(a) The prescriber shall allow for substitution with a generic equivalent of a brand name drug or drug product under all circumstances, unless:

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Terms Used In Tennessee Code 53-10-204

  • Brand name: means the registered trademark name of a drug or drug product given by its manufacturer, labeler or distributor. See Tennessee Code 53-10-203
  • 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. See Tennessee Code 53-10-203
  • Prescriber: means an individual authorized by law to prescribe drugs. See Tennessee Code 53-10-203
  • written: includes printing, typewriting, engraving, lithography, and any other mode of representing words and letters. See Tennessee Code 1-3-105
(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.
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