reglab/statecodes huggingface dataset:
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 1 - GENERAL PROVISIONS (§§ 53-10-101 — 53-10-113) › Section 53-10-106 - Adulterated drugs or devices

(a)
(1)
Any drug or device that is misbranded, out of date, old, deteriorated, not kept under proper refrigeration as required, or that has been exposed to fire, heat, smoke, water, flood or windstorm damage is deemed to be adulterated, and the possession, sale or distribution of those drugs or devices is prohibited.
(2)
Any drug or device that is deemed misbranded or adulterated by federal law is deemed misbranded or adulterated within the purview of this section.
(b)
The drugs or devices listed in subsection (a) are subject to seizure and subsequent destruction unless specifically exempted by the board of pharmacy.
(c)
Prior to the destruction of any drugs or devices deemed to be adulterated, the owner or person in legal possession of the drugs or devices shall be given written notice of the intent to destroy the drug or device and the reason for the destruction.
(d)
The owner or person in legal possession shall have ten (10) days from the receipt of the written notice to request in writing a hearing to show cause to the board why the drugs or devices are not within the purview of this section.
Acts 1973, ch. 110, § 14; T.C.A., § 52-1209.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 1 - GENERAL PROVISIONS (§§ 53-10-101 — 53-10-113) › Section 53-10-107 - Fines and fees to be paid to board of pharmacy

All fines and fees received in the regulation and enforcement of this part shall be paid to the secretary-treasurer of the board of pharmacy.
Acts 1965, ch. 271, § 1; T.C.A., § 52-1207.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 1 - GENERAL PROVISIONS (§§ 53-10-101 — 53-10-113) › Section 53-10-108 - Violation - Penalty

Any person, firm or corporation possessing, selling, bartering or giving away any drug in violation of this part or violating any other provision of this part commits a Class C misdemeanor.
Acts 1972, ch. 597, § 8; T.C.A., § 52-1208; Acts 1989, ch. 591, § 113.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 1 - GENERAL PROVISIONS (§§ 53-10-101 — 53-10-113) › Section 53-10-109 - Prescription of certain stimulants for weight control prohibited

(a)
No amphetamine classified as a Schedule II stimulant under §
39-17-408(d)
shall be prescribed for the purpose of assisting a patient to gain or lose weight.
(b)
A violation of this section is a ground for license denial, suspension or revocation.
Acts 1990, ch. 934, § 1.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 1 - GENERAL PROVISIONS (§§ 53-10-101 — 53-10-113) › Section 53-10-110 - Contents of label - Damages in civil action

(a)
Any person dispensing a legend drug for a patient shall include on the label of the container in which the legend drug is dispensed the indication or indications for which the drug is being prescribed if requested by the prescriber, patient, or patient's caregiver and the prescriber, patient, or patient's caregiver provides the indication or indications to the person dispensing the legend drug.
(b)
Any person dispensing a legend drug shall not be liable in any civil action for any alleged injury resulting solely from:
(1)
Failing to include the indication or indications on the label when not requested to do so by the prescriber, patient or patient's caregiver; or
(2)
Reasonably relying upon the prescriber, patient or patient's caregiver in obtaining the indication or indications included on the label.
(c)
No prescriber shall be liable for damages in any civil action solely:
(1)
For refusing a patient or patient's caregiver's request to the prescriber that the prescriber request that the dispenser provide the indication or indications on the label of the legend drug container;
(2)
Alleging any cause of action for violation of the patient's privacy for complying with a patient or the patient's caregiver's request that the prescriber request that the dispenser provide the indication or indications on the label of the legend drug container; or
(3)
For any incorrect information placed on the label of any legend drug by the dispenser pursuant to the terms of this section unless the dispenser only relied on information provided by the prescriber.
(d)
This section shall not apply to prescriptions dispensed for inpatients of a hospital, a nursing home or an assisted care living facility as defined in §
68-11-201
or inpatients or residents of a mental health hospital or residential facility licensed under title 33 or individuals incarcerated in a local, state or federal correctional facility.
(e)
Nothing in this section shall limit in any manner the civil liability of any person guilty of willful or wanton misconduct, gross negligence, reckless conduct or criminal conduct.
Acts 2008, ch. 936, § 1; 2011, ch. 166, § 1.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 1 - GENERAL PROVISIONS (§§ 53-10-101 — 53-10-113) › Section 53-10-111 - Requirements for filling prescriptions of prescribers who have died

