(a)

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Terms Used In Tennessee Code 63-10-216

  • Board: means the Tennessee board of pharmacy. See Tennessee Code 63-10-204
  • Compounding: means the preparation, mixing, assembling, packaging or labeling of a drug or device:
    (A) As the result of a prescription order or initiative based on the prescriber-patient-pharmacist relationship in the course of professional practice. See Tennessee Code 63-10-204
  • Director: means the director of the health related boards. See Tennessee Code 63-10-204
  • Executive director: means the executive director of the Tennessee board of pharmacy. See Tennessee Code 63-10-204
  • Licensure: means the process by which an agency of government grants permission to an individual to engage in a given occupation upon finding that the applicant has attained the minimal degree of competency necessary to ensure that the public health, safety and welfare will be reasonably protected. See Tennessee Code 63-10-204
  • Pharmacy: means a location licensed by this state where drugs are compounded or dispensed under the supervision of a pharmacist, as defined in the rules of the board and where prescription orders are received or processed. See Tennessee Code 63-10-204
  • 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
  • United States: includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
(1) Prior to initial licensure in this state as a compounding pharmacy, a pharmacy located outside of this state must have an inspection by the regulatory or licensing agency of the state in which the pharmacy practice site is physically located. Out-of-state pharmacy practice sites must provide to the board a copy of the most recent inspection by the regulatory or licensing agency of the state in which the pharmacy practice site is physically located, or an equivalent inspection accepted by the board, that must have been within the previous twelve (12) months.
(2) Prior to renewal of its license in this state, an out-of-state pharmacy practice site must provide to the board the most recent inspection by the regulatory or licensing agency of the state in which the pharmacy practice site is physically located, or an equivalent inspection accepted by the board, that must have been within the previous twelve (12) months.
(3) The board may require additional information before issuing or renewing a pharmacy license to ensure compliance with applicable laws of this state and rules of the board.
(b) A compounding pharmacy that has an active license issued by the board shall notify the board within fourteen (14) business days of receipt of an order or decision by a regulatory or licensing agency, other than the board, imposing a disciplinary action, including a warning, on the pharmacy.
(c) A pharmacy engaged in compounding must comply with relevant United States Pharmacopeia (USP) guidelines as adopted by the board by rule.
(d) A pharmacy that engages in sterile compounding, except hospital pharmacies compounding for inpatients of a hospital, shall, upon request, make available to the board the quantity of sterile compounded products dispensed in a defined time period in accordance with rules promulgated by the board. However, the executive director of the board may request this information from a hospital pharmacy for cause and the hospital pharmacy shall respond in a timely manner as defined by the executive director of the board.
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