healthcare practitioner or healthcare practitioner's agent shall, regarding each controlled substance dispensed, submit to the database all of the following information:
      1. Prescriber identifier;
      2. Dispensing date of controlled substance;
      3. Patient identifier;
      4. Controlled substance dispensed identifier;
      5. Quantity of controlled substance dispensed;
      6. Strength of controlled substance dispensed;
      7. Estimated days' supply;
      8. Dispenser identifier;
      9. Date the prescription was issued by the prescriber;
      10. Whether the prescription was new or a refill;
      11. Source of payment;
      12. The ICD-10 code for any prescription that contains an ICD-10 code; provided, that this shall not be mandatory prior to January 1, 2019, for a dispenser who has not updated the dispenser's software system to enable submission of ICD-10 codes;
      13. A value signifying opioid treatment is occurring pursuant to a medical necessity under § 63-1-164 for any prescription containing the words “medical necessity.” The value will be determined by the committee and published through the committee's website; and
      14. Other relevant information as required by rule.
   2. The information in the database, as required by subdivision (b)(1), shall be submitted by a procedure and in a format established by the committee, for each business day but no later than the close of business on the following business day; provided, that a veterinarian shall submit information at least once every fourteen (14) days and shall not be required to use a computerized system in order to submit required information pursuant to this section.
3. The commissioner, pursuant to § 53-10-311, shall have the authority to change the length of time in which healthcare practitioners are required to submit information to the database through the promulgation of rules pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5. When the committee shortens the length of time in which healthcare practitioners are required to submit information to the database, the department shall provide notice to all healthcare practitioners who are registered in the database at least sixty (60) days prior to the date in which the rule goes into effect. If the committee, pursuant to § 53-10-311, shortens the length of time in which healthcare practitioners must submit information to the database, a healthcare practitioner may provide to the committee a written statement indicating why it creates a hardship for that healthcare practitioner to submit information within that time period, and the committee may grant an extension of up to seven (7) days within which that healthcare practitioner shall submit the information to the database. Such a hardship extension shall be valid for two (2) years and may be renewed by the committee upon request of the healthcare practitioner.
4. Any healthcare practitioner, except veterinarian healthcare practitioners, that uses a computerized system to record information concerning the dispensing of controlled substances, shall submit the required information to the database utilizing nationally recognized pharmacy telecommunications format standards.
5. The commissioner, pursuant to § 53-10-311, shall maintain the database in an electronic file or by other means established by the commissioner in such a manner so as not to infringe on the legal use of controlled substances, and in such a manner as to facilitate use of the database for identification of:
   1. Prescribing and dispensing practices and patterns of prescribing and dispensing controlled substances; and
   2. Individuals, facilities, or entities that receive prescriptions for controlled substances from healthcare practitioners, and who subsequently obtain dispensed controlled substances from a healthcare practitioner in quantities or with a frequency inconsistent with generally recognized standards of dosage for that controlled substance, or by means of forged or otherwise false or altered prescriptions.
6. The committee or the commissioner or a designee appointed by the committee or commissioner may review information in the database. If the committee or commissioner or their designee determines from review that a healthcare practitioner has committed a violation of the law, the committee or commissioner shall notify the entity responsible for licensure, regulation, or discipline of that healthcare practitioner and shall supply information required by the entity for an investigation of the violation of the law that may have occurred.
7. 1. 1. The commissioner, pursuant to § 53-10-311, shall by rule establish the electronic format in which the information required under this section shall be submitted to the database, and the committee shall allow for waiver of electronic reporting for individual healthcare practitioners for whom it would cause undue hardship as determined by the committee. The waiver may be valid for two (2) years from ratification by the committee.
      2. The committee may authorize a designee to initially approve a waiver subject to ratification by the committee.
   2. The commissioner shall ensure the database system records and maintains for reference, for a period of at least one (1) year:
      1. The identification of each person who requests or receives information from the database;
      2. The information provided to each person; and
      3. The date and time the information is requested or provided.
8. The commissioner, in consultation with the committee, shall make rules to:
   1. Effectively enforce the limitations on access to the database as described in this part; and
   2. Establish standards and procedures to ensure accurate identification of individuals requesting information or receiving information from the database without a request.

Acts 2016, ch. 1002, § 5; 2018, ch. 1039, § 2.

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 present (b)(1)(L) and (b)(1)(M); and redesignated former (b)(1)(L) as present (b)(1)(N).

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

Acts 2018, ch. 1039, § 10. July 1, 2018; provided that for rulemaking purposes, the act took effect on May 21, 2018.

Law Reviews.

Defining the Opioid Crisis and the Limited Role of the Criminal Justice System Resolving It, 48 U. Mem. L. Rev. 1206 (Summer 2018).

53-10-306. Confidentiality — Disclosure of information — Penalties.

