(a) This chapter does not apply to a facility to the extent the facility engages in the distribution of dialysate or devices necessary to perform home peritoneal kidney dialysis to patients with end stage renal disease if:

Terms Used In Tennessee Code 63-10-220

  • Board: means the Tennessee board of pharmacy. See Tennessee Code 63-10-204
  • delivery: means the actual, constructive or attempted transfer from one person to another whether or not there is an agency relationship. See Tennessee Code 63-10-204
  • distribution: means the sale, purchase, trade, delivery, handling, storage, or receipt of a product or the arrangement of the sale, purchase, trade, delivery, handling, storage, or receipt of a product through third parties. See Tennessee Code 63-10-204
  • Drug: means any of the following:
    (A) Articles recognized as drugs or drug products in any official compendium or supplement thereto. See Tennessee Code 63-10-204
  • Manufacturer: means any person, except a pharmacist compounding in the normal course of professional practice, engaged in the commercial production, preparation, propagation, conversion or processing of a drug, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis, or both, and includes any packaging or repackaging of a drug or the labeling or relabeling of its container and the promotion and marketing of such drugs or devices. See Tennessee Code 63-10-204
  • Oversight: Committee review of the activities of a Federal agency or program.
  • Pharmacist: means an individual health care provider licensed by the state, pursuant to parts 4-6 of this chapter, to practice the profession of pharmacy. 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
  • Third-party logistics provider: means a person who provides or coordinates warehousing or other logistics services of a drug or device on behalf of a manufacturer, wholesale distributor, or dispenser of the drug or device, but does not take ownership of the drug or device, nor has responsibility to direct the sale or disposition of the drug or device. See Tennessee Code 63-10-204
(1) The dialysate are comprised of dextrose or icodextrin, and the dialysate and devices are approved or cleared by the federal food and drug administration, as required by federal law;
(2) The dialysate and devices are lawfully held by a manufacturer or manufacturer’s agent that is properly registered with the board as a manufacturer or third-party logistics provider;
(3) The dialysate and devices are held and delivered in their original, sealed packaging from the facility;
(4) The dialysate and devices are delivered only by the manufacturer or the manufacturer’s agent and only upon receipt and review of a physician’s prescription by a pharmacist licensed in this state before dispensing; and
(5) The manufacturer or manufacturer’s agent delivers the dialysate and devices directly to:

(A) Patients with end stage renal disease or such patient’s designee for the patient’s self-administration of the dialysis therapy; or
(B) Healthcare providers or institutions for administration or delivery of the dialysis therapy to a patient with end stage renal disease.
(b) Records of all sales and distribution of dialysate and devices made pursuant to this section must be retained and made readily available for inspection and copying by the board of pharmacy for two (2) years from the date of distribution.
(c) The board of pharmacy retains oversight of all drugs for peritoneal dialysis except dialysate.
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