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AN ACT
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relating to restrictions on the interchange of transplant |
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immunosuppressant drugs. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 562.014, Occupations Code, is amended to |
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read as follows: |
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Sec. 562.014. [APPLICATION TO] NARROW THERAPEUTIC INDEX |
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DRUGS. (a) Except as provided by this section, drug selection as |
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authorized by this subchapter does not apply to the refill of a |
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prescription for a narrow therapeutic index drug. The board, in |
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consultation with the Texas Medical [State] Board [of Medical
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Examiners], shall by rule establish a list of narrow therapeutic |
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index drugs to which this subsection applies. A prescription for a |
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narrow therapeutic index drug may be refilled only by using the same |
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drug product by the same manufacturer that the pharmacist last |
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dispensed under the prescription, unless otherwise agreed to by the |
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prescribing practitioner [physician]. If a pharmacist does not |
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have the same drug product by the same manufacturer in stock to |
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refill the prescription, the pharmacist may dispense a drug product |
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that is generically equivalent if the pharmacist, before dispensing |
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the generically equivalent drug product, notifies: |
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(1) the patient, at the time the prescription is |
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dispensed, that a substitution of the prescribed drug product has |
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been made; and |
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(2) the prescribing practitioner [physician] of the |
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drug product substitution by telephone, facsimile, or mail, at the |
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earliest reasonable time, but not later than 72 hours after |
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dispensing the prescription. |
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(b) The board and the Texas Medical Board shall establish a |
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joint committee to recommend to the board a list of narrow |
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therapeutic index drugs and the rules, if any, by which this section |
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applies to those drugs. The committee must consist of an equal |
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number of members from each board. The committee members shall |
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select a member of the committee to serve as presiding officer for a |
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one year term. The presiding officer may not represent the same |
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board as the presiding officer's predecessor. |
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(c) The joint committee shall make a recommendation to the |
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board on whether to include a drug on the list of narrow therapeutic |
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index drugs as required by Section 562.0142. In the event of a tie |
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vote by the committee on whether to recommend that a drug listed in |
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this subsection be included on the list of narrow therapeutic index |
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drugs, the committee shall recommend to the board that the drug not |
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be placed on the list. The committee shall consider for inclusion |
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in the list of narrow therapeutic index drugs the following drugs: |
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(1) Prograf; |
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(2) Cellcept; |
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(3) Neoral; |
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(4) Rapamune; and |
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(5) Sandimmune. |
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(d) Subsection (c) and this subsection expire December 31, |
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2008. |
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SECTION 2. Subchapter A, Chapter 562, Occupations Code, is |
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amended by adding Sections 562.0141 and 562.0142 to read as |
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follows: |
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Sec. 562.0141. TRANSPLANT IMMUNOSUPPRESSANT DRUG PRODUCT |
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SELECTION PROHIBITED. (a) In this section: |
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(1) "Immunosuppressant drug" means any drug |
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prescribed for immunosuppressant therapy following a transplant. |
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(2) "Interchange" means the substitution of one |
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version of the same immunosuppressant drug, including a generic |
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version for the prescribed brand, a brand version for the |
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prescribed generic version, a generic version by one manufacturer |
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for a generic version by a different manufacturer, a different |
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formulation of the prescribed immunosuppressant drug, or a |
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different immunosuppressant drug for the immunosuppressant drug |
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originally prescribed. |
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(b) A pharmacist may not interchange an immunosuppressant |
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drug or formulation of an immunosuppressant drug, brand or generic, |
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for the treatment of a patient following a transplant without prior |
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consent to the interchange from the prescribing practitioner. |
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(c) To comply with Subsection (b), a pharmacist shall notify |
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a prescribing practitioner orally or electronically to secure |
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permission to interchange an immunosuppressant drug or formulation |
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of an immunosuppressant drug, brand or generic. The practitioner's |
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authorization or denial of authorization must be documented by the |
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pharmacist and by the practitioner. |
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(d) If a pharmacist does not have the same drug product by |
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the same manufacturer in stock to refill the prescription, or if the |
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practitioner is unavailable to give authorization, the pharmacist |
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may dispense a drug product that is generically equivalent if the |
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pharmacist, before dispensing the generally equivalent drug |
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product: |
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(1) notifies and receives consent from the patient, at |
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the time the prescription is dispensed, to substitute the |
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prescribed drug product; and |
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(2) notifies the prescribing practitioner of the drug |
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product substitution orally or electronically at the earliest |
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reasonable time, but not later than 24 hours after dispensing the |
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prescription. |
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(e) This section is only effective subject to the conditions |
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established by Section 562.0142. |
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Sec. 562.0142. ADOPTION OF RULES. (a) If, not later than |
