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