(a) A prescription drug or supplies may be accepted and dispensed under the prescription drug donation repository program if all of the following conditions are met:

Terms Used In Tennessee Code 63-10-503

  • Board: means the board of pharmacy. See Tennessee Code 63-10-501
  • Contract: A legal written agreement that becomes binding when signed.
  • Department: means the department of health. See Tennessee Code 63-10-501
  • Dispense: means preparing, packaging, compounding or labeling for delivery and actual delivery of a prescription drug, nonprescription drug or device in the course of professional practice to a patient or the patient's agent, to include a licensed health care practitioner or a health care facility providing services or treatment to the patient or patients, by or pursuant to the lawful order of a prescriber. See Tennessee Code 63-10-204
  • Donor: means a person, a pharmacy, or medical facility as well as any drug manufacturer or wholesaler licensed by the board of pharmacy, who donates prescription drugs to a repository program approved pursuant to this part. See Tennessee Code 63-10-501
  • Donor: The person who makes a gift.
  • 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
  • Eligible individual: means an indigent person or an uninsured person who meets all other criteria established by board rule. See Tennessee Code 63-10-501
  • Indigent: means a person with an income that is below two hundred percent (200%) of the federal poverty level as defined by the most recently revised poverty income guidelines published by the United States department of health and human services. See Tennessee Code 63-10-501
  • Medical facility: means any of the following:
    (A) A physician's office. See Tennessee Code 63-10-501
  • 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 pharmacy as defined in §. See Tennessee Code 63-10-501
  • Prescription drug: means the same as defined in §. See Tennessee Code 63-10-501
  • Supplies: means the supplies necessary to administer the prescription drugs donated. See Tennessee Code 63-10-501
(1) The prescription drug is in its original sealed and tamper-evident packaging. However, a prescription drug in a single-unit dose or blister pack with the outside packaging opened may be accepted if the single-unit dose packaging remains intact;
(2) The prescription drug or supplies are inspected before the prescription drug or supplies are dispensed by a licensed pharmacist employed by or under contract with the medical facility or pharmacy, and the licensed pharmacist determines that the prescription drug or supplies are not adulterated or misbranded; and
(3) The prescription drug or supplies are prescribed by a healthcare practitioner for use by an eligible individual and are dispensed by a pharmacist.
(b) A prescription drug or supplies donated under this part shall not be resold.
(c)

(1) If a donor receives official notice of a recall of a prescription drug donated pursuant to this part, the donor shall make every effort, as required by rule, to notify the repository program to whom the drugs were donated of the recall.
(2) If an organization who is administering a drug repository program receives official notice of a recall of a prescription drug donated pursuant to this part, the organization shall make every effort as required by rule, to notify the pharmacy, medical facility, or patient, if known, to whom such donated drugs were dispensed, of the recall.
(3) Any donor or drug repository program who receives notice of a recall shall dispose of all recalled prescription drugs pursuant to board of pharmacy rules.
(d) A prescription drug dispensed through the prescription drug donation repository program is not eligible for reimbursement under the medical assistance program.
(e) The department shall adopt rules establishing all of the following:

(1) Requirements for medical facilities and pharmacies to accept and dispense donated prescription drugs and supplies, including all of the following:

(A) Eligibility criteria for participation by medical facilities and pharmacies;
(B) Standards and procedures for accepting, safely storing, and dispensing donated prescription drugs and supplies;
(C) Standards and procedures for inspecting donated prescription drugs to determine if the prescription drugs are in their original sealed and tamper-evident packaging, or if the prescription drugs are in single-unit doses or blister packs and the outside packaging is opened, if the single-unit dose packaging remains intact; and
(D) Standards and procedures for inspecting donated prescription drugs and supplies to determine that the prescription drugs and supplies are not adulterated or misbranded;
(2) Additional eligibility criteria for indigent or uninsured persons;
(3) Necessary forms for administration of the prescription drug donation repository program, including forms for use by individuals who donate, accept, distribute, or dispense the prescription drugs or supplies under the program;
(4) A means by which an individual who is eligible to receive donated prescription drugs and supplies may indicate eligibility;
(5) The maximum handling fee that a medical facility or pharmacy may charge for accepting, distributing, or dispensing donated prescription drugs and supplies under the program; and
(6) A list of prescription drugs that the prescription drug donation repository program will accept.