(a) A pharmacy may elect to participate in the prescription drug donation repository program by providing written notification to the department of the following:

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Terms Used In Tennessee Code 63-10-503

  • Board: means the board of pharmacy. See Tennessee Code 63-10-502
  • Contract: A legal written agreement that becomes binding when signed.
  • Department: means the department of health. See Tennessee Code 63-10-502
  • 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
  • Eligible individual: means an indigent, an uninsured person, or an underinsured person who meets the criteria for eligibility pursuant to this part. See Tennessee Code 63-10-502
  • Indigent: means a person with an income that is below six hundred percent (600%) 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 63-10-502
  • 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
  • Person: means any individual, partnership, association, corporation and the state, its departments, agencies and employees, and the political subdivisions of Tennessee and their departments, agencies and employees, except the department of health and local health departments. See Tennessee Code 63-10-204
  • 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 63-10-502
  • Prescription drug: means a drug that under federal or state law is required to be dispensed only pursuant to a prescription order or is restricted to use by prescribers and that under federal law must be labeled with either the symbol "Rx only" or the statement "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian". See Tennessee Code 63-10-204
  • Repository: means a pharmacy that:
    (A) Has a license or permit in good standing with the board. See Tennessee Code 63-10-502
  • signed: includes a mark, the name being written near the mark and witnessed, or any other symbol or methodology executed or adopted by a party with intention to authenticate a writing or record, regardless of being witnessed. See Tennessee Code 1-3-105
  • Supplies: means the supplies necessary to administer the prescription drugs donated pursuant to this part. See Tennessee Code 63-10-502
  • written: includes printing, typewriting, engraving, lithography, and any other mode of representing words and letters. See Tennessee Code 1-3-105
(1) The name, street address, and telephone number of the pharmacy and the license or registration number issued by the board;
(2) The name, telephone number, and pharmacy license number of the responsible pharmacist who is employed, or under contract, with the repository; and
(3) A statement signed and dated by the responsible pharmacist indicating that the repository meets the eligibility requirements and will comply with the program.
(b) The repository shall develop and implement standards and procedures to determine, based on basic visual inspection, that the prescription drugs appear to be unadulterated, safe, and suitable for dispensing.
(c) Donated prescription drugs must be in unopened tamper-evident packaging. However, drugs packaged in single use doses may be accepted and dispensed when the outside packaging is opened if the single unit dose packaging is undisturbed.
(d) Donations of prescription drugs and supplies may be made on the premises of, or mailed to, a repository that participates in the program.
(e) A repository may receive, accept, replenish, repackage, and store donated prescription drugs and supplies in accordance with this part.
(f) Donation and facilitation of a donation are not considered wholesale distribution, and a person donating or facilitating a donation does not require licensure as a wholesaler.
(g) Repositories shall prioritize dispensing of donated prescription drugs and supplies as follows:

(1) First, to an indigent person;
(2) Second, to a person who has no prescription insurance or cannot afford the out-of-pocket expenses for the prescription drug or supplies prescribed; and
(3) Lastly, to another individual if an indigent, uninsured, or underinsured person is unavailable.
(h) A repository shall not charge or collect fees from an eligible individual for prescription drugs or supplies dispensed pursuant to the program. However, a repository may charge a handling fee for each donated prescription drug or supply that is dispensed.
(i) A repository may charge fees, including, but not limited to, a usual and customary charge, to donors, eligible individuals, health plans, pharmacy benefit managers, drug manufacturers, veterans’ affairs hospitals, and government agencies.
(j) A repository that receives donated prescription drugs or supplies may distribute the donated prescription drugs or supplies to another repository for use pursuant to the program or to similar repository programs in other states.
(k) Participation in the program is voluntary.
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