(a)
Notwithstanding any other provision of law to the contrary, when a pharmacist becomes aware that a healthcare practitioner authorized to prescribe by the law of this state has died, a prescription issued by the practitioner may continue to be dispensed based on the pharmacist's professional judgment and in accordance with the following requirements:
(1)
If the prescription is a new prescription that has not been previously dispensed, it may be dispensed within ninety (90) days of the date on which the practitioner has died;
(2)
If the prescription has been previously dispensed and has valid authorization to be refilled, the refills may be dispensed but not for a period of more than ninety (90) days from the date on which the practitioner died for Schedule III, IV and V drugs and one hundred eighty (180) days from the date on which the practitioner died for non-scheduled drugs; and
(3)
Nothing in this section shall authorize the dispensing of a prescription that was issued for a controlled substance unless permitted by the federal Controlled Substances Act and regulations of the federal drug enforcement administration.
(b)
These provisions shall not apply to a schedule II controlled substance.
Acts 2010, ch. 767, § 1.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 1 - GENERAL PROVISIONS (§§ 53-10-101 — 53-10-113) › Section 53-10-112 - Prevention of abuse of drugs dispensed by pharmacist

(a)
For purposes of this section:
(1)
"Pharmacist" has the same meaning as defined in §
63-10-204
; and
(2)
"Pharmacy" has the same meaning as defined in §
63-10-204
.
(b)
A pharmacy owner, manager or operator shall respect the professional judgment of the pharmacist in holding the health and safety of a patient to be their first consideration.
(c)
A pharmacist shall, by utilizing education, skill, experience and professional judgment, make every reasonable effort to prevent the abuse of drugs which the pharmacist dispenses. In doing so, a pharmacist may decline to dispense to a patient a legend drug which in that pharmacist's professional judgment, lacks a therapeutic value for the patient or which is not for a legitimate medical purpose.
(d)
A pharmacist shall not be subject to any penalty or fine when fulfilling the pharmacist's obligation to uphold the health and safety of a patient which results in the pharmacist declining to dispense any legend drug.
(e)
It shall be a Class A misdemeanor, punishable by fine only, for the owner, manager or operator of a pharmacy to knowingly restrict or interfere with, or knowingly require a protocol or procedure that restricts or interferes with, a pharmacist's professional duty to counsel with patients and to evaluate the patients' appropriate pharmaceutical needs and the exercise of the pharmacist's professional judgment as to whether it is appropriate to dispense a legend drug to a patient.
Added by 2013 Tenn. Acts, ch. 276,s 1, eff. 7/1/2013.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 1 - GENERAL PROVISIONS (§§ 53-10-101 — 53-10-113) › Section 53-10-113 - Off-label drug use

(a)
As used in this section, and unless the context otherwise requires:
(1)
"Misbranding" means either the federal definition under
21 U.S.C. § 352
or drugs or devices that are misbranded under §
53-10-106
; and
(2)
"Off-label" means the use of a United States food and drug administration (FDA) approved drug, biological product, or device other than the use or uses approved by the FDA.
(b)
(1)
A pharmaceutical manufacturer or its representatives may engage in truthful promotion of off-label uses.
(2)
This section does not require a health insurance entity, as defined in §
56-7-109
, other third-party payer, or other health plan sponsor to provide coverage for the cost of any off-label treatment. A health insurance entity, other third-party payer, or other health plan sponsor may provide coverage for an off-label treatment.
(c)
(1)
Notwithstanding any other law, no official, employee, or agent of this state shall enforce or apply §
53-10-106(a)(2)
against or otherwise prosecute a pharmaceutical manufacturer or its representatives for engaging in truthful promotion of off-label uses.
(2)
Notwithstanding any other law, no state regulatory board may revoke, fail to renew or take any other action against a pharmaceutical manufacturer's or representative's, healthcare institution's, or physician's license solely for engaging in truthful promotion of off-label uses.
Acts 2018 , ch. 893, § 1.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 2 - TENNESSEE AFFORDABLE DRUG ACT OF 2005 (§§ 53-10-201 — 53-10-211) › Section 53-10-201 - Short title

This part shall be known and may be cited as the "Tennessee Affordable Drug Act of 2005."
Acts 2005, ch. 434, § 3.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 2 - TENNESSEE AFFORDABLE DRUG ACT OF 2005 (§§ 53-10-201 — 53-10-211) › Section 53-10-202 - Legislative intent