1. Information sent to, contained in, and reported from the database in any format is confidential and not subject to title 10, chapter 7, regarding public records, and not subject to subpoena from any court and shall be made available only as provided for in § 53-10-308 and to the following persons in accordance with the limitations stated and rules promulgated pursuant to this part, or as otherwise provided for in § 53-10-311:
   1. Personnel of the committee specifically assigned to conduct analysis or research;
   2. Authorized committee, board, or department personnel or any designee appointed by the committee engaged in analysis of controlled substances prescription information as a part of their assigned duties and responsibilities;
   3. A healthcare practitioner conducting medication history reviews who is involved in the care of a patient or making decisions regarding patient care or patient enrollment; a healthcare practitioner or supervising physician of a healthcare practitioner conducting a review of all medications dispensed by prescription attributed to that healthcare practitioner or a healthcare practitioner having authority to prescribe or dispense controlled substances, to the extent the information relates specifically to a current or bona fide prospective patient of the healthcare practitioner, to whom the healthcare practitioner has prescribed or dispensed, is prescribing, dispensing, approving of the prescribing or dispensing, or considering prescribing or dispensing any controlled substance. Each authorized individual referenced under this subdivision (a)(3) shall have a separate identifiable authentication for access;
   4. A healthcare practitioner under review by a quality improvement committee, as defined in § 63-1-150, who submits information contained in, and reported from the database to a quality improvement committee;
   5. A licensed pharmacist conducting drug utilization or medication history reviews who is actively involved in the care of the patient or making decisions regarding care of the patient or patient enrollment. Each authorized individual referenced under this subdivision (a)(5) shall have a separate identifiable authentication for access;
   6. The state chief medical examiner, or deputy state chief medical examiner appointed pursuant to § 38-7-103, or a county medical examiner appointed pursuant to § 38-7-104 when acting in an official capacity as established in § 38-7-109; provided, any access to information from the database shall be subject to the confidentiality provisions of this part except where information obtained from the database is appropriately included in any official report of the county medical examiners, toxicological reports, or autopsy reports issued by the county medical examiner, state chief medical examiner, or deputy state chief medical examiner under § 38-7-110(c);
   7. Personnel of the following entities actively engaged in analysis of controlled substances prescription information as a part of their assigned duties and responsibilities related directly to the TennCare program:
      1. The office of inspector general;
      2. The medicaid fraud control unit; and
      3. The bureau of TennCare's chief medical officer, associate chief medical directors, director of quality oversight, and directors of pharmacy;
   8. Personnel of the bureau of TennCare who request aggregate controlled substances prescribing information from the database which does not contain personally identifiable data but only on request by the following personnel of the bureau:
      1. The chief medical officer;
      2. Associate chief medical directors;
      3. Director of quality oversight; and
      4. Directors of pharmacy;
   9. A quality improvement committee, as defined in § 63-1-150, of a group practice that is engaged in the provision of healthcare services, as part of the committee's confidential and privileged activities under § 63-1-150(c)(3) with respect to the evaluation of the safety, quality, appropriateness, or necessity of healthcare services performed by a healthcare practitioner, if the information is furnished to a quality improvement committee by the healthcare practitioner that is the subject of review by the quality improvement committee;
   10. A quality improvement committee, as defined in § 68-11-272, of a hospital licensed under title 68 or title 33, as part of the committee's confidential and privileged activities under § 68-11-272(b)(4) with respect to the evaluation, supervision, or discipline of a healthcare provider employed by the hospital or any of its affiliates or subsidiaries, who is known or suspected by the hospital's administrator to be prescribing controlled substances for the healthcare practitioner's personal use;
   11. 1. Law enforcement personnel; provided, that such personnel are engaged in the official investigation and enforcement of state or federal laws involving controlled substances or violations under this part; and that any law enforcement personnel receiving information from the database pursuant to this section shall comply with this subsection (a);
       2. Any law enforcement personnel; provided, that for an officer or agent to have the authorization to request information from the database, the officer or agent shall first be preapproved. Preapproval shall require:
          1. Agents of a judicial drug task force employed by the United States department of justice, law enforcement officers certified pursuant to § 38-8-107, and law enforcement officers certified by other states to require:
             1. The list of preapproved agents to be sent to the district attorney general in the judicial district in the district in which the task force has jurisdiction; and
             2. By December 1 of each year, each district attorney general shall send to the director a list of applicants authorized to request information from the database from that general's judicial district; or
          2. Tennessee bureau of investigation (TBI) agents or drug enforcement administration agents to require:
             1. Preapproval by the assistant special agent in charge or the agent's immediate supervisor and division head. Approved applicants shall be sent to the board by the director; and
             2. By December 1 of each year, the TBI director or the assistant special agent in charge shall send to the director of the controlled substance database, committee, or commissioner a list of applicants authorized to request information from the database;
       3. An application submitted by law enforcement personnel shall include, but not be limited to, the:
          1. Applicant's name; title; agency; agency address; agency contact number; agency supervisor; and badge number, identification number, or commission number; and the business e-mail address of each applicant officer or agent, the appropriate district attorney general, DEA agent, and, if a TBI agent, the TBI director and their business e-mail addresses; and
          2. Signatures of the applicant, the applicant's approving supervisor, and the district attorney general of the judicial district, assistant special agent in charge in which the applicant has jurisdiction, or the approving division head and the TBI director; and
       4. It shall be a duty of the committee or commissioner, through the director, as part of the duties to maintain the database pursuant to § 53-10-305(e), to receive and verify the lists of authorized applications sent to it by the district attorneys general, assistant special agent in charge, and the director of the TBI pursuant to this subsection (a);
   12. The judge of a drug court treatment program, created under the Drug Court Treatment Act of 2003, compiled in title 16, chapter 22, and pursuant to this part to the extent the information relates specifically to a current participant in the drug court treatment program. Any judge or personnel of a drug court treatment program receiving information from the database pursuant to this subdivision (a)(12) shall comply with this subsection (a) and the following:
       1. Any judge of a participating drug court requesting information from the database shall submit an application to the director pursuant to subdivision (a)(12)(B) that must include acknowledgment by the district attorney general of the judge's judicial district that the judge is seeking information from the database on a current participant in the drug court treatment program;
       2. An application submitted by the judge of a drug court treatment program shall include:
          1. The applicant's name, title, agency, agency address, and business e-mail address;
          2. The signatures of the judge and the district attorney general of the judicial district in which the judge has jurisdiction; and
          3. The names of any current participants in the drug court treatment program that the judge has a reasonable belief may not be in compliance with the guidelines or rules of participation in the drug court treatment program as they pertain solely to the participant's unauthorized use or misuse of controlled substances. Such information shall not be considered a public record as defined by § 10-7-503; and
       3. The commissioner, through the director, shall, as part of the duty to maintain the database pursuant to this part, receive the authorized application sent by the judge of the participating drug court treatment program pursuant to this subsection (a); and
   13. A healthcare practitioner delegate, who is acting under the direction and supervision of a healthcare practitioner as an agent of a healthcare practitioner. Each authorized individual shall have a separate identifiable authentication for access.
2. When requesting information from the database, law enforcement personnel shall provide a case number as part of the process for requesting information from the database. The case number entered shall correspond with an official investigation involving controlled substances and information requested should directly relate to the investigation.
3. The commissioner, in consultation with the committee, may, by rule, establish a fee for providing information to a law enforcement agency, judicial district drug task force, TBI, or a judge of a drug court treatment program pursuant to this section. In determining the fee and type of fee to be charged, the commissioner may consider options such as an annual fee or a per use, incremental cost basis fee, or other methods as the commissioner deems appropriate.
4. Law enforcement personnel, who are authorized to request information from the database, shall resubmit their identifying application information that was submitted pursuant to this section to the appropriate district attorney, United States attorney, TBI director, or assistant special agent in charge by November 20 of each year. Such resubmitted applications shall be sent by the appropriate district attorney general, TBI director, or assistant special agent in charge to the board by December 1 of each year. If during the calendar year a name is added to the list, removed from the list, or information about a person on the list changes, the appropriate district attorney, or special agent in charge, shall immediately notify the director of the controlled substance database, committee, or commissioner of any changes to the list submitted or in the information submitted for each attorney, officer, or agent on the list application.
5. 1. Information obtained by law enforcement personnel from the database may be shared with other law enforcement personnel or prosecutorial officials only upon the direction of the officer or agent who originally requested the information and may only be shared with law enforcement personnel from other law enforcement agencies who are directly participating in an official joint investigation.
   2. Any information obtained from the database that is sent to law enforcement personnel shall also be sent to the district attorney general of the judicial district to the district in which such officer or agent has jurisdiction. Likewise, any database information sent to a TBI agent or DEA agent shall also be sent to the TBI director or the assistant special agent in charge.
   3. 1. Information obtained from the database by the judge of a drug court treatment program may be shared with personnel of a drug court treatment program.
      2. For the purposes of this subdivision (e)(3), “personnel of a drug court treatment program” includes a judge of a drug court and any person employed by the drug court and designated by the judge to require access to the information in order to efficiently administer the drug court treatment program.
   4. Any information obtained from the database that is sent to a judge of a drug court treatment program shall also be sent to the district attorney general of the judicial district in which the judge has jurisdiction.
6. 1. To ensure the privacy and confidentiality of patient records, information obtained from the database by law enforcement personnel shall be retained by the law enforcement personnel's respective department or agency. The information obtained from the database shall not be made a public record. Any information used in a criminal or administrative action from the controlled substance monitoring database shall be placed under seal or have patient names and all other personally identifying information of patients redacted. Information obtained from the database shall be maintained as evidence in accordance with each law enforcement agency's respective procedures relating to the maintenance of evidence.
   2. To ensure the privacy and confidentiality of patient records, information obtained from the database by a drug court treatment program shall be retained by the program director of the drug court treatment program. The information obtained from the database shall not be made a public record, notwithstanding the use of the information in court for prosecution purposes.
7. Any information disseminated pursuant to subdivisions (a)(1)-(a)(3), and (a)(5)-(a)(8) shall be released to the individual or entity requesting the information by the database manager or by password-protected Internet access.
8. Any healthcare practitioner or healthcare practitioner delegate receiving patient-specific information pursuant to subdivision (a)(1), (a)(2), (a)(3), or (a)(5) shall not disclose the information to any person other than:
   1. The patient to whom the information relates;
   2. Other healthcare practitioners who are involved or have a bona fide prospective involvement in the treatment of the patient, or healthcare practitioners identified by the information for the purpose of verifying the accuracy of the information;
   3. Any law enforcement personnel to whom reporting of controlled substances being obtained in a manner prohibited by § 53-11-401, or § 53-11-402(a)(3) or (a)(7), is required by § 53-11-309, or any agent of the healthcare practitioner who is directed by the healthcare practitioner to cause a report to law enforcement to be made in accordance with § 53-11-309(a) and (d); or
   4. A healthcare practitioner or healthcare practitioner delegate who may place a copy of a patient's report obtained from the database pursuant to this section in that patient's medical records. Once placed in a patient's medical records, any copy of a patient's report obtained from the database pursuant to this section shall be subject to disclosure on the same terms and conditions as medical records under §§ 63-2-101 and 63-1-117.
9. If law enforcement personnel or a judge of a drug court treatment program has probable cause to believe, based upon information received from a database request, that a healthcare practitioner may be acting or may have acted in violation of the law, the officer, agent, or judge shall consult with the appropriate licensing board as established under title 63 or title 68.
10. 1. 1. At least every six (6) months, the committee or commissioner or their designee shall send a list to each district attorney general containing all requests made for database information during the previous six (6) months.
       2. The list shall include:
          1. The name of the requesting attorney, officer, or agent;
          2. The attorney, officer, or agent's agency;
          3. The date of the request; and
          4. The nature of the request, including the case number for each attorney, officer, or agent making a request in such district attorney's judicial district.
       3. Likewise, a list shall be sent to the director of the TBI for all TBI agents or the assistant special agent in charge for all DEA agents making requests during the previous six (6) months.
    2. Each district attorney general, or assistant special agent in charge and the TBI director shall use the list to perform an audit to determine if the database information requests made during the preceding six-month period correspond to specific cases under investigation in the applicable judicial district or by the bureau and if the information requested is relevant and pertinent to an investigation.
    3. Each district attorney general, assistant special agent in charge, and the TBI director shall verify all database information requests contained on the list received and send it back to the board within sixty (60) days of receipt. If a database information request does not correspond to an investigation in the applicable jurisdiction or if the information requested was not relevant or pertinent to the information requested, the district attorney general, assistant special agent in charge, or TBI director shall so note on the verified list and shall investigate the discrepancy and make a report back to the director of the controlled substance database within a reasonable period of time.
    4. The results of the audit conducted pursuant to subdivision (j)(2) shall be discoverable by a healthcare practitioner or healthcare practitioner delegate charged with violating any state or federal law involving controlled substances or under a notice of charges proffered by an appropriate licensing board for a violation of any law involving controlled substances, but only the results pertaining to that healthcare practitioner or healthcare practitioner delegate are discoverable. If, however, there is an active criminal investigation involving a healthcare practitioner or healthcare practitioner delegate or the healthcare practitioner or healthcare practitioner delegate is under investigation by any investigations or prosecution unit of the appropriate licensure board, the results of the audit conducted pursuant to subdivision (j)(2) shall not be discoverable by the healthcare practitioner or the healthcare practitioner delegate during either such period.
11. 1. Any person who obtains or attempts to obtain information from the database by misrepresentation or fraud is guilty of a Class A misdemeanor.
    2. Any person who knowingly uses, releases, publishes, or otherwise makes available to any other person or entity any information submitted to, contained in, or obtained from the database for any purpose other than those specified in this part is guilty of a Class A misdemeanor.
    3. Intentional unauthorized use or disclosure of database information by law enforcement personnel is a Class A misdemeanor.
    4. Any law enforcement personnel whom the department has reason to suspect of violation of this section or who has been charged with a violation of this section shall have such person's authorization to request information from the database suspended. Any law enforcement personnel, found guilty of a violation of this subsection (k) shall have such person's authorization to request information from the database permanently revoked.
    5. Where an individual authorized under subsection (a) acts in good faith in accessing or using information from the database in accordance with the limitations under this part, that person shall not incur any civil or criminal liability as a result of that use or access.
12. 1. The following personnel of the department of mental health and substance abuse services actively engaged in analysis of controlled substances prescription information as a part of their assigned duties and responsibilities shall have access to the database for controlled substances prescription information for specific patients or healthcare practitioners:
       1. The chief pharmacist;
       2. The state opioid treatment authority (SOTA) or SOTA designee; and
       3. The medical director.
    2. Aggregate controlled substances prescribing information from the database which does not contain personally identifiable data may be provided upon request by the following personnel of the department of mental health and substance abuse services, who are actively engaged in analysis of controlled substances prescription information as provided in this subsection (l ), and may be provided upon request to other personnel of the department of mental health and substance abuse services and other state government agencies as needed to fulfill assigned duties and responsibilities:
       1. The chief pharmacist;
       2. The SOTA; or
       3. The medical director.
13. Where an investigation is conducted under § 38-7-109, and information within the database is obtained pursuant to the requirements of this part, there exists a rebuttable presumption that the county medical examiner is acting in good faith.
14. Authorized committee, board, or department personnel and any designee appointed by the committee engaged in analysis of controlled substances prescription information as a part of the assigned duties and responsibilities of their employment may publish, or otherwise make available to healthcare practitioners and to the general public, aggregate unidentifiable personal data contained in or derived from the database for the purpose of educational outreach.
15. Prohibited access to, an inappropriate request for, or illegal disclosure of information from the database by a judge of a drug court treatment program shall be considered a violation of the canons of the Code of Judicial Conduct, including Rules 1.2, 1.3, and 3.5.

