Rules & Regulations of the State of Tennessee
Title 1140 - Pharmacy
Chapter 1140-12 - Charitable Clinic Pharmacies
Section 1140-12-.05 - PHARMACIST RESPONSIBILITIES

Universal Citation: TN Comp Rules and Regs 1140-12-.05

Current through April 3, 2024

(1) Medication Transfers.

(a) Any pharmacist working at a charitable clinic pharmacy shall ensure that the following criteria are satisfied upon receiving medications from the institutional facility:
1. the only drugs that are accepted by the pharmacy to be dispensed are those drugs that are in their dispensed, sealed and tamper-evident packaging which includes, but is not limited to, single-unit doses or blister packs with the outside packaging opened if the single unit dose packaging remains intact;

2. the donor patient or donor patient's representative executed a drug donation form for the drugs transferred from the institutional facility to the pharmacy. In the event that the pharmacist does not receive a copy of the donor form with the transferred drugs, then the pharmacist shall not dispense the drugs;

3. the donor patient's name, prescription number, and any other identifying marks have been removed or redacted from the package by the institutional facility. In the event that the identifying patient information is not removed when received by the charitable clinic pharmacist from the institutional facility, then the pharmacist shall remove or redact this information;

4. the drug name, strength, lot number, and expiration date is on the drug package or label. In the event that the identifying drug information is not on the package or label when received from the institutional facility, the pharmacist shall not dispense these drugs and shall destroy them;

5. drug(s) that are being transferred are accompanied by a manifest from the institutional facility;

6. drugs that are expired, misbranded, recalled, deteriorated or not kept under the proper conditions shall not be dispensed from the pharmacy if they are transferred from the institutional facility. In the event that the pharmacist receives drugs that are expired, misbranded, recalled, deteriorated or not kept under the proper conditions from the institutional facility, the pharmacist shall not dispense these drugs and shall destroy them after creating the documentation required in Rule 1140-12-.05(3)(a);

7. controlled substances are not accepted or dispensed from the pharmacy if they are transferred. In the event that institutional facility transfers controlled substances, the pharmacist shall send the controlled substances back to the institutional facility;

8. the donated drugs may be transferred from one (1) pharmacy to another by an individual designated by the pharmacist in charge or through any other means by which the donated drugs may be tracked and delivery confirmed; and

9. the donated drugs are physically transferred from the institutional facility to the pharmacy by an individual designated by the pharmacist in charge of the pharmacy or through any other means by which the donated drugs may be tracked and delivery confirmed.

(2) Prohibited Activities.

(a) Any pharmacist working at a charitable clinic pharmacy shall not purchase, possess, trade, distribute or dispense any controlled substances from the charitable clinic pharmacy.

(3) Recordkeeping.

(a) Any pharmacist working at a charitable clinic pharmacy shall create and maintain a manifest of the prescription drugs transferred from the institutional facility to the pharmacy that were not dispensed because the drugs were expired, adulterated, misbranded, recalled, deteriorated, not kept under proper conditions, or did not have the identifying drug information on them as provided in Rule 1140-12-.05(4). Pharmacists shall maintain this manifest at the pharmacy for two (2) years from the date of destruction.

(b) The pharmacists working at the charitable clinic pharmacy shall maintain a manifest of all prescription drugs transferred from the institutional facility to the pharmacy and dispensed from the pharmacy for two (2) years from the date of receipt.

(c) The pharmacists working at the pharmacy shall maintain a manifest of all prescription drugs transferred from one (1) pharmacy to another for two (2) years from the date of transfer.

(4) Labeling.

(a) Any pharmacist working at a charitable clinic pharmacy shall ensure that the donor patient's identifying information is redacted from the donated drugs prior to redispensing.

(b) Any pharmacist working at a charitable clinic pharmacy shall redispense the donated drugs to an indigent patient and place a label on the drugs with the indigent patient's identifying information, dosage instructions, auxiliary labels, and drug expiration date.

(5) All pharmacists working at a charitable clinic pharmacy shall comply with all other applicable Board rules.

Authority: Chapter 919 of the Public Acts of 2006, §1 and T.C.A. § 63-10-505(c)(1) and (g)(4)(A).

Disclaimer: These regulations may not be the most recent version. Tennessee may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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