The general assembly declares it to be the public policy that, in order to lower the cost of prescription drugs to its citizens, pharmacists may substitute less costly generic drugs or drug products for higher priced brand name or trade name drugs or drug products.
Acts 2005, ch. 434, § 4.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 2 - TENNESSEE AFFORDABLE DRUG ACT OF 2005 (§§ 53-10-201 — 53-10-211) › Section 53-10-203 - Part definitions

As used in this part, unless the context otherwise requires:
(1)
"Biological product" has the same meaning as defined in
42 U.S.C. § 262(i)
;
(2)
"Brand name" means the registered trademark name of a drug or drug product given by its manufacturer, labeler or distributor;
(3)
"Finished dosage form" means that form of a drug that is, or is intended to be, dispensed or administered to a patient and requires no further manufacturing or processing other than packaging, reconstitution or labeling;
(4)
"Generic equivalent" means a drug product that has the same established name, active ingredients, strength or concentration, dosage form, and route of administration and that is formulated to contain the same amount of active ingredients, in the same dosage form, and to meet the same compendial or other applicable standards, i.e. strength, quality, purity, and identity, but that may differ in characteristics, such as shape, scoring, configuration, packaging, excipients, including colors, flavors, preservatives, and expiration time;
(5)
"Interchangeable biological product" means:
(A)
A biological product licensed by the federal food and drug administration and determined to meet the safety standards for determining interchangeability pursuant to
42 U.S.C. § 262(k)(4)
; or
(B)
A biological product determined by the federal food and drug administration to be therapeutically equivalent as set forth in the latest edition or supplement of the federal food and drug administration's "Approved Drug Products with Therapeutic Equivalence Evaluations," also known as the "Orange Book"; and
(6)
"Prescriber" means an individual authorized by law to prescribe drugs.
Amended by 2015 Tenn. Acts, ch. 371,s 1, eff. 5/4/2015.
Acts 2005, ch. 434, § 5.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 2 - TENNESSEE AFFORDABLE DRUG ACT OF 2005 (§§ 53-10-201 — 53-10-211) › Section 53-10-204 - Substitution authorized - Instructions of prescriber

(a)
The prescriber shall allow for substitution with a generic equivalent of a brand name drug or drug product under all circumstances, unless:
(1)
The prescriber determines the medical necessity of a brand name drug or drug product due to:
(A)
An adverse reaction previously experienced by the patient to a generic equivalent;
(B)
A generic equivalent has previously been demonstrated as ineffective for the patient; or
(C)
Any other clinically based prescriber determined need;
(2)
A generic equivalent is not available; or
(3)
Section
53-10-210
concerning notification to the patient and the prescriber have not been complied with in instances involving an anti-epileptic drug.
(b)
If the prescriber determines a brand name drug or drug product is medically necessary for a patient, the prescriber shall, in the prescriber's own handwriting, place the instruction showing intent upon the prescription at the time it is prepared and issued. For the purposes of this subsection (b), instructions showing intent may include, but not be limited to, the following language:
(1)
"Brand name medically necessary", "dispense as written", "medically necessary", "brand name", "no generic";
(2)
Any abbreviation of the language in subdivision (b)(1); or
(3)
Any other prescriber handwritten notation, such as circling a preprinted instruction to dispense as written on the prescription order, that clearly conveys the intent that a brand name is necessary for this patient.
(c)
If the prescriber determines a brand name drug or drug product is medically necessary for a patient and that prescription order is issued verbally, the prescriber shall alert the pharmacist that use of the brand name drug or drug product is medically necessary for the patient.
(d)
If the prescriber determines a brand name drug or drug product is medically necessary for a patient and that prescription order is issued by the prescriber in the form of an electronic prescription order or facsimile prescription order, the prescriber shall place, or cause to be placed, the proper instruction on the electronic prescription order or facsimile prescription order prior to it being transmitted to the pharmacist.
(e)
Nothing in this section shall be construed to prevent a prescriber from informing a patient of the prescriber's professional opinion as to the capabilities, effectiveness and acceptability of any drug.
Acts 2005, ch. 434, § 6; 2006, ch. 564, §§ 1, 2; 2007, ch. 370, § 2.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 2 - TENNESSEE AFFORDABLE DRUG ACT OF 2005 (§§ 53-10-201 — 53-10-211) › Section 53-10-205 - Least expensive generic equivalent if authorized by prescriber

