SECTION 95.6. Standards and Procedures for Dispensing Donated Prescription Drugs

(a) Donated drugs may be dispensed only if the drugs are prescribed by a health care professional for use by an eligible recipient and are dispensed by a licensed pharmacist who has determined that the drugs are of an acceptable integrity.

(b) The recipient must sign a Recipient Form prescribed by the Department stating that the recipient:

(1) understands that the drugs are donated;

(2) accepts any risk associated with accidental mishandling of the drugs; and

(3) acknowledges that the donor and the participating provider are acting in good faith and are therefore released from liability.

(c) The participating provider shall dispense donated prescription drugs in compliance with applicable federal and state laws and regulations for dispensing prescription drugs, including all requirements relating to packaging, labeling, record keeping, drug utilization review and patient counseling.

(d) The participating provider shall remove the original donor’s identification and the name of the original dispensing pharmacy from the package prior to dispensing the drugs.

(e) The participating provider shall be responsible for drug recalls and shall have an established mechanism to notify recipients in the event of a drug recall.

(f) Prescription drugs donated under this Program shall not be resold.

(g) All participating providers shall comply with the laws and rules pertaining to dispensing of prescription drugs as contained in the Occupations Code, Chapters 551-566, and 569 (relating to the Texas Pharmacy Act); and Title 22 Texas Administrative Code, Chapters 281, 283, 291, 295, 297, 303, 305, 309, and 311 (relating to the Texas State Board of Pharmacy).

Source Note: The provisions of this §95.6 adopted to be effective March 1, 2018, 43 TexReg 872