Acts 2016, ch. 1002, § 6; 2019, ch. 124, §§ 1, 2.

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 2019 amendment, in (a),  added present (4) and redesignated former (4)-(7) as present (5)-(8), respectively; and added present (9) and redesignated former (8)-(11) as present (10)-(13), respectively.

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

Acts 2019, ch. 124, § 16. April 9,  2019.

Cross-References. Confidentiality of public records, § 10-7-504.

Penalty for Class A misdemeanor, § 40-35-111.

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).

53-10-307. Failure to submit information — Liability.

1. The failure of a healthcare practitioner to submit information to the database required under this part after the committee or the commissioner has submitted a specific written request for the information, or when the committee or the commissioner determines the individual has a demonstrable pattern of failing to submit the information as required, is grounds for the denial of licensure, renewal of licensure, or other disciplinary action against the healthcare practitioner before the licensing board with jurisdiction over the healthcare practitioner and for the committee to take the following actions:
   1. Recommend to the appropriate licensure board that it should refuse to issue a license to the individual;
   2. Recommend to the appropriate licensure board that it should refuse to renew the individual's license; and
   3. Recommend to the appropriate licensure board that it should commence disciplinary action against the licensee seeking revocation, suspension, or other appropriate discipline, including civil penalties.
2. An individual or entity that has submitted information to the database in accordance with this part and in good faith shall not be subject to a suit for civil damages nor held civilly liable for having submitted the information.
3. An individual or entity that in good faith disseminates information contained in, or derived from, the database to the individuals authorized by this part to receive it in the manner authorized by this part or rules promulgated pursuant to this part, shall not be subject to a suit for civil damages nor held individually liable for having done so.
4. Submitting information as required by this part shall not subject the person submitting the information to licensure disciplinary action or any action for breach of confidentiality, ethical duty to a patient, or the sharing of any professional secret.
5. 1. Failure to submit the required information by any healthcare practitioner shall not be considered a violation if a good faith effort was made and the failure of the report to be transmitted was due to technical difficulties or the inability to have the report received by the database.
   2. Technical difficulties shall include the failure of the database to receive the transmission of any report, the failure of any healthcare practitioner's system or switch used in the transmission of a report, electrical problems, natural disasters, fires, flooding, or other unforeseen circumstances as defined in rules by the commissioner pursuant to § 53-10-311.

Acts 2016, ch. 1002, § 7.

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.

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

Law Reviews.

Defining the Opioid Crisis and the Limited Role of the Criminal Justice System Resolving It, 48 U. Mem. L. Rev. 1206 (Summer 2018).

53-10-308. Release of confidential information.

1. Notwithstanding this part to the contrary, the committee or the commissioner:
   1. May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to department personnel engaged in an investigation, adjudication, or prosecution of a violation under any state or federal law that involves a controlled substance;
   2. May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to law enforcement personnel engaged in an investigation, adjudication, or prosecution of a violation under any state or federal law that involves a controlled substance, pursuant to the procedure established in § 53-10-306(a)(11);
   3. Shall release information from the database when ordered by a court to do so upon the court's finding that disclosure is necessary for the conduct of proceedings before the court regarding the investigation, adjudication, or prosecution of a violation under any state or federal law that involves controlled substances and after an appropriate protective order is issued regarding the information to be released to the court; and
   4. 1. Shall release confidential information from the database to the attorney general and reporter upon request for the purpose of reviewing, querying, or otherwise using the data in conjunction with investigating or litigating a civil action involving controlled substances. The data may be disclosed at the attorney general and reporter's discretion to:
         1. Designees within the office of the attorney general and reporter who are participating in, assisting with, or supervising any such investigation or litigation;
         2. Other parties to litigation to which the attorney general and reporter is a party in which the data is relevant so long as disclosure of the data is in furtherance of litigation or resolution of litigation, and the data is provided only after an appropriate protective order is issued prohibiting the other parties from using the confidential information for any purpose other than defending or resolving the litigation and prohibiting the sharing of confidential information with litigants in other cases or other parties;
         3. Targets of an investigation conducted by the attorney general and reporter for the purpose of negotiating a settlement regarding conduct to which the data is relevant only after an appropriate protective order is issued or a confidentiality agreement is executed regarding the data;
         4. Designated consultants or experts who agree to maintain the confidentiality of the data and who are retained, in conjunction with an investigation or litigation, by:
            1. The attorney general and reporter;
            2. Other parties to litigation to which the attorney general and reporter is a party as described in subdivision (a)(4)(A)(ii); or
            3. Targets of an investigation conducted by the attorney general and reporter as described in subdivision (a)(4)(A)(iii); and
         5. A court for evidentiary or other purposes after an appropriate protective order is issued regarding the confidential information.
      2. The attorney general and reporter shall comply with the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.) to the extent that it applies to any such disclosure.
2. Any data authorized to be released under this section or § 53-10-306, other than aggregate data or data released to personnel of the department, the attorney general and reporter, or a health-related board is limited to reports of drugs prescribed to specific patients or prescribed by specific providers, and nothing in this part creates a right to other data such as provider query audits or registration information, nor does anything in this part require the committee or department to provide analytics or analysis of any data available in the database.

Acts 2016, ch. 1002, § 8; 2019, ch. 264, §§ 1, 2.

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 2019 amendment added (a)(4); and inserted “, the attorney general and reporter,” in (b).

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

Acts 2019, ch. 264, § 3. April 30, 2019.

Cross-References. Confidentiality of public records, § 10-7-504.

53-10-309. Reports.

The commissioner or commissioner's designee shall report annually on the outcome of the program with respect to its effect on distribution and abuse of controlled substances, including recommendations for improving control and prevention of diversion of controlled substances in this state. The committee, its designee, or the commissioner shall also file an annual report with the health and welfare committee of the senate and the health committee of the house of representatives by March 1, 2017, and each March 1 thereafter, to include analysis about tracking the individuals or entities that access the database and the security measures taken to ensure that only authorized persons or entities access the database. In addition to the annual report submitted to the general assembly by the commissioner, authorized committee, board, or department personnel engaged in analysis of controlled substance prescription information as a part of the assigned duties and responsibilities of their employment shall release information from the database requested by a member of the general assembly that is related to research, statistical analysis, or education of healthcare practitioners relative to controlled substances. However, no report released pursuant to this section shall contain the name or other identifying information of a specific healthcare practitioner or specific healthcare practitioner delegate contained in the report. All information released from the database for such a report shall be in the aggregate.

Acts 2016, ch. 1002, § 9.

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.

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

Law Reviews.

Defining the Opioid Crisis and the Limited Role of the Criminal Justice System Resolving It, 48 U. Mem. L. Rev. 1206 (Summer 2018).

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.

1. 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.
2. 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).
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

Acts 2016, ch. 1002, § 10; 2018, ch. 1039, §§ 3-5.

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, in (e)(1), inserted “, prior to the issuance of each new prescription for the controlled substance for the first ninety (90) days of a new episode of treatment”, substituted “every six (6) months” for “annually” preceding “when that”, and substituted “six (6) months” for “twelve (12) months” at the end; in (e)(2), substituted “six (6) months” for “twelve (12) months” following “every”, inserted “for the duration of time the controlled substance is dispensed to that patient”, and, in the penultimate sentence, substituted “check requirement for the first six-month period” for “first annual check”; deleted (e)(6)(B) which read: “The committee has determined that healthcare practitioners in a particular medical specialty shall not be required to check the database as a result of the low potential for abuse by patients receiving treatment in that medical specialty;”; and, in (e)(6)(C), substituted “three-day treatment period” for “seven-day treatment period” following “single,”.

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

Acts 2018, ch. 1039, § 10. July 1, 2018; provided that for rulemaking purposes, the act took effect on May 21, 2018.

53-10-311. Establishment of operations committee — Agreements with federal government and other jurisdictions for sharing and dissemination of data and information.