(a)
When a pharmacist receives a written, verbal, electronic or facsimile prescription order, and the prescriber has not noted medical necessity of the brand name prescribed, as required in §
53-10-204
, the pharmacist shall dispense the least expensive generic equivalent in stock, or a generic equivalent covered under the patient's drug plan, except as provided in subsections (c) and (d).
(b)
A pharmacist shall make a reasonable attempt to notify a prescriber if a generic equivalent has become available since the last dispensing of a prescription, and, if authorized by the prescriber, the pharmacist shall dispense the least expensive generic equivalent in stock, or a generic equivalent covered under the patient's drug plan.
(c)
If a pharmacist has reason to believe that the brand name drug or drug product is less expensive to the patient or patient's drug plan than the generic equivalent, the pharmacist shall fill the prescription with the brand name drug or drug product.
(d)
Nothing in this section shall be construed as prohibiting a pharmacist from complying with the request of a patient with a valid prescription order to obtain a brand name drug or drug product, if:
(1)
The patient has prescription drug coverage under a prescription benefit plan and agrees to pay the additional cost, if any, of purchasing the brand name drug or drug product, as that cost is determined according to the benefits provided by the patient's prescription benefit plan and when cost sharing that would be required to cover the additional cost is permissible under the patient's prescription benefit plan guidelines and all applicable laws and regulations; or
(2)
The patient does not have a prescription benefit plan or the patient's prescription benefit plan does not provide coverage for the brand name drug or drug product, and the patient agrees to pay the entire cost at the pharmacy of the brand name drug or drug product.
Acts 2005, ch. 434, § 7; 2006, ch. 564, § 3.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 2 - TENNESSEE AFFORDABLE DRUG ACT OF 2005 (§§ 53-10-201 — 53-10-211) › Section 53-10-206 - Responsibility of pharmacist

A pharmacist who selects a generic equivalent for substitution, pursuant to §
53-10-204
, has the same responsibility for the selected drug as the pharmacist would in dispensing a prescription for the drug prescribed by the drug's trade or brand name.
Acts 2005, ch. 434, § 8.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 2 - TENNESSEE AFFORDABLE DRUG ACT OF 2005 (§§ 53-10-201 — 53-10-211) › Section 53-10-207 - Contents of label

(a)
The manufacturer, packager, or distributor of any human use legend drug sold, delivered or offered for sale in the state must have printed on the label of the immediate container of the drug the name and address of the manufacturer, packager, or distributor of the finished dosage form of the drug.
(b)
The pharmacist shall notify the patient of the substitution with a generic equivalent by noting the substitution on the prescription label.
(c)
This section shall not apply to prescriptions dispensed for inpatients of a hospital, a nursing home or an assisted care living facility, as defined in §
68-11-201
.
Acts 2005, ch. 434, § 9.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 2 - TENNESSEE AFFORDABLE DRUG ACT OF 2005 (§§ 53-10-201 — 53-10-211) › Section 53-10-208 - Source of products substituted - FDA approval required

(a)
In making substitutions as allowed by this part, the pharmacist may use drugs and drug products manufactured within the territorial limits of any one (1) of the states of the United States, or of any other country, if the products have been approved by the federal food and drug administration (FDA), and have been given an "A" therapeutic equivalent rating by the FDA in the agency's publication, "Approved Drug Products with Therapeutic Equivalence Evaluations", also known as the "Orange Book". "A" rated drug products are those that the FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, including, but not limited to, drug products for which:
(1)
There are no known or suspected bioequivalence problems and are designated "AA", "AN", "AO", "AP" or "AT", depending on the dosage form; or
(2)
Actual or potential bioequivalence problems have been resolved with adequate in vivo or in vitro evidence supporting bioequivalence and are designated "AB".
(b)
This section shall not apply to generic drugs and drug products that have not been rated.
(c)
For those drugs that have not been evaluated and rated for bioequivalency by the FDA, pharmacists are permitted to use their professional judgment in selecting a generic product for substitution.
Acts 2005, ch. 434, § 10; 2006, ch. 866, § 1.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 2 - TENNESSEE AFFORDABLE DRUG ACT OF 2005 (§§ 53-10-201 — 53-10-211) › Section 53-10-209 - Construction

