(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.

Terms Used In Tennessee Code 53-10-207

  • 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. 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
  • State: when applied to the different parts of the United States, includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
(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.