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October 1, 2007, a drug manufacturer requests that the joint |
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committee under Section 562.014 conduct a hearing and make a |
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recommendation to include a drug listed in Section 562.014(c) on |
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the list of narrow therapeutic index drugs, the joint committee |
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shall make a recommendation to the board to enable the board to |
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adopt a rule and issue findings not later than July 1, 2008. |
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(b) If, not later than October 1, 2007, no drug manufacturer |
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requests that the joint committee conduct a hearing and make |
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recommendations to the board to include a drug listed in Section |
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562.014(c) on the list of narrow therapeutic index drugs, Section |
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562.0141 expires October 1, 2007. |
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(c) If all drug manufacturers that request, before October |
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1, 2007, the joint committee to conduct a hearing and make a |
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recommendation to the board to include a drug listed in Section |
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562.014(c) on the list of narrow therapeutic index drugs |
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subsequently withdraw those requests before the date the joint |
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committee makes a recommendation to include the drug on that list, |
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Section 562.0141 expires effective on the date of the |
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manufacturers' withdrawal of those requests. |
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(d) If the joint committee receives a request under |
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Subsection (a), the recommendation of the joint committee under |
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that subsection may include the drugs listed in Section 562.014(c) |
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or the joint committee may recommend that no drug should be added to |
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the list of narrow therapeutic index drugs following the review by |
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the joint committee. |
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(e) If the joint committee receives a request under |
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Subsection (a) and, not later than July 1, 2008, the board adopts a |
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rule to include any drug listed in Section 562.014(c) on the list of |
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narrow therapeutic index drugs or determines by rule that no drug |
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should be added to the list of narrow therapeutic index drugs, |
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Section 562.0141 expires on July 1, 2008. |
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(f) If the joint committee receives a request under |
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Subsection (a) and the board does not before July 1, 2008, adopt a |
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rule to include any drug listed in Section 562.014(c) on the list of |
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narrow therapeutic index drugs or determine by rule that no drug |
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should be added to the list of narrow therapeutic index drugs, |
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Section 562.0141 takes effect July 1, 2008. |
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(g) If the joint committee receives a request under |
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Subsection (a) and litigation or a request for an attorney |
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general's opinion regarding this section, Section 562.014, or |
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Section 562.0141 is filed by a drug manufacturer between the |
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effective date of this section and July 1, 2008, the time limits |
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established by Subsections (e) and (f) are tolled until the |
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litigation is resolved or the attorney general renders an opinion. |
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(h) For purposes of this section, notice of the following |
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must be published in the Texas Register not later than the third |
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business day after the date of occurrence: |
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(1) a request by a drug manufacturer for inclusion of a |
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drug on the list of narrow therapeutic index drugs; |
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(2) withdrawal of a request described by Subdivision |
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(1); |
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(3) litigation described by Subsection (g); |
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(4) resolution of litigation described by Subsection |
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(g); and |
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(5) a request for an attorney general's opinion |
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described by Subsection (g). |
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SECTION 3. Section 562.009, Occupations Code, is amended by |
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adding Subsection (e) to read as follows: |
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(e) If the prescription is for an immunosuppressant drug, as |
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defined by Section 562.0141(a)(1), the pharmacist must comply with |
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the provisions of Section 562.0141. This subsection expires if |
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Section 562.0141 expires under the requirements of Section |
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562.0142. |
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SECTION 4. The Texas State Board of Pharmacy and Texas |
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Medical Board shall establish the joint committee required by |
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Subsection (b), Section 562.014, Occupations Code, as added by this |
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Act, not later than the 90th day after the effective date of this |
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Act or September 1, 2007, whichever date occurs first. |
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SECTION 5. This Act takes effect immediately if it receives |
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a vote of two-thirds of all members elected to each house, as |
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provided by Section 39, Article III, Texas Constitution. If this |
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Act does not receive the vote necessary for immediate effect, this |
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Act takes effect September 1, 2007. |
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______________________________ |
______________________________ |
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President of the Senate |
Speaker of the House |
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I hereby certify that S.B. No. 625 passed the Senate on |
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April 12, 2007, by the following vote: Yeas 31, Nays 0; and that |
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the Senate concurred in House amendments on May 15, 2007, by the |
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following vote: Yeas 31, Nays 0. |
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______________________________ |
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Secretary of the Senate |
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I hereby certify that S.B. No. 625 passed the House, with |
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amendments, on May 10, 2007, by the following vote: Yeas 124, |
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Nays 16, two present not voting. |
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______________________________ |
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Chief Clerk of the House |
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Approved: |
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______________________________ |
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Date |
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______________________________ |
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Governor |