(a)
Nothing in this part shall be construed as authorizing any person or entity to interfere with a prescriber's obligation to exercise independent medical judgment in rendering health care services to patients.
(b)
Nothing in this part shall be construed to interfere with or otherwise limit, constrain or alter the ability of any health plan or payor, including the bureau of TennCare, to utilize prior authorization in the implementation of a formulary or preferred drug list.
Acts 2005, ch. 434, §§ 11, 13.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 2 - TENNESSEE AFFORDABLE DRUG ACT OF 2005 (§§ 53-10-201 — 53-10-211) › Section 53-10-210 - Prescription drugs for epilepsy patients

(a)
As used in this section, unless the context otherwise requires:
(1)
"Anti-epileptic drug" means:
(A)
Any drug prescribed for the treatment of epilepsy; or
(B)
A drug used to treat or prevent seizures;
(2)
"Epilepsy" means a neurological condition characterized by recurrent seizures;
(3)
"Interchange" means the dispensing of one (1) manufacturer of an anti-epileptic drug for a different manufacturer of an anti-epileptic drug for which the patient is currently receiving therapy. This includes the substitution of a generic version for a brand version, a brand version for a generic version, or a generic version for a generic version by a different manufacturer; and
(4)
"Seizure" means a brief disturbance in electrical activity of the brain.
(b)
A pharmacist, pharmacy intern or pharmacy technician shall provide notification to the patient, a family member, other relative, or a close personal friend of the individual or any other person identified by the patient before interchanging one manufacturer of an anti-epileptic drug for another manufacturer of an anti-epileptic drug in instances where the patient's epilepsy or seizures are currently being controlled on a specific drug, strength, dosage form, and dosing regimen from a specific manufacturer. The prescriber of the medication shall also be notified prior to the interchange.
(c)
This section shall not apply to prescriptions dispensed for inpatients of a hospital, nursing home or assisted care living facility as defined in §
68-11-201
, or inpatients or residents of a mental health hospital or residential facility licensed under title 33.
Acts 2007, ch. 370, § 1.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 3 - TENNESSEE PRESCRIPTION SAFETY ACT OF 2016 (§§ 53-10-301 — 53-10-312) › Section 53-10-301 - Short title

This part shall be known and may be cited as the "Tennessee Prescription Safety Act of 2016".
Acts 2002, ch. 840, § 1; 2012 , ch. 880, § 1.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 3 - TENNESSEE PRESCRIPTION SAFETY ACT OF 2016 (§§ 53-10-301 — 53-10-312) › Section 53-10-307 - Failure to submit information - Liability

(a)
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.
(b)
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.
(c)
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.
(d)
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.
(e)
(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 2002, ch. 840, § 1; 2012 , ch. 880, § 16; 2014, ch. 1011, §§ 2, 4.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 3 - TENNESSEE PRESCRIPTION SAFETY ACT OF 2016 (§§ 53-10-301 — 53-10-312) › Section 53-10-309 - 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 2002, ch. 840, § 1; 2007 , ch. 498, § 3; 2011 , ch. 310, § 5; 2012 , ch. 880, §§ 19, 26; 2013 , ch. 236, § 50.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 3 - TENNESSEE PRESCRIPTION SAFETY ACT OF 2016 (§§ 53-10-301 — 53-10-312) › Section 53-10-312 - Minimum reporting requirements for wholesalers and manufacturers - Establishment of rules as to reporting requirements

(a)
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.
(b)
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.
(c)
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.
(d)
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.
Amended by 2016 Tenn. Acts, ch. 1002, s 12, eff. 4/27/2016.
Acts 2013 , ch. 430, § 6; 2014, ch. 983, § 2.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 11 - NARCOTIC DRUGS AND DRUG CONTROL (§§ 53-11-201 — 53-11-452) › Part 2 - CONFISCATION (§§ 53-11-201 — 53-11-204) › Section 53-11-203 - Procedure final when no claim interposed

If no claim is interposed, narcotic drugs, marijuana or other property shall be forfeited without further proceedings and the drugs, marijuana or other property shall be sold or disposed of as provided in this chapter.
Acts 1955, ch. 83, § 6; T.C.A., § 52-1406.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 11 - NARCOTIC DRUGS AND DRUG CONTROL (§§ 53-11-201 — 53-11-452) › Part 2 - CONFISCATION (§§ 53-11-201 — 53-11-204) › Section 53-11-204 - Disposition of proceeds

