2023 Tennessee Code › Title 63 - PROFESSIONS OF THE HEALING ARTS (§§ 63-1-NEW — 63-32-119) › Chapter 10 - PHARMACY (§§ 63-10-101 — 63-10-706) › Part 5 - KEVIN CLAUSON DRUG DONATION ACT (§§ 63-10-501 — 63-10-510) › Section 63-10-504 - Acceptance and dispensing of donated prescription drugs and supplies

Prescription drugs or supplies may be accepted and dispensed under the prescription drug donation repository program in accordance with the following:
(1)
Prior to the first donation from a new donor, a repository shall verify and record the following:
(A)
The person or entity qualifies as a donor as defined in §
63-10-502
;
(B)
The donor's name, address, phone number, and license number, if applicable; and
(C)
That the donor will only make donations in accordance with this part;
(2)
A licensed pharmacist employed, or under contract, with the program shall inspect donated prescription drugs and supplies prior to dispensing to determine if the donated prescription drugs and supplies are suitable for dispensing pursuant to this section;
(3)
Repositories shall store donated prescription drugs and supplies in a secure area in compliance with all United States food and drug administration and United States Pharmacopeia packaging and storage requirements;
(4)
Donated prescription drugs and supplies must be physically or electronically separated from non-donated prescription drugs and supplies;
(5)
Repositories shall redact donor information from the packaging of donated prescription drugs and supplies prior to dispensing;
(6)
Donated prescription drugs and supplies may be repackaged. Repackaged donated prescription drugs must be relabeled with the drug name, dose, and expiration date;
(7)
Repositories shall maintain an electronic inventory of accepted donated prescription drugs and supplies that includes the drug name, national drug code number, quantity, and date of donation;
(8)
Repositories shall return or destroy donated prescription drugs or supplies that are not suitable for dispensing;
(9)
Repositories shall dispose of donated prescription drugs and supplies by returning to the donor, transferring to a reverse distributor, or incinerating in an incinerator that is approved by the federal environmental protection agency;
(10)
The record of transaction history for donated prescription drugs and supplies must be maintained, beginning with the donor, including all prior donations, but not including information that is not required by law to be placed on the prescription drug's label;
(11)
An identifier or bar code may be used in place of information required by law for a record or label if the identifier or bar code allows for that information to be readily retrievable;
(12)
Repositories shall dispense in compliance with all applicable federal and state laws and regulations for dispensing, labeling, packaging, and record keeping;
(13)
An expiration date is required on all dispensed prescription drugs and supplies. If multiple packaged donated drugs are used to fill a single prescription, then the shortest expiration date must be used for the dispensed prescription;
(14)
A donated prescription drug or supply must not be dispensed after its expiration date;
(15)
Donated prescription drugs must not expire before the end-use date by the patient based on the prescriber's directions;
(16)
Controlled substances are not acceptable for donation and must be disposed of pursuant to regulations promulgated by the federal drug enforcement administration (DEA);
(17)
Prescription drugs that are part of a risk evaluation and mitigation strategy (REMS) program of the federal food and drug administration must not be accepted for donation;
(18)
Records required pursuant to this section must be retained in physical or electronic format for a period of three (3) years. A donor or repository may contract with one another or a third party to create or maintain records on each other's behalf; and
(19)
Donated prescription drugs and supplies may be used to replenish inventory in compliance with applicable provisions of
42 U.S.C. § 256b
and regulations promulgated pursuant to that statute.
Added by 2023 Tenn. Acts, ch. 200, s 1, eff. 1/1/2024.