1. There is created an operations committee. The committee shall be composed of:
   1. The board of medical examiners' medical director for special projects;
   2. An epidemiologist employed by the department of health;
   3. The executive director of the board of pharmacy;
   4. The director of the controlled substance database;
   5. A member of the controlled substance database committee;
   6. The executive director of the board of nursing as an ex officio non-voting member; and
   7. The executive director of the board of medical examiners as an ex officio non-voting member.
2. 1. The commissioner shall have the duty to convene the operations committee at least annually and request approval by that committee of actions taken under the authority granted by this part prior to those actions becoming final. The operations committee shall meet at such other times as needed and as convened by the commissioner to confirm or deny decisions made by the commissioner pursuant to the authority granted to the commissioner by this part.
   2. The operations committee's approval shall be necessary for all rules, agreements, and policies concerning:
      1. Access to the database and how that access is obtained;
      2. Dissemination of data and information in the database and control over that data; and
      3. The control, sharing, and dissemination of data and information in the database with other states or other entities acting on behalf of a state.
   3. The operations committee's approval shall not be necessary for any rules, agreements, or policies that concern the daily operations decisions, which may be delegated to the director of the database, concerning establishing, maintaining, or operating the database. The operations committee shall not set fees.
   4. The operations committee may make formal recommendations to the commissioner with respect to any contemplated rulemaking under this part, which does not require its approval.
3. Three (3) voting members of the operations committee shall constitute a quorum for official actions. A majority of those voting members present shall be necessary to approve an action proposed by the commissioner.
4. The operations committee shall not be subject to title 8, chapter 44, part 1, regarding public meetings.
5. 1. Notwithstanding this part to the contrary, the commissioner is authorized to enter into agreements with the federal centers for disease control and prevention (CDC), other states, or other entities acting on behalf of a state for the purposes of sharing and dissemination of data and information in the database.
   2. Any information disseminated pursuant to this subsection (e) shall be for:
      1. Analysis of controlled substance prescriptions for public health research by other state or federal entities charged with protecting the public health; or
      2. Interstate data sharing; provided, the sharing shall only be consistent with the requirements of § 53-10-306.
   3. The commissioner shall have any agreements that the commissioner enters into with the CDC, other states, or other entities acting on behalf of a state or federal government, approved by the operations committee prior to that agreement becoming final.
   4. All agreements entered into by the commissioner subject to this subsection (e) shall be governed by a contract entered into between the two (2) parties.

Acts 2016, ch. 1002, § 11.

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.

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

53-10-312. Minimum reporting requirements for wholesalers and manufacturers — Establishment of rules as to reporting requirements.

1. Wholesalers and manufacturers, as defined in § 63-10-204, that sell controlled substances at wholesale must at least report the following information to the committee in Automation of Reports and Consolidated Orders System (ARCOS) format or other mutually acceptable format:
   1. Wholesaler or manufacturer with a drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier;
   2. Purchaser's drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier;
   3. National drug code number of the actual drug sold;
   4. Quantity of the drug sold;
   5. Date of sale; and
   6. Transaction identifier or invoice number.
2. The board may establish such rules as are necessary to specify which medications shall be reported, the time frames for such reporting, and other reporting requirements as required.
3. A wholesaler shall design and operate a system to disclose to the wholesaler suspicious orders of controlled substances. A wholesaler shall inform the board of pharmacy and the boards whose licensees have prescribing authority of suspicious orders when discovered. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
4. In the event of the discovery of the theft or significant loss of controlled substances, a wholesaler shall report such theft or significant loss to the committee and local law enforcement within one (1) business day of discovery of the theft or loss.

Acts 2016, ch. 1002, § 12.

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.

Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016.

Law Reviews.

Defining the Opioid Crisis and the Limited Role of the Criminal Justice System Resolving It, 48 U. Mem. L. Rev. 1206 (Summer 2018).

Part 4
Tamper-Proof Prescriptions

NOTES TO DECISIONS

1. Bond of Claimants.

Prior to the 1973 amendment, the statute by imposing a $250 cost bond as a condition precedent to the hearing before the commissioner of safety violated the rights of indigent owners to due process under the fourteenth amendment. Fell v. Armour, 355 F. Supp. 1319, 1972 U.S. Dist. LEXIS 10982 (M.D. Tenn. 1972).

2. Hearings.

All parties to the proceeding had the statutory right to have those witnesses necessary for a full and complete hearing subpoenaed for the hearing. Fell v. Armour, 355 F. Supp. 1319, 1972 U.S. Dist. LEXIS 10982 (M.D. Tenn. 1972).

Plaintiff was a proper representative of a class consisting of all those persons who have had or will have conveyances owned by them seized pursuant to the authority of the Tennessee Drug Control Act of 1971 (repealed). Fell v. Armour, 355 F. Supp. 1319, 1972 U.S. Dist. LEXIS 10982 (M.D. Tenn. 1972).

Commissioner of safety is not required to set a date for a hearing within 15 days unless a defendant complies with the statutory requirements. Johnson v. Roberts, 638 S.W.2d 401, 1982 Tenn. App. LEXIS 393 (Tenn. Ct. App. 1982).

There is no right to a jury trial in Tennessee statutory proceedings involving the forfeiture of personal property. Helms v. Tennessee Dep't of Safety, 987 S.W.2d 545, 1999 Tenn. LEXIS 42 (Tenn. 1999), review or rehearing denied, — S.W.3d —, 987 S.W.2d 545, 1999 Tenn. LEXIS 229 (Tenn. 1999).

3. Notice to Owners.

Prior to the 1973 amendment, the statute failed to provide to owners of seized conveyances notice subsequent to seizure sufficient to comport with the requirements of the due process clause of the fourteenth amendment. Fell v. Armour, 355 F. Supp. 1319, 1972 U.S. Dist. LEXIS 10982 (M.D. Tenn. 1972).

Where the department of safety had knowledge of petitioner's possible proprietary interest in property confiscated in connection with a drug arrest, it was required to give notice to the petitioner of the seizure and possible forfeiture. Redd v. Tennessee Dep't of Safety, 895 S.W.2d 332, 1995 Tenn. LEXIS 53 (Tenn. 1995).

4. Validity.

Claimant's fifth amendment rights against self-incrimination were not violated, since notice of proposed forfeiture and sale of his plane in absence of claim and request for hearing was issued to claimant and signed by him at the time of seizure, but never subsequently acted upon by him. Hayes v. Armour, 407 F. Supp. 837, 1976 U.S. Dist. LEXIS 16695 (W.D. Tenn. 1976).

Where plaintiff failed to show that the proceedings under statutory forfeiture procedures, which provided for forfeiture of conveyances used, or intended to be used, for transportation of contraband such as illegal drugs or controlled substances, were criminal in nature or that he was called upon to testify or produce evidence that might be used against him in the separate criminal case in which he was charged with possession of illegal drugs, the plaintiff failed to prove that this part was unconstitutional. Hayes v. Armour, 407 F. Supp. 837, 1976 U.S. Dist. LEXIS 16695 (W.D. Tenn. 1976).

Where forfeiture serves remedial goal of discouraging use of property for illegal purposes, abates a nuisance by ensuring persons do not profit from illegal acts, and acts as deterrent, there is no punishment for purposes of double jeopardy. Stuart v. State Department of Safety, 963 S.W.2d 28, 1998 Tenn. LEXIS 96 (Tenn. 1998).

Where legislature intends that forfeiture be a civil in rem proceeding, it does not violate constitutional double jeopardy protections. Stuart v. State Department of Safety, 963 S.W.2d 28, 1998 Tenn. LEXIS 96 (Tenn. 1998).

5. Evidence Sufficient.

Evidence was sufficient to sustain a forfeiture where the owner's credibility was inherently suspect because the property was confiscated after she was caught selling illegal drugs, and the record provided ample basis to conclude that the bulk of the owner's purchases were not made with legitimate funds. McEwen v. Tenn. Dep't of Safety, 173 S.W.3d 815, 2005 Tenn. App. LEXIS 157 (Tenn. Ct. App. 2005).

6. Jurisdiction.

Tennessee Department of Safety had broad power to determine whether confiscated property was subject to forfeiture under T.C.A. § 53-11-201, and the dismissal of a criminal case did not divest the authority of the Commissioner of Safety to determine whether personal property that had been seized under Tennessee's drug statutes should be forfeited. Watson v. Tenn. Dep't of Safety, 361 S.W.3d 549, 2011 Tenn. App. LEXIS 535 (Tenn. Ct. App. Sept. 30, 2011), appeal denied, Watson v. State Dep't of Safety, — S.W.3d —, 2012 Tenn. LEXIS 80 (Tenn. Feb. 15, 2012).

Trial court did not err in dismissing for lack of jurisdiction appellants'  action seeking the return of seized property pursuant to T.C.A. § 53-11-451(d) and Tenn. R. Crim. P. 41(g) because it was a civil matter under the jurisdiction of the Department of Safety; the provisions of T.C.A. § 53-11-201 et seq. are civil, not criminal, in nature and are not to be addressed in a criminal forum. Harmon v. Jones, — S.W.3d —, 2012 Tenn. App. LEXIS 560 (Tenn. Ct. App. Aug. 14, 2012), appeal denied, — S.W.3d —, 2013 Tenn. LEXIS 226 (Tenn. Feb. 26, 2013).

