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A BILL TO BE ENTITLED
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AN ACT
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relating to the substitution by a pharmacist of certain opioid |
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analgesic drugs. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter A, Chapter 562, Occupations Code, is |
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amended by adding Section 562.016 to read as follows: |
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Sec. 562.016. SUBSTITUTION OF CERTAIN OPIOID DRUGS. (a) In |
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this section, "opioid analgesic drug" means a drug in the opioid |
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analgesic drug class that is prescribed to treat moderate to severe |
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pain or other conditions, including: |
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(1) immediate-release and extended-release forms of |
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the drug; and |
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(2) drugs formed by a combination of drugs, one of |
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which is an opioid analgesic drug. |
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(b) The board by rule shall establish a list of opioid |
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analgesic drugs that: |
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(1) incorporate a tamper-resistant technology; and |
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(2) have been approved by the United States Food and |
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Drug Administration from an application that included at least: |
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(A) one human tampering or abuse potential study; |
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or |
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(B) a laboratory study comparing the |
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tamper-resistant or abuse-resistant properties of the drug to a |
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control opioid analgesic drug approved by the United States Food |
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and Drug Administration. |
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(c) The board shall include on the list under Subsection (b) |
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a determination of which listed opioid analgesic drugs provide |
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substantially similar tamper-resistant properties, based on the |
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study described by Subsection (b)(2). |
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(d) Notwithstanding Section 562.008, a pharmacist may not |
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substitute an opioid analgesic drug unless the pharmacist: |
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(1) verifies: |
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(A) from the list under Subsection (b) that the |
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substituted opioid analgesic drug has substantially similar |
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tamper-resistant properties to the originally prescribed drug; and |
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(B) from the most recent version of the United |
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States Food and Drug Administration publication Approved Drug |
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Products with Therapeutic Equivalence Evaluations that the |
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substituted drug is considered to be equivalent to the prescribed |
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drug; or |
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(2) obtains consent for the substitution from the |
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prescribing physician. |
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SECTION 2. The Texas State Board of Pharmacy shall adopt the |
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rules necessary to implement Section 562.016, Occupations Code, as |
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added by this Act, not later than December 1, 2013. |
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SECTION 3. The changes in law made by this Act apply only to |
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an opioid analgesic drug dispensed on or after January 1, 2014. |
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SECTION 4. This Act takes effect September 1, 2013. |