reglab/housing_qa huggingface dataset:
TN Code § 53-10-113 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 1 - General Provisions|§ 53-10-113. Off-Label Drug Use

  As used in this section, and unless the context otherwise requires:  “Misbranding” means either the federal definition under 21 U.S.C. § 352 or drugs or devices that are misbranded under § 53-10-106; and   “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.      A pharmaceutical manufacturer or its representatives may engage in truthful promotion of off-label uses.   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.      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.   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.
TN Code § 53-10-201 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 2 - Tennessee Affordable Drug Act of 2005|§ 53-10-201. Short Title

 This part shall be known and may be cited as the “Tennessee Affordable Drug Act of 2005.”
TN Code § 53-10-202 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 2 - Tennessee Affordable Drug Act of 2005|§ 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.
TN Code § 53-10-203 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 2 - Tennessee Affordable Drug Act of 2005|§ 53-10-203. Part Definitions

 As used in this part, unless the context otherwise requires:   “Biological product” has the same meaning as defined in 42 U.S.C. § 262(i);   “Brand name” means the registered trademark name of a drug or drug product given by its manufacturer, labeler or distributor;   “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;   “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;   “Interchangeable biological product” means:  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   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     “Prescriber” means an individual authorized by law to prescribe drugs.
TN Code § 53-10-204 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 2 - Tennessee Affordable Drug Act of 2005|§ 53-10-204. Substitution Authorized — Instructions of Prescriber

  The prescriber shall allow for substitution with a generic equivalent of a brand name drug or drug product under all circumstances, unless:  The prescriber determines the medical necessity of a brand name drug or drug product due to:  An adverse reaction previously experienced by the patient to a generic equivalent;   A generic equivalent has previously been demonstrated as ineffective for the patient; or   Any other clinically based prescriber determined need;     A generic equivalent is not available; or   Section 53-10-210 concerning notification to the patient and the prescriber have not been complied with in instances involving an anti-epileptic drug.     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:  “Brand name medically necessary”, “dispense as written”, “medically necessary”, “brand name”, “no generic”;   Any abbreviation of the language in subdivision (b)(1); or   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.     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.   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.   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.
TN Code § 53-10-205 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 2 - Tennessee Affordable Drug Act of 2005|§ 53-10-205. Least Expensive Generic Equivalent if Authorized by Prescriber

  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).   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.   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.   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:  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   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.
TN Code § 53-10-206 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 2 - Tennessee Affordable Drug Act of 2005|§ 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.
TN Code § 53-10-207 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 2 - Tennessee Affordable Drug Act of 2005|§ 53-10-207. Contents of Label

  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.   The pharmacist shall notify the patient of the substitution with a generic equivalent by noting the substitution on the prescription label.   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.
TN Code § 53-10-208 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 2 - Tennessee Affordable Drug Act of 2005|§ 53-10-208. Source of Products Substituted — Fda Approval Required

  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:  There are no known or suspected bioequivalence problems and are designated “AA”, “AN”, “AO”, “AP” or “AT”, depending on the dosage form; or   Actual or potential bioequivalence problems have been resolved with adequate in vivo or in vitro evidence supporting bioequivalence and are designated “AB”.     This section shall not apply to generic drugs and drug products that have not been rated.   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.
TN Code § 53-10-209 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 2 - Tennessee Affordable Drug Act of 2005|§ 53-10-209. Construction

  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.   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.
TN Code § 53-10-210 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 2 - Tennessee Affordable Drug Act of 2005|§ 53-10-210. Prescription Drugs for Epilepsy Patients

  As used in this section, unless the context otherwise requires:  “Anti-epileptic drug” means:  Any drug prescribed for the treatment of epilepsy; or   A drug used to treat or prevent seizures;     “Epilepsy” means a neurological condition characterized by recurrent seizures;   “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   “Seizure” means a brief disturbance in electrical activity of the brain.     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.   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.
TN Code § 53-10-301 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 3 - Tennessee Prescription Safety Act of 2016|§ 53-10-301. Short Title

 This part shall be known and may be cited as the “Tennessee Prescription Safety Act of 2016”.
TN Code § 53-10-307 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 3 - Tennessee Prescription Safety Act of 2016|§ 53-10-307. Failure to Submit Information — Liability

  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:  Recommend to the appropriate licensure board that it should refuse to issue a license to the individual;   Recommend to the appropriate licensure board that it should refuse to renew the individual's license; and   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.     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.   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.   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.    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.   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.
TN Code § 53-10-309 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 3 - Tennessee Prescription Safety Act of 2016|§ 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.
TN Code § 53-10-312 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 3 - Tennessee Prescription Safety Act of 2016|§ 53-10-312. Minimum Reporting Requirements for Wholesalers and Manufacturers — Establishment of Rules as to Reporting Requirements

  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:  Wholesaler or manufacturer with a drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier;   Purchaser's drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier;   National drug code number of the actual drug sold;   Quantity of the drug sold;   Date of sale; and   Transaction identifier or invoice number.     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.   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.   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.
TN Code § 53-10-401 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 10 - Legend Drugs|Part 4 - Tamper-Proof Prescriptions|§ 53-10-401. Tamper-Proof Prescriptions

  All prescriptions written or printed by practitioners authorized to write prescriptions in this state shall be written on either tamper-resistant prescription paper or printed utilizing a technology that results in a tamper-resistant prescription that meets the current centers for medicare and medicaid services guidance to state medicaid directors regarding § 7002(b) of the United States Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007, P.L. 110-28, and meets or exceeds specific TennCare requirements for tamper-resistant prescriptions.   A pharmacist shall not fill a written prescription from a Tennessee practitioner unless issued in compliance with tamper-resistant prescription requirements as described in subsection (a), except that a pharmacist may provide emergency supplies in accordance with TennCare or other insurance contract requirements. Nothing in this section shall be construed to impact regulations regarding verbal, facsimile, electronic, or out-of-state prescription practices.   All existing statutory requirements regarding prescriber-specific information to be included on prescriptions shall also apply to tamper-resistant prescriptions.   Unique serial numbers may be included on tamper-resistant prescriptions for purposes of enhancing efforts to track and enforce any potential fraud. Inclusion of such numbers on the prescription shall not be construed as obligating prescribers or pharmacists to any additional tracking, monitoring or reporting requirements and prescribers and pharmacists shall bear no responsibility or liability with respect to the potential use of these unique serial numbers for enforcement purposes.   Practitioners shall utilize reasonable safeguards to assure against theft or unauthorized use of any prescriptions.   Manufacturers of tamper-resistant prescription paper shall have an annual industry-approved SAS 70 audit that shall be made available by the manufacturer upon request by the board of pharmacy. The board of pharmacy shall maintain a list of any manufacturers who fail to show proof of such audit. The list shall be made available to prescribers and pharmacists in this state in a manner deemed appropriate by the board of pharmacy.   This section shall not apply to prescriptions written by veterinarians.   This section shall not apply to prescriptions written for inpatients of a hospital, outpatients of a hospital where the doctor, or other person authorized to write prescriptions, writes the order into the hospital medical record and then the order is given directly to the hospital pharmacy and the patient never has the opportunity to handle the written order, 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.
TN Code § 53-11-203 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 11 - Narcotic Drugs and Drug Control|Part 2 - Confiscation|§ 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.