7. Standing.

Co-owner of a mobile home lacked standing to contest the forfeiture of currency that was properly seized as proceeds from drug trafficking during a search of the mobile home, which was leased to the co-owner's adult child, because the co-owner failed to demonstrate an ownership interest in the currency. The trial court's application of an incorrect standard of review was harmless error as, under the correct standard of review, the evidence preponderated in favor of the administrative law judge's determination that the co-owner lacked standing. Tubbs v. Long, 610 S.W.3d 1, 2020 Tenn. App. LEXIS 198 (Tenn. Ct. App. Apr. 28, 2020), appeal denied, — S.W.3d —, 2020 Tenn. LEXIS 550 (Tenn. Sept. 16, 2020).

Decisions Under Prior Law

1. Validity.

The Drug Control Act is in all respects constitutional as it applies to marijuana. Gaskin v. State, 530 S.W.2d 533, 1975 Tenn. Crim. App. LEXIS 280 (Tenn. Crim. App. 1975), appeal dismissed, Gaskin v. Tennessee, 425 U.S. 901, 96 S. Ct. 1490, 47 L. Ed. 2d 751, 1976 U.S. LEXIS 779 (1976).

Neither the fact that petitioners were prosecuted for manufacturing marijuana while others were not, nor the fact that manufacturing marijuana was made a felony while possession was only a misdemeanor violated the equal protection clause of the federal constitution.Gaskin v. State, 530 S.W.2d 533, 1975 Tenn. Crim. App. LEXIS 280 (Tenn. Crim. App. 1975), appeal dismissed, Gaskin v. Tennessee, 425 U.S. 901, 96 S. Ct. 1490, 47 L. Ed. 2d 751, 1976 U.S. LEXIS 779 (1976).

Collateral References.

Evidence considered in tracing currency, bank account, or cash equivalent to illegal drug trafficking so as to permit forfeiture, or declaration as contraband, under state law — Odor of drugs. 116 A.L.R.5th 325.

Evidence considered in tracing currency, bank account, or cash equivalent to illegal drug trafficking so as to permit forfeiture, or declaration as contraband, under state law — Proximity of asset to drugs, paraphernalia, or records. 115 A.L.R.5th 403.

Controlled substances 1 et seq.

NOTES TO DECISIONS

1. Constitutionality.

Where plaintiff failed to show that the proceedings under statutory forfeiture procedures were criminal in nature or that he was called upon to testify or produce evidence that might be used against him in the separate criminal case in which he was charged with possession of illegal drugs, the plaintiff failed to prove that this section was unconstitutional. Hayes v. Armour, 407 F. Supp. 837, 1976 U.S. Dist. LEXIS 16695 (W.D. Tenn. 1976).

NOTES TO DECISIONS

1. Constitutionality.

Where plaintiff failed to show that the proceedings under statutory forfeiture procedures were criminal in nature or that he was called upon to testify or produce evidence that might be used against him in the separate criminal case in which he was charged with possession of illegal drugs, the plaintiff failed to prove that this section was unconstitutional. Hayes v. Armour, 407 F. Supp. 837, 1976 U.S. Dist. LEXIS 16695 (W.D. Tenn. 1976).

53-11-301. Rules and fees for controlled drugs.

The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances may promulgate rules and charge reasonable fees relating to the registration and control of the manufacture, distribution, dispensing, warehousing of, and the provision of logistics services for controlled substances within this state.

Acts 1971, ch. 163, § 17; 1971, ch. 408, § 1; 1981, ch. 358, § 1; T.C.A., § 52-1424; Acts 1990, ch. 1026, § 13; 2015, ch. 293, § 6.

Compiler's Notes. Section 39-17-401 provides that title 39, ch. 17, part 4 and title 53, ch. 11, parts 3 and 4 shall be known and may be cited as the “Tennessee Drug Control Act of 1989.”

Amendments. The 2015 amendment substituted “the manufacture, distribution, dispensing, warehousing of, and the provision of logistics services for controlled substances” for “the manufacture, distribution, and dispensing of controlled substances”.

Effective Dates. Acts 2015, ch. 293, § 7. April 24, 2015.

Cross-References. Definition of terms used in this part, § 39-17-402.

Drugs, criminal offenses, title 39, ch. 17, part 4.

Smoking offenses concerning children, §§ 39-15-407 — 39-15-413.

Cited: McLean v. State, 527 S.W.2d 76, 1975 Tenn. LEXIS 635 (Tenn. 1975); Moore v. State, 568 S.W.2d 632, 1978 Tenn. Crim. App. LEXIS 309 (Tenn. Crim. App. 1978).

53-11-302. Handlers of controlled substances — Registration and inspection.

1. Every person who manufactures, distributes, dispenses, or is a third-party logistics provider for any controlled substance pursuant to § 53-11-301 within this state or who proposes to engage in the manufacture, distribution, dispensing, warehousing, or providing logistics services for any controlled substance within this state, shall annually obtain a registration issued by the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances in accordance with the licensing board's rules.
2. Persons registered by the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances under this part, part 4 of this chapter, and title 39, chapter 17, part 4, to manufacture, distribute, dispense, warehouse, or provide logistics services for controlled substances may possess, manufacture, warehouse, distribute, or dispense those substances to the extent authorized by their registration and in conformity with this section.
3. The following persons need not register and may lawfully possess controlled substances under this part, part 4 of this chapter and title 39, chapter 17, part 4:
   1. A common or contract carrier or warehouseman, or an employee of a common or contract carrier or warehouseman, whose possession of any controlled substance is in the usual course of business or employment; or
   2. An ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner or in lawful possession of a Schedule V substance.
4. The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances may waive by rule the requirement for registration of certain manufacturers, distributors, dispensers, or entities providing warehousing or logistics services if they find it consistent with the public health and safety.
5. A separate registration is required at each principal place of business or professional practice where the applicant manufactures, distributes or dispenses controlled substances.
6. The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances may inspect the establishment of a registrant or applicant for registration in accordance with the board's rules and regulations.

Acts 1971, ch. 163, § 18; 1977, ch. 180, § 3; T.C.A., § 52-1425; Acts 1996, ch. 675, §§ 51, 52; 2015, ch. 293, § 1.

Amendments. The 2015 amendment rewrote (a), which read: “Every person who manufactures, distributes or dispenses any controlled substance pursuant to § 53-11-301 within this state or who proposes to engage in the manufacture, distribution or dispensing of any controlled substance within this state, must obtain annually a registration issued by the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances in accordance with the licensing board's rules;” in (b), added “, warehouse, or provide logistics services for” preceding “controlled substances”  and added “warehouse” preceding “, distribute”, and deleted “the other provisions of” preceding “this section” at the end; and in (d), added “or entities providing warehousing or logistics services” following “dispensers”.

Effective Dates. Acts 2015, ch. 293, § 7. April 24, 2015.

Cited: McLean v. State, 527 S.W.2d 76, 1975 Tenn. LEXIS 635 (Tenn. 1975).

53-11-303. Criteria for registration issuance.

1. The state board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances shall register an applicant to manufacture or distribute controlled substances included in title 39, chapter 17, part 4, unless it determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances shall consider the following factors:
   1. Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific or industrial channels;
   2. Compliance with applicable state and local law;
   3. Any convictions of the applicant under any federal and state laws relating to any controlled substance;
   4. Past experience in the manufacture or distribution of controlled substances, and the existence in the applicant's establishment of effective controls against diversion;
   5. Furnishing by the applicant of false or fraudulent material in any application filed under this part and part 4 of this chapter, or title 39, chapter 17, part 4;
   6. Suspension or revocation of the applicant's federal registration to manufacture, distribute or dispense controlled substances as authorized by federal law; and
   7. Any other factors relevant to and consistent with the public health and safety.
2. Registration under subsection (a) does not entitle a registrant to manufacture and distribute controlled substances in Schedule I, II or VI other than those specified in the registration.
3. Practitioners must be registered to dispense any controlled substances in Schedules II through V if they are authorized to dispense under the law of this state.
4. Compliance by manufacturers and distributors with the federal law respecting registration, excluding fees, entitles them to be registered under this part, part 4 of this chapter and title 39, chapter 17, part 4.

Acts 1971, ch. 163, § 19; T.C.A., § 52-1426; Acts 1996, ch. 675, §§ 53, 54.

Compiler's Notes. The controlled substances schedules referred to in (b) and (c) appear in title 39, ch. 17, part 4.

53-11-304. Suspension and revocation of registration.

1. A registration under § 53-11-302 to manufacture, warehouse, distribute, dispense, or provide logistics services for a controlled substance may be suspended or revoked by the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances upon a finding that the registrant has:
   1. Furnished false or fraudulent material information in any application filed under this part and part 4 of this chapter, or title 39, chapter 17, part 4;
   2. Been convicted of a felony under any state or federal law relating to any controlled substance; or
   3. Had the registrant's federal registration suspended or revoked to manufacture, distribute or dispense controlled substances.
2. The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances may limit revocation or suspension of a registration to the particular controlled substance with respect to which grounds for revocation or suspension exist.
3. 1. If the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances suspend or revoke a registration, all controlled substances owned or possessed by the registrant at the time of suspension or the effective date of the revocation order may be placed under seal.
   2. No disposition may be made of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded, unless a court, upon application for disposition, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court.
   3. Upon a revocation order becoming final, all controlled substances may be forfeited to the state.
4. The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances shall promptly notify the bureau, as defined in § 39-17-402, of all orders suspending or revoking registration and all forfeitures of controlled substances.

Acts 1971, ch. 163, § 20; T.C.A., § 52-1427; Acts 1996, ch. 675, § 55; 2015, ch. 293, § 2.

