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A BILL TO BE ENTITLED
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AN ACT
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relating to the distribution of a prescription drug. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 431.401(5), Health and Safety Code, is |
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amended to read as follows: |
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(5) "Normal distribution channel" means a chain of |
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custody for a prescription drug, either directly or by drop |
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shipment, from the manufacturer of the prescription drug, the |
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manufacturer to the manufacturer's co-licensed product partner, |
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the manufacturer to the manufacturer's third-party logistics |
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provider, or the manufacturer to the manufacturer's exclusive |
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distributor, to: |
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(A) a pharmacy to: |
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(i) a patient; or |
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(ii) another designated person authorized |
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by law to dispense or administer the drug to a patient; |
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(B) an authorized distributor of record to: |
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(i) a pharmacy to a patient; or |
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(ii) another designated person authorized |
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by law to dispense or administer the drug to a patient; |
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(C) an authorized distributor of record to a |
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wholesale distributor licensed under this chapter to another |
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designated person authorized by law to dispense or administer the |
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drug to a patient; |
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(D) an authorized distributor of record to a |
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pharmacy warehouse to the pharmacy warehouse's intracompany |
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pharmacy; |
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(E) [(D)] a pharmacy warehouse to the pharmacy |
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warehouse's intracompany pharmacy or another designated person |
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authorized by law to dispense or administer the drug to a patient; |
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(F) [(E)] a person authorized by law to prescribe |
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a prescription drug that by law may be administered only under the |
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supervision of the prescriber; or |
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(G) [(F)] an authorized distributor of record to |
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one other authorized distributor of record to a licensed |
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practitioner for office use. |
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SECTION 2. Section 431.4031, Health and Safety Code, is |
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amended to read as follows: |
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Sec. 431.4031. EXEMPTION FROM CERTAIN PROVISIONS FOR |
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CERTAIN WHOLESALE DISTRIBUTORS. (a) A wholesale distributor that |
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distributes prescription drugs that are medical gases or a |
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wholesale distributor that is a manufacturer or a third-party |
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logistics provider on behalf of a manufacturer is exempt from |
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Sections 431.404(a)(5) and (6), (b), and (c), 431.4045(2), 431.405, |
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431.407, and 431.408. |
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(b) A state agency or a political subdivision of this state |
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that distributes prescription drugs using federal or state funding |
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to nonprofit health care facilities or local mental health or |
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mental retardation authorities for distribution to a pharmacy, |
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practitioner, or patient is exempt from Sections 431.405(b), |
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431.407, 431.408, 431.412, and 431.413. |
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SECTION 3. As soon as practicable after the effective date |
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of this Act, the executive commissioner of the Health and Human |
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Services Commission shall adopt, modify, or repeal rules as |
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necessary to implement the changes in law made by this Act. |
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SECTION 4. This Act takes effect immediately if it receives |
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a vote of two-thirds of all the 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, 2009. |