(a) Except for acts of gross negligence, willful misconduct, or bad faith, a drug manufacturer is not civilly liable or subject to criminal prosecution for injury, death, or loss to a person or property for matters related to the donation, acceptance, or dispensing of a prescription drug manufactured by the drug manufacturer that is donated under this part, including liability for failure to transfer or communicate product or consumer information or the expiration date of the donated prescription drug.

Terms Used In Tennessee Code 63-10-505

  • Board: means the board of pharmacy. See Tennessee Code 63-10-502
  • 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
  • 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
  • Medical facility: means :
    (A) A physician's office. See Tennessee Code 63-10-502
  • 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
  • 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
  • Property: includes both personal and real property. See Tennessee Code 1-3-105
(b) Except as provided in subsection (d), a medical facility or another person who is not a drug manufacturer subject to subsection (a) is not civilly liable or subject to criminal prosecution for injury to or the death of an individual to whom a donated prescription drug is dispensed under this part except due to its own acts of gross negligence, willful misconduct, or bad faith.
(c) Except for acts of gross negligence, willful misconduct, or bad faith, the department of health or the board of pharmacy are not civilly liable or subject to criminal prosecution for injury, death, or loss to a person or property resulting from matters related to the donation, acceptance, distribution, or dispensing of a prescription drug donated pursuant to this part.
(d) The immunity and exemption provided in subsections (b) and (c) do not apply to the following:

(1) The donation, acceptance, distribution, or dispensing of a donated prescription drug under this part by a person if the person’s acts or omissions are not performed reasonably and in good faith; or
(2) Acts or omissions outside the scope of the program.
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