Amendments. The 2015 amendment substituted “A registration under § 53-11-302 to manufacture, warehouse, distribute, dispense, or provide logistics services for a controlled substance” for “A registration under § 53-11-302 to manufacture, distribute or dispense a controlled substance” at the beginning of (a).

Effective Dates. Acts 2015, ch. 293, § 7. April 24, 2015.

Cross-References. Uniform Administrative Procedures Act, title 4, ch. 5, part 1.

53-11-305. Revocation, suspension or denial of registration.

1. Before denying, suspending or revoking a registration, or refusing a renewal of registration, the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked or suspended, or why the renewal should not be refused.
2. The order to show cause shall contain a statement of the basis for denying, suspending or revoking a registration, or refusing a renewal of registration and shall call upon the applicant or registrant to appear before the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances at a time and place not less than thirty (30) days after the date of service of the order, but in the case of a denial of renewal of registration, the show cause order shall be served not later than thirty (30) days before the expiration of the registration.
3. Proceedings to refuse renewal of registration shall not abate the existing registration, which shall remain in effect pending the outcome of the administrative hearing.
4. 1. The board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances may suspend, without an order to show cause, any registration simultaneously with the institution of proceedings under § 53-11-304, or where renewal of registration is refused, if they find that there is an imminent danger to the public health or safety that warrants this action.
   2. The suspension shall continue in effect until the conclusion of the proceedings, including judicial review of the suspension, unless sooner withdrawn by the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances or dissolved by a court of competent jurisdiction.

Acts 1971, ch. 163, § 21; 1973, ch. 110, § 15; T.C.A., § 52-1428.

Cross-References. Uniform Administrative Procedures Act, title 4, ch. 5, part 1.

53-11-306. Records and inventories required.

Persons registered to manufacture, distribute or dispense controlled substances under this part and part 4 of this chapter and title 39, chapter 17, part 4, shall keep records and maintain inventories in conformance with the record keeping and inventory requirements of federal law, and with any additional rules the board of pharmacy and the appropriate occupational or professional licensing board governing persons who may legally dispense controlled substances.

Acts 1971, ch. 163, § 22; T.C.A., § 52-1429; Acts 1996, ch. 675, § 56.

53-11-307. Inter-registrant distribution.

1. Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to an order form.
2. Compliance with federal law respecting order forms shall be deemed compliance with this section.

Acts 1971, ch. 163, § 23; T.C.A., § 52-1430.

Compiler's Notes. The controlled substances schedules, referred to in this section, appear in title 39, ch. 17, part 4.

53-11-308. Prescription requirements.

1. Except when dispensed directly by a health care prescriber other than a pharmacy to an ultimate user, no controlled substance in Schedule II may be dispensed without the electronic prescription of a health care prescriber, unless authorized by § 63-1-160. To the extent federal law does not permit an electronic prescription, a written prescription from a health care prescriber is required.
2. In emergency situations, Schedule II drugs may be dispensed upon oral prescription of a health care prescriber, reduced promptly to writing or to electronic form, as appropriate, and filed by the pharmacy. Prescriptions shall be retained in conformity with the requirements of § 53-11-306. No prescription for a Schedule II substance may be refilled.
3. Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, a controlled substance included in Schedule III or IV that is a prescription drug shall not be dispensed without a written or oral prescription of a practitioner. The prescription shall not be filled or refilled more than six (6) months after the date of the written or oral prescription or be refilled more than five (5) times, unless renewed by the practitioner.
4. A controlled substance included in Schedule V shall not be distributed or dispensed other than for a medical purpose.
5. No prescription for any opioids or benzodiazepines may be dispensed in quantities greater than a thirty-day supply.
6. If a prescriber dispenses any opioids, benzodiazepines, barbiturates, or carisoprodol, then the prescriber shall submit the transaction to the controlled substances monitoring database operated under chapter 10, part 3 of this title.
7. Any prescribers of opioids, benzodiazepines, barbiturates or carisoprodol, either alone, concurrently, or sequentially with any other opioids, benzodiazepines, barbiturates, or carisoprodol to patients who are in chronic, long-term drug therapy for ninety (90) days or longer shall consider mandatory urine drug testing. This subsection (g) shall not supercede any rules promulgated by the commissioner for urine drug testing by registered pain management clinics.
8. 1. Prior to prescribing more than a three-day supply of an opioid or an opioid dosage that exceeds a total of a one hundred eighty (180) morphine milligram equivalent dose to a woman of childbearing age, a prescriber shall:
      1. Advise the patient of the risk associated with opioid use during pregnancy;
      2. Counsel the patient on appropriate and effective forms of birth control; and
      3. Offer information about the availability of free or reduced cost birth control to the patient.
   2. As used in this subsection (h) “a woman of childbearing age” means any woman between the ages of fifteen (15) and forty-four (44).
   3. This subsection (h) does not apply if:
      1. The prescriber has previously taken all actions required by subdivision (h)(1) with respect to the patient within the past three (3) months; or
      2. The prescriber reasonably believes that the patient is not capable of becoming pregnant.
   4. If the patient is under eighteen (18) years of age, the physician may satisfy this subsection (h) by advising, counseling, and providing information to the parent or guardian instead of the patient. This subdivision (h)(4) does not prohibit a physician from advising, counseling, and providing information directly to the patient if not otherwise prohibited by law.
   5. The department of health shall develop and publish guidance to assist prescribers of opioids in complying with this subsection (h).

Acts 1971, ch. 163, § 24; T.C.A., § 52-1431; Acts 2013, ch. 430, § 4; 2018, ch. 883, § 2; 2018, ch. 901, § 1.

Compiler's Notes. The controlled substances schedules, referred to in this section, appear in title 39, ch. 17, part 4.

Acts 2013, ch. 430, § 1 provided that the act, which added subsections (e)-(g), shall be known and may be cited as the “Addison Sharp Prescription Regulatory Act of 2013.”

Acts 2013, ch. 430, § 11 provided that the department of health, the board of pharmacy or any board operating under title 63, is authorized to use emergency rules under § 4-5-208(a)(5), in order to promulgate any rules required by the act.

Acts 2018, ch. 883, § 10 provided that the commissioner of health is authorized to promulgate rules to effectuate the purposes of the act. All rules must be promulgated in accordance with the Uniform Administrative Procedures Act, compiled in Tennessee Code Annotated, Title 4, Chapter 5.

Amendments. The 2013 amendment added (e)-(g).

The 2018 amendment by ch. 883, effective January 1, 2019, in (a), substituted “health care prescriber” for “practitioner” preceding “other” and “electronic prescription of a health care prescriber, unless authorized by §  63-1-160. To the extent federal law does not permit an electronic prescription, a written prescription from a health care prescriber is required” for “written prescription of a practitioner” at the end; in (b), substituted “health care prescriber” for “practitioner” following “prescription of a”, inserted “or to electronic form, as appropriate,” and substituted “§ 53-11-306” for “§ 53-11-305”.

The 2018 amendment by ch. 901, effective July 1, 2018, added (h).

Effective Dates. Acts 2013, ch. 430, § 16. October 1, 2013; provided, that, for the purpose of promulgating rules and regulations, the act took effect May 16, 2013.

Acts 2018, ch. 883, § 12. January 1, 2019; provided that for rulemaking purposes the act took effect May 3, 2018.

Acts 2018, ch. 901, § 3. July 1, 2018.

Cross-References. Substitution of drugs in filling prescriptions prohibited, § 39-17-421.

Cited: State v. Dominy, 6 S.W.3d 472, 1999 Tenn. LEXIS 571 (Tenn. 1999); State v. Robinson, 139 S.W.3d 661, 2004 Tenn. Crim. App. LEXIS 82 (Tenn. Crim. App. 2004).

53-11-309. Reporting persons obtaining or attempting to obtain controlled substances — Immunity — Exception.

1. Any physician, dentist, optometrist, podiatrist, veterinarian, pharmacist, advanced practice registered nurse with a certificate of fitness issued under title 63, chapter 7, or physician assistant, hereinafter referred to collectively as “health care providers”, who has actual knowledge that a person has knowingly, willfully and with intent to deceive, obtained or attempted to obtain controlled substances in the manner prohibited by § 53-11-402(a)(6) shall cause a report to be submitted regarding such activity within five (5) business days of obtaining such knowledge. The report should be submitted to the local law enforcement agency where the health care provider is located or, where one exists, to a judicial district or multi-judicial district drug task force. The controlled substance database advisory committee established by § 53-10-303 shall develop a form by no later than August 1, 2010, that health care providers may choose to use to make reports. The department of health shall make the form available on its web site.
2. Any physician or advanced practice registered nurse with a certificate of fitness issued under title 63, chapter 7, or physician assistant who has actual knowledge that a person has knowingly, willfully and with the intent to deceive, obtained or attempted to obtain controlled substances in the manner prohibited by § 53-11-402(a)(6) and who is providing treatment to a person with a mental illness as defined in § 33-1-101 may, but is not required to, report as provided for under subsection (a).
3. If the health care provider's actual knowledge of conduct prohibited by § 53-11-402(a)(6) is a result of the health care provider accessing the information available in the controlled substance database established in § 53-10-304, then notwithstanding the confidentiality provisions in § 53-10-306, the local law enforcement agency or, where one exists, a judicial district or multi-judicial district drug task force may receive from the health care provider only the pertinent information from the database for the thirty (30) days prior to the date of treatment leading to the alleged offense which ostensibly demonstrates non-compliance with § 53-11-402(a)(6). A report with information from the database not exceeding thirty (30) days prior to the date of treatment made under this provision to local law enforcement or, where one exists, to a judicial district or multi-judicial district drug task force is sufficient grounds for the production of complete or more detailed controlled substance database information for purposes of a criminal investigation or pending prosecution pursuant to the procedures established by § 53-10-306(b).
4. A health care provider, or any person under the direction of the health care provider or any entity that assumes the responsibility of reporting for the provider who furnishes any information in good faith is immune from liability if a complaint, report, information, or record is furnished to a law enforcement agency.
5. This section shall not apply in the case of a person who, on the date of treatment by the health care provider, is enrolled in or covered by TennCare.