The proceeds of all seizures, confiscations and sales made by a state agency pursuant to this chapter shall be transmitted to the state treasurer and deposited in the state treasury; provided, that upon application of the commissioner, the proceeds or any part of the proceeds may be allocated by the commissioner of finance and administration to the department of safety as expendable receipts for use in the enforcement of this chapter and the other laws of this state regulating narcotic drugs and marijuana.
Acts 1955, ch. 83, § 7; impl. am. Acts 1959, ch. 9, § 3; impl. am. Acts 1961, ch. 97, § 3; Acts 1976, ch. 499, § 2; T.C.A., § 52-1407.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 11 - NARCOTIC DRUGS AND DRUG CONTROL (§§ 53-11-201 — 53-11-452) › Part 3 - REGULATIONS AND REGISTRATION (§§ 53-11-301 — 53-11-314) › Section 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.
Amended by 2015 Tenn. Acts, ch. 293,s 6, eff. 4/24/2015.
Acts 1971, ch. 163, § 17; 1971, ch. 408, § 1; 1981, ch. 358, § 1; T.C.A., § 52-1424; Acts 1990, ch. 1026, § 13.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 11 - NARCOTIC DRUGS AND DRUG CONTROL (§§ 53-11-201 — 53-11-452) › Part 3 - REGULATIONS AND REGISTRATION (§§ 53-11-301 — 53-11-314) › Section 53-11-302 - Handlers of controlled substances - Registration and inspection

(a)
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.
(b)
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.
(c)
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.
(d)
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.
(e)
A separate registration is required at each principal place of business or professional practice where the applicant manufactures, distributes or dispenses controlled substances.
(f)
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.
Amended by 2015 Tenn. Acts, ch. 293,s 1, eff. 4/24/2015.
Acts 1971, ch. 163, § 18; 1977, ch. 180, § 3; T.C.A., § 52-1425; Acts 1996, ch. 675, §§ 51, 52.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 11 - NARCOTIC DRUGS AND DRUG CONTROL (§§ 53-11-201 — 53-11-452) › Part 3 - REGULATIONS AND REGISTRATION (§§ 53-11-301 — 53-11-314) › Section 53-11-303 - Criteria for registration issuance

(a)
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.
(b)
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.
(c)
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.
(d)
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.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 11 - NARCOTIC DRUGS AND DRUG CONTROL (§§ 53-11-201 — 53-11-452) › Part 3 - REGULATIONS AND REGISTRATION (§§ 53-11-301 — 53-11-314) › Section 53-11-304 - Suspension and revocation of registration

(a)
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.
(b)
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.
(c)
(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.
(d)
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.
Amended by 2015 Tenn. Acts, ch. 293,s 2, eff. 4/24/2015.
Acts 1971, ch. 163, § 20; T.C.A., § 52-1427; Acts 1996, ch. 675, § 55.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 11 - NARCOTIC DRUGS AND DRUG CONTROL (§§ 53-11-201 — 53-11-452) › Part 3 - REGULATIONS AND REGISTRATION (§§ 53-11-301 — 53-11-314) › Section 53-11-305 - Revocation, suspension or denial of registration

(a)
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.
(b)
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.
(c)
Proceedings to refuse renewal of registration shall not abate the existing registration, which shall remain in effect pending the outcome of the administrative hearing.
(d)
(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.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 11 - NARCOTIC DRUGS AND DRUG CONTROL (§§ 53-11-201 — 53-11-452) › Part 3 - REGULATIONS AND REGISTRATION (§§ 53-11-301 — 53-11-314) › Section 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.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 11 - NARCOTIC DRUGS AND DRUG CONTROL (§§ 53-11-201 — 53-11-452) › Part 3 - REGULATIONS AND REGISTRATION (§§ 53-11-301 — 53-11-314) › Section 53-11-307 - Inter-registrant distribution

(a)
Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to an order form.
(b)
Compliance with federal law respecting order forms shall be deemed compliance with this section.
Acts 1971, ch. 163, § 23; T.C.A., § 52-1430.
2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 11 - NARCOTIC DRUGS AND DRUG CONTROL (§§ 53-11-201 — 53-11-452) › Part 3 - REGULATIONS AND REGISTRATION (§§ 53-11-301 — 53-11-314) › Section 53-11-312 - Educational materials for providers and facilities where medication assisted treatment is prescribed or provided

(a)
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.
(b)
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.