1 | 1 | | 84R11416 JSC-D |
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2 | 2 | | By: Sheffield H.B. No. 2936 |
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3 | 3 | | |
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4 | 4 | | |
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5 | 5 | | A BILL TO BE ENTITLED |
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6 | 6 | | AN ACT |
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7 | 7 | | relating to a pilot program for donation and redistribution of |
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8 | 8 | | certain unused prescription medications; authorizing a fee. |
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9 | 9 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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10 | 10 | | SECTION 1. Chapter 431, Health and Safety Code, is amended |
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11 | 11 | | by adding Subchapter O to read as follows: |
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12 | 12 | | SUBCHAPTER O. PRESCRIPTION DRUG DONATION PILOT PROGRAM |
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13 | 13 | | Sec. 431.451. DEFINITIONS. In this subchapter: |
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14 | 14 | | (1) "Board" means the Texas State Board of Pharmacy. |
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15 | 15 | | (2) "Charitable medical clinic" has the meaning |
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16 | 16 | | assigned by Section 431.321. |
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17 | 17 | | (3) "Health center" means a federally qualified health |
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18 | 18 | | center under 42 U.S.C. Section 1396d(l)(2)(B). |
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19 | 19 | | (4) "Nursing home" means a facility licensed under |
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20 | 20 | | Chapter 242. |
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21 | 21 | | (5) "Pilot program" means the prescription drug |
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22 | 22 | | donation pilot program under this subchapter. |
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23 | 23 | | (6) "Prescription drug" has the meaning assigned by |
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24 | 24 | | Section 551.003, Occupations Code. |
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25 | 25 | | Sec. 431.452. ESTABLISHMENT OF PILOT PROGRAM. (a) The |
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26 | 26 | | board shall establish a pilot program for donation and |
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27 | 27 | | redistribution of prescription drugs under this subchapter. |
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28 | 28 | | (b) The board shall conduct the pilot program in Coryell, |
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29 | 29 | | McLennan, and Bell Counties. |
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30 | 30 | | Sec. 431.453. DONATION OF PRESCRIPTION DRUGS. (a) Only a |
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31 | 31 | | nursing home may donate prescription drugs under this subchapter. |
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32 | 32 | | (b) The donated drugs must be oral prescription drugs |
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33 | 33 | | approved by the federal Food and Drug Administration that are |
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34 | 34 | | sealed in the manufacturer's unopened original tamper-evident |
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35 | 35 | | packaging and either individually packaged or packaged in unit-dose |
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36 | 36 | | packaging. |
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37 | 37 | | (c) Donated drugs may not: |
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38 | 38 | | (1) be subject to a mandatory recall by a state or |
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39 | 39 | | federal agency or a voluntary recall by a drug seller or |
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40 | 40 | | manufacturer; |
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41 | 41 | | (2) be a controlled substance under Chapter 481; |
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42 | 42 | | (3) require refrigeration; or |
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43 | 43 | | (4) expire less than 60 days after the date of |
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44 | 44 | | donation. |
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45 | 45 | | Sec. 431.454. ACCEPTING DONATIONS. (a) A health center may |
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46 | 46 | | accept a drug donated under this subchapter. |
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47 | 47 | | (b) A health center may dispense or administer the drugs to |
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48 | 48 | | the health center's patients or distribute the drugs to another |
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49 | 49 | | health center or a charitable medical clinic. |
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50 | 50 | | (c) Before the health center may dispense, administer, or |
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51 | 51 | | distribute the drugs, a licensed pharmacist must determine that the |
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52 | 52 | | drugs are of acceptable integrity. |
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53 | 53 | | Sec. 431.455. DISPENSING OR ADMINISTERING DONATED DRUGS. |
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54 | 54 | | (a) Donated drugs may be dispensed or administered by a health |
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55 | 55 | | center or a charitable medical clinic. |
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56 | 56 | | (b) A prescription drug dispensed or administered to a |
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57 | 57 | | patient under the pilot program must be prescribed by a physician |
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58 | 58 | | for use by that patient. |
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59 | 59 | | Sec. 431.456. FEES. A health center or charitable medical |
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60 | 60 | | clinic may charge only a nominal handling fee for distributing, |
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61 | 61 | | dispensing, or administering a drug under the pilot program. |
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62 | 62 | | Sec. 431.457. RESALE PROHIBITED. A health center or |
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63 | 63 | | charitable medical clinic may not resell donated drugs. |
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64 | 64 | | Sec. 431.458. DATABASE OF DONATED DRUGS. The board shall |
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65 | 65 | | establish and maintain an electronic database in which: |
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66 | 66 | | (1) each health center shall list the name and |
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67 | 67 | | quantity of each drug donated to the health center under the pilot |
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68 | 68 | | program that has been verified by a pharmacist; and |
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69 | 69 | | (2) a health center or charitable medical clinic may |
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70 | 70 | | search for and request donated drugs from a health center that |
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71 | 71 | | possesses those drugs. |
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72 | 72 | | Sec. 431.459. RULES. The board shall adopt rules for |
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73 | 73 | | implementation of this subchapter. |
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74 | 74 | | Sec. 431.460. LIMITATION ON LIABILITY. A participant in |
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75 | 75 | | the pilot program is not civilly or criminally liable or subject to |
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76 | 76 | | disciplinary action for harm caused by distributing, accepting, |
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77 | 77 | | dispensing, or administering drugs under the pilot program unless |
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78 | 78 | | the harm is caused by wilful or wanton acts of negligence, conscious |
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79 | 79 | | indifference to or reckless disregard for the safety of others, or |
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80 | 80 | | intentional conduct. |
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81 | 81 | | Sec. 431.461. REPORTS TO LEGISLATURE. Not later than |
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82 | 82 | | January 1 of each odd-numbered year, the board shall report to the |
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83 | 83 | | legislature on the results of the pilot program. The report must |
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84 | 84 | | include: |
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85 | 85 | | (1) the program's efficacy in expanding access to |
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86 | 86 | | prescription medications; |
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87 | 87 | | (2) an evaluation of the program's database and system |
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88 | 88 | | of distribution; |
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89 | 89 | | (3) any health and safety issues posed by accepting |
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90 | 90 | | and dispensing donated drugs; |
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91 | 91 | | (4) recommendations on improvements to the program; |
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92 | 92 | | and |
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93 | 93 | | (5) an evaluation of potential expansion of the |
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94 | 94 | | program. |
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95 | 95 | | Sec. 431.462. EXPIRATION. This subchapter expires |
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96 | 96 | | September 1, 2019. |
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97 | 97 | | SECTION 2. (a) The Texas State Board of Pharmacy shall adopt |
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98 | 98 | | any necessary rules and establish the database required by |
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99 | 99 | | Subchapter O, Chapter 431, Health and Safety Code, as added by this |
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100 | 100 | | Act, not later than December 1, 2015. |
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101 | 101 | | (b) A nursing home, federally qualified health center, or |
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102 | 102 | | charitable medical clinic may donate, distribute, accept, |
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103 | 103 | | administer, or dispense a prescription drug under the pilot program |
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104 | 104 | | under Subchapter O, Chapter 431, Health and Safety Code, as added by |
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105 | 105 | | this Act, on or after January 1, 2016. |
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106 | 106 | | SECTION 3. This Act takes effect September 1, 2015. |
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