Acts 2009, ch. 67, § 1; 2010, ch. 663, § 1; 2012, ch. 880, § 22; 2016, ch. 980, § 3; 2016, ch. 1002, § 13.

Compiler's Notes. Acts 2012, ch. 880, § 25 provided that the act, which amended subdivision (b)(1) effective from January 1, 2013, until July 1, 2016, shall be interpreted to be consistent with all state and federal laws addressing privacy of patient records.

Acts 2016, ch. 1002, § 13, deleted the provisions of Acts 2012, ch. 880, § 29 that provided for the expiration of the amendments by Acts 2012, ch. 880,  § 22.  Therefore, those amendments remain in effect.

Amendments. The 2010 amendment rewrote the section which read: “(a)  Any physician, dentist, optometrist, podiatrist, veterinarian, nurse authorized pursuant to § 63-6-204 or § 63-9-113, or physician assistant who has good reason to believe a person has obtained or attempts to obtain controlled substances prohibited under § 53-11-402(a)(6) shall report the activity within three (3) business days to the local law enforcement agency for investigation.“(b) A health care provider is immune from civil liability if the health care provider, operating in good faith, makes a complaint or furnishes a report, information or records to law enforcement agencies pursuant to this section.”

The 2012 amendment by ch. 880, as amended by Acts 2016, ch. 1002, inserted “pharmacist,” in the first sentence of (a).

The 2016 amendment by ch. 980, substituted “advanced practice registered nurse” for “advanced practice nurse” in the first sentence of (a) and near the beginning of (b).

Effective Dates. Acts 2009, ch. 67, § 4. July 1, 2009.

Acts 2010, ch. 663, § 4. March 30, 2010.

Acts 2012, ch. 880, § 29. January 1, 2013; provided, that, for purposes of promulgating rules and regulations, including emergency rulemaking, the act shall take effect May 9, 2012; and provided further, that the provisions of the act shall expire and be of no force and effect after June 30, 2016, and on July 1, 2016, the existing provisions of title 53, chapter 10, part 3, shall be revived and reenacted as they were codified on March 1, 2012.

Acts 2016, ch. 980, § 25. July  1, 2016.

Acts 2016, ch. 1002, § 17.  April 27, 2016.

Cross-References. Employee or contractor’s unauthorized use of medical doctor’s DEA registration number to write prescriptions, § 63-6-242.

53-11-310. Identification requirements for dispensing of certain Schedule II to IV prescription medications for greater than a seven-day supply.

1. Prior to an authorized dispenser dispensing a prescription for any Schedule II-IV opioid, benzodiazepine, zolpidem, barbiturate, or carisoprodol medication for greater than a seven-day supply, a pharmacist, pharmacy technician, pharmacy intern, or any other person authorized to dispense controlled substances shall require the person taking possession of the dispensed prescription to present a valid government issued identification or public or private insurance card, unless the person is personally known to the pharmacist, pharmacy technician, pharmacy intern or any other person authorized to dispense controlled substances. The identification requirements described in subsection (a) shall apply to all authorized dispensers who dispense Schedule II-IV opioid, benzodiazepine, zolpidem, barbiturate, and carisoprodol medications for greater than a seven-day supply.
2. Should any person who is a minor or who is homeless seek to take possession of a dispensed prescription for a Schedule II-IV opioid, benzodiazepine, zolpidem, barbiturate, or carisoprodol medication not have a valid identification, the pharmacist, pharmacy technician, pharmacy intern or any other person authorized to dispense controlled substances shall use professional judgment in determining whether to dispense the prescription to the person.
3. Nothing in this section shall be construed to:
   1. Require that the person taking possession of a Schedule II-IV opioid, benzodiazepine, zolpidem, barbiturate, or carisoprodol medication and the person for whom the prescription is written be the same person;
   2. Apply to any controlled substance dispensed by a licensed veterinarian;
   3. Apply to drug samples dispensed by a healthcare professional; or
   4. Apply to prescriptions written for:
      1. Inpatients in a hospital;
      2. Outpatients of a hospital where the prescriber writes the order in the medical chart and the order is given directly to the hospital pharmacy and the patient does not have the opportunity to handle the written order;
      3. Residents of a nursing home or an assisted living facility;
      4. Inpatients or residents of a mental health hospital or residential facility licensed under title 33;
      5. Inpatients or residents of any facility that is registered by the United States drug enforcement administration as a narcotic treatment program and is subject to the record keeping provisions of 21 CFR § 1304.24;
      6. Individuals incarcerated in a local, state or federal correctional facility;
      7. Patients receiving prescriptions from mail order pharmacies; or
      8. Patients receiving home deliveries from pharmacies.
4. A healthcare provider in violation of this section shall only be subject to a civil penalty assessed by the provider's licensing board. Section 53-11-401 shall not apply to penalties imposed under this section.
5. The board of pharmacy is authorized to promulgate rules to implement this section in accord with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.

Acts 2014, ch. 872, § 1.

Effective Dates. Acts 2014, ch. 872, § 2. July 1, 2014.

53-11-311. Use of buprenorphine products.

