84R11416 JSC-D By: Sheffield H.B. No. 2936 A BILL TO BE ENTITLED AN ACT relating to a pilot program for donation and redistribution of certain unused prescription medications; authorizing a fee. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: SECTION 1. Chapter 431, Health and Safety Code, is amended by adding Subchapter O to read as follows: SUBCHAPTER O. PRESCRIPTION DRUG DONATION PILOT PROGRAM Sec. 431.451. DEFINITIONS. In this subchapter: (1) "Board" means the Texas State Board of Pharmacy. (2) "Charitable medical clinic" has the meaning assigned by Section 431.321. (3) "Health center" means a federally qualified health center under 42 U.S.C. Section 1396d(l)(2)(B). (4) "Nursing home" means a facility licensed under Chapter 242. (5) "Pilot program" means the prescription drug donation pilot program under this subchapter. (6) "Prescription drug" has the meaning assigned by Section 551.003, Occupations Code. Sec. 431.452. ESTABLISHMENT OF PILOT PROGRAM. (a) The board shall establish a pilot program for donation and redistribution of prescription drugs under this subchapter. (b) The board shall conduct the pilot program in Coryell, McLennan, and Bell Counties. Sec. 431.453. DONATION OF PRESCRIPTION DRUGS. (a) Only a nursing home may donate prescription drugs under this subchapter. (b) The donated drugs must be oral prescription drugs approved by the federal Food and Drug Administration that are sealed in the manufacturer's unopened original tamper-evident packaging and either individually packaged or packaged in unit-dose packaging. (c) Donated drugs may not: (1) be subject to a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer; (2) be a controlled substance under Chapter 481; (3) require refrigeration; or (4) expire less than 60 days after the date of donation. Sec. 431.454. ACCEPTING DONATIONS. (a) A health center may accept a drug donated under this subchapter. (b) A health center may dispense or administer the drugs to the health center's patients or distribute the drugs to another health center or a charitable medical clinic. (c) Before the health center may dispense, administer, or distribute the drugs, a licensed pharmacist must determine that the drugs are of acceptable integrity. Sec. 431.455. DISPENSING OR ADMINISTERING DONATED DRUGS. (a) Donated drugs may be dispensed or administered by a health center or a charitable medical clinic. (b) A prescription drug dispensed or administered to a patient under the pilot program must be prescribed by a physician for use by that patient. Sec. 431.456. FEES. A health center or charitable medical clinic may charge only a nominal handling fee for distributing, dispensing, or administering a drug under the pilot program. Sec. 431.457. RESALE PROHIBITED. A health center or charitable medical clinic may not resell donated drugs. Sec. 431.458. DATABASE OF DONATED DRUGS. The board shall establish and maintain an electronic database in which: (1) each health center shall list the name and quantity of each drug donated to the health center under the pilot program that has been verified by a pharmacist; and (2) a health center or charitable medical clinic may search for and request donated drugs from a health center that possesses those drugs. Sec. 431.459. RULES. The board shall adopt rules for implementation of this subchapter. Sec. 431.460. LIMITATION ON LIABILITY. A participant in the pilot program is not civilly or criminally liable or subject to disciplinary action for harm caused by distributing, accepting, dispensing, or administering drugs under the pilot program unless the harm is caused by wilful or wanton acts of negligence, conscious indifference to or reckless disregard for the safety of others, or intentional conduct. Sec. 431.461. REPORTS TO LEGISLATURE. Not later than January 1 of each odd-numbered year, the board shall report to the legislature on the results of the pilot program. The report must include: (1) the program's efficacy in expanding access to prescription medications; (2) an evaluation of the program's database and system of distribution; (3) any health and safety issues posed by accepting and dispensing donated drugs; (4) recommendations on improvements to the program; and (5) an evaluation of potential expansion of the program. Sec. 431.462. EXPIRATION. This subchapter expires September 1, 2019. SECTION 2. (a) The Texas State Board of Pharmacy shall adopt any necessary rules and establish the database required by Subchapter O, Chapter 431, Health and Safety Code, as added by this Act, not later than December 1, 2015. (b) A nursing home, federally qualified health center, or charitable medical clinic may donate, distribute, accept, administer, or dispense a prescription drug under the pilot program under Subchapter O, Chapter 431, Health and Safety Code, as added by this Act, on or after January 1, 2016. SECTION 3. This Act takes effect September 1, 2015.