1. Any product containing buprenorphine, whether with or without naloxone, may only be prescribed for a use recognized by the federal food and drug administration. This subsection (a) shall not apply to a person:
   1. Who has a documented diagnosis of opiate addiction as shown in their medical record;
   2. Who receives treatment from a provider practicing under 21 U.S.C. § 823(g)(2); and
   3. Who is counted against the total number of patients allowed to the provider as set forth in 21 U.S.C. § 823(g)(2).
2. 1. Any prescription for buprenorphine mono or for buprenorphine without use of naloxone for the treatment of substance use disorder shall only be permitted to a patient who is:
      1. Pregnant;
      2. A nursing mother;
      3. Has a documented history of an adverse reaction or hypersensitivity to naloxone; or
      4. Directly administered the buprenorphine mono or buprenorphine without use of naloxone by a healthcare provider, acting within the healthcare provider's scope of practice, for the treatment of substance use disorder pursuant to a medical order or prescription order from a physician licensed under title 63, chapter 6 or 9; provided, however, that this subdivision (b)(1)(D) does not permit buprenorphine mono or buprenorphine without use of naloxone to be dispensed to a patient in a manner that would permit it to be administered away from the premises on which it is dispensed.
   2. If the prescriber of buprenorphine mono or buprenorphine without use of naloxone for a patient under subdivision (b)(1)(A) or (b)(1)(B) is not the patient's obstetrical or gynecological provider, the prescriber shall consult with the patient's obstetrical or gynecological provider to the extent possible to determine whether the prescription is appropriate for the patient.
3. 1. Notwithstanding any other provision of this title, and except as otherwise provided in subdivision (c)(2), a physician licensed under title 63, chapter 6 or 9, is the only healthcare provider authorized to prescribe any buprenorphine product for any federal food and drug administration approved use in recovery or medication-assisted treatment.
   2. Healthcare providers not licensed pursuant to title 63, chapter 6 or 9, and who are otherwise permitted to prescribe Schedule II or III drugs under this title, are prohibited from prescribing any buprenorphine product for the treatment of opioid use disorder unless the provider:
      1. Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state;
      2. Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years;
      3. Is employed by a community mental health center, as defined in § 33-1-101, or a federally qualified health center, as defined in § 63-10-601(a), that employs one (1) or more physicians and has adopted clinical protocols for medication-assisted treatment;
      4. Is employed at a facility at which healthcare providers are contracted and credentialed with TennCare and TennCare's managed care organizations to treat opioid use disorder with buprenorphine products for use in recovery or medication-assisted treatment;
      5. Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction;
      6. Is employed by a facility that requires patients to verify identification;
      7. Does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent;
      8. Does not prescribe or dispense a mono product or buprenorphine without naloxone;
      9. Works under the supervision of a physician who holds an active federal Drug Addiction Treatment Act of 2000 (DATA 2000) waiver registration from the federal drug enforcement agency that authorizes the physician to prescribe buprenorphine products and is actively treating patients with buprenorphine products for recovery or medication-assisted treatment;
      10. Obtains a waiver registration pursuant to the federal Drug Addiction Treatment Act of 2000 (DATA 2000) from the federal drug enforcement agency that authorizes the provider to prescribe buprenorphine products under federal law;
      11. Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider;
      12. Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration for, a maximum of four (4) licensed nurse practitioners or physician assistants;
      13. Is supervised by or collaborates with a physician who reviews one hundred percent (100%) of the charts of the patients being prescribed a buprenorphine product;
      14. Weighs the risk of relapse with the benefit of tapering down or off of buprenorphine when, similar to other disease states, tapering from the treatment medication is clinically appropriate and in agreement with the patient and tapering schedules and durations are patient specific. Providers shall initiate and lead a discussion regarding patient readiness to taper down or taper off treatment medications employed in the patient's treatment with each patient at any time upon the patient's request but no later than one (1) year after initiating treatment and then every six (6) months thereafter;
      15. Writes prescriptions that can only be dispensed by a licensed pharmacy to ensure entry into the controlled substance database; and
      16. Writes prescriptions of buprenorphine products to fifty (50) or fewer patients at any given time.
4. 1. A prescriber who treats a patient with more than sixteen milligrams (16 mg) per day of buprenorphine or its therapeutic equivalent for more than thirty (30) consecutive days for treatment of opioid dependence shall clearly document in the patient's medical record why the patient needs the higher dosage amounts of buprenorphine. A prescriber who does not meet the requirements established in the manner described in subdivision (d)(2) and treats a patient with more than twenty milligrams (20 mg) per day of buprenorphine or its therapeutic equivalent for more than thirty (30) consecutive days for treatment of opioid dependence shall, to the extent possible, either consult with an addiction specialist meeting the requirements established in the manner described in subdivision (d)(2) or refer the patient to the addiction specialist for management of the patient's treatment plan. If a prescribing physician cannot make the required consultation or referral as outlined in this subsection (d), the reasons shall be set out in the medical record.
   2. The board of medical examiners and the board of osteopathic examination shall promulgate rules establishing the requirements for licensees to qualify as addiction specialists.
5. This section shall not apply to perioperative surgery or ventilator sedation that is performed in a licensed healthcare facility set forth in § 68-11-201(3) or (26).
6. When patients are admitted as inpatients of a hospital, or registered as outpatients of a hospital, prescribers may continue orders for these drug products as part of a medication reconciliation process to continue home medications as previously prescribed and without restrictions pertaining to the use of the product until the patient is discharged from the facility. However, prescriptions written upon discharge from the facility and intended to be filled by the patient at a retail pharmacy and consumed post-discharge shall follow the requirements of this section.
7. 1. 1. Notwithstanding any other law, the dispensing of buprenorphine products is prohibited by any person or entity unless the dispensing is done by a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, with approval from the department of mental health and substance abuse services, a nonresidential substitution-based treatment center for opiate addiction as defined in § 33-2-402, a pharmacy licensed under title 63, chapter 10, or a hospital licensed under title 33, or title 68, chapter 11. This subsection (g) does not apply to the administering of buprenorphine products as otherwise permitted by law.
      2. A pharmacy and a distributor, as defined in § 63-10-204, shall report to the department of health the quantities of buprenorphine that the pharmacy or distributor delivers to nonresidential office-based opiate treatment facilities in this state.
   2. The department of mental health and substance abuse services shall promulgate rules to establish requirements for approval of dispensing of buprenorphine products at a nonresidential office-based opiate treatment facility as defined in § 33-2-402. These rules shall include a requirement that a provider who dispenses buprenorphine products at a nonresidential office-based opiate treatment facility must report the fact that the provider dispenses buprenorphine products to the provider's licensing board, check the controlled substance database prior to dispensing, and enter the amounts dispensed into the controlled substance database, to the extent permitted by 42 CFR part 2.
8. 1. Notwithstanding subsection (c), this subsection (h) controls the prescription of buprenorphine products by any healthcare provider licensed under title 63, chapter 7 or 19, who is employed by or contracted with a nonresidential office-based opiate treatment facility, as defined in § 33-2-402.
   2. A healthcare provider licensed under title 63, chapter 7 or 19, may prescribe a buprenorphine product, as approved by the federal food and drug administration for use in recovery or medication-assisted treatment if:
      1. The provider works in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, that is licensed by the department of mental health and substance abuse services and that does not have authority to dispense buprenorphine products;
      2. The provider practices under the direct supervision of a physician who is licensed under title 63, chapter 6 or chapter 9; holds an active Drug Addiction Treatment Act of 2000 (DATA 2000) waiver from the United States drug enforcement administration; and is actively treating patients with buprenorphine products for recovery or medication-assisted treatment at the same nonresidential office-based opiate treatment facility, as defined in § 33-2-402, as the provider;
      3. The facility and its healthcare providers are contracted and credentialed with TennCare and TennCare's managed care organizations to treat opioid use disorder with buprenorphine products for use in recovery or medication-assisted treatment;
      4. The facility or its healthcare providers are directly billing TennCare and TennCare's managed care organizations for the services provided within the facility;
      5. The facility or its healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction;
      6. The provider does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent;
      7. Except as provided in subdivision (h)(2)(H), the provider does not prescribe or dispense a mono product or buprenorphine without naloxone;
      8. The provider uses injectable or implantable buprenorphine formulations in accordance with subdivision (b)(1)(D);
      9. The provider has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state;
      10. The provider obtains a waiver registration from the United States drug enforcement administration that authorizes the provider to prescribe buprenorphine products under federal law and regulations;
      11. The provider prescribes buprenorphine products only to patients who are treated through a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, that employs or contracts with the provider;
      12. The provider writes prescriptions of buprenorphine products that can only be dispensed by a licensed pharmacy to ensure entry into the controlled substance monitoring database;
      13. The provider writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time;
      14. When providing direct supervision, the physician does not oversee more than two (2) providers licensed under title 63, chapter 7 or 19, at one (1) time during clinical operations; and
      15. The supervising physician ensures all rules of operation for a nonresidential office-based opiate treatment facility, as defined in § 33-2-402; the Tennessee Nonresidential Buprenorphine Treatment Guidelines as established by the department of mental health and substance abuse services and the department of health; and all other state laws, rules, and guidelines regarding use of buprenorphine products for medication assisted treatment are followed.

Acts 2015, ch. 396, § 3; 2018, ch. 674, § 1; 2018, ch. 978, § 7; 2020, ch. 761, § 1; 2020, ch. 771, § 1.

Compiler's Notes. Acts 2015, ch. 396, § 1 provided that the act, which enacted this section, shall be known and may be cited as the “Addiction Treatment Act of 2015”.

Amendments. The 2018 amendment by ch. 674, added (b)(1)(D).

The 2018 amendment by ch. 978, added (g).

The 2020 amendment by ch. 761,  inserted “and except as otherwise provided in subdivision (c)(2),” in (c)(1); substituted “the treatment of opioid use disorder unless the provider:” for “treatment of opioid dependence. However, the providers may participate in the assessment and management of patients with an opiate addiction.” in the introductory paragraph of (c)(2); and added (c)(2)(A) – (c)(2)(P).

The 2020 amendment by ch. 771, added (h).

Effective Dates. Acts 2015, ch. 396, § 6. July 1, 2015.

Acts 2018, ch. 674, § 2. April 12, 2018.

Acts 2018, ch. 978, § 15. July 1, 2018; provided that for rulemaking purposes, the act took effect on May 21, 2018.

Acts 2020, ch. 761, § 2. July 1, 2020.

Acts 2020, ch. 771, § 3. August 1, 2020.

Law Reviews.

Defining the Opioid Crisis and the Limited Role of the Criminal Justice System Resolving It, 48 U. Mem. L. Rev. 1206 (Summer 2018).

53-11-312. Educational materials for providers and facilities where medication assisted treatment is prescribed or provided.

1. No later than January 1, 2021, the departments of health and mental health and substance abuse services, and the bureau of TennCare shall collaborate to develop educational materials for providers and facilities where medication assisted treatment including treatment involving controlled substances is prescribed or provided. The educational materials shall include the following:
   1. Access to and availability of family planning services and contraception;
   2. Risks and effects of neonatal abstinence syndrome; and
   3. Approaches to client-centered counseling.
2. The departments of health and mental health and substance abuse services and the bureau of TennCare shall make the educational materials available to prescribers of medication assisted treatment and facilities that use medication assisted treatment for the treatment of substance use disorder.

Acts 2020, ch. 747, § 1.

Effective Dates. Acts 2020, ch. 747, § 2. June 22, 2020.

53-11-313. Payment for buprenorphine products.

1. Except as provided in subsection (b), a healthcare prescriber of a buprenorphine product for use in recovery or medication-assisted treatment, or a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, shall only accept a check, money order, or debit card or credit card that is linked to a bank or credit card account from a financial institution, in payment for services provided by the healthcare prescriber or facility. Use of prepaid debit cards, prepaid credit cards, gift cards, or any other card not linked with a bank or credit card account from a financial institution is prohibited. As used in this subsection (a), “financial institution” means a state or national bank, a state or federally chartered credit union, or a savings bank.
2. A healthcare prescriber or facility described in subsection (a) may accept payment for services provided to a patient by the prescriber or facility in cash for a co-pay, coinsurance, or deductible if the prescriber or facility submits the remainder of the bill for the services provided to the patient's insurance plan for reimbursement. If the patient does not have an insurance plan, then the healthcare prescriber or facility shall not accept cash as payment for services provided.
3. No healthcare provider, licensed by title 63, chapter 6, 7, 9, or 19, shall be compensated or receive payment for services related to buprenorphine treatment:
   1. By which the provider receives an amount per patient that is treated within the office or other setting; or
   2. By any means by which the provider receives a percentage of a payment that is directly received by a patient to the office, nonresidential office-based opiate treatment facility, as defined in § 33-2-402, or other provider.
4. A healthcare provider licensed under title 63, or a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, shall not knowingly treat any TennCare enrollee with buprenorphine products for use in recovery or medication-assisted treatment unless that provider directly bills or seeks reimbursement from TennCare or TennCare's managed care organizations for services provided to the TennCare enrollee. A person is required to disclose to the healthcare provider or nonresidential office-based opiate treatment facility, as defined in § 33-2-402, that the person is a TennCare enrollee seeking treatment with buprenorphine products for use in recovery or medication-assisted treatment.

Acts 2020, ch. 771, § 2.

Effective Dates. Acts 2020, ch. 771, § 3. August 1, 2020.

Part 4
Criminal